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PAD procedure overuse: A field in peril or ‘a few bad apples’?
On May 24, the news outlet ProPublica published a scathing investigation of Jeffery Dormu, DO, said to have performed hundreds of “medically unnecessary and invasive vascular procedures” in his Laurel, Md. office, putting patients’ limbs and lives at risk.
On July 15, The New York Times published a broader-based investigation of several vascular specialists said to have performed “risky” procedures on patients with peripheral artery disease (PAD) who subsequently had to have amputations, or died. The focus was mainly on Michigan-based interventional cardiologist Jihad Mustapha, MD.
This follows a 2019 analysis of Medicare claims data that identified outlier physicians with a high early intervention rate for patients newly diagnosed with claudication. According to the American Heart Association statistics, PAD affects approximately 8.5 million U.S. adults age 40 and older (some claim that’s an underestimate); most cases don’t require invasive treatment.
Responding to the Times’ revelations, Joseph L. Mills, MD, president of the Society for Vascular Surgery, wrote on the society’s website: “The overwhelming majority of vascular surgeons, and a vast majority of other specialists that receive some training and play a role in the care of vascular patients, including those trained in vascular medicine, interventional cardiology, and interventional radiology are providing high-quality, evidence-based care with safety and the best patient outcomes in mind.
“This is a complex issue that requires the examination not only of the events detailed in this story ... but of the underlying health care economic, legal and regulatory policies that created fertile soil for this behavior to germinate and take root.”
‘A few bad apples’
“I think it’s a case of a few bad apples,” Sunil V. Rao, MD, director of interventional cardiology at NYU Langone Health, New York, said in an interview. “In general, I think physicians who take care of patients with vascular issues are trying to do the right thing. I think all of us who take care of patients with vascular disease see patients who are very, very complex, and there are going to be some procedures that have complications.
“Without knowing the clinical details, it’s hard to know whether the procedures described in the articles were overuse or unnecessary, or exactly what led to the amputations,” he said. “All we know is that these physicians are outliers in terms of the number of procedures they were billing for.
“But although correlation is not causation, it certainly is cause for concern because you would expect that the use of procedures for specific indications would fall within a certain range,” he added.
Lifestyle changes first
PAD is often asymptomatic or mild, making it difficult to diagnose. Revascularization procedures usually are reserved for the 5%-8% of patients at risk for chronic limb-threatening ischemia (CLTI) or those in whom the cornerstones of PAD treatment – lifestyle changes and, if needed, medication – fail.
Revascularization options include balloon angioplasty or stent placement; atherectomy to remove plaques from the artery; or bypass surgery if a long portion of a leg artery is completely blocked. All carry a risk of long-term adverse outcomes, but the rates are highest for atherectomy.
Lifestyle changes include regular exercise, following a healthy diet, quitting smoking, and controlling diabetes and high blood pressure. When PAD continues or progresses despite these modifications, medications such as antiplatelet agents, antihypertensives, and/or lipid-lowering drugs may be prescribed.
‘Medically unnecessary’
According to the latest American Heart Association/American College of Cardiology guideline on managing patients with lower-extremity PAD, patients should be selected for revascularization based on symptom severity.
Factors to consider include a significant disability as assessed by the patient, and adequacy of response to medical and structured exercise therapy.
There’s the rub regarding the clinicians investigated in the Times and ProPublica. Many patients, apparently, were not encouraged to make lifestyle changes, nor did they receive medication. Instead, they were advised from the get-go to undergo invasive procedures, and often multiple times. Underuse of prevention and lifestyle counseling n the management of PAD has long been a concern.
Furthermore, in at least some cases, patients without any symptoms were encouraged to be screened for blockages that were then treated invasively, according to the Times.
Dr. Dormu, as highlighted in ProPublica, positioned his practice as “life and limb saving.” Yet, in investigative findings that led to a suspension of Dr. Dormu’s license to practice medicine in Maryland, peer reviewers expressed concern regarding his repeated use of invasive and medically unnecessary procedures, exposing patients to “potential risks such as bleeding, infection, blood vessel injuries which could acutely or chronically worsen the patient’s circulation, and limb loss.”
The peer reviewers concurred that Dr. Dormu failed to use conservative management techniques to address the patients’ vascular complaints before resorting to invasive procedures.
Dr. Mustapha is described in the Times as a “high-volume” atherectomy provider. From 2017 to 2021, about half of Medicare’s atherectomy payments – $1.4 billion – went to 200 high-volume providers, with Dr. Mustapha near the top of the list.
Some of Dr. Mustapha’s patients underwent multiple procedures said to help prevent leg amputation, but their legs were amputated anyway, possibly because of the multiple atherectomies, according to the Times.
Judith Lin, MD, MBA, who treated some of Dr. Mustapha’s former patients, was among those who complained about his practice to Michigan’s licensing board. Some of the patients she treated needed amputations; others needed to have leftover wires extracted from their legs.
In 2020, the board investigated Dr. Lin’s complaint and referred it to Michigan’s attorney general, who brought a disciplinary action against Dr. Mustapha. An expert hired by the state to review eight patient cases concluded that Dr. Mustapha’s practice “was characterized by overtreatment and poor documentation.” In some cases, the expert wrote, “unnecessary procedures hastened amputations.”
The statement issued by Dr. Mills, the president of SVS, noted that the society’s practice guideline proposes a threshold of at least 2 years of likely durability for an intervention performed for claudication.
“The growing frequency of multiple, repeated procedures [is] emblematic of poor patient selection and inadequate durability of the chosen procedure, leading to a vicious cycle of repetitive interventions that is not only costly, but also dangerous,” he wrote.
Financial incentives to blame?
In 2008, Medicare created incentives for physicians to perform vascular procedures in offices rather than hospitals, in an effort to reduce medical costs, according to both investigative articles. But the effort backfired.
Before the changes, an office provider inserting a stent could make about $1,700 from Medicare; deploying a balloon could bring in roughly $3,800. By 2011, the payments rose to about $6,400 and $4,800, respectively.
Office-based atherectomies soared when, in 2011, the Centers for Medicare & Medicaid Services started reimbursing $13,500 per procedure, as opposed to roughly $11,450 in a hospital. Atherectomies increased by 60% from 2011 to 2014, and Medicare’s overall costs for peripheral vascular treatments climbed by nearly half a billion dollars.
“The government is really to blame for setting these tremendously high reimbursement values without looking into whether these procedures are helping people or are just worthless procedures or, in fact, are hurting people,” Dipankar Mukherjee, MD, a vascular surgeon and chief of vascular surgery at Inova Fairfax (Va.) Hospital, said in ProPublica.
The result, noted Dr. Rao, is that “there can be perverse or nefarious incentives for doing these procedures. People are incentivized by reimbursement to do something that really falls in the area of clinical judgment and guidelines.”
Major incentives also come from device manufacturers, who often reward physicians who do the most vascular procedures with payments for consulting and other services, according to the Times. In addition, these companies lend money to help physicians or their clinics to finance the purchase of equipment used to perform the procedures.
“Vascular medicine now is the frontier of the Wild West,” Marty Makary, MD, MPH, a professor of surgery and health care quality researcher at Johns Hopkins University, Baltimore, told ProPublica. “People are flying blind walking into the clinics of these doctors with egregious practice patterns, and we know that their pattern is indefensible.”
Recognizing that the situation posed a threat to patients and also damaged the credibility of his specialty, Kim J. Hodgson, MD, a former SVS president, told attendees at the 2021 annual meeting of the SVS, “Somebody has to address what should never have been allowed to get to this level of threat to us and our patients in the first place. We can play whack-a-mole every time the bad actors surface until the cows come home, but that leaves a trail of harmed patients and wasted resources.”
Dr. Hodgson described atherectomy as “a procedure that many believe provides no demonstrable value whatsoever to the patient” and challenged those who disagree to prove it.
Multidisciplinary teams needed
Other experts believe there are times that revascularization procedures, including atherectomy, are appropriate. However, the majority of patients with PAD do not require a procedure, Soo Hyun (Esther) Kim, MD, MPH, director of the Center for Women’s Cardiovascular Health at Atrium Health Sanger Heart and Vascular Institute in Charlotte, N.C., said in an interview. In fact, “many patients do not even know they have leg artery blockages.”
Invasive procedures may well be appropriate for patients with severe PAD, especially those with CLTI, and disparities may be keeping those who truly need such interventions – or for whom they may be at least considered – from accessing them. If PAD is not diagnosed and treated in a timely way, Dr. Kim said, those individuals “do indeed lose their limbs.”
Multidisciplinary teams can help, Dr. Kim said. “Specialists from multiple different training backgrounds [can] take good care of patients with PAD,” she said. This is important when access to a particular type of specialist is limited, and because patients with PAD often have complex medical problems that can benefit from a team approach.
Transcatheter aortic valve replacement heart teams and complex coronary disease heart teams are two examples, Dr. Kim noted. “When a high-stakes procedure is being considered, the patient’s case is reviewed by multiple stakeholders to ensure appropriateness of the procedure and collaboratively evaluate risk.”
Dr. Rao also emphasized a team approach. “PAD does not belong to a single specialty,” he said. The revelations from the Times, ProPublica, and other sources “point to the fact that we all – cardiologists, vascular surgeons, interventional radiologists – should start thinking about how best to police ourselves and also account for the variation in clinical judgment.”
Use of a multidisciplinary team is a “guideline-recommended approach” for coronary artery revascularization, he said, “I think the same should apply for PAD.”
PAD is a sign of systemic atherosclerosis, Dr. Kim noted. “The treatment of PAD includes addressing leg pain and wounds with procedures, but the interventions that will keep people alive are the medications we use to prevent heart attack and stroke. Patients with PAD need to understand that treatment is much more than opening up a blockage in the leg.”
Dr. Rao and Dr. Kim disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
On May 24, the news outlet ProPublica published a scathing investigation of Jeffery Dormu, DO, said to have performed hundreds of “medically unnecessary and invasive vascular procedures” in his Laurel, Md. office, putting patients’ limbs and lives at risk.
On July 15, The New York Times published a broader-based investigation of several vascular specialists said to have performed “risky” procedures on patients with peripheral artery disease (PAD) who subsequently had to have amputations, or died. The focus was mainly on Michigan-based interventional cardiologist Jihad Mustapha, MD.
This follows a 2019 analysis of Medicare claims data that identified outlier physicians with a high early intervention rate for patients newly diagnosed with claudication. According to the American Heart Association statistics, PAD affects approximately 8.5 million U.S. adults age 40 and older (some claim that’s an underestimate); most cases don’t require invasive treatment.
Responding to the Times’ revelations, Joseph L. Mills, MD, president of the Society for Vascular Surgery, wrote on the society’s website: “The overwhelming majority of vascular surgeons, and a vast majority of other specialists that receive some training and play a role in the care of vascular patients, including those trained in vascular medicine, interventional cardiology, and interventional radiology are providing high-quality, evidence-based care with safety and the best patient outcomes in mind.
“This is a complex issue that requires the examination not only of the events detailed in this story ... but of the underlying health care economic, legal and regulatory policies that created fertile soil for this behavior to germinate and take root.”
‘A few bad apples’
“I think it’s a case of a few bad apples,” Sunil V. Rao, MD, director of interventional cardiology at NYU Langone Health, New York, said in an interview. “In general, I think physicians who take care of patients with vascular issues are trying to do the right thing. I think all of us who take care of patients with vascular disease see patients who are very, very complex, and there are going to be some procedures that have complications.
“Without knowing the clinical details, it’s hard to know whether the procedures described in the articles were overuse or unnecessary, or exactly what led to the amputations,” he said. “All we know is that these physicians are outliers in terms of the number of procedures they were billing for.
“But although correlation is not causation, it certainly is cause for concern because you would expect that the use of procedures for specific indications would fall within a certain range,” he added.
Lifestyle changes first
PAD is often asymptomatic or mild, making it difficult to diagnose. Revascularization procedures usually are reserved for the 5%-8% of patients at risk for chronic limb-threatening ischemia (CLTI) or those in whom the cornerstones of PAD treatment – lifestyle changes and, if needed, medication – fail.
Revascularization options include balloon angioplasty or stent placement; atherectomy to remove plaques from the artery; or bypass surgery if a long portion of a leg artery is completely blocked. All carry a risk of long-term adverse outcomes, but the rates are highest for atherectomy.
Lifestyle changes include regular exercise, following a healthy diet, quitting smoking, and controlling diabetes and high blood pressure. When PAD continues or progresses despite these modifications, medications such as antiplatelet agents, antihypertensives, and/or lipid-lowering drugs may be prescribed.
‘Medically unnecessary’
According to the latest American Heart Association/American College of Cardiology guideline on managing patients with lower-extremity PAD, patients should be selected for revascularization based on symptom severity.
Factors to consider include a significant disability as assessed by the patient, and adequacy of response to medical and structured exercise therapy.
There’s the rub regarding the clinicians investigated in the Times and ProPublica. Many patients, apparently, were not encouraged to make lifestyle changes, nor did they receive medication. Instead, they were advised from the get-go to undergo invasive procedures, and often multiple times. Underuse of prevention and lifestyle counseling n the management of PAD has long been a concern.
Furthermore, in at least some cases, patients without any symptoms were encouraged to be screened for blockages that were then treated invasively, according to the Times.
Dr. Dormu, as highlighted in ProPublica, positioned his practice as “life and limb saving.” Yet, in investigative findings that led to a suspension of Dr. Dormu’s license to practice medicine in Maryland, peer reviewers expressed concern regarding his repeated use of invasive and medically unnecessary procedures, exposing patients to “potential risks such as bleeding, infection, blood vessel injuries which could acutely or chronically worsen the patient’s circulation, and limb loss.”
The peer reviewers concurred that Dr. Dormu failed to use conservative management techniques to address the patients’ vascular complaints before resorting to invasive procedures.
Dr. Mustapha is described in the Times as a “high-volume” atherectomy provider. From 2017 to 2021, about half of Medicare’s atherectomy payments – $1.4 billion – went to 200 high-volume providers, with Dr. Mustapha near the top of the list.
Some of Dr. Mustapha’s patients underwent multiple procedures said to help prevent leg amputation, but their legs were amputated anyway, possibly because of the multiple atherectomies, according to the Times.
Judith Lin, MD, MBA, who treated some of Dr. Mustapha’s former patients, was among those who complained about his practice to Michigan’s licensing board. Some of the patients she treated needed amputations; others needed to have leftover wires extracted from their legs.
In 2020, the board investigated Dr. Lin’s complaint and referred it to Michigan’s attorney general, who brought a disciplinary action against Dr. Mustapha. An expert hired by the state to review eight patient cases concluded that Dr. Mustapha’s practice “was characterized by overtreatment and poor documentation.” In some cases, the expert wrote, “unnecessary procedures hastened amputations.”
The statement issued by Dr. Mills, the president of SVS, noted that the society’s practice guideline proposes a threshold of at least 2 years of likely durability for an intervention performed for claudication.
“The growing frequency of multiple, repeated procedures [is] emblematic of poor patient selection and inadequate durability of the chosen procedure, leading to a vicious cycle of repetitive interventions that is not only costly, but also dangerous,” he wrote.
Financial incentives to blame?
In 2008, Medicare created incentives for physicians to perform vascular procedures in offices rather than hospitals, in an effort to reduce medical costs, according to both investigative articles. But the effort backfired.
Before the changes, an office provider inserting a stent could make about $1,700 from Medicare; deploying a balloon could bring in roughly $3,800. By 2011, the payments rose to about $6,400 and $4,800, respectively.
Office-based atherectomies soared when, in 2011, the Centers for Medicare & Medicaid Services started reimbursing $13,500 per procedure, as opposed to roughly $11,450 in a hospital. Atherectomies increased by 60% from 2011 to 2014, and Medicare’s overall costs for peripheral vascular treatments climbed by nearly half a billion dollars.
“The government is really to blame for setting these tremendously high reimbursement values without looking into whether these procedures are helping people or are just worthless procedures or, in fact, are hurting people,” Dipankar Mukherjee, MD, a vascular surgeon and chief of vascular surgery at Inova Fairfax (Va.) Hospital, said in ProPublica.
The result, noted Dr. Rao, is that “there can be perverse or nefarious incentives for doing these procedures. People are incentivized by reimbursement to do something that really falls in the area of clinical judgment and guidelines.”
Major incentives also come from device manufacturers, who often reward physicians who do the most vascular procedures with payments for consulting and other services, according to the Times. In addition, these companies lend money to help physicians or their clinics to finance the purchase of equipment used to perform the procedures.
“Vascular medicine now is the frontier of the Wild West,” Marty Makary, MD, MPH, a professor of surgery and health care quality researcher at Johns Hopkins University, Baltimore, told ProPublica. “People are flying blind walking into the clinics of these doctors with egregious practice patterns, and we know that their pattern is indefensible.”
Recognizing that the situation posed a threat to patients and also damaged the credibility of his specialty, Kim J. Hodgson, MD, a former SVS president, told attendees at the 2021 annual meeting of the SVS, “Somebody has to address what should never have been allowed to get to this level of threat to us and our patients in the first place. We can play whack-a-mole every time the bad actors surface until the cows come home, but that leaves a trail of harmed patients and wasted resources.”
Dr. Hodgson described atherectomy as “a procedure that many believe provides no demonstrable value whatsoever to the patient” and challenged those who disagree to prove it.
Multidisciplinary teams needed
Other experts believe there are times that revascularization procedures, including atherectomy, are appropriate. However, the majority of patients with PAD do not require a procedure, Soo Hyun (Esther) Kim, MD, MPH, director of the Center for Women’s Cardiovascular Health at Atrium Health Sanger Heart and Vascular Institute in Charlotte, N.C., said in an interview. In fact, “many patients do not even know they have leg artery blockages.”
Invasive procedures may well be appropriate for patients with severe PAD, especially those with CLTI, and disparities may be keeping those who truly need such interventions – or for whom they may be at least considered – from accessing them. If PAD is not diagnosed and treated in a timely way, Dr. Kim said, those individuals “do indeed lose their limbs.”
Multidisciplinary teams can help, Dr. Kim said. “Specialists from multiple different training backgrounds [can] take good care of patients with PAD,” she said. This is important when access to a particular type of specialist is limited, and because patients with PAD often have complex medical problems that can benefit from a team approach.
Transcatheter aortic valve replacement heart teams and complex coronary disease heart teams are two examples, Dr. Kim noted. “When a high-stakes procedure is being considered, the patient’s case is reviewed by multiple stakeholders to ensure appropriateness of the procedure and collaboratively evaluate risk.”
Dr. Rao also emphasized a team approach. “PAD does not belong to a single specialty,” he said. The revelations from the Times, ProPublica, and other sources “point to the fact that we all – cardiologists, vascular surgeons, interventional radiologists – should start thinking about how best to police ourselves and also account for the variation in clinical judgment.”
Use of a multidisciplinary team is a “guideline-recommended approach” for coronary artery revascularization, he said, “I think the same should apply for PAD.”
PAD is a sign of systemic atherosclerosis, Dr. Kim noted. “The treatment of PAD includes addressing leg pain and wounds with procedures, but the interventions that will keep people alive are the medications we use to prevent heart attack and stroke. Patients with PAD need to understand that treatment is much more than opening up a blockage in the leg.”
Dr. Rao and Dr. Kim disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
On May 24, the news outlet ProPublica published a scathing investigation of Jeffery Dormu, DO, said to have performed hundreds of “medically unnecessary and invasive vascular procedures” in his Laurel, Md. office, putting patients’ limbs and lives at risk.
On July 15, The New York Times published a broader-based investigation of several vascular specialists said to have performed “risky” procedures on patients with peripheral artery disease (PAD) who subsequently had to have amputations, or died. The focus was mainly on Michigan-based interventional cardiologist Jihad Mustapha, MD.
This follows a 2019 analysis of Medicare claims data that identified outlier physicians with a high early intervention rate for patients newly diagnosed with claudication. According to the American Heart Association statistics, PAD affects approximately 8.5 million U.S. adults age 40 and older (some claim that’s an underestimate); most cases don’t require invasive treatment.
Responding to the Times’ revelations, Joseph L. Mills, MD, president of the Society for Vascular Surgery, wrote on the society’s website: “The overwhelming majority of vascular surgeons, and a vast majority of other specialists that receive some training and play a role in the care of vascular patients, including those trained in vascular medicine, interventional cardiology, and interventional radiology are providing high-quality, evidence-based care with safety and the best patient outcomes in mind.
“This is a complex issue that requires the examination not only of the events detailed in this story ... but of the underlying health care economic, legal and regulatory policies that created fertile soil for this behavior to germinate and take root.”
‘A few bad apples’
“I think it’s a case of a few bad apples,” Sunil V. Rao, MD, director of interventional cardiology at NYU Langone Health, New York, said in an interview. “In general, I think physicians who take care of patients with vascular issues are trying to do the right thing. I think all of us who take care of patients with vascular disease see patients who are very, very complex, and there are going to be some procedures that have complications.
“Without knowing the clinical details, it’s hard to know whether the procedures described in the articles were overuse or unnecessary, or exactly what led to the amputations,” he said. “All we know is that these physicians are outliers in terms of the number of procedures they were billing for.
“But although correlation is not causation, it certainly is cause for concern because you would expect that the use of procedures for specific indications would fall within a certain range,” he added.
Lifestyle changes first
PAD is often asymptomatic or mild, making it difficult to diagnose. Revascularization procedures usually are reserved for the 5%-8% of patients at risk for chronic limb-threatening ischemia (CLTI) or those in whom the cornerstones of PAD treatment – lifestyle changes and, if needed, medication – fail.
Revascularization options include balloon angioplasty or stent placement; atherectomy to remove plaques from the artery; or bypass surgery if a long portion of a leg artery is completely blocked. All carry a risk of long-term adverse outcomes, but the rates are highest for atherectomy.
Lifestyle changes include regular exercise, following a healthy diet, quitting smoking, and controlling diabetes and high blood pressure. When PAD continues or progresses despite these modifications, medications such as antiplatelet agents, antihypertensives, and/or lipid-lowering drugs may be prescribed.
‘Medically unnecessary’
According to the latest American Heart Association/American College of Cardiology guideline on managing patients with lower-extremity PAD, patients should be selected for revascularization based on symptom severity.
Factors to consider include a significant disability as assessed by the patient, and adequacy of response to medical and structured exercise therapy.
There’s the rub regarding the clinicians investigated in the Times and ProPublica. Many patients, apparently, were not encouraged to make lifestyle changes, nor did they receive medication. Instead, they were advised from the get-go to undergo invasive procedures, and often multiple times. Underuse of prevention and lifestyle counseling n the management of PAD has long been a concern.
Furthermore, in at least some cases, patients without any symptoms were encouraged to be screened for blockages that were then treated invasively, according to the Times.
Dr. Dormu, as highlighted in ProPublica, positioned his practice as “life and limb saving.” Yet, in investigative findings that led to a suspension of Dr. Dormu’s license to practice medicine in Maryland, peer reviewers expressed concern regarding his repeated use of invasive and medically unnecessary procedures, exposing patients to “potential risks such as bleeding, infection, blood vessel injuries which could acutely or chronically worsen the patient’s circulation, and limb loss.”
The peer reviewers concurred that Dr. Dormu failed to use conservative management techniques to address the patients’ vascular complaints before resorting to invasive procedures.
Dr. Mustapha is described in the Times as a “high-volume” atherectomy provider. From 2017 to 2021, about half of Medicare’s atherectomy payments – $1.4 billion – went to 200 high-volume providers, with Dr. Mustapha near the top of the list.
Some of Dr. Mustapha’s patients underwent multiple procedures said to help prevent leg amputation, but their legs were amputated anyway, possibly because of the multiple atherectomies, according to the Times.
Judith Lin, MD, MBA, who treated some of Dr. Mustapha’s former patients, was among those who complained about his practice to Michigan’s licensing board. Some of the patients she treated needed amputations; others needed to have leftover wires extracted from their legs.
In 2020, the board investigated Dr. Lin’s complaint and referred it to Michigan’s attorney general, who brought a disciplinary action against Dr. Mustapha. An expert hired by the state to review eight patient cases concluded that Dr. Mustapha’s practice “was characterized by overtreatment and poor documentation.” In some cases, the expert wrote, “unnecessary procedures hastened amputations.”
The statement issued by Dr. Mills, the president of SVS, noted that the society’s practice guideline proposes a threshold of at least 2 years of likely durability for an intervention performed for claudication.
“The growing frequency of multiple, repeated procedures [is] emblematic of poor patient selection and inadequate durability of the chosen procedure, leading to a vicious cycle of repetitive interventions that is not only costly, but also dangerous,” he wrote.
Financial incentives to blame?
In 2008, Medicare created incentives for physicians to perform vascular procedures in offices rather than hospitals, in an effort to reduce medical costs, according to both investigative articles. But the effort backfired.
Before the changes, an office provider inserting a stent could make about $1,700 from Medicare; deploying a balloon could bring in roughly $3,800. By 2011, the payments rose to about $6,400 and $4,800, respectively.
Office-based atherectomies soared when, in 2011, the Centers for Medicare & Medicaid Services started reimbursing $13,500 per procedure, as opposed to roughly $11,450 in a hospital. Atherectomies increased by 60% from 2011 to 2014, and Medicare’s overall costs for peripheral vascular treatments climbed by nearly half a billion dollars.
“The government is really to blame for setting these tremendously high reimbursement values without looking into whether these procedures are helping people or are just worthless procedures or, in fact, are hurting people,” Dipankar Mukherjee, MD, a vascular surgeon and chief of vascular surgery at Inova Fairfax (Va.) Hospital, said in ProPublica.
The result, noted Dr. Rao, is that “there can be perverse or nefarious incentives for doing these procedures. People are incentivized by reimbursement to do something that really falls in the area of clinical judgment and guidelines.”
Major incentives also come from device manufacturers, who often reward physicians who do the most vascular procedures with payments for consulting and other services, according to the Times. In addition, these companies lend money to help physicians or their clinics to finance the purchase of equipment used to perform the procedures.
“Vascular medicine now is the frontier of the Wild West,” Marty Makary, MD, MPH, a professor of surgery and health care quality researcher at Johns Hopkins University, Baltimore, told ProPublica. “People are flying blind walking into the clinics of these doctors with egregious practice patterns, and we know that their pattern is indefensible.”
Recognizing that the situation posed a threat to patients and also damaged the credibility of his specialty, Kim J. Hodgson, MD, a former SVS president, told attendees at the 2021 annual meeting of the SVS, “Somebody has to address what should never have been allowed to get to this level of threat to us and our patients in the first place. We can play whack-a-mole every time the bad actors surface until the cows come home, but that leaves a trail of harmed patients and wasted resources.”
Dr. Hodgson described atherectomy as “a procedure that many believe provides no demonstrable value whatsoever to the patient” and challenged those who disagree to prove it.
Multidisciplinary teams needed
Other experts believe there are times that revascularization procedures, including atherectomy, are appropriate. However, the majority of patients with PAD do not require a procedure, Soo Hyun (Esther) Kim, MD, MPH, director of the Center for Women’s Cardiovascular Health at Atrium Health Sanger Heart and Vascular Institute in Charlotte, N.C., said in an interview. In fact, “many patients do not even know they have leg artery blockages.”
Invasive procedures may well be appropriate for patients with severe PAD, especially those with CLTI, and disparities may be keeping those who truly need such interventions – or for whom they may be at least considered – from accessing them. If PAD is not diagnosed and treated in a timely way, Dr. Kim said, those individuals “do indeed lose their limbs.”
Multidisciplinary teams can help, Dr. Kim said. “Specialists from multiple different training backgrounds [can] take good care of patients with PAD,” she said. This is important when access to a particular type of specialist is limited, and because patients with PAD often have complex medical problems that can benefit from a team approach.
Transcatheter aortic valve replacement heart teams and complex coronary disease heart teams are two examples, Dr. Kim noted. “When a high-stakes procedure is being considered, the patient’s case is reviewed by multiple stakeholders to ensure appropriateness of the procedure and collaboratively evaluate risk.”
Dr. Rao also emphasized a team approach. “PAD does not belong to a single specialty,” he said. The revelations from the Times, ProPublica, and other sources “point to the fact that we all – cardiologists, vascular surgeons, interventional radiologists – should start thinking about how best to police ourselves and also account for the variation in clinical judgment.”
Use of a multidisciplinary team is a “guideline-recommended approach” for coronary artery revascularization, he said, “I think the same should apply for PAD.”
PAD is a sign of systemic atherosclerosis, Dr. Kim noted. “The treatment of PAD includes addressing leg pain and wounds with procedures, but the interventions that will keep people alive are the medications we use to prevent heart attack and stroke. Patients with PAD need to understand that treatment is much more than opening up a blockage in the leg.”
Dr. Rao and Dr. Kim disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Class I recall of all Impella left-sided heart pumps
– something that is not adequately addressed in the pumps’ current instructions for use (IFU).
This recall represents a “voluntary correction, not a product removal.” Impella heart pumps do not need to be returned, the U.S. Food and Drug Administration says.
Instead, the company will update the pump’s IFU to include guidance to clinicians on how to manage use of Impella in patients with TAVR.
Clinicians may continue to use the Impella devices, with the additional instructions for patients with TAVR in mind, the FDA says.
As explained in the recall notice, there is a potential risk that the Impella motor housing may come into contact with the distal stent of a TAVR, which may damage or destroy the motor’s impeller blades.
“The damaged Impella system may have reduced blood flow or pump stop, which may delay therapy or fail to provide enough support to the patient. This could be life threatening in people who require high levels of support. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream,” the notice warns.
The recall covers 7895 devices distributed from May 1, 2021, to the present, including the following devices:
- Impella 5.0 Blood Pump, product number 005062
- Impella CP Blood Pump, product number 0048-0032
- Impella 2.5 Blood Pump, product number 005042
- Impella CP with SmartAssist Blood Pump, product numbers 0048-0024, 0048-0045, and 1000080
- Impella LD Blood Pump, product number 005082
- Impella 5.5 with SmartAssist Blood Pump, product numbers 0550-0008 and 1000100.
Abiomed reports 30 complaints, 26 injuries, and 4 deaths related to this issue, which has garnered a class I recall from the FDA, the most serious type.
In an urgent device correction letter sent to health care professionals in June, Abiomed says, “For a patient with TAVR who needs hemodynamic support, clinicians should factor this risk into the risk benefit analysis and are cautioned to position the Impella system carefully as directed in this notification.
“The risk of interaction is increased for oversized or under expanded frames with the distal ends not flush with the aortic wall, resulting in the distal stent structures oriented in such a way as to potentially enter the outflow window and allow contact of the end of the stent with the spinning impeller,” the letter states.
Clinicians are advised to avoid repositioning while the device is spinning and to turn the device to P0 during repositioning or any movement that could bring the outlet windows into proximity with the valve stent structures.
If low flow is observed in a patient implanted with a TAVR while on Impella heart pump support, clinicians should consider damage of the impeller and replace the Impella pump as soon as possible, the company says.
Questions about this recall can be addressed to Shashi Thoutam at 734-262-6255 and/or local clinical field staff.
Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
– something that is not adequately addressed in the pumps’ current instructions for use (IFU).
This recall represents a “voluntary correction, not a product removal.” Impella heart pumps do not need to be returned, the U.S. Food and Drug Administration says.
Instead, the company will update the pump’s IFU to include guidance to clinicians on how to manage use of Impella in patients with TAVR.
Clinicians may continue to use the Impella devices, with the additional instructions for patients with TAVR in mind, the FDA says.
As explained in the recall notice, there is a potential risk that the Impella motor housing may come into contact with the distal stent of a TAVR, which may damage or destroy the motor’s impeller blades.
“The damaged Impella system may have reduced blood flow or pump stop, which may delay therapy or fail to provide enough support to the patient. This could be life threatening in people who require high levels of support. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream,” the notice warns.
The recall covers 7895 devices distributed from May 1, 2021, to the present, including the following devices:
- Impella 5.0 Blood Pump, product number 005062
- Impella CP Blood Pump, product number 0048-0032
- Impella 2.5 Blood Pump, product number 005042
- Impella CP with SmartAssist Blood Pump, product numbers 0048-0024, 0048-0045, and 1000080
- Impella LD Blood Pump, product number 005082
- Impella 5.5 with SmartAssist Blood Pump, product numbers 0550-0008 and 1000100.
Abiomed reports 30 complaints, 26 injuries, and 4 deaths related to this issue, which has garnered a class I recall from the FDA, the most serious type.
In an urgent device correction letter sent to health care professionals in June, Abiomed says, “For a patient with TAVR who needs hemodynamic support, clinicians should factor this risk into the risk benefit analysis and are cautioned to position the Impella system carefully as directed in this notification.
“The risk of interaction is increased for oversized or under expanded frames with the distal ends not flush with the aortic wall, resulting in the distal stent structures oriented in such a way as to potentially enter the outflow window and allow contact of the end of the stent with the spinning impeller,” the letter states.
Clinicians are advised to avoid repositioning while the device is spinning and to turn the device to P0 during repositioning or any movement that could bring the outlet windows into proximity with the valve stent structures.
If low flow is observed in a patient implanted with a TAVR while on Impella heart pump support, clinicians should consider damage of the impeller and replace the Impella pump as soon as possible, the company says.
Questions about this recall can be addressed to Shashi Thoutam at 734-262-6255 and/or local clinical field staff.
Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
– something that is not adequately addressed in the pumps’ current instructions for use (IFU).
This recall represents a “voluntary correction, not a product removal.” Impella heart pumps do not need to be returned, the U.S. Food and Drug Administration says.
Instead, the company will update the pump’s IFU to include guidance to clinicians on how to manage use of Impella in patients with TAVR.
Clinicians may continue to use the Impella devices, with the additional instructions for patients with TAVR in mind, the FDA says.
As explained in the recall notice, there is a potential risk that the Impella motor housing may come into contact with the distal stent of a TAVR, which may damage or destroy the motor’s impeller blades.
“The damaged Impella system may have reduced blood flow or pump stop, which may delay therapy or fail to provide enough support to the patient. This could be life threatening in people who require high levels of support. There is also a risk that pieces of the broken blades could enter the patient’s bloodstream,” the notice warns.
The recall covers 7895 devices distributed from May 1, 2021, to the present, including the following devices:
- Impella 5.0 Blood Pump, product number 005062
- Impella CP Blood Pump, product number 0048-0032
- Impella 2.5 Blood Pump, product number 005042
- Impella CP with SmartAssist Blood Pump, product numbers 0048-0024, 0048-0045, and 1000080
- Impella LD Blood Pump, product number 005082
- Impella 5.5 with SmartAssist Blood Pump, product numbers 0550-0008 and 1000100.
Abiomed reports 30 complaints, 26 injuries, and 4 deaths related to this issue, which has garnered a class I recall from the FDA, the most serious type.
In an urgent device correction letter sent to health care professionals in June, Abiomed says, “For a patient with TAVR who needs hemodynamic support, clinicians should factor this risk into the risk benefit analysis and are cautioned to position the Impella system carefully as directed in this notification.
“The risk of interaction is increased for oversized or under expanded frames with the distal ends not flush with the aortic wall, resulting in the distal stent structures oriented in such a way as to potentially enter the outflow window and allow contact of the end of the stent with the spinning impeller,” the letter states.
Clinicians are advised to avoid repositioning while the device is spinning and to turn the device to P0 during repositioning or any movement that could bring the outlet windows into proximity with the valve stent structures.
If low flow is observed in a patient implanted with a TAVR while on Impella heart pump support, clinicians should consider damage of the impeller and replace the Impella pump as soon as possible, the company says.
Questions about this recall can be addressed to Shashi Thoutam at 734-262-6255 and/or local clinical field staff.
Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
Statins post PCI: Moderate intensity plus ezetimibe may be preferable
, suggests a “real-world” cohort study that is consistent with trial evidence.
In the observational study with more than 273,000 patients who received percutaneous coronary intervention (PCI) with drug-eluting stents (DES), risk for a broad composite clinical primary endpoint fell by one-fourth (P < .001) among those put on the two-drug regimen with a moderate-intensity statin, compared with those getting a high-intensity statin alone.
The dual-agent approach was also associated with a 15% drop in statin discontinuation and a 20% reduced risk for new-onset diabetes requiring medication (P < .001 for both benefits), reported investigators in the Journal of the American College of Cardiology.
The study’s primary endpoint – a composite of cardiovascular (CV) death, myocardial infarction (MI), coronary revascularization, heart failure (HF) hospitalization, or nonfatal stroke at 3 years – replicated that of the randomized RACING trial conducted by many of the same researchers and published about a year ago in The Lancet.
RACING demonstrated that ezetimibe plus a moderate-intensity statin could be as effective as a high-intensity statin in patients with CV disease, “but have fewer side effects and better compliance,” Myeong-Ki Hong, MD, PhD, Severance Hospital, Yonsei University, Seoul, South Korea, said in an interview.
Dr. Hong is senior author on the current observational study based on the CONNECT-DES registry, which compared rosuvastatin 10 mg/day plus ezetimibe 10 mg/day – used in RACING – with rosuvastatin 20 mg/day in a nationwide cohort of 72,050 patients.
“As we know, populations who are enrolled in randomized studies do not sufficiently represent real patients in practice,” he observed, “so we wanted to evaluate the generalizability of the RACING results in daily clinical practice.”
Deepak L. Bhatt, MD, said he likes studies that look at whether clinical trial results “play out in the real world,” as this one did. “They have largely replicated the results of the RACING trial,” suggesting the approach using a moderate-intensity statin “is the way to go,” Dr. Bhatt of Mount Sinai Health System, New York, who was not affiliated with the current report, said in an interview. “In fact, the moderate-intensity combination regimen was actually better in this study.”
He said the observed reduction in new-onset diabetes with the moderate-intensity statin approach is also important. “There is a link between high-dose statins and diabetes. So, if given the choice, if you can get the benefits from a cardiovascular perspective with a lower risk of diabetes, it makes sense to use the combination therapy.”
Dr. Bhatt said he had been using high-intensity statin monotherapy in his high-risk patients, but RACING made him reconsider the value of moderate-dose statin combination therapy. “Going with lower doses of two drugs instead of high doses of one drug minimizes side effects and, in some cases, can even enhance efficacy – so this is not an unreasonable paradigm.”
In the current cohort study of patients prescribed rosuvastatin after DES implantation, 10,794 received rosuvastatin 10 mg/day plus ezetimibe 10 mg/day, and 61,256 were put on rosuvastatin 20 mg/day.
Hazard ratio risk reductions with the dual-agent lipid-lowering therapy approach, compared with high-intensity statin monotherapy, were more favorable for the primary composite clinical endpoint and important secondary events:
- HR, 0.75; 95% confidence interval, 0.70-0.79; P < .001) for CV death, MI, coronary artery revascularization, HF, or stroke at 3 years.
- HR, 0.85; 95% CI, 0.78-0.94; P = .001) for statin discontinuation.
- HR, 0.80; 95% CI, 0.72-0.88; P < .001) for new-onset diabetes requiring medication.
But HRs for rhabdomyolysis, cholecystectomy, or a new cancer diagnosis did not indicate significant differences between the two groups.
“Now that there is evidence to support the favorable clinical outcomes of combination lipid-lowering therapy with moderate-intensity statin plus ezetimibe” for secondary prevention from both RACING and a study reflecting daily clinical practice, Dr. Hong said, “physicians may feel more comfortable with this approach.”
The registry analysis “is remarkable not only for validating the results of the RACING trial in routine clinical practice in a high-risk secondary prevention population, but also for its innovative methodology,” states an accompanying editorial by Ori Ben-Yehuda, MD, Sulpizio Cardiovascular Center, University of California, San Diego.
Use of such a large single-payer database in their study “affords even greater external validity to the findings, complementing the internal validity of the randomized RACING trial,” Dr. Ben-Yehuda writes.
The rationale for combination therapy is strong, but additional data would be helpful, particularly for informing guidelines, he continues. “A pragmatic trial randomizing a broad racial and ethnic group of patients to low-dose statin,” such as a starting dose of 10 mg/day atorvastatin or 5 mg/day rosuvastatin “plus ezetimibe vs. high-intensity statin alone would provide much needed data to help guide lipid-lowering therapy for millions of patients and hopefully increase persistence on therapy.”
The study was supported by the Cardiovascular Research Center, Seoul, South Korea. Dr. Hong and Dr. Ben-Yehuda have disclosed no relevant financial relationships. Dr. Bhatt has previously disclosed grants and/or personal fees from many companies; personal fees from WebMD and other publications or organizations; and having other relationships with Medscape Cardiology and other publications or organizations.
A version of this article appeared on Medscape.com.
, suggests a “real-world” cohort study that is consistent with trial evidence.
In the observational study with more than 273,000 patients who received percutaneous coronary intervention (PCI) with drug-eluting stents (DES), risk for a broad composite clinical primary endpoint fell by one-fourth (P < .001) among those put on the two-drug regimen with a moderate-intensity statin, compared with those getting a high-intensity statin alone.
The dual-agent approach was also associated with a 15% drop in statin discontinuation and a 20% reduced risk for new-onset diabetes requiring medication (P < .001 for both benefits), reported investigators in the Journal of the American College of Cardiology.
The study’s primary endpoint – a composite of cardiovascular (CV) death, myocardial infarction (MI), coronary revascularization, heart failure (HF) hospitalization, or nonfatal stroke at 3 years – replicated that of the randomized RACING trial conducted by many of the same researchers and published about a year ago in The Lancet.
RACING demonstrated that ezetimibe plus a moderate-intensity statin could be as effective as a high-intensity statin in patients with CV disease, “but have fewer side effects and better compliance,” Myeong-Ki Hong, MD, PhD, Severance Hospital, Yonsei University, Seoul, South Korea, said in an interview.
Dr. Hong is senior author on the current observational study based on the CONNECT-DES registry, which compared rosuvastatin 10 mg/day plus ezetimibe 10 mg/day – used in RACING – with rosuvastatin 20 mg/day in a nationwide cohort of 72,050 patients.
“As we know, populations who are enrolled in randomized studies do not sufficiently represent real patients in practice,” he observed, “so we wanted to evaluate the generalizability of the RACING results in daily clinical practice.”
Deepak L. Bhatt, MD, said he likes studies that look at whether clinical trial results “play out in the real world,” as this one did. “They have largely replicated the results of the RACING trial,” suggesting the approach using a moderate-intensity statin “is the way to go,” Dr. Bhatt of Mount Sinai Health System, New York, who was not affiliated with the current report, said in an interview. “In fact, the moderate-intensity combination regimen was actually better in this study.”
He said the observed reduction in new-onset diabetes with the moderate-intensity statin approach is also important. “There is a link between high-dose statins and diabetes. So, if given the choice, if you can get the benefits from a cardiovascular perspective with a lower risk of diabetes, it makes sense to use the combination therapy.”
Dr. Bhatt said he had been using high-intensity statin monotherapy in his high-risk patients, but RACING made him reconsider the value of moderate-dose statin combination therapy. “Going with lower doses of two drugs instead of high doses of one drug minimizes side effects and, in some cases, can even enhance efficacy – so this is not an unreasonable paradigm.”
In the current cohort study of patients prescribed rosuvastatin after DES implantation, 10,794 received rosuvastatin 10 mg/day plus ezetimibe 10 mg/day, and 61,256 were put on rosuvastatin 20 mg/day.
Hazard ratio risk reductions with the dual-agent lipid-lowering therapy approach, compared with high-intensity statin monotherapy, were more favorable for the primary composite clinical endpoint and important secondary events:
- HR, 0.75; 95% confidence interval, 0.70-0.79; P < .001) for CV death, MI, coronary artery revascularization, HF, or stroke at 3 years.
- HR, 0.85; 95% CI, 0.78-0.94; P = .001) for statin discontinuation.
- HR, 0.80; 95% CI, 0.72-0.88; P < .001) for new-onset diabetes requiring medication.
But HRs for rhabdomyolysis, cholecystectomy, or a new cancer diagnosis did not indicate significant differences between the two groups.
“Now that there is evidence to support the favorable clinical outcomes of combination lipid-lowering therapy with moderate-intensity statin plus ezetimibe” for secondary prevention from both RACING and a study reflecting daily clinical practice, Dr. Hong said, “physicians may feel more comfortable with this approach.”
The registry analysis “is remarkable not only for validating the results of the RACING trial in routine clinical practice in a high-risk secondary prevention population, but also for its innovative methodology,” states an accompanying editorial by Ori Ben-Yehuda, MD, Sulpizio Cardiovascular Center, University of California, San Diego.
Use of such a large single-payer database in their study “affords even greater external validity to the findings, complementing the internal validity of the randomized RACING trial,” Dr. Ben-Yehuda writes.
The rationale for combination therapy is strong, but additional data would be helpful, particularly for informing guidelines, he continues. “A pragmatic trial randomizing a broad racial and ethnic group of patients to low-dose statin,” such as a starting dose of 10 mg/day atorvastatin or 5 mg/day rosuvastatin “plus ezetimibe vs. high-intensity statin alone would provide much needed data to help guide lipid-lowering therapy for millions of patients and hopefully increase persistence on therapy.”
The study was supported by the Cardiovascular Research Center, Seoul, South Korea. Dr. Hong and Dr. Ben-Yehuda have disclosed no relevant financial relationships. Dr. Bhatt has previously disclosed grants and/or personal fees from many companies; personal fees from WebMD and other publications or organizations; and having other relationships with Medscape Cardiology and other publications or organizations.
A version of this article appeared on Medscape.com.
, suggests a “real-world” cohort study that is consistent with trial evidence.
In the observational study with more than 273,000 patients who received percutaneous coronary intervention (PCI) with drug-eluting stents (DES), risk for a broad composite clinical primary endpoint fell by one-fourth (P < .001) among those put on the two-drug regimen with a moderate-intensity statin, compared with those getting a high-intensity statin alone.
The dual-agent approach was also associated with a 15% drop in statin discontinuation and a 20% reduced risk for new-onset diabetes requiring medication (P < .001 for both benefits), reported investigators in the Journal of the American College of Cardiology.
The study’s primary endpoint – a composite of cardiovascular (CV) death, myocardial infarction (MI), coronary revascularization, heart failure (HF) hospitalization, or nonfatal stroke at 3 years – replicated that of the randomized RACING trial conducted by many of the same researchers and published about a year ago in The Lancet.
RACING demonstrated that ezetimibe plus a moderate-intensity statin could be as effective as a high-intensity statin in patients with CV disease, “but have fewer side effects and better compliance,” Myeong-Ki Hong, MD, PhD, Severance Hospital, Yonsei University, Seoul, South Korea, said in an interview.
Dr. Hong is senior author on the current observational study based on the CONNECT-DES registry, which compared rosuvastatin 10 mg/day plus ezetimibe 10 mg/day – used in RACING – with rosuvastatin 20 mg/day in a nationwide cohort of 72,050 patients.
“As we know, populations who are enrolled in randomized studies do not sufficiently represent real patients in practice,” he observed, “so we wanted to evaluate the generalizability of the RACING results in daily clinical practice.”
Deepak L. Bhatt, MD, said he likes studies that look at whether clinical trial results “play out in the real world,” as this one did. “They have largely replicated the results of the RACING trial,” suggesting the approach using a moderate-intensity statin “is the way to go,” Dr. Bhatt of Mount Sinai Health System, New York, who was not affiliated with the current report, said in an interview. “In fact, the moderate-intensity combination regimen was actually better in this study.”
He said the observed reduction in new-onset diabetes with the moderate-intensity statin approach is also important. “There is a link between high-dose statins and diabetes. So, if given the choice, if you can get the benefits from a cardiovascular perspective with a lower risk of diabetes, it makes sense to use the combination therapy.”
Dr. Bhatt said he had been using high-intensity statin monotherapy in his high-risk patients, but RACING made him reconsider the value of moderate-dose statin combination therapy. “Going with lower doses of two drugs instead of high doses of one drug minimizes side effects and, in some cases, can even enhance efficacy – so this is not an unreasonable paradigm.”
In the current cohort study of patients prescribed rosuvastatin after DES implantation, 10,794 received rosuvastatin 10 mg/day plus ezetimibe 10 mg/day, and 61,256 were put on rosuvastatin 20 mg/day.
Hazard ratio risk reductions with the dual-agent lipid-lowering therapy approach, compared with high-intensity statin monotherapy, were more favorable for the primary composite clinical endpoint and important secondary events:
- HR, 0.75; 95% confidence interval, 0.70-0.79; P < .001) for CV death, MI, coronary artery revascularization, HF, or stroke at 3 years.
- HR, 0.85; 95% CI, 0.78-0.94; P = .001) for statin discontinuation.
- HR, 0.80; 95% CI, 0.72-0.88; P < .001) for new-onset diabetes requiring medication.
But HRs for rhabdomyolysis, cholecystectomy, or a new cancer diagnosis did not indicate significant differences between the two groups.
“Now that there is evidence to support the favorable clinical outcomes of combination lipid-lowering therapy with moderate-intensity statin plus ezetimibe” for secondary prevention from both RACING and a study reflecting daily clinical practice, Dr. Hong said, “physicians may feel more comfortable with this approach.”
The registry analysis “is remarkable not only for validating the results of the RACING trial in routine clinical practice in a high-risk secondary prevention population, but also for its innovative methodology,” states an accompanying editorial by Ori Ben-Yehuda, MD, Sulpizio Cardiovascular Center, University of California, San Diego.
Use of such a large single-payer database in their study “affords even greater external validity to the findings, complementing the internal validity of the randomized RACING trial,” Dr. Ben-Yehuda writes.
The rationale for combination therapy is strong, but additional data would be helpful, particularly for informing guidelines, he continues. “A pragmatic trial randomizing a broad racial and ethnic group of patients to low-dose statin,” such as a starting dose of 10 mg/day atorvastatin or 5 mg/day rosuvastatin “plus ezetimibe vs. high-intensity statin alone would provide much needed data to help guide lipid-lowering therapy for millions of patients and hopefully increase persistence on therapy.”
The study was supported by the Cardiovascular Research Center, Seoul, South Korea. Dr. Hong and Dr. Ben-Yehuda have disclosed no relevant financial relationships. Dr. Bhatt has previously disclosed grants and/or personal fees from many companies; personal fees from WebMD and other publications or organizations; and having other relationships with Medscape Cardiology and other publications or organizations.
A version of this article appeared on Medscape.com.
FROM JACC
Class I recall of Abbott Amplatzer delivery sheath
because of an increased risk of air embolism, the Food and Drug Administration has announced.
Air embolism can lead to injuries such as acute reduction in blood flow to the heart (indicated by ST elevation), tachycardia, bradycardia, hypotension, and oxygen desaturation, as well as stroke and death, the FDA said in a recall notice.
Because of the potential for serious injury or death, the agency has identified this as a class I recall, the most serious type.
To date, Abbott has reported 26 incidents, 16 injuries, and no deaths related to this issue.
According to the recall notice, the overall reported incidence rate of observed or potential cases of air embolism during procedures in which the product was used is 0.77%.
The recall includes 672 devices (model: ASDS-14F-075) that were distributed from Oct. 4, 2022, to Feb. 22, 2023.
Abbott sent a medical device recall notice to customers in June asking them to return any remaining unused Amplatzer steerable delivery sheaths to Abbott and to complete an enclosed acknowledgment form.
The company advises use of the fixed curve TorqVue 45° x 45° delivery system for future Amplatzer Amulet left atrial appendage occluder implants.
Customers with questions about this recall should contact their local Abbott representative or Abbott support at 1-800-544-1664 (option 2).
A version of this article appeared on Medscape.com.
because of an increased risk of air embolism, the Food and Drug Administration has announced.
Air embolism can lead to injuries such as acute reduction in blood flow to the heart (indicated by ST elevation), tachycardia, bradycardia, hypotension, and oxygen desaturation, as well as stroke and death, the FDA said in a recall notice.
Because of the potential for serious injury or death, the agency has identified this as a class I recall, the most serious type.
To date, Abbott has reported 26 incidents, 16 injuries, and no deaths related to this issue.
According to the recall notice, the overall reported incidence rate of observed or potential cases of air embolism during procedures in which the product was used is 0.77%.
The recall includes 672 devices (model: ASDS-14F-075) that were distributed from Oct. 4, 2022, to Feb. 22, 2023.
Abbott sent a medical device recall notice to customers in June asking them to return any remaining unused Amplatzer steerable delivery sheaths to Abbott and to complete an enclosed acknowledgment form.
The company advises use of the fixed curve TorqVue 45° x 45° delivery system for future Amplatzer Amulet left atrial appendage occluder implants.
Customers with questions about this recall should contact their local Abbott representative or Abbott support at 1-800-544-1664 (option 2).
A version of this article appeared on Medscape.com.
because of an increased risk of air embolism, the Food and Drug Administration has announced.
Air embolism can lead to injuries such as acute reduction in blood flow to the heart (indicated by ST elevation), tachycardia, bradycardia, hypotension, and oxygen desaturation, as well as stroke and death, the FDA said in a recall notice.
Because of the potential for serious injury or death, the agency has identified this as a class I recall, the most serious type.
To date, Abbott has reported 26 incidents, 16 injuries, and no deaths related to this issue.
According to the recall notice, the overall reported incidence rate of observed or potential cases of air embolism during procedures in which the product was used is 0.77%.
The recall includes 672 devices (model: ASDS-14F-075) that were distributed from Oct. 4, 2022, to Feb. 22, 2023.
Abbott sent a medical device recall notice to customers in June asking them to return any remaining unused Amplatzer steerable delivery sheaths to Abbott and to complete an enclosed acknowledgment form.
The company advises use of the fixed curve TorqVue 45° x 45° delivery system for future Amplatzer Amulet left atrial appendage occluder implants.
Customers with questions about this recall should contact their local Abbott representative or Abbott support at 1-800-544-1664 (option 2).
A version of this article appeared on Medscape.com.
Same-session PCI rates ‘surprisingly high’
Stable patients who have a diagnostic cardiac catheterization for multivessel disease or two-vessel proximal left anterior descending disease often have percutaneous coronary intervention (PCI) in the same session, possibly without input from a multidisciplinary heart team, a new study suggests.
The study, a retrospective analysis of more than 8,000 catheterization procedures in New York State during 2018 and 2019, was published in JACC: Cardiovascular Interventions.
Among the stable patients with multivessel disease or left main (LM) disease who had PCI, 78.4% of PCIs were performed in the same session as their diagnostic catheterization procedure, known as ad hoc PCI, a “surprisingly high rate,” the authors wrote.
The 2011 clinical guidelines in place during the study period advised coronary artery bypass graft (CABG) surgery as a class 1 recommendation for LM disease, whereas PCI is a lower-class recommendation (J Am Coll Cardiol. 2011;58:e44-e-122), they noted.
“Ad hoc PCI can be inadvisable when guidelines indicate that patients can realize better outcomes with CABG surgery,” lead study author Edward L. Hannan, PhD, MS, said in an interview. “The issue is that ad hoc PCI eliminates the opportunity for a multidisciplinary heart team to evaluate the patient.”
Dr. Hannan is principal investigator for the cardiac services program at the New York State Department of Health in Albany and distinguished professor emeritus at the University of Albany School of Public Health.
The researchers analyzed data from two mandatory New York State PCI and cardiac surgery registries, the Percutaneous Coronary Interventions Reporting System and the Cardiac Surgery Reporting System. A total of 91,146 patients had an index PCI from Dec. 1, 2017, to Nov. 30, 2019.
The study included patients who had two-vessel disease with proximal left anterior descending (PLAD) disease, three-vessel disease or unprotected LM disease. Exclusion criteria included a previous revascularization, among a host of other factors. The analysis also identified 10,122 patients who had coronary artery bypass graft (CABG) surgery in addition to the 8,196 patients who had PCI.
The percentage for ad hoc PCI ranged from 58.7% for those with unprotected LM disease to 85.4% for patients with two-vessel PLAD. Among the patients who had PCI for three-vessel disease, 76.7% had an ad hoc PCI.
Selected subgroups had lower ad hoc PCI rates. When patients who had a myocardial infarction within 1-7 days were excluded, the ad hoc percentage decreased slightly to 77.2%. PCI patients with diabetes were also less likely to have ad hoc PCI (75.7% vs. 80.4%, P < .0001), as were patients with compromised left ventricular ejection fraction (< 35%; 64.6% vs. 80.5%, P < .0001).
When all revascularizations – PCI plus CABG – were taken into account, the rate of ad hoc PCIs was 35.1%. Rates were 63.9% for patients with two-vessel PLAD disease, 32.4% for those with three-vessel disease, and 11.5% for patients with unprotected LM disease.
One potential disadvantage of ad hoc PCI, the authors noted, is that it doesn’t allow time for a multidisciplinary heart team to evaluate the patient for a different treatment, such as CABG or medical therapy. “This multidisciplinary team can evaluate all the pros and cons of different approaches, such as PCI vs. CABG surgery in this case,” Dr. Hannan said.
The study findings imply a potential overutilization of PCI and a greater likelihood of forgoing a more appropriate intervention, he said, “given that we have chosen for the study groups of patients who in general benefit more with CABG surgery.”
The results also showed variability in ad hoc PCI rates among hospitals and physicians. “They are large enough to suggest that there is a fairly large variation across the state in the use of heart teams,” he said.
For unprotected LM disease, the risk adjusted rate for hospitals of ad hoc PCIs among all PCIs ranged from 25.6% in the lowest quartile to 93.7% in the highest. Physician rates of ad hoc PCIs for the same indication, which were ranked by tertile, ranged from 22% for the lowest to 84.3% for the highest (P < .001).
One strength of the study, Dr. Hannan said, is that it is a large population-based study that excluded groups for whom an ad hoc PCI would be appropriate, such as emergency patients. One limitation is that it did not account for legitimate reasons for ad hoc PCI, including contraindications for CABG surgery and patient refusal of CABG surgery.
In an invited editorial comment, James C. Blankenship, MD, and Krishna Patel, MD, wrote that this study shows that “past criticisms of ad hoc PCI have had seemingly little effect.”
“The article provides a striking example of a difference between guideline-directed practice and real-life practice,” Dr. Blankenship said in an interview. “Guideline recommendations for the heart team approach are well known by interventionalists, so the findings of this study do not reflect ignorance of cardiologists.” Dr. Blankenship, a cardiologist and professor of medicine at the University of New Mexico in Albuquerque, is a coauthor of the 2011 PCI guidelines.
It’s more likely the study findings “reflect unconscious biases and sincere beliefs of patients and interventionalists that PCI rather than CABG is in patients’ best interests,” Dr. Blankenship said.
He noted the variation in practice across hospitals and individuals suggests an opportunity for improvement. “If the guidelines are correct, then perhaps interventionalists should be held accountable for making sure the heart team approach is followed,” he said. “Alternatively, perhaps a modified approach that guarantees patient-centered decision making and is ethically acceptable could be identified.”
The study received funding from the New York State Department of Health. Dr. Hannan and Dr. Blankenship and Dr. Patel have no relevant disclosures.
Stable patients who have a diagnostic cardiac catheterization for multivessel disease or two-vessel proximal left anterior descending disease often have percutaneous coronary intervention (PCI) in the same session, possibly without input from a multidisciplinary heart team, a new study suggests.
The study, a retrospective analysis of more than 8,000 catheterization procedures in New York State during 2018 and 2019, was published in JACC: Cardiovascular Interventions.
Among the stable patients with multivessel disease or left main (LM) disease who had PCI, 78.4% of PCIs were performed in the same session as their diagnostic catheterization procedure, known as ad hoc PCI, a “surprisingly high rate,” the authors wrote.
The 2011 clinical guidelines in place during the study period advised coronary artery bypass graft (CABG) surgery as a class 1 recommendation for LM disease, whereas PCI is a lower-class recommendation (J Am Coll Cardiol. 2011;58:e44-e-122), they noted.
“Ad hoc PCI can be inadvisable when guidelines indicate that patients can realize better outcomes with CABG surgery,” lead study author Edward L. Hannan, PhD, MS, said in an interview. “The issue is that ad hoc PCI eliminates the opportunity for a multidisciplinary heart team to evaluate the patient.”
Dr. Hannan is principal investigator for the cardiac services program at the New York State Department of Health in Albany and distinguished professor emeritus at the University of Albany School of Public Health.
The researchers analyzed data from two mandatory New York State PCI and cardiac surgery registries, the Percutaneous Coronary Interventions Reporting System and the Cardiac Surgery Reporting System. A total of 91,146 patients had an index PCI from Dec. 1, 2017, to Nov. 30, 2019.
The study included patients who had two-vessel disease with proximal left anterior descending (PLAD) disease, three-vessel disease or unprotected LM disease. Exclusion criteria included a previous revascularization, among a host of other factors. The analysis also identified 10,122 patients who had coronary artery bypass graft (CABG) surgery in addition to the 8,196 patients who had PCI.
The percentage for ad hoc PCI ranged from 58.7% for those with unprotected LM disease to 85.4% for patients with two-vessel PLAD. Among the patients who had PCI for three-vessel disease, 76.7% had an ad hoc PCI.
Selected subgroups had lower ad hoc PCI rates. When patients who had a myocardial infarction within 1-7 days were excluded, the ad hoc percentage decreased slightly to 77.2%. PCI patients with diabetes were also less likely to have ad hoc PCI (75.7% vs. 80.4%, P < .0001), as were patients with compromised left ventricular ejection fraction (< 35%; 64.6% vs. 80.5%, P < .0001).
When all revascularizations – PCI plus CABG – were taken into account, the rate of ad hoc PCIs was 35.1%. Rates were 63.9% for patients with two-vessel PLAD disease, 32.4% for those with three-vessel disease, and 11.5% for patients with unprotected LM disease.
One potential disadvantage of ad hoc PCI, the authors noted, is that it doesn’t allow time for a multidisciplinary heart team to evaluate the patient for a different treatment, such as CABG or medical therapy. “This multidisciplinary team can evaluate all the pros and cons of different approaches, such as PCI vs. CABG surgery in this case,” Dr. Hannan said.
The study findings imply a potential overutilization of PCI and a greater likelihood of forgoing a more appropriate intervention, he said, “given that we have chosen for the study groups of patients who in general benefit more with CABG surgery.”
The results also showed variability in ad hoc PCI rates among hospitals and physicians. “They are large enough to suggest that there is a fairly large variation across the state in the use of heart teams,” he said.
For unprotected LM disease, the risk adjusted rate for hospitals of ad hoc PCIs among all PCIs ranged from 25.6% in the lowest quartile to 93.7% in the highest. Physician rates of ad hoc PCIs for the same indication, which were ranked by tertile, ranged from 22% for the lowest to 84.3% for the highest (P < .001).
One strength of the study, Dr. Hannan said, is that it is a large population-based study that excluded groups for whom an ad hoc PCI would be appropriate, such as emergency patients. One limitation is that it did not account for legitimate reasons for ad hoc PCI, including contraindications for CABG surgery and patient refusal of CABG surgery.
In an invited editorial comment, James C. Blankenship, MD, and Krishna Patel, MD, wrote that this study shows that “past criticisms of ad hoc PCI have had seemingly little effect.”
“The article provides a striking example of a difference between guideline-directed practice and real-life practice,” Dr. Blankenship said in an interview. “Guideline recommendations for the heart team approach are well known by interventionalists, so the findings of this study do not reflect ignorance of cardiologists.” Dr. Blankenship, a cardiologist and professor of medicine at the University of New Mexico in Albuquerque, is a coauthor of the 2011 PCI guidelines.
It’s more likely the study findings “reflect unconscious biases and sincere beliefs of patients and interventionalists that PCI rather than CABG is in patients’ best interests,” Dr. Blankenship said.
He noted the variation in practice across hospitals and individuals suggests an opportunity for improvement. “If the guidelines are correct, then perhaps interventionalists should be held accountable for making sure the heart team approach is followed,” he said. “Alternatively, perhaps a modified approach that guarantees patient-centered decision making and is ethically acceptable could be identified.”
The study received funding from the New York State Department of Health. Dr. Hannan and Dr. Blankenship and Dr. Patel have no relevant disclosures.
Stable patients who have a diagnostic cardiac catheterization for multivessel disease or two-vessel proximal left anterior descending disease often have percutaneous coronary intervention (PCI) in the same session, possibly without input from a multidisciplinary heart team, a new study suggests.
The study, a retrospective analysis of more than 8,000 catheterization procedures in New York State during 2018 and 2019, was published in JACC: Cardiovascular Interventions.
Among the stable patients with multivessel disease or left main (LM) disease who had PCI, 78.4% of PCIs were performed in the same session as their diagnostic catheterization procedure, known as ad hoc PCI, a “surprisingly high rate,” the authors wrote.
The 2011 clinical guidelines in place during the study period advised coronary artery bypass graft (CABG) surgery as a class 1 recommendation for LM disease, whereas PCI is a lower-class recommendation (J Am Coll Cardiol. 2011;58:e44-e-122), they noted.
“Ad hoc PCI can be inadvisable when guidelines indicate that patients can realize better outcomes with CABG surgery,” lead study author Edward L. Hannan, PhD, MS, said in an interview. “The issue is that ad hoc PCI eliminates the opportunity for a multidisciplinary heart team to evaluate the patient.”
Dr. Hannan is principal investigator for the cardiac services program at the New York State Department of Health in Albany and distinguished professor emeritus at the University of Albany School of Public Health.
The researchers analyzed data from two mandatory New York State PCI and cardiac surgery registries, the Percutaneous Coronary Interventions Reporting System and the Cardiac Surgery Reporting System. A total of 91,146 patients had an index PCI from Dec. 1, 2017, to Nov. 30, 2019.
The study included patients who had two-vessel disease with proximal left anterior descending (PLAD) disease, three-vessel disease or unprotected LM disease. Exclusion criteria included a previous revascularization, among a host of other factors. The analysis also identified 10,122 patients who had coronary artery bypass graft (CABG) surgery in addition to the 8,196 patients who had PCI.
The percentage for ad hoc PCI ranged from 58.7% for those with unprotected LM disease to 85.4% for patients with two-vessel PLAD. Among the patients who had PCI for three-vessel disease, 76.7% had an ad hoc PCI.
Selected subgroups had lower ad hoc PCI rates. When patients who had a myocardial infarction within 1-7 days were excluded, the ad hoc percentage decreased slightly to 77.2%. PCI patients with diabetes were also less likely to have ad hoc PCI (75.7% vs. 80.4%, P < .0001), as were patients with compromised left ventricular ejection fraction (< 35%; 64.6% vs. 80.5%, P < .0001).
When all revascularizations – PCI plus CABG – were taken into account, the rate of ad hoc PCIs was 35.1%. Rates were 63.9% for patients with two-vessel PLAD disease, 32.4% for those with three-vessel disease, and 11.5% for patients with unprotected LM disease.
One potential disadvantage of ad hoc PCI, the authors noted, is that it doesn’t allow time for a multidisciplinary heart team to evaluate the patient for a different treatment, such as CABG or medical therapy. “This multidisciplinary team can evaluate all the pros and cons of different approaches, such as PCI vs. CABG surgery in this case,” Dr. Hannan said.
The study findings imply a potential overutilization of PCI and a greater likelihood of forgoing a more appropriate intervention, he said, “given that we have chosen for the study groups of patients who in general benefit more with CABG surgery.”
The results also showed variability in ad hoc PCI rates among hospitals and physicians. “They are large enough to suggest that there is a fairly large variation across the state in the use of heart teams,” he said.
For unprotected LM disease, the risk adjusted rate for hospitals of ad hoc PCIs among all PCIs ranged from 25.6% in the lowest quartile to 93.7% in the highest. Physician rates of ad hoc PCIs for the same indication, which were ranked by tertile, ranged from 22% for the lowest to 84.3% for the highest (P < .001).
One strength of the study, Dr. Hannan said, is that it is a large population-based study that excluded groups for whom an ad hoc PCI would be appropriate, such as emergency patients. One limitation is that it did not account for legitimate reasons for ad hoc PCI, including contraindications for CABG surgery and patient refusal of CABG surgery.
In an invited editorial comment, James C. Blankenship, MD, and Krishna Patel, MD, wrote that this study shows that “past criticisms of ad hoc PCI have had seemingly little effect.”
“The article provides a striking example of a difference between guideline-directed practice and real-life practice,” Dr. Blankenship said in an interview. “Guideline recommendations for the heart team approach are well known by interventionalists, so the findings of this study do not reflect ignorance of cardiologists.” Dr. Blankenship, a cardiologist and professor of medicine at the University of New Mexico in Albuquerque, is a coauthor of the 2011 PCI guidelines.
It’s more likely the study findings “reflect unconscious biases and sincere beliefs of patients and interventionalists that PCI rather than CABG is in patients’ best interests,” Dr. Blankenship said.
He noted the variation in practice across hospitals and individuals suggests an opportunity for improvement. “If the guidelines are correct, then perhaps interventionalists should be held accountable for making sure the heart team approach is followed,” he said. “Alternatively, perhaps a modified approach that guarantees patient-centered decision making and is ethically acceptable could be identified.”
The study received funding from the New York State Department of Health. Dr. Hannan and Dr. Blankenship and Dr. Patel have no relevant disclosures.
FROM JACC; CARDIOVASCULAR INTERVENTIONS
Invasive test may cut health care costs related to angina without obstructive CAD
Performing coronary reactivity (CR) testing during angiography in patients with angina without obstructive coronary disease (ANOCA) adds complexity and cost to the procedure but may, in the end, turn out to be a bargain.
probably by helping to limit downstream procedures and other use of health care resources.
In the retrospective study, CR testing included both adenosine and acetylcholine challenges to differentiate endothelium-dependent from endothelium-independent coronary reactivity as the physiological cause of ANOCA in individuals. Clarifying the cause at this stage of the patient’s clinical journey seemed to sharpen subsequent testing and management decisions, the researchers said.
Of the 414 patients with ANOCA who underwent invasive diagnostic angiography, 207 also received CR testing during the procedure. The difference in total healthcare costs between the two groups over 2 years averaged about $20,000, largely because of the CR-testing group’s reduced use of downstream imaging, interventional procedures, and other tests, notes a report on the study published in Circulation: Cardiovascular Interventions.
For such patients referred for coronary angiography found to be without obstructive disease, “the right thing to do is a vascular reactivity test to assess if there is any abnormality that can contribute to this patient’s symptoms and events,” senior author Amir Lerman, MD, Mayo Clinic, Rochester, Minn., said in an interview. Coronary reactivity testing “is expensive to set up initially, but it actually saves money by reducing the need for additional unnecessary testing and hospitalizations in these patients.”
The financial burden linked to the diagnosis and treatment of patients with chest pain is considerable, Dr. Lerman observed. It can involve a series of tests and culminate in a coronary angiogram. However, symptoms may continue if therapy does not correctly target one or more of several different potential mechanisms, including microvascular dysfunction and vasospastic disorders.
“This paper says that if you establish a program of coronary reactivity testing you will ultimately reduce health care costs, because patients stop coming back to the hospital, or their physician stops ordering more tests or repeat angiograms because the patient has a true diagnosis,” observed Morton J. Kern, MD, University of California, Irvine, and VA Long Beach (Calif.) Health Care.
“That elimination of uncertainty and reduction of testing has a good payoff,” Dr. Kern said in an interview. “The concept is good; the only challenge is that this is a complicated set of manipulations in the cath lab to get to the results.”
A minority of cardiac cath labs in the United States perform CR testing, despite its inclusion for ANOCA in guidelines from both the European Society of Cardiology and the American Heart Association/American College of Cardiology, the authors noted. Cost and its requirement for specialized expertise may contribute to its poor uptake in practice.
In an editorial accompanying the report, Dr. Kern and David J. Cohen, MD, Cardiovascular Research Foundation, New York, and St. Francis Hospital and Heart Center, Roslyn, N.Y., said they agree with the authors’ recommendation for more widespread use of CR testing.
However, the initiation of a CR testing program is no small task. “In addition to motivated practitioners, operators with specific procedural expertise must have formalized technical training to produce valid results and to limit the procedural risks,” they wrote.
Moreover, expenses for a CR testing program “will likely be incurred without balanced reimbursement, but the health care system will benefit in the long run.”
The total health-related costs for the two groups of 207 in the analysis were tracked for 2 years after the procedure and found to be significantly higher (P < .001) in the group that had received coronary angiography without CR testing. Their average annual cost was $37,804 (range, $26,933-$48,674), compared with $13,679 (range, $9,447-$17,910) for those that had undergone CR testing.
The angiography-only group’s costs for procedures (including surgical or percutaneous intervention, endoscopy, and bronchoscopy) averaged $5,872 (range, $3,798-$7,946), compared with $2,104 (range, $1,202-$3,006) in the CR testing group (P = .001).
Similarly, costs for any type of imaging, including at cardiac catheterization, averaged $2,639 (range, $2,093 to $3,185) and $1,426 (range, $1,090 to $1,761), respectively (P < .001).
Annual total hospital services costs were also higher in the angiography-only group at $21,820 versus $6,409 (P < .001) for the group that underwent CR testing.
Caution is required when interpreting these results, Matthew Tomey, MD, Mount Sinai Morningside Hospital and Icahn School of Medicine at Mount Sinai, New York, said in an interview.
“The observed cost differences are interesting and hypothesis generating but they fall short of providing strong evidence that [CR testing] saves money or that [it] should be incorporated into routine practice,” Dr. Tomey said. “Multiple biases can skew findings of retrospective observational studies. A prospective, randomized study would be needed to draw stronger conclusions.”
Still, it’s true that “there is substantial opportunity to do better in diagnosing chest pain in our patients with no apparent, explanatory obstructive coronary atherosclerosis,” he said. “There are emerging invasive and noninvasive ways to do so. Helping our patients get to the right diagnosis is the right thing to do. It will lead to better treatment recommendations, improved patient symptoms, improved patient confidence, and – it stands to reason – cost benefits in the long term.”
The study was funded by a grant from Philips. Dr. Lerman reported receiving honoraria from Philips Volcano. Dr. Kern disclosed speaking for Abbott Vascular, Boston Scientific, Acist, Opsens, and Zoll. Dr. Cohen disclosed receiving institutional grant support from Abbott Vascular, Boston Scientific, CathWorks, and Philips; and consulting income from Abbott, Boston Scientific, and Medtronic. Dr. Tomey reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Performing coronary reactivity (CR) testing during angiography in patients with angina without obstructive coronary disease (ANOCA) adds complexity and cost to the procedure but may, in the end, turn out to be a bargain.
probably by helping to limit downstream procedures and other use of health care resources.
In the retrospective study, CR testing included both adenosine and acetylcholine challenges to differentiate endothelium-dependent from endothelium-independent coronary reactivity as the physiological cause of ANOCA in individuals. Clarifying the cause at this stage of the patient’s clinical journey seemed to sharpen subsequent testing and management decisions, the researchers said.
Of the 414 patients with ANOCA who underwent invasive diagnostic angiography, 207 also received CR testing during the procedure. The difference in total healthcare costs between the two groups over 2 years averaged about $20,000, largely because of the CR-testing group’s reduced use of downstream imaging, interventional procedures, and other tests, notes a report on the study published in Circulation: Cardiovascular Interventions.
For such patients referred for coronary angiography found to be without obstructive disease, “the right thing to do is a vascular reactivity test to assess if there is any abnormality that can contribute to this patient’s symptoms and events,” senior author Amir Lerman, MD, Mayo Clinic, Rochester, Minn., said in an interview. Coronary reactivity testing “is expensive to set up initially, but it actually saves money by reducing the need for additional unnecessary testing and hospitalizations in these patients.”
The financial burden linked to the diagnosis and treatment of patients with chest pain is considerable, Dr. Lerman observed. It can involve a series of tests and culminate in a coronary angiogram. However, symptoms may continue if therapy does not correctly target one or more of several different potential mechanisms, including microvascular dysfunction and vasospastic disorders.
“This paper says that if you establish a program of coronary reactivity testing you will ultimately reduce health care costs, because patients stop coming back to the hospital, or their physician stops ordering more tests or repeat angiograms because the patient has a true diagnosis,” observed Morton J. Kern, MD, University of California, Irvine, and VA Long Beach (Calif.) Health Care.
“That elimination of uncertainty and reduction of testing has a good payoff,” Dr. Kern said in an interview. “The concept is good; the only challenge is that this is a complicated set of manipulations in the cath lab to get to the results.”
A minority of cardiac cath labs in the United States perform CR testing, despite its inclusion for ANOCA in guidelines from both the European Society of Cardiology and the American Heart Association/American College of Cardiology, the authors noted. Cost and its requirement for specialized expertise may contribute to its poor uptake in practice.
In an editorial accompanying the report, Dr. Kern and David J. Cohen, MD, Cardiovascular Research Foundation, New York, and St. Francis Hospital and Heart Center, Roslyn, N.Y., said they agree with the authors’ recommendation for more widespread use of CR testing.
However, the initiation of a CR testing program is no small task. “In addition to motivated practitioners, operators with specific procedural expertise must have formalized technical training to produce valid results and to limit the procedural risks,” they wrote.
Moreover, expenses for a CR testing program “will likely be incurred without balanced reimbursement, but the health care system will benefit in the long run.”
The total health-related costs for the two groups of 207 in the analysis were tracked for 2 years after the procedure and found to be significantly higher (P < .001) in the group that had received coronary angiography without CR testing. Their average annual cost was $37,804 (range, $26,933-$48,674), compared with $13,679 (range, $9,447-$17,910) for those that had undergone CR testing.
The angiography-only group’s costs for procedures (including surgical or percutaneous intervention, endoscopy, and bronchoscopy) averaged $5,872 (range, $3,798-$7,946), compared with $2,104 (range, $1,202-$3,006) in the CR testing group (P = .001).
Similarly, costs for any type of imaging, including at cardiac catheterization, averaged $2,639 (range, $2,093 to $3,185) and $1,426 (range, $1,090 to $1,761), respectively (P < .001).
Annual total hospital services costs were also higher in the angiography-only group at $21,820 versus $6,409 (P < .001) for the group that underwent CR testing.
Caution is required when interpreting these results, Matthew Tomey, MD, Mount Sinai Morningside Hospital and Icahn School of Medicine at Mount Sinai, New York, said in an interview.
“The observed cost differences are interesting and hypothesis generating but they fall short of providing strong evidence that [CR testing] saves money or that [it] should be incorporated into routine practice,” Dr. Tomey said. “Multiple biases can skew findings of retrospective observational studies. A prospective, randomized study would be needed to draw stronger conclusions.”
Still, it’s true that “there is substantial opportunity to do better in diagnosing chest pain in our patients with no apparent, explanatory obstructive coronary atherosclerosis,” he said. “There are emerging invasive and noninvasive ways to do so. Helping our patients get to the right diagnosis is the right thing to do. It will lead to better treatment recommendations, improved patient symptoms, improved patient confidence, and – it stands to reason – cost benefits in the long term.”
The study was funded by a grant from Philips. Dr. Lerman reported receiving honoraria from Philips Volcano. Dr. Kern disclosed speaking for Abbott Vascular, Boston Scientific, Acist, Opsens, and Zoll. Dr. Cohen disclosed receiving institutional grant support from Abbott Vascular, Boston Scientific, CathWorks, and Philips; and consulting income from Abbott, Boston Scientific, and Medtronic. Dr. Tomey reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Performing coronary reactivity (CR) testing during angiography in patients with angina without obstructive coronary disease (ANOCA) adds complexity and cost to the procedure but may, in the end, turn out to be a bargain.
probably by helping to limit downstream procedures and other use of health care resources.
In the retrospective study, CR testing included both adenosine and acetylcholine challenges to differentiate endothelium-dependent from endothelium-independent coronary reactivity as the physiological cause of ANOCA in individuals. Clarifying the cause at this stage of the patient’s clinical journey seemed to sharpen subsequent testing and management decisions, the researchers said.
Of the 414 patients with ANOCA who underwent invasive diagnostic angiography, 207 also received CR testing during the procedure. The difference in total healthcare costs between the two groups over 2 years averaged about $20,000, largely because of the CR-testing group’s reduced use of downstream imaging, interventional procedures, and other tests, notes a report on the study published in Circulation: Cardiovascular Interventions.
For such patients referred for coronary angiography found to be without obstructive disease, “the right thing to do is a vascular reactivity test to assess if there is any abnormality that can contribute to this patient’s symptoms and events,” senior author Amir Lerman, MD, Mayo Clinic, Rochester, Minn., said in an interview. Coronary reactivity testing “is expensive to set up initially, but it actually saves money by reducing the need for additional unnecessary testing and hospitalizations in these patients.”
The financial burden linked to the diagnosis and treatment of patients with chest pain is considerable, Dr. Lerman observed. It can involve a series of tests and culminate in a coronary angiogram. However, symptoms may continue if therapy does not correctly target one or more of several different potential mechanisms, including microvascular dysfunction and vasospastic disorders.
“This paper says that if you establish a program of coronary reactivity testing you will ultimately reduce health care costs, because patients stop coming back to the hospital, or their physician stops ordering more tests or repeat angiograms because the patient has a true diagnosis,” observed Morton J. Kern, MD, University of California, Irvine, and VA Long Beach (Calif.) Health Care.
“That elimination of uncertainty and reduction of testing has a good payoff,” Dr. Kern said in an interview. “The concept is good; the only challenge is that this is a complicated set of manipulations in the cath lab to get to the results.”
A minority of cardiac cath labs in the United States perform CR testing, despite its inclusion for ANOCA in guidelines from both the European Society of Cardiology and the American Heart Association/American College of Cardiology, the authors noted. Cost and its requirement for specialized expertise may contribute to its poor uptake in practice.
In an editorial accompanying the report, Dr. Kern and David J. Cohen, MD, Cardiovascular Research Foundation, New York, and St. Francis Hospital and Heart Center, Roslyn, N.Y., said they agree with the authors’ recommendation for more widespread use of CR testing.
However, the initiation of a CR testing program is no small task. “In addition to motivated practitioners, operators with specific procedural expertise must have formalized technical training to produce valid results and to limit the procedural risks,” they wrote.
Moreover, expenses for a CR testing program “will likely be incurred without balanced reimbursement, but the health care system will benefit in the long run.”
The total health-related costs for the two groups of 207 in the analysis were tracked for 2 years after the procedure and found to be significantly higher (P < .001) in the group that had received coronary angiography without CR testing. Their average annual cost was $37,804 (range, $26,933-$48,674), compared with $13,679 (range, $9,447-$17,910) for those that had undergone CR testing.
The angiography-only group’s costs for procedures (including surgical or percutaneous intervention, endoscopy, and bronchoscopy) averaged $5,872 (range, $3,798-$7,946), compared with $2,104 (range, $1,202-$3,006) in the CR testing group (P = .001).
Similarly, costs for any type of imaging, including at cardiac catheterization, averaged $2,639 (range, $2,093 to $3,185) and $1,426 (range, $1,090 to $1,761), respectively (P < .001).
Annual total hospital services costs were also higher in the angiography-only group at $21,820 versus $6,409 (P < .001) for the group that underwent CR testing.
Caution is required when interpreting these results, Matthew Tomey, MD, Mount Sinai Morningside Hospital and Icahn School of Medicine at Mount Sinai, New York, said in an interview.
“The observed cost differences are interesting and hypothesis generating but they fall short of providing strong evidence that [CR testing] saves money or that [it] should be incorporated into routine practice,” Dr. Tomey said. “Multiple biases can skew findings of retrospective observational studies. A prospective, randomized study would be needed to draw stronger conclusions.”
Still, it’s true that “there is substantial opportunity to do better in diagnosing chest pain in our patients with no apparent, explanatory obstructive coronary atherosclerosis,” he said. “There are emerging invasive and noninvasive ways to do so. Helping our patients get to the right diagnosis is the right thing to do. It will lead to better treatment recommendations, improved patient symptoms, improved patient confidence, and – it stands to reason – cost benefits in the long term.”
The study was funded by a grant from Philips. Dr. Lerman reported receiving honoraria from Philips Volcano. Dr. Kern disclosed speaking for Abbott Vascular, Boston Scientific, Acist, Opsens, and Zoll. Dr. Cohen disclosed receiving institutional grant support from Abbott Vascular, Boston Scientific, CathWorks, and Philips; and consulting income from Abbott, Boston Scientific, and Medtronic. Dr. Tomey reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CIRCULATION: CARDIOVASCULAR INTERVENTIONS
Aspirin not the best antiplatelet for CAD secondary prevention in meta-analysis
such as clopidogrel or ticagrelor rather than aspirin, suggests a patient-level meta-analysis of seven randomized trials.
The more than 24,000 patients in the meta-analysis, called PANTHER, had documented stable CAD, prior myocardial infarction (MI), or recent or remote surgical or percutaneous coronary revascularization.
About half of patients in each antiplatelet monotherapy trial received clopidogrel or ticagrelor, and the other half received aspirin. Follow-ups ranged from 6 months to 3 years.
Those taking a P2Y12 inhibitor showed a 12% reduction in risk (P = .012) for the primary efficacy outcome, a composite of cardiovascular (CV) death, MI, and stroke, over a median of about 1.35 years. The difference was driven primarily by a 23% reduction in risk for MI (P < .001); mortality seemed unaffected by antiplatelet treatment assignment.
Although the P2Y12 inhibitor and aspirin groups were similar with respect to risk of major bleeding, the P2Y12 inhibitor group showed significant reductions in risk for gastrointestinal (GI) bleeding, definite stent thrombosis, and hemorrhagic stroke; rates of hemorrhagic stroke were well under 1% in both groups.
The treatment effects were consistent across patient subgroups, including whether the aspirin comparison was with clopidogrel or ticagrelor.
“Taken together, our data challenge the central role of aspirin in secondary prevention and support a paradigm shift toward P2Y12 inhibitor monotherapy as long-term antiplatelet strategy in the sizable population of patients with coronary atherosclerosis,” Felice Gragnano, MD, PhD, said in an interview. “Given [their] superior efficacy and similar overall safety, P2Y12 inhibitors may be preferred [over] aspirin for the prevention of cardiovascular events in patients with CAD.”
Dr. Gragnano, of the University of Campania Luigi Vanvitelli, Caserta, Italy, who called PANTHER “the largest and most comprehensive synthesis of individual patient data from randomized trials comparing P2Y12 inhibitor monotherapy with aspirin monotherapy,” is lead author of the study, which was published online in the Journal of the American College of Cardiology.
Current guidelines recommend aspirin for antiplatelet monotherapy for patients with established CAD, Dr. Gragnano said, but “the primacy of aspirin in secondary prevention is based on historical trials conducted in the 1970s and 1980s and may not apply to contemporary practice.”
Moreover, later trials that compared P2Y12 inhibitors with aspirin for secondary prevention produced “inconsistent results,” possibly owing to their heterogeneous populations of patients with coronary, cerebrovascular, or peripheral vascular disease, he said. Study-level meta-analyses in this area “provide inconclusive evidence” because they haven’t evaluated treatment effects exclusively in patients with established CAD.
Most of the seven trials’ 24,325 participants had a history of MI, and some had peripheral artery disease (PAD); the rates were 56.2% and 9.1%, respectively. Coronary revascularization, either percutaneous or surgical, had been performed for about 70%. Most (61%) had presented with acute coronary syndromes, and the remainder had presented with chronic CAD.
About 76% of the combined cohorts were from Europe or North America; the rest were from Asia. The mean age of the patients was 64 years, and about 22% were women.
In all, 12,175 had been assigned to P2Y12 inhibitor monotherapy (62% received clopidogrel and 38% received ticagrelor); 12,147 received aspirin at dosages ranging from 75 mg to 325 mg daily.
The hazard ratio (HR) for the primary efficacy outcome, P2Y12 inhibitors vs. aspirin, was significantly reduced, at 0.88 (95% confidence interval [CI], 0.79-0.97; P = .012); the number needed to treat (NNT) to prevent one primary event over 2 years was 121, the report states.
The corresponding HR for MI was 0.77 (95% CI, 0.66-0.90; P < .001), for an NNT benefit of 136. For net adverse clinical events, the HR was 0.89 (95% CI, 0.81-0.98; P = .020), for an NNT benefit of 121.
Risk for major bleeding was not significantly different (HR, 0.87; 95% CI, 0.70-1.09; P = .23), nor were risks for stroke (HR, 0.84; 95% CI, 0.70-1.02; P = .076) or cardiovascular death (HR, 1.02; 95% CI, 0.86-1.20; P = .82).
Still, the P2Y12 inhibitor group showed significant risk reductions for the following:
- GI bleeding: HR, 0.75 (95% CI, 0.57-0.97; P = .027)
- Definite stent thrombosis: HR, 0.42 (95% CI, 0.19-0.97; P = .028)
- Hemorrhagic stroke: HR, 0.43 (95% CI, 0.23-0.83; P = .012)
The current findings are “hypothesis-generating but not definitive,” Dharam Kumbhani, MD, University of Texas Southwestern, Dallas, said in an interview.
It remains unclear “whether aspirin or P2Y12 inhibitor monotherapy is better for long-term maintenance use among patients with established CAD. Aspirin has historically been the agent of choice for this indication,” said Dr. Kumbhani, who with James A. de Lemos, MD, of the same institution, wrote an editorial accompanying the PANTHER report.
“It certainly would be appropriate to consider P2Y12 monotherapy preferentially for patients with prior or currently at high risk for GI or intracranial bleeding, for instance,” Dr. Kumbhani said. For the remainder, aspirin and P2Y12 inhibitors are both “reasonable alternatives.”
In their editorial, Dr. Kumbhani and Dr. de Lemos call the PANTHER meta-analysis “a well-done study with potentially important clinical implications.” The findings “make biological sense: P2Y12 inhibitors are more potent antiplatelet agents than aspirin and have less effect on gastrointestinal mucosal integrity.”
But for now, they wrote, “both aspirin and P2Y12 inhibitors remain viable alternatives for prevention of atherothrombotic events among patients with established CAD.”
Dr. Gragnano had no disclosures; potential conflicts for the other authors are in the report. Dr. Kumbhani reports no relevant relationships; Dr. de Lemos has received honoraria for participation in data safety monitoring boards from Eli Lilly, Novo Nordisk, AstraZeneca, and Janssen.
A version of this article first appeared on Medscape.com.
such as clopidogrel or ticagrelor rather than aspirin, suggests a patient-level meta-analysis of seven randomized trials.
The more than 24,000 patients in the meta-analysis, called PANTHER, had documented stable CAD, prior myocardial infarction (MI), or recent or remote surgical or percutaneous coronary revascularization.
About half of patients in each antiplatelet monotherapy trial received clopidogrel or ticagrelor, and the other half received aspirin. Follow-ups ranged from 6 months to 3 years.
Those taking a P2Y12 inhibitor showed a 12% reduction in risk (P = .012) for the primary efficacy outcome, a composite of cardiovascular (CV) death, MI, and stroke, over a median of about 1.35 years. The difference was driven primarily by a 23% reduction in risk for MI (P < .001); mortality seemed unaffected by antiplatelet treatment assignment.
Although the P2Y12 inhibitor and aspirin groups were similar with respect to risk of major bleeding, the P2Y12 inhibitor group showed significant reductions in risk for gastrointestinal (GI) bleeding, definite stent thrombosis, and hemorrhagic stroke; rates of hemorrhagic stroke were well under 1% in both groups.
The treatment effects were consistent across patient subgroups, including whether the aspirin comparison was with clopidogrel or ticagrelor.
“Taken together, our data challenge the central role of aspirin in secondary prevention and support a paradigm shift toward P2Y12 inhibitor monotherapy as long-term antiplatelet strategy in the sizable population of patients with coronary atherosclerosis,” Felice Gragnano, MD, PhD, said in an interview. “Given [their] superior efficacy and similar overall safety, P2Y12 inhibitors may be preferred [over] aspirin for the prevention of cardiovascular events in patients with CAD.”
Dr. Gragnano, of the University of Campania Luigi Vanvitelli, Caserta, Italy, who called PANTHER “the largest and most comprehensive synthesis of individual patient data from randomized trials comparing P2Y12 inhibitor monotherapy with aspirin monotherapy,” is lead author of the study, which was published online in the Journal of the American College of Cardiology.
Current guidelines recommend aspirin for antiplatelet monotherapy for patients with established CAD, Dr. Gragnano said, but “the primacy of aspirin in secondary prevention is based on historical trials conducted in the 1970s and 1980s and may not apply to contemporary practice.”
Moreover, later trials that compared P2Y12 inhibitors with aspirin for secondary prevention produced “inconsistent results,” possibly owing to their heterogeneous populations of patients with coronary, cerebrovascular, or peripheral vascular disease, he said. Study-level meta-analyses in this area “provide inconclusive evidence” because they haven’t evaluated treatment effects exclusively in patients with established CAD.
Most of the seven trials’ 24,325 participants had a history of MI, and some had peripheral artery disease (PAD); the rates were 56.2% and 9.1%, respectively. Coronary revascularization, either percutaneous or surgical, had been performed for about 70%. Most (61%) had presented with acute coronary syndromes, and the remainder had presented with chronic CAD.
About 76% of the combined cohorts were from Europe or North America; the rest were from Asia. The mean age of the patients was 64 years, and about 22% were women.
In all, 12,175 had been assigned to P2Y12 inhibitor monotherapy (62% received clopidogrel and 38% received ticagrelor); 12,147 received aspirin at dosages ranging from 75 mg to 325 mg daily.
The hazard ratio (HR) for the primary efficacy outcome, P2Y12 inhibitors vs. aspirin, was significantly reduced, at 0.88 (95% confidence interval [CI], 0.79-0.97; P = .012); the number needed to treat (NNT) to prevent one primary event over 2 years was 121, the report states.
The corresponding HR for MI was 0.77 (95% CI, 0.66-0.90; P < .001), for an NNT benefit of 136. For net adverse clinical events, the HR was 0.89 (95% CI, 0.81-0.98; P = .020), for an NNT benefit of 121.
Risk for major bleeding was not significantly different (HR, 0.87; 95% CI, 0.70-1.09; P = .23), nor were risks for stroke (HR, 0.84; 95% CI, 0.70-1.02; P = .076) or cardiovascular death (HR, 1.02; 95% CI, 0.86-1.20; P = .82).
Still, the P2Y12 inhibitor group showed significant risk reductions for the following:
- GI bleeding: HR, 0.75 (95% CI, 0.57-0.97; P = .027)
- Definite stent thrombosis: HR, 0.42 (95% CI, 0.19-0.97; P = .028)
- Hemorrhagic stroke: HR, 0.43 (95% CI, 0.23-0.83; P = .012)
The current findings are “hypothesis-generating but not definitive,” Dharam Kumbhani, MD, University of Texas Southwestern, Dallas, said in an interview.
It remains unclear “whether aspirin or P2Y12 inhibitor monotherapy is better for long-term maintenance use among patients with established CAD. Aspirin has historically been the agent of choice for this indication,” said Dr. Kumbhani, who with James A. de Lemos, MD, of the same institution, wrote an editorial accompanying the PANTHER report.
“It certainly would be appropriate to consider P2Y12 monotherapy preferentially for patients with prior or currently at high risk for GI or intracranial bleeding, for instance,” Dr. Kumbhani said. For the remainder, aspirin and P2Y12 inhibitors are both “reasonable alternatives.”
In their editorial, Dr. Kumbhani and Dr. de Lemos call the PANTHER meta-analysis “a well-done study with potentially important clinical implications.” The findings “make biological sense: P2Y12 inhibitors are more potent antiplatelet agents than aspirin and have less effect on gastrointestinal mucosal integrity.”
But for now, they wrote, “both aspirin and P2Y12 inhibitors remain viable alternatives for prevention of atherothrombotic events among patients with established CAD.”
Dr. Gragnano had no disclosures; potential conflicts for the other authors are in the report. Dr. Kumbhani reports no relevant relationships; Dr. de Lemos has received honoraria for participation in data safety monitoring boards from Eli Lilly, Novo Nordisk, AstraZeneca, and Janssen.
A version of this article first appeared on Medscape.com.
such as clopidogrel or ticagrelor rather than aspirin, suggests a patient-level meta-analysis of seven randomized trials.
The more than 24,000 patients in the meta-analysis, called PANTHER, had documented stable CAD, prior myocardial infarction (MI), or recent or remote surgical or percutaneous coronary revascularization.
About half of patients in each antiplatelet monotherapy trial received clopidogrel or ticagrelor, and the other half received aspirin. Follow-ups ranged from 6 months to 3 years.
Those taking a P2Y12 inhibitor showed a 12% reduction in risk (P = .012) for the primary efficacy outcome, a composite of cardiovascular (CV) death, MI, and stroke, over a median of about 1.35 years. The difference was driven primarily by a 23% reduction in risk for MI (P < .001); mortality seemed unaffected by antiplatelet treatment assignment.
Although the P2Y12 inhibitor and aspirin groups were similar with respect to risk of major bleeding, the P2Y12 inhibitor group showed significant reductions in risk for gastrointestinal (GI) bleeding, definite stent thrombosis, and hemorrhagic stroke; rates of hemorrhagic stroke were well under 1% in both groups.
The treatment effects were consistent across patient subgroups, including whether the aspirin comparison was with clopidogrel or ticagrelor.
“Taken together, our data challenge the central role of aspirin in secondary prevention and support a paradigm shift toward P2Y12 inhibitor monotherapy as long-term antiplatelet strategy in the sizable population of patients with coronary atherosclerosis,” Felice Gragnano, MD, PhD, said in an interview. “Given [their] superior efficacy and similar overall safety, P2Y12 inhibitors may be preferred [over] aspirin for the prevention of cardiovascular events in patients with CAD.”
Dr. Gragnano, of the University of Campania Luigi Vanvitelli, Caserta, Italy, who called PANTHER “the largest and most comprehensive synthesis of individual patient data from randomized trials comparing P2Y12 inhibitor monotherapy with aspirin monotherapy,” is lead author of the study, which was published online in the Journal of the American College of Cardiology.
Current guidelines recommend aspirin for antiplatelet monotherapy for patients with established CAD, Dr. Gragnano said, but “the primacy of aspirin in secondary prevention is based on historical trials conducted in the 1970s and 1980s and may not apply to contemporary practice.”
Moreover, later trials that compared P2Y12 inhibitors with aspirin for secondary prevention produced “inconsistent results,” possibly owing to their heterogeneous populations of patients with coronary, cerebrovascular, or peripheral vascular disease, he said. Study-level meta-analyses in this area “provide inconclusive evidence” because they haven’t evaluated treatment effects exclusively in patients with established CAD.
Most of the seven trials’ 24,325 participants had a history of MI, and some had peripheral artery disease (PAD); the rates were 56.2% and 9.1%, respectively. Coronary revascularization, either percutaneous or surgical, had been performed for about 70%. Most (61%) had presented with acute coronary syndromes, and the remainder had presented with chronic CAD.
About 76% of the combined cohorts were from Europe or North America; the rest were from Asia. The mean age of the patients was 64 years, and about 22% were women.
In all, 12,175 had been assigned to P2Y12 inhibitor monotherapy (62% received clopidogrel and 38% received ticagrelor); 12,147 received aspirin at dosages ranging from 75 mg to 325 mg daily.
The hazard ratio (HR) for the primary efficacy outcome, P2Y12 inhibitors vs. aspirin, was significantly reduced, at 0.88 (95% confidence interval [CI], 0.79-0.97; P = .012); the number needed to treat (NNT) to prevent one primary event over 2 years was 121, the report states.
The corresponding HR for MI was 0.77 (95% CI, 0.66-0.90; P < .001), for an NNT benefit of 136. For net adverse clinical events, the HR was 0.89 (95% CI, 0.81-0.98; P = .020), for an NNT benefit of 121.
Risk for major bleeding was not significantly different (HR, 0.87; 95% CI, 0.70-1.09; P = .23), nor were risks for stroke (HR, 0.84; 95% CI, 0.70-1.02; P = .076) or cardiovascular death (HR, 1.02; 95% CI, 0.86-1.20; P = .82).
Still, the P2Y12 inhibitor group showed significant risk reductions for the following:
- GI bleeding: HR, 0.75 (95% CI, 0.57-0.97; P = .027)
- Definite stent thrombosis: HR, 0.42 (95% CI, 0.19-0.97; P = .028)
- Hemorrhagic stroke: HR, 0.43 (95% CI, 0.23-0.83; P = .012)
The current findings are “hypothesis-generating but not definitive,” Dharam Kumbhani, MD, University of Texas Southwestern, Dallas, said in an interview.
It remains unclear “whether aspirin or P2Y12 inhibitor monotherapy is better for long-term maintenance use among patients with established CAD. Aspirin has historically been the agent of choice for this indication,” said Dr. Kumbhani, who with James A. de Lemos, MD, of the same institution, wrote an editorial accompanying the PANTHER report.
“It certainly would be appropriate to consider P2Y12 monotherapy preferentially for patients with prior or currently at high risk for GI or intracranial bleeding, for instance,” Dr. Kumbhani said. For the remainder, aspirin and P2Y12 inhibitors are both “reasonable alternatives.”
In their editorial, Dr. Kumbhani and Dr. de Lemos call the PANTHER meta-analysis “a well-done study with potentially important clinical implications.” The findings “make biological sense: P2Y12 inhibitors are more potent antiplatelet agents than aspirin and have less effect on gastrointestinal mucosal integrity.”
But for now, they wrote, “both aspirin and P2Y12 inhibitors remain viable alternatives for prevention of atherothrombotic events among patients with established CAD.”
Dr. Gragnano had no disclosures; potential conflicts for the other authors are in the report. Dr. Kumbhani reports no relevant relationships; Dr. de Lemos has received honoraria for participation in data safety monitoring boards from Eli Lilly, Novo Nordisk, AstraZeneca, and Janssen.
A version of this article first appeared on Medscape.com.
FROM JACC
Expanded coverage of carotid stenting in CMS draft proposal
The new memo follows a national coverage analysis for CAS that was initiated in January 2023 and considers 193 public comments received in the ensuing month.
That analysis followed a request from the Multispecialty Carotid Alliance (MSCA) to make the existing guidelines less restrictive.
The decision proposal would expand coverage for CAS “to standard surgical risk patients by removing the limitation of coverage to only high surgical risk patients.” It would limit it to patients for whom CAS is considered “reasonable and necessary” and who are either symptomatic with carotid stenosis of 50% or greater or asymptomatic with carotid stenosis of at least 70%.
The proposal would require practitioners to “engage in a formal shared decision-making interaction with the beneficiary” that involves use of a “validated decision-making tool.” The conversation must include discussion of all treatment options and their risks and benefits and cover information from the clinical guidelines, as well as “incorporate the patient’s personal preferences and priorities.”
Much of the proposed coverage criteria resemble recommendations from several societies that offered comments in response to the Jan. 12 CMS statement that led to the current draft proposal. They include, along with MSCA, the American Association of Neurological Surgeons and the Congress of Neurological Surgeons, and jointly the American College of Cardiology and the American Heart Association.
Carotid stenting, commented the ACC/AHA, “was first introduced in 1994, and the field has matured in the last 3 decades.” The procedure “is a well-established treatment option.” The groups declared support for “removal of the facility and operator requirement for CAS consistent with the current state of the published literature and standard clinical practice.”
The current CMS draft proposal acknowledges the publication of five major randomized controlled trials and a number of “large, prospective registry-based studies” since 2009 that support its proposed coverage criteria.
Collectively, it states, the evidence “suffices to demonstrate that CAS and [carotid endarterectomy] are similarly effective” with respect to the clinical primary endpoints of recent trials “in patients with either standard or high surgical risk and who are symptomatic with carotid artery stenosis ≥ 50% or asymptomatic with stenosis ≥ 70%.”
A version of this article appeared on Medscape.com.
The new memo follows a national coverage analysis for CAS that was initiated in January 2023 and considers 193 public comments received in the ensuing month.
That analysis followed a request from the Multispecialty Carotid Alliance (MSCA) to make the existing guidelines less restrictive.
The decision proposal would expand coverage for CAS “to standard surgical risk patients by removing the limitation of coverage to only high surgical risk patients.” It would limit it to patients for whom CAS is considered “reasonable and necessary” and who are either symptomatic with carotid stenosis of 50% or greater or asymptomatic with carotid stenosis of at least 70%.
The proposal would require practitioners to “engage in a formal shared decision-making interaction with the beneficiary” that involves use of a “validated decision-making tool.” The conversation must include discussion of all treatment options and their risks and benefits and cover information from the clinical guidelines, as well as “incorporate the patient’s personal preferences and priorities.”
Much of the proposed coverage criteria resemble recommendations from several societies that offered comments in response to the Jan. 12 CMS statement that led to the current draft proposal. They include, along with MSCA, the American Association of Neurological Surgeons and the Congress of Neurological Surgeons, and jointly the American College of Cardiology and the American Heart Association.
Carotid stenting, commented the ACC/AHA, “was first introduced in 1994, and the field has matured in the last 3 decades.” The procedure “is a well-established treatment option.” The groups declared support for “removal of the facility and operator requirement for CAS consistent with the current state of the published literature and standard clinical practice.”
The current CMS draft proposal acknowledges the publication of five major randomized controlled trials and a number of “large, prospective registry-based studies” since 2009 that support its proposed coverage criteria.
Collectively, it states, the evidence “suffices to demonstrate that CAS and [carotid endarterectomy] are similarly effective” with respect to the clinical primary endpoints of recent trials “in patients with either standard or high surgical risk and who are symptomatic with carotid artery stenosis ≥ 50% or asymptomatic with stenosis ≥ 70%.”
A version of this article appeared on Medscape.com.
The new memo follows a national coverage analysis for CAS that was initiated in January 2023 and considers 193 public comments received in the ensuing month.
That analysis followed a request from the Multispecialty Carotid Alliance (MSCA) to make the existing guidelines less restrictive.
The decision proposal would expand coverage for CAS “to standard surgical risk patients by removing the limitation of coverage to only high surgical risk patients.” It would limit it to patients for whom CAS is considered “reasonable and necessary” and who are either symptomatic with carotid stenosis of 50% or greater or asymptomatic with carotid stenosis of at least 70%.
The proposal would require practitioners to “engage in a formal shared decision-making interaction with the beneficiary” that involves use of a “validated decision-making tool.” The conversation must include discussion of all treatment options and their risks and benefits and cover information from the clinical guidelines, as well as “incorporate the patient’s personal preferences and priorities.”
Much of the proposed coverage criteria resemble recommendations from several societies that offered comments in response to the Jan. 12 CMS statement that led to the current draft proposal. They include, along with MSCA, the American Association of Neurological Surgeons and the Congress of Neurological Surgeons, and jointly the American College of Cardiology and the American Heart Association.
Carotid stenting, commented the ACC/AHA, “was first introduced in 1994, and the field has matured in the last 3 decades.” The procedure “is a well-established treatment option.” The groups declared support for “removal of the facility and operator requirement for CAS consistent with the current state of the published literature and standard clinical practice.”
The current CMS draft proposal acknowledges the publication of five major randomized controlled trials and a number of “large, prospective registry-based studies” since 2009 that support its proposed coverage criteria.
Collectively, it states, the evidence “suffices to demonstrate that CAS and [carotid endarterectomy] are similarly effective” with respect to the clinical primary endpoints of recent trials “in patients with either standard or high surgical risk and who are symptomatic with carotid artery stenosis ≥ 50% or asymptomatic with stenosis ≥ 70%.”
A version of this article appeared on Medscape.com.
Mixed bag: New performance data on femoral-popliteal artery revascularization
Measured one way, success for peripheral vascular intervention (PVI) in the femoropopliteal arteries for patients with intermittent claudication has improved, as the need for repeat PVI appears to be very low, and lower than in recent years, a new analysis suggests. But measured another way, the researchers said, PVI’s record of success in peripheral arterial disease (PAD) remains marred by a substantial risk for amputation involving the treated limb.
In their analysis, The rate for popliteal interventions was significantly higher than for PVI limited to the superficial femoral artery (SFA), 7.5% and 3.4%, respectively.
The 4-year rate of repeat target-vessel revascularization, however, was “lower than expected” at 15.2% in the analysis, which was based on the PINC AI Healthcare Data database covering over 1,100 U.S. hospitals. The study was published online in JACC: Cardiovascular Interventions.
The amputation rates for index treated limbs “surprised us,” lead author S. Elissa Altin, MD, Yale University, New Haven, Conn., said in an interview. The increased rate after procedures limited to the popliteal artery, compared with the SFA, “were even more concerning,” she said. “This is higher than accepted natural history rates of amputation in patients with conservatively managed claudication.”
Of particular concern in the study, agreed the author of an accompanying editorial, “is the finding of a 1 in 25 risk for amputation among patients with [intermittent claudication] undergoing revascularization, which underscores that both patients and physicians must ensure that evidence-based lifestyle and medical therapies are exhausted prior to pursuing [femoropopliteal] revascularization.”
Given such amputation concerns “and the availability of effective lifestyle and medical therapies,” wrote Debabrata Mukherjee, MD, Texas Tech University Health Sciences Center, El Paso, “PVI should be restricted in stable PAD only for those with persistent lifestyle-limiting claudication despite [guideline-directed medical therapy] and structured exercise therapy.”
Dr. Altin and colleagues analyzed data from 19,324 patients with intermittent claudication (mean age, 69 years; 59% men) who underwent femoropopliteal PVI from 2016 to 2020.
Use of atherectomy and of drug-eluting balloons were both similarly prevalent for popliteal and SFA target arteries; however, SFA lesions were more commonly treated with stents.
The rate of amputation in the treated limb over 4 years was 4.3%; the rate of major (above the ankle) amputation was 3.2%.
The multivariable-adjusted treated-limb amputation hazard ratio for popliteal versus SFA procedures was for 2.10 (95% confidence interval, 1.52-2.92) for any amputation and 1.98 (95% CI, 1.32-2.95) for major amputation.
The 4-year rate of index-limb repeat revascularization was 16.7% overall, 20.1% for patients with an index procedure in both the popliteal and SFA segments, 19% after popliteal-only procedures, and 15.4% after SFA-only procedures (P < .0001), the report stated.
The overall lower-than-expected revascularization rates, the authors proposed, may reflect improvements in endovascular therapies for femoropopliteal lesions, such as drug-eluting stents and advances in medical therapy.
“Additionally, this may underscore a difference between trial-defined target-lesion revascularization compared with clinically driven target-lesion revascularization in practice,” they wrote.
The study’s revascularization rates could have been underestimated because “some of the patients in this study may have had procedures conducted in other hospital systems or at an office-based lab during the study period,” proposed interventional cardiologist Seyi Bolorunduro MD, MPH, INOVA Heart and Vascular Institute, Falls Church, Va.
“This and other studies highlight the need to be cautious about offering PVI to patients with intermittent claudication,” said Dr. Bolorunduro, who was not connected with the current study. On the other hand, he added, randomized trial data show “that combination therapy with PVI followed by supervised exercise results in greater improvement in walking distances and quality-of-life scores, compared with supervised exercise alone, at 1 year.’
Femoropopliteal PVI “is an important tool for patients with residual, truly lifestyle-limiting claudication after exhausting medical therapies, complete smoking cessation, and structured exercise programs,” Dr. Altin said. Future studies, she added, should look prospectively at patients with claudication who underwent early versus delayed invasive management.
In his editorial, Dr. Mukherjee said that, for patients with PAD and claudication, a proprotein convertase subtilisin/kexin type 9 inhibitor may be recommended if LDL cholesterol remains 70 mg/dL or higher and symptoms persist after a regimen of lifestyle modification, exercise, antiplatelet therapy, and high-intensity statins and other guideline-directed medical therapy. He also suggests a direct oral anticoagulant be considered before resorting to endovascular or surgical revascularization.
“We need to optimize risk-factor modification, medical therapy and exercise, and only reserve PVI for patients with severe lifestyle-limiting intermittent claudication who have tried and failed everything else,” Dr. Bolorunduro agreed in an interview. “I educate my patients about [the amputation] risk and let them know that PVI is not a panacea.”
Dr. Altin has disclosed no relevant relationships. Dr. Mukherjee and Dr. Bolorunduro have no relevant disclosures.
A version of this article first appeared on Medscape.com.
Measured one way, success for peripheral vascular intervention (PVI) in the femoropopliteal arteries for patients with intermittent claudication has improved, as the need for repeat PVI appears to be very low, and lower than in recent years, a new analysis suggests. But measured another way, the researchers said, PVI’s record of success in peripheral arterial disease (PAD) remains marred by a substantial risk for amputation involving the treated limb.
In their analysis, The rate for popliteal interventions was significantly higher than for PVI limited to the superficial femoral artery (SFA), 7.5% and 3.4%, respectively.
The 4-year rate of repeat target-vessel revascularization, however, was “lower than expected” at 15.2% in the analysis, which was based on the PINC AI Healthcare Data database covering over 1,100 U.S. hospitals. The study was published online in JACC: Cardiovascular Interventions.
The amputation rates for index treated limbs “surprised us,” lead author S. Elissa Altin, MD, Yale University, New Haven, Conn., said in an interview. The increased rate after procedures limited to the popliteal artery, compared with the SFA, “were even more concerning,” she said. “This is higher than accepted natural history rates of amputation in patients with conservatively managed claudication.”
Of particular concern in the study, agreed the author of an accompanying editorial, “is the finding of a 1 in 25 risk for amputation among patients with [intermittent claudication] undergoing revascularization, which underscores that both patients and physicians must ensure that evidence-based lifestyle and medical therapies are exhausted prior to pursuing [femoropopliteal] revascularization.”
Given such amputation concerns “and the availability of effective lifestyle and medical therapies,” wrote Debabrata Mukherjee, MD, Texas Tech University Health Sciences Center, El Paso, “PVI should be restricted in stable PAD only for those with persistent lifestyle-limiting claudication despite [guideline-directed medical therapy] and structured exercise therapy.”
Dr. Altin and colleagues analyzed data from 19,324 patients with intermittent claudication (mean age, 69 years; 59% men) who underwent femoropopliteal PVI from 2016 to 2020.
Use of atherectomy and of drug-eluting balloons were both similarly prevalent for popliteal and SFA target arteries; however, SFA lesions were more commonly treated with stents.
The rate of amputation in the treated limb over 4 years was 4.3%; the rate of major (above the ankle) amputation was 3.2%.
The multivariable-adjusted treated-limb amputation hazard ratio for popliteal versus SFA procedures was for 2.10 (95% confidence interval, 1.52-2.92) for any amputation and 1.98 (95% CI, 1.32-2.95) for major amputation.
The 4-year rate of index-limb repeat revascularization was 16.7% overall, 20.1% for patients with an index procedure in both the popliteal and SFA segments, 19% after popliteal-only procedures, and 15.4% after SFA-only procedures (P < .0001), the report stated.
The overall lower-than-expected revascularization rates, the authors proposed, may reflect improvements in endovascular therapies for femoropopliteal lesions, such as drug-eluting stents and advances in medical therapy.
“Additionally, this may underscore a difference between trial-defined target-lesion revascularization compared with clinically driven target-lesion revascularization in practice,” they wrote.
The study’s revascularization rates could have been underestimated because “some of the patients in this study may have had procedures conducted in other hospital systems or at an office-based lab during the study period,” proposed interventional cardiologist Seyi Bolorunduro MD, MPH, INOVA Heart and Vascular Institute, Falls Church, Va.
“This and other studies highlight the need to be cautious about offering PVI to patients with intermittent claudication,” said Dr. Bolorunduro, who was not connected with the current study. On the other hand, he added, randomized trial data show “that combination therapy with PVI followed by supervised exercise results in greater improvement in walking distances and quality-of-life scores, compared with supervised exercise alone, at 1 year.’
Femoropopliteal PVI “is an important tool for patients with residual, truly lifestyle-limiting claudication after exhausting medical therapies, complete smoking cessation, and structured exercise programs,” Dr. Altin said. Future studies, she added, should look prospectively at patients with claudication who underwent early versus delayed invasive management.
In his editorial, Dr. Mukherjee said that, for patients with PAD and claudication, a proprotein convertase subtilisin/kexin type 9 inhibitor may be recommended if LDL cholesterol remains 70 mg/dL or higher and symptoms persist after a regimen of lifestyle modification, exercise, antiplatelet therapy, and high-intensity statins and other guideline-directed medical therapy. He also suggests a direct oral anticoagulant be considered before resorting to endovascular or surgical revascularization.
“We need to optimize risk-factor modification, medical therapy and exercise, and only reserve PVI for patients with severe lifestyle-limiting intermittent claudication who have tried and failed everything else,” Dr. Bolorunduro agreed in an interview. “I educate my patients about [the amputation] risk and let them know that PVI is not a panacea.”
Dr. Altin has disclosed no relevant relationships. Dr. Mukherjee and Dr. Bolorunduro have no relevant disclosures.
A version of this article first appeared on Medscape.com.
Measured one way, success for peripheral vascular intervention (PVI) in the femoropopliteal arteries for patients with intermittent claudication has improved, as the need for repeat PVI appears to be very low, and lower than in recent years, a new analysis suggests. But measured another way, the researchers said, PVI’s record of success in peripheral arterial disease (PAD) remains marred by a substantial risk for amputation involving the treated limb.
In their analysis, The rate for popliteal interventions was significantly higher than for PVI limited to the superficial femoral artery (SFA), 7.5% and 3.4%, respectively.
The 4-year rate of repeat target-vessel revascularization, however, was “lower than expected” at 15.2% in the analysis, which was based on the PINC AI Healthcare Data database covering over 1,100 U.S. hospitals. The study was published online in JACC: Cardiovascular Interventions.
The amputation rates for index treated limbs “surprised us,” lead author S. Elissa Altin, MD, Yale University, New Haven, Conn., said in an interview. The increased rate after procedures limited to the popliteal artery, compared with the SFA, “were even more concerning,” she said. “This is higher than accepted natural history rates of amputation in patients with conservatively managed claudication.”
Of particular concern in the study, agreed the author of an accompanying editorial, “is the finding of a 1 in 25 risk for amputation among patients with [intermittent claudication] undergoing revascularization, which underscores that both patients and physicians must ensure that evidence-based lifestyle and medical therapies are exhausted prior to pursuing [femoropopliteal] revascularization.”
Given such amputation concerns “and the availability of effective lifestyle and medical therapies,” wrote Debabrata Mukherjee, MD, Texas Tech University Health Sciences Center, El Paso, “PVI should be restricted in stable PAD only for those with persistent lifestyle-limiting claudication despite [guideline-directed medical therapy] and structured exercise therapy.”
Dr. Altin and colleagues analyzed data from 19,324 patients with intermittent claudication (mean age, 69 years; 59% men) who underwent femoropopliteal PVI from 2016 to 2020.
Use of atherectomy and of drug-eluting balloons were both similarly prevalent for popliteal and SFA target arteries; however, SFA lesions were more commonly treated with stents.
The rate of amputation in the treated limb over 4 years was 4.3%; the rate of major (above the ankle) amputation was 3.2%.
The multivariable-adjusted treated-limb amputation hazard ratio for popliteal versus SFA procedures was for 2.10 (95% confidence interval, 1.52-2.92) for any amputation and 1.98 (95% CI, 1.32-2.95) for major amputation.
The 4-year rate of index-limb repeat revascularization was 16.7% overall, 20.1% for patients with an index procedure in both the popliteal and SFA segments, 19% after popliteal-only procedures, and 15.4% after SFA-only procedures (P < .0001), the report stated.
The overall lower-than-expected revascularization rates, the authors proposed, may reflect improvements in endovascular therapies for femoropopliteal lesions, such as drug-eluting stents and advances in medical therapy.
“Additionally, this may underscore a difference between trial-defined target-lesion revascularization compared with clinically driven target-lesion revascularization in practice,” they wrote.
The study’s revascularization rates could have been underestimated because “some of the patients in this study may have had procedures conducted in other hospital systems or at an office-based lab during the study period,” proposed interventional cardiologist Seyi Bolorunduro MD, MPH, INOVA Heart and Vascular Institute, Falls Church, Va.
“This and other studies highlight the need to be cautious about offering PVI to patients with intermittent claudication,” said Dr. Bolorunduro, who was not connected with the current study. On the other hand, he added, randomized trial data show “that combination therapy with PVI followed by supervised exercise results in greater improvement in walking distances and quality-of-life scores, compared with supervised exercise alone, at 1 year.’
Femoropopliteal PVI “is an important tool for patients with residual, truly lifestyle-limiting claudication after exhausting medical therapies, complete smoking cessation, and structured exercise programs,” Dr. Altin said. Future studies, she added, should look prospectively at patients with claudication who underwent early versus delayed invasive management.
In his editorial, Dr. Mukherjee said that, for patients with PAD and claudication, a proprotein convertase subtilisin/kexin type 9 inhibitor may be recommended if LDL cholesterol remains 70 mg/dL or higher and symptoms persist after a regimen of lifestyle modification, exercise, antiplatelet therapy, and high-intensity statins and other guideline-directed medical therapy. He also suggests a direct oral anticoagulant be considered before resorting to endovascular or surgical revascularization.
“We need to optimize risk-factor modification, medical therapy and exercise, and only reserve PVI for patients with severe lifestyle-limiting intermittent claudication who have tried and failed everything else,” Dr. Bolorunduro agreed in an interview. “I educate my patients about [the amputation] risk and let them know that PVI is not a panacea.”
Dr. Altin has disclosed no relevant relationships. Dr. Mukherjee and Dr. Bolorunduro have no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM JACC: CARDIOVASCULAR INTERVENTIONS
FDA: No excess mortality risk from paclitaxel stents, balloons for peripheral intervention
, the agency July 11 in a statement to health care providers.
The FDA announcement comes about 4 years after it warned physicians of a “potentially concerning” signal of excess mortality linked to paclitaxel-coated balloons and paclitaxel-eluting stents in published analysis.
The agency’s concerns had been based on a December 2018 meta-analysis in the Journal of the American Heart Association that saw a 68% jump in mortality risk at 2 years and a 93% excess risk at 5 years associated with the paclitaxel devices in the periphery.
The findings, which led an FDA advisory committee to recommend device labeling changes and otherwise upended the practice of peripheral interventions, were followed by an FDA recommendation to limit the use of paclitaxel devices in the periphery to higher-risk cases.
In its July 11 update to providers, the FDA said it was satisfied the devices do not pose an excess mortality risk. It based its conclusion on extensive further evidence review and recently available “additional data” from the randomized controlled trials (RCTs) contributing to the meta-analysis that had ignited the controversy.
“FDA clinicians and statisticians reviewed the study data,” the agency said, “and concluded that the updated RCT meta-analysis does not indicate that the use of paclitaxel-coated devices is associated with a late mortality risk.”
A version of this article originally appeared on Medscape.com.
, the agency July 11 in a statement to health care providers.
The FDA announcement comes about 4 years after it warned physicians of a “potentially concerning” signal of excess mortality linked to paclitaxel-coated balloons and paclitaxel-eluting stents in published analysis.
The agency’s concerns had been based on a December 2018 meta-analysis in the Journal of the American Heart Association that saw a 68% jump in mortality risk at 2 years and a 93% excess risk at 5 years associated with the paclitaxel devices in the periphery.
The findings, which led an FDA advisory committee to recommend device labeling changes and otherwise upended the practice of peripheral interventions, were followed by an FDA recommendation to limit the use of paclitaxel devices in the periphery to higher-risk cases.
In its July 11 update to providers, the FDA said it was satisfied the devices do not pose an excess mortality risk. It based its conclusion on extensive further evidence review and recently available “additional data” from the randomized controlled trials (RCTs) contributing to the meta-analysis that had ignited the controversy.
“FDA clinicians and statisticians reviewed the study data,” the agency said, “and concluded that the updated RCT meta-analysis does not indicate that the use of paclitaxel-coated devices is associated with a late mortality risk.”
A version of this article originally appeared on Medscape.com.
, the agency July 11 in a statement to health care providers.
The FDA announcement comes about 4 years after it warned physicians of a “potentially concerning” signal of excess mortality linked to paclitaxel-coated balloons and paclitaxel-eluting stents in published analysis.
The agency’s concerns had been based on a December 2018 meta-analysis in the Journal of the American Heart Association that saw a 68% jump in mortality risk at 2 years and a 93% excess risk at 5 years associated with the paclitaxel devices in the periphery.
The findings, which led an FDA advisory committee to recommend device labeling changes and otherwise upended the practice of peripheral interventions, were followed by an FDA recommendation to limit the use of paclitaxel devices in the periphery to higher-risk cases.
In its July 11 update to providers, the FDA said it was satisfied the devices do not pose an excess mortality risk. It based its conclusion on extensive further evidence review and recently available “additional data” from the randomized controlled trials (RCTs) contributing to the meta-analysis that had ignited the controversy.
“FDA clinicians and statisticians reviewed the study data,” the agency said, “and concluded that the updated RCT meta-analysis does not indicate that the use of paclitaxel-coated devices is associated with a late mortality risk.”
A version of this article originally appeared on Medscape.com.