Anticoagulation Hub

The type of surgical procedure performed is a significant predictor of hospital readmission, reported Dr. Kevin R. Kasten and his associates at East Carolina University, Greenville, N.C.

In an analysis of 217,389 surgery patients, postoperative adverse events, specifically unplanned operating room return (odds ratio, 8.5; CI, 8.0-9.0), pulmonary embolism (OR, 8.2; CI, 7.1-9.6), deep incisional infection (OR, 7.5; CI, 6.7-8.5), and organ space infection (OR, 5.8; CI, 5.3-6.3), were significantly associated with an increased readmission risk. In addition, specific procedures associated with a higher risk for readmission included cystectomy, proctectomy, pancreatectomy, and lower-extremity vascular interventions.

The findings of this study suggest that “adverse events are a better predictor of 30[-day] readmission than patient comorbidity,” the authors said in the report. “As such, efforts to prevent adverse events such as return to the operating room, pulmonary embolism, surgical site infections, and myocardial infarction are crucial to prevention of readmission.”

Read the full article in the Journal of Surgical Research.

The type of surgical procedure performed is a significant predictor of hospital readmission, reported Dr. Kevin R. Kasten and his associates at East Carolina University, Greenville, N.C.

In an analysis of 217,389 surgery patients, postoperative adverse events, specifically unplanned operating room return (odds ratio, 8.5; CI, 8.0-9.0), pulmonary embolism (OR, 8.2; CI, 7.1-9.6), deep incisional infection (OR, 7.5; CI, 6.7-8.5), and organ space infection (OR, 5.8; CI, 5.3-6.3), were significantly associated with an increased readmission risk. In addition, specific procedures associated with a higher risk for readmission included cystectomy, proctectomy, pancreatectomy, and lower-extremity vascular interventions.

The findings of this study suggest that “adverse events are a better predictor of 30[-day] readmission than patient comorbidity,” the authors said in the report. “As such, efforts to prevent adverse events such as return to the operating room, pulmonary embolism, surgical site infections, and myocardial infarction are crucial to prevention of readmission.”

Read the full article in the Journal of Surgical Research.

The type of surgical procedure performed is a significant predictor of hospital readmission, reported Dr. Kevin R. Kasten and his associates at East Carolina University, Greenville, N.C.

In an analysis of 217,389 surgery patients, postoperative adverse events, specifically unplanned operating room return (odds ratio, 8.5; CI, 8.0-9.0), pulmonary embolism (OR, 8.2; CI, 7.1-9.6), deep incisional infection (OR, 7.5; CI, 6.7-8.5), and organ space infection (OR, 5.8; CI, 5.3-6.3), were significantly associated with an increased readmission risk. In addition, specific procedures associated with a higher risk for readmission included cystectomy, proctectomy, pancreatectomy, and lower-extremity vascular interventions.

The findings of this study suggest that “adverse events are a better predictor of 30[-day] readmission than patient comorbidity,” the authors said in the report. “As such, efforts to prevent adverse events such as return to the operating room, pulmonary embolism, surgical site infections, and myocardial infarction are crucial to prevention of readmission.”

Read the full article in the Journal of Surgical Research.

Even after excluding patients with atrial fibrillation, the duration of anticoagulant treatment for patients with unprovoked venous thromboembolism (VTE) and patients with transient risk factors often exceeded 1 year, according to a study published in Thrombosis Research.

In a large prospective cohort study, lead author Dr. Walter Ageno of the University of Insubria, Varese, Italy, and his associates examined 6,944 patients with a first episode of VTE. In this sample, 55% of patients with unprovoked events, 42% of patients with a transient risk factor, and 43% of patients with cancer received anticoagulant treatment for more than 12 months. The American College of Chest Physicians guideline recommends a 3-month treatment duration for patients with VTE secondary to transient risk factors. Pulmonary embolism at presentation, VTE recurrence while on treatment, chronic heart failure, and advanced age were independently associated with treatment for more than 12 months. Patients who died during the first year of treatment were excluded from the results.

Although clinicians tend to base their VTE treatment decisions on individual risk stratification, “this approach may expose a substantial proportion of patients, in particular those with VTE secondary to transient risk factors, to a possibly unnecessary risk of bleeding,” the investigators concluded.

Read the full article here: Thrombosis Research 2015.

Even after excluding patients with atrial fibrillation, the duration of anticoagulant treatment for patients with unprovoked venous thromboembolism (VTE) and patients with transient risk factors often exceeded 1 year, according to a study published in Thrombosis Research.

In a large prospective cohort study, lead author Dr. Walter Ageno of the University of Insubria, Varese, Italy, and his associates examined 6,944 patients with a first episode of VTE. In this sample, 55% of patients with unprovoked events, 42% of patients with a transient risk factor, and 43% of patients with cancer received anticoagulant treatment for more than 12 months. The American College of Chest Physicians guideline recommends a 3-month treatment duration for patients with VTE secondary to transient risk factors. Pulmonary embolism at presentation, VTE recurrence while on treatment, chronic heart failure, and advanced age were independently associated with treatment for more than 12 months. Patients who died during the first year of treatment were excluded from the results.

Although clinicians tend to base their VTE treatment decisions on individual risk stratification, “this approach may expose a substantial proportion of patients, in particular those with VTE secondary to transient risk factors, to a possibly unnecessary risk of bleeding,” the investigators concluded.

Read the full article here: Thrombosis Research 2015.

Even after excluding patients with atrial fibrillation, the duration of anticoagulant treatment for patients with unprovoked venous thromboembolism (VTE) and patients with transient risk factors often exceeded 1 year, according to a study published in Thrombosis Research.

In a large prospective cohort study, lead author Dr. Walter Ageno of the University of Insubria, Varese, Italy, and his associates examined 6,944 patients with a first episode of VTE. In this sample, 55% of patients with unprovoked events, 42% of patients with a transient risk factor, and 43% of patients with cancer received anticoagulant treatment for more than 12 months. The American College of Chest Physicians guideline recommends a 3-month treatment duration for patients with VTE secondary to transient risk factors. Pulmonary embolism at presentation, VTE recurrence while on treatment, chronic heart failure, and advanced age were independently associated with treatment for more than 12 months. Patients who died during the first year of treatment were excluded from the results.

Although clinicians tend to base their VTE treatment decisions on individual risk stratification, “this approach may expose a substantial proportion of patients, in particular those with VTE secondary to transient risk factors, to a possibly unnecessary risk of bleeding,” the investigators concluded.

Read the full article here: Thrombosis Research 2015.

Among surgical patients treated in and discharged from VA hospitals, 49.4% of possible venous thromboembolism s and 47.8% of probable VTEs were diagnosed within 30 days after surgery, and 63.1% of possible VTEs and 62.9% of probable VTEs were diagnosed within 90 days after surgery, according to Dr. Richard E. Nelson of the University of Utah, Salt Lake City.

In a retrospective cohort study, researchers examined medical records from 468,515 operations on 383,551 patients who underwent surgery without prior VTE between Jan. 1, 2005 and Dec. 31, 2010. In total, VTE occurred in 1.3% of surgical admissions for VA patients in the 90 days after surgery. However, the researchers argued that presumed VTE diagnoses should not be monitored based on inpatient records alone.

“Reliable monitoring of postoperative VTE events should incorporate two aspects. First, it should use data sources that allow for extraction of information from unstructured medical records. Second, it should use data sources that have the ability to follow patients after discharge from the hospital,” they said.

Read the full article in Thrombosis Research.

Among surgical patients treated in and discharged from VA hospitals, 49.4% of possible venous thromboembolism s and 47.8% of probable VTEs were diagnosed within 30 days after surgery, and 63.1% of possible VTEs and 62.9% of probable VTEs were diagnosed within 90 days after surgery, according to Dr. Richard E. Nelson of the University of Utah, Salt Lake City.

In a retrospective cohort study, researchers examined medical records from 468,515 operations on 383,551 patients who underwent surgery without prior VTE between Jan. 1, 2005 and Dec. 31, 2010. In total, VTE occurred in 1.3% of surgical admissions for VA patients in the 90 days after surgery. However, the researchers argued that presumed VTE diagnoses should not be monitored based on inpatient records alone.

“Reliable monitoring of postoperative VTE events should incorporate two aspects. First, it should use data sources that allow for extraction of information from unstructured medical records. Second, it should use data sources that have the ability to follow patients after discharge from the hospital,” they said.

Read the full article in Thrombosis Research.

Among surgical patients treated in and discharged from VA hospitals, 49.4% of possible venous thromboembolism s and 47.8% of probable VTEs were diagnosed within 30 days after surgery, and 63.1% of possible VTEs and 62.9% of probable VTEs were diagnosed within 90 days after surgery, according to Dr. Richard E. Nelson of the University of Utah, Salt Lake City.

In a retrospective cohort study, researchers examined medical records from 468,515 operations on 383,551 patients who underwent surgery without prior VTE between Jan. 1, 2005 and Dec. 31, 2010. In total, VTE occurred in 1.3% of surgical admissions for VA patients in the 90 days after surgery. However, the researchers argued that presumed VTE diagnoses should not be monitored based on inpatient records alone.

“Reliable monitoring of postoperative VTE events should incorporate two aspects. First, it should use data sources that allow for extraction of information from unstructured medical records. Second, it should use data sources that have the ability to follow patients after discharge from the hospital,” they said.

Read the full article in Thrombosis Research.

The Watchman left atrial appendage (LAA) closure device has been approved in the United States as an alternative to warfarin for patients with nonvalvular atrial fibrillation, for a narrower indication than the one submitted for approval to the Food and Drug Administration.

The device is a percutaneously delivered permanent cardiac implant placed in the LAA to prevent the embolization of thrombi formed in the LAA, and is manufactured by Boston Scientific. The FDA approved the Watchman for reducing the risk of thromboembolism from the LAA in patients with nonvalvular atrial fibrillation “who are at increased risk for stroke and systemic embolism based on CHADS₂ or CHA₂DS₂-VASc scores, are deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device, compared to warfarin,” according to a statement issued by the company on March 13.

Courtesy Boston Scientific

The approved indication is worded differently than the proposed indication that was submitted to the FDA for approval and discussed at an FDA panel meeting in October, to “prevent thromboembolism from the left atrial appendage.” The changes in the indication include the replacement of “prevent” with “reduce the risk” of thromboembolism, and the addition of the following qualifiers: In patients who “are deemed by their physicians to be suitable for warfarin,” and who have “an appropriate rationale to seek a nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.”

“These changes were made to more accurately reflect the appropriate patient population for this device,” according to an FDA spokesperson.

At a meeting in October 2014, the FDA’s Circulatory System Devices Panel voted 6-5 with one abstention that the benefits of the device outweighed its risks for the proposed indication, but several panelists who voted no said they would support approval of a second-line indication. In addition, panelists voting on both sides of this question said that the indication was too broad and should be revised to describe the device as a second-line alternative to warfarin, making clear it is not appropriate for all warfarin-eligible patients. (At the meeting, the panel unanimously agreed that there was “reasonable assurance” that the device was safe for use in this population.)

At the first advisory panel meeting on the device, in December 2013, the panel voted 13-1 to recommend approval, based on data from the PREVAIL and PROTECT-AF studies, which compared the device to chronic warfarin, and information from the Continued Access to PREVAIL (CAP2) registry.PREVAIL compared implantation of the device – with 45 days of warfarin plus 81 mg of aspirin for 45 days, followed by 325 mg of aspirin and 75 mg of clopidogrel through 6 months, followed by 325 mg of aspirin a day indefinitely – to chronic warfarin.

The October meeting was convened by the FDA to review longer follow-up data from PREVAIL, which found additional cases of ischemic strokes in the Watchman group and none in the warfarin-treated group.

The Watchman device has been available outside of the United States since 2009, is registered in 75 countries, and has been used to treat more than 10,000 patients, according to Boston Scientific.

[email protected]

The Watchman left atrial appendage (LAA) closure device has been approved in the United States as an alternative to warfarin for patients with nonvalvular atrial fibrillation, for a narrower indication than the one submitted for approval to the Food and Drug Administration.

The device is a percutaneously delivered permanent cardiac implant placed in the LAA to prevent the embolization of thrombi formed in the LAA, and is manufactured by Boston Scientific. The FDA approved the Watchman for reducing the risk of thromboembolism from the LAA in patients with nonvalvular atrial fibrillation “who are at increased risk for stroke and systemic embolism based on CHADS₂ or CHA₂DS₂-VASc scores, are deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device, compared to warfarin,” according to a statement issued by the company on March 13.

Courtesy Boston Scientific

The approved indication is worded differently than the proposed indication that was submitted to the FDA for approval and discussed at an FDA panel meeting in October, to “prevent thromboembolism from the left atrial appendage.” The changes in the indication include the replacement of “prevent” with “reduce the risk” of thromboembolism, and the addition of the following qualifiers: In patients who “are deemed by their physicians to be suitable for warfarin,” and who have “an appropriate rationale to seek a nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.”

“These changes were made to more accurately reflect the appropriate patient population for this device,” according to an FDA spokesperson.

At a meeting in October 2014, the FDA’s Circulatory System Devices Panel voted 6-5 with one abstention that the benefits of the device outweighed its risks for the proposed indication, but several panelists who voted no said they would support approval of a second-line indication. In addition, panelists voting on both sides of this question said that the indication was too broad and should be revised to describe the device as a second-line alternative to warfarin, making clear it is not appropriate for all warfarin-eligible patients. (At the meeting, the panel unanimously agreed that there was “reasonable assurance” that the device was safe for use in this population.)

At the first advisory panel meeting on the device, in December 2013, the panel voted 13-1 to recommend approval, based on data from the PREVAIL and PROTECT-AF studies, which compared the device to chronic warfarin, and information from the Continued Access to PREVAIL (CAP2) registry.PREVAIL compared implantation of the device – with 45 days of warfarin plus 81 mg of aspirin for 45 days, followed by 325 mg of aspirin and 75 mg of clopidogrel through 6 months, followed by 325 mg of aspirin a day indefinitely – to chronic warfarin.

The October meeting was convened by the FDA to review longer follow-up data from PREVAIL, which found additional cases of ischemic strokes in the Watchman group and none in the warfarin-treated group.

The Watchman device has been available outside of the United States since 2009, is registered in 75 countries, and has been used to treat more than 10,000 patients, according to Boston Scientific.

[email protected]

The Watchman left atrial appendage (LAA) closure device has been approved in the United States as an alternative to warfarin for patients with nonvalvular atrial fibrillation, for a narrower indication than the one submitted for approval to the Food and Drug Administration.

The device is a percutaneously delivered permanent cardiac implant placed in the LAA to prevent the embolization of thrombi formed in the LAA, and is manufactured by Boston Scientific. The FDA approved the Watchman for reducing the risk of thromboembolism from the LAA in patients with nonvalvular atrial fibrillation “who are at increased risk for stroke and systemic embolism based on CHADS₂ or CHA₂DS₂-VASc scores, are deemed by their physicians to be suitable for warfarin; and have an appropriate rationale to seek a nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device, compared to warfarin,” according to a statement issued by the company on March 13.

Courtesy Boston Scientific

The approved indication is worded differently than the proposed indication that was submitted to the FDA for approval and discussed at an FDA panel meeting in October, to “prevent thromboembolism from the left atrial appendage.” The changes in the indication include the replacement of “prevent” with “reduce the risk” of thromboembolism, and the addition of the following qualifiers: In patients who “are deemed by their physicians to be suitable for warfarin,” and who have “an appropriate rationale to seek a nonpharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.”

“These changes were made to more accurately reflect the appropriate patient population for this device,” according to an FDA spokesperson.

At a meeting in October 2014, the FDA’s Circulatory System Devices Panel voted 6-5 with one abstention that the benefits of the device outweighed its risks for the proposed indication, but several panelists who voted no said they would support approval of a second-line indication. In addition, panelists voting on both sides of this question said that the indication was too broad and should be revised to describe the device as a second-line alternative to warfarin, making clear it is not appropriate for all warfarin-eligible patients. (At the meeting, the panel unanimously agreed that there was “reasonable assurance” that the device was safe for use in this population.)

At the first advisory panel meeting on the device, in December 2013, the panel voted 13-1 to recommend approval, based on data from the PREVAIL and PROTECT-AF studies, which compared the device to chronic warfarin, and information from the Continued Access to PREVAIL (CAP2) registry.PREVAIL compared implantation of the device – with 45 days of warfarin plus 81 mg of aspirin for 45 days, followed by 325 mg of aspirin and 75 mg of clopidogrel through 6 months, followed by 325 mg of aspirin a day indefinitely – to chronic warfarin.

The October meeting was convened by the FDA to review longer follow-up data from PREVAIL, which found additional cases of ischemic strokes in the Watchman group and none in the warfarin-treated group.

The Watchman device has been available outside of the United States since 2009, is registered in 75 countries, and has been used to treat more than 10,000 patients, according to Boston Scientific.

[email protected]

Percutaneous coronary intervention with a sirolimus-eluting stent showed comparable rates of death, myocardial infarction and stroke to coronary artery bypass grafting in patients with coronary artery stenosis after 5 years in a randomized trial.

The PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) study randomized trial in 600 patients with unprotected left main coronary artery stenosis – 300 of whom were randomized to PCI and the rest to CABG – showed no significant difference in major adverse cardiac or cerebrovascular events (hazard ratio, 1.27; 95% confidence interval, 0.84-1.90; P = 0.26), according to a presentation at the American College of Cardiology meeting in San Diego.

However, the study did observe a twofold increase in the rate of ischemia-driven target vessel revascularization among patients treated with PCI, compared to those who underwent CABG (HR, 2.11; 95% CI, 1.16-3.84; P = 0.012), although the authors pointed out that this did not appear to impact the study’s harder endpoints.

“Given a higher rate of repeat revascularization even after the use of second-generation drug-eluting stents for unprotected left main coronary artery stenosis, frequent repeat revascularization could be an inherent weakness of stent-related treatments,” wrote Dr. Jung-Min Ahn, from the Asan Medical Center, Seoul, and coauthors (J. Am. Coll. Cardiol. 2015; March 15 [doi:10.1016/j.jacc.2015.03.033]).

The study was supported by the CardioVascular Research Foundation, Cordis, Johnson and Johnson, and the Korean Ministry of Health & Welfare. No conflicts of interest were disclosed.

Percutaneous coronary intervention with a sirolimus-eluting stent showed comparable rates of death, myocardial infarction and stroke to coronary artery bypass grafting in patients with coronary artery stenosis after 5 years in a randomized trial.

The PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) study randomized trial in 600 patients with unprotected left main coronary artery stenosis – 300 of whom were randomized to PCI and the rest to CABG – showed no significant difference in major adverse cardiac or cerebrovascular events (hazard ratio, 1.27; 95% confidence interval, 0.84-1.90; P = 0.26), according to a presentation at the American College of Cardiology meeting in San Diego.

However, the study did observe a twofold increase in the rate of ischemia-driven target vessel revascularization among patients treated with PCI, compared to those who underwent CABG (HR, 2.11; 95% CI, 1.16-3.84; P = 0.012), although the authors pointed out that this did not appear to impact the study’s harder endpoints.

“Given a higher rate of repeat revascularization even after the use of second-generation drug-eluting stents for unprotected left main coronary artery stenosis, frequent repeat revascularization could be an inherent weakness of stent-related treatments,” wrote Dr. Jung-Min Ahn, from the Asan Medical Center, Seoul, and coauthors (J. Am. Coll. Cardiol. 2015; March 15 [doi:10.1016/j.jacc.2015.03.033]).

The study was supported by the CardioVascular Research Foundation, Cordis, Johnson and Johnson, and the Korean Ministry of Health & Welfare. No conflicts of interest were disclosed.

Percutaneous coronary intervention with a sirolimus-eluting stent showed comparable rates of death, myocardial infarction and stroke to coronary artery bypass grafting in patients with coronary artery stenosis after 5 years in a randomized trial.

The PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease) study randomized trial in 600 patients with unprotected left main coronary artery stenosis – 300 of whom were randomized to PCI and the rest to CABG – showed no significant difference in major adverse cardiac or cerebrovascular events (hazard ratio, 1.27; 95% confidence interval, 0.84-1.90; P = 0.26), according to a presentation at the American College of Cardiology meeting in San Diego.

However, the study did observe a twofold increase in the rate of ischemia-driven target vessel revascularization among patients treated with PCI, compared to those who underwent CABG (HR, 2.11; 95% CI, 1.16-3.84; P = 0.012), although the authors pointed out that this did not appear to impact the study’s harder endpoints.

“Given a higher rate of repeat revascularization even after the use of second-generation drug-eluting stents for unprotected left main coronary artery stenosis, frequent repeat revascularization could be an inherent weakness of stent-related treatments,” wrote Dr. Jung-Min Ahn, from the Asan Medical Center, Seoul, and coauthors (J. Am. Coll. Cardiol. 2015; March 15 [doi:10.1016/j.jacc.2015.03.033]).

The study was supported by the CardioVascular Research Foundation, Cordis, Johnson and Johnson, and the Korean Ministry of Health & Welfare. No conflicts of interest were disclosed.

SAN DIEGO – The idea that patients with established coronary disease can derive important, secondary-prevention benefit from prolonged dual-antiplatelet therapy received a major boost with the results of a major, international, controlled trial with more than 21,000 patients.

Results from the PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54) showed putting post-myocardial infarction patients on dual-antiplatelet therapy (DAPT) with aspirin and the thienopyridine ticagrelor (Brilinta) for a median of 33 months cut the combined incidence of cardiovascular death, MI, or stroke by a relative 15%, compared with patients on aspirin alone as well as the other standard treatments used for post-MI patients, Dr. Marc S. Sabatine reported at the annual meeting of the American College of Cardiology.

Nick Piegari/Frontline Medical News

The findings added to the growing body of evidence that long-term – and possibly lifelong – DAPT is a key part of secondary prevention. Last year, results from the DAPT (Dual Antiplatelet Therapy) trial (N. Engl. J. Med. 2014;371:2155-66) supplied evidence for this in acute coronary syndrome patients who had undergone percutaneous coronary intervention (PCI). The PEGASUS-TIMI 54 trial did not require that enrolled post-MI patients had undergone PCI, but the reality is that this is the way most MI patients get managed, and in PEGASUS-TIMI 54 roughly 83% of the patients had a PCI history.

The new findings also highlighted the risk-benefit trade-off that DAPT means for patients. In PEGASUS-TIMI 54 the increased incidence of major bleeding events roughly matched the decreased rate of major cardiovascular events prevented. But while the incidence of bleeds categorized as TIMI major bleeds more than doubled in the patients randomized to DAPT compared with those on aspirin only, the prolonged treatment with ticagrelor did not result in an increase in fatal bleeds or in intracranial hemorrhages, the two most feared types of TIMI major bleeds.

“I’d much rather prevent cardiovascular deaths, MIs, and strokes even at the expense of causing reversible, nonfatal bleeding events,” said Dr. Sabatine, professor of medicine at Harvard Medical School in Boston and chairman of the TIMI Study Group at Brigham and Women’s Hospital.

Another notable adverse effect from ticagrelor treatment was a roughly threefold increased incidence of dyspnea, which led to drug discontinuation in 5%-7% of patients, depending on whether they received ticagrelor at 60 mg b.i.d. or 90 mg b.i.d. The study results showed a reduced rate of both bleeding and dyspnea in patients randomized to receive the 60-mg b.i.d. dosage, compared with those who received the 90-mg b.i.d. dosage, which is the standard ticagrelor dosage and the formulation now sold. At the same time, the efficacy of the 60-mg b.i.d. dosage for preventing ischemic events equaled that of the higher dosage. But as of today, it is impossible for a physician to prescribe a 60-mg formulation of ticagrelor because the manufacturer does not sell it.

Mitchel L. Zoler/Frontline Medical News

Several cardiologists PEGASUS-TIMI 54 at the meeting said that they agreed with Dr. Sabatine and felt that the benefits from prolonged DAPT with ticagrelor outweighed the downside of an increased bleeding risk.

“I think that the benefit is greater than the risk. None of us wants to see patients experience bleeding, but I was encouraged that fatal bleeds and intracranial hemorrhages were no different,” commented Dr. Elliott M. Antman, a professor of medicine at Harvard.

“The benefits outweigh the bleeding risk, but I wouldn’t trivialize the bleeding risk. Assessing a patient’s bleeding risk is really important,” commented Dr. Robert Harrington, professor of medicine at Stanford (Calif.) University.

But others at the meeting said that the elevated bleeding risk gave them pause. “There clearly is a price to be paid even if extended-duration DAPT reduces MI and stent thrombosis. I believe only the highest risk patients – those with acute coronary syndrome and ST-elevation MI – are the ones for whom I’d even consider it. Unless we can reduce bleeding risk, maybe with even lower doses [of ticagrelor], stopping aspirin, or using a reversal agent, we will be causing bleeds that are very relevant to patients,” commented Dr. Ajay J. Kirtane, an interventional cardiologist at Columbia University in New York.

Mitchel L. Zoler/Frontline Medical News

Dr. Kirtane also questioned whether TIMI major bleeds was the appropriate measure of bleeding risk in the context of a study like PEGASUS-TIMI 54. “Historically, TIMI major bleeding was derived from studies of acute heart attack patients getting fibrinolytic therapy. That is a very different population from this one. In my mind, the combination of TIMI major and minor bleeding would be more encompassing, and for patients the bleeding risks of these therapies are real and have been associated with bad sequelae,” he said in an interview.

When placed in the context of prior reports the new findings also raise the possibility that the generic, and hence much cheaper, thienopyridine clopidogrel might provide roughly the same long-term benefit as more expensive ticagrelor, especially for patients without a genetic profile that makes them poor clopidogrel metabolizers. This may be an attractive option for patients who have a problem paying for ticagrelor long term.

“I’d rather prescribe a patient a cheaper medication that might be a bit less effective than create an economic hardship,” Dr. Harrington said in an interview. The results from the DAPT trial, which included some post-PCI patients who received long-term DAPT with clopidogrel plus aspirin “give you a certain comfort” with the idea of substituting clopidogrel for ticagrelor when affordability is a major concern, Dr. Harrington noted.

PEGASUS-TIMI 54 enrolled 21, 162 patients who were 1-3 years out from a prior myocardial infarction at 1,161 sites in 31 countries. Enrolled patients also had to be at least 50 years old, and have at least one additional risk factor for ischemic events such as age 65 years or older, diabetes, multivessel coronary artery disease, or chronic renal dysfunction. The enrolled patients averaged 1.7 years out from their index MI. Randomization assigned patients to treatment with 90 mg ticagrelor b.i.d., 60 mg ticagrelor b.i.d., or placebo, and all patients also received daily treatment with 75-150 mg aspirin.

After a median follow-up of 33 months on treatment, the combined rate of cardiovascular death, myocardial infarction, or stroke – the study’s primary endpoint – occurred in 7.85% of patients on the 90-mg ticagrelor dosage, 7.77% of those on the 60-mg dosage, and in 9.04% of patients on placebo receiving aspirin only, statistically significant differences for the study’s primary endpoint for each of the two ticagrelor dosages. Concurrent with the report at the meeting the results also appeared online (N. Engl. J. Med. 2015; [doi:10.1056/nejmoa1500857]). This translated into hazard ratios of 0.85 for the 90 mg dosage and 0.84 for the 60 mg dosage compared with placebo.

The study’s primary safety outcome was the incidence of TIMI major bleeding events, which occurred in 2.60% of patients on the higher ticagrelor dosage, 2.30% of those on the 60 mg dosage, and in 1.06% of those on placebo, which converted into hazard ratios of 2.69 for the 90-mg dosage and 2.32 for the lower dosage for TIMI major bleeds compared with aspirin alone.

[email protected]

On Twitter @mitchelzoler

SAN DIEGO – The idea that patients with established coronary disease can derive important, secondary-prevention benefit from prolonged dual-antiplatelet therapy received a major boost with the results of a major, international, controlled trial with more than 21,000 patients.

Results from the PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54) showed putting post-myocardial infarction patients on dual-antiplatelet therapy (DAPT) with aspirin and the thienopyridine ticagrelor (Brilinta) for a median of 33 months cut the combined incidence of cardiovascular death, MI, or stroke by a relative 15%, compared with patients on aspirin alone as well as the other standard treatments used for post-MI patients, Dr. Marc S. Sabatine reported at the annual meeting of the American College of Cardiology.

Nick Piegari/Frontline Medical News

The findings added to the growing body of evidence that long-term – and possibly lifelong – DAPT is a key part of secondary prevention. Last year, results from the DAPT (Dual Antiplatelet Therapy) trial (N. Engl. J. Med. 2014;371:2155-66) supplied evidence for this in acute coronary syndrome patients who had undergone percutaneous coronary intervention (PCI). The PEGASUS-TIMI 54 trial did not require that enrolled post-MI patients had undergone PCI, but the reality is that this is the way most MI patients get managed, and in PEGASUS-TIMI 54 roughly 83% of the patients had a PCI history.

The new findings also highlighted the risk-benefit trade-off that DAPT means for patients. In PEGASUS-TIMI 54 the increased incidence of major bleeding events roughly matched the decreased rate of major cardiovascular events prevented. But while the incidence of bleeds categorized as TIMI major bleeds more than doubled in the patients randomized to DAPT compared with those on aspirin only, the prolonged treatment with ticagrelor did not result in an increase in fatal bleeds or in intracranial hemorrhages, the two most feared types of TIMI major bleeds.

“I’d much rather prevent cardiovascular deaths, MIs, and strokes even at the expense of causing reversible, nonfatal bleeding events,” said Dr. Sabatine, professor of medicine at Harvard Medical School in Boston and chairman of the TIMI Study Group at Brigham and Women’s Hospital.

Another notable adverse effect from ticagrelor treatment was a roughly threefold increased incidence of dyspnea, which led to drug discontinuation in 5%-7% of patients, depending on whether they received ticagrelor at 60 mg b.i.d. or 90 mg b.i.d. The study results showed a reduced rate of both bleeding and dyspnea in patients randomized to receive the 60-mg b.i.d. dosage, compared with those who received the 90-mg b.i.d. dosage, which is the standard ticagrelor dosage and the formulation now sold. At the same time, the efficacy of the 60-mg b.i.d. dosage for preventing ischemic events equaled that of the higher dosage. But as of today, it is impossible for a physician to prescribe a 60-mg formulation of ticagrelor because the manufacturer does not sell it.

Mitchel L. Zoler/Frontline Medical News

Several cardiologists PEGASUS-TIMI 54 at the meeting said that they agreed with Dr. Sabatine and felt that the benefits from prolonged DAPT with ticagrelor outweighed the downside of an increased bleeding risk.

“I think that the benefit is greater than the risk. None of us wants to see patients experience bleeding, but I was encouraged that fatal bleeds and intracranial hemorrhages were no different,” commented Dr. Elliott M. Antman, a professor of medicine at Harvard.

“The benefits outweigh the bleeding risk, but I wouldn’t trivialize the bleeding risk. Assessing a patient’s bleeding risk is really important,” commented Dr. Robert Harrington, professor of medicine at Stanford (Calif.) University.

But others at the meeting said that the elevated bleeding risk gave them pause. “There clearly is a price to be paid even if extended-duration DAPT reduces MI and stent thrombosis. I believe only the highest risk patients – those with acute coronary syndrome and ST-elevation MI – are the ones for whom I’d even consider it. Unless we can reduce bleeding risk, maybe with even lower doses [of ticagrelor], stopping aspirin, or using a reversal agent, we will be causing bleeds that are very relevant to patients,” commented Dr. Ajay J. Kirtane, an interventional cardiologist at Columbia University in New York.

Mitchel L. Zoler/Frontline Medical News

Dr. Kirtane also questioned whether TIMI major bleeds was the appropriate measure of bleeding risk in the context of a study like PEGASUS-TIMI 54. “Historically, TIMI major bleeding was derived from studies of acute heart attack patients getting fibrinolytic therapy. That is a very different population from this one. In my mind, the combination of TIMI major and minor bleeding would be more encompassing, and for patients the bleeding risks of these therapies are real and have been associated with bad sequelae,” he said in an interview.

When placed in the context of prior reports the new findings also raise the possibility that the generic, and hence much cheaper, thienopyridine clopidogrel might provide roughly the same long-term benefit as more expensive ticagrelor, especially for patients without a genetic profile that makes them poor clopidogrel metabolizers. This may be an attractive option for patients who have a problem paying for ticagrelor long term.

“I’d rather prescribe a patient a cheaper medication that might be a bit less effective than create an economic hardship,” Dr. Harrington said in an interview. The results from the DAPT trial, which included some post-PCI patients who received long-term DAPT with clopidogrel plus aspirin “give you a certain comfort” with the idea of substituting clopidogrel for ticagrelor when affordability is a major concern, Dr. Harrington noted.

PEGASUS-TIMI 54 enrolled 21, 162 patients who were 1-3 years out from a prior myocardial infarction at 1,161 sites in 31 countries. Enrolled patients also had to be at least 50 years old, and have at least one additional risk factor for ischemic events such as age 65 years or older, diabetes, multivessel coronary artery disease, or chronic renal dysfunction. The enrolled patients averaged 1.7 years out from their index MI. Randomization assigned patients to treatment with 90 mg ticagrelor b.i.d., 60 mg ticagrelor b.i.d., or placebo, and all patients also received daily treatment with 75-150 mg aspirin.

After a median follow-up of 33 months on treatment, the combined rate of cardiovascular death, myocardial infarction, or stroke – the study’s primary endpoint – occurred in 7.85% of patients on the 90-mg ticagrelor dosage, 7.77% of those on the 60-mg dosage, and in 9.04% of patients on placebo receiving aspirin only, statistically significant differences for the study’s primary endpoint for each of the two ticagrelor dosages. Concurrent with the report at the meeting the results also appeared online (N. Engl. J. Med. 2015; [doi:10.1056/nejmoa1500857]). This translated into hazard ratios of 0.85 for the 90 mg dosage and 0.84 for the 60 mg dosage compared with placebo.

The study’s primary safety outcome was the incidence of TIMI major bleeding events, which occurred in 2.60% of patients on the higher ticagrelor dosage, 2.30% of those on the 60 mg dosage, and in 1.06% of those on placebo, which converted into hazard ratios of 2.69 for the 90-mg dosage and 2.32 for the lower dosage for TIMI major bleeds compared with aspirin alone.

[email protected]

On Twitter @mitchelzoler

SAN DIEGO – The idea that patients with established coronary disease can derive important, secondary-prevention benefit from prolonged dual-antiplatelet therapy received a major boost with the results of a major, international, controlled trial with more than 21,000 patients.

Results from the PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54) showed putting post-myocardial infarction patients on dual-antiplatelet therapy (DAPT) with aspirin and the thienopyridine ticagrelor (Brilinta) for a median of 33 months cut the combined incidence of cardiovascular death, MI, or stroke by a relative 15%, compared with patients on aspirin alone as well as the other standard treatments used for post-MI patients, Dr. Marc S. Sabatine reported at the annual meeting of the American College of Cardiology.

Nick Piegari/Frontline Medical News

The findings added to the growing body of evidence that long-term – and possibly lifelong – DAPT is a key part of secondary prevention. Last year, results from the DAPT (Dual Antiplatelet Therapy) trial (N. Engl. J. Med. 2014;371:2155-66) supplied evidence for this in acute coronary syndrome patients who had undergone percutaneous coronary intervention (PCI). The PEGASUS-TIMI 54 trial did not require that enrolled post-MI patients had undergone PCI, but the reality is that this is the way most MI patients get managed, and in PEGASUS-TIMI 54 roughly 83% of the patients had a PCI history.

The new findings also highlighted the risk-benefit trade-off that DAPT means for patients. In PEGASUS-TIMI 54 the increased incidence of major bleeding events roughly matched the decreased rate of major cardiovascular events prevented. But while the incidence of bleeds categorized as TIMI major bleeds more than doubled in the patients randomized to DAPT compared with those on aspirin only, the prolonged treatment with ticagrelor did not result in an increase in fatal bleeds or in intracranial hemorrhages, the two most feared types of TIMI major bleeds.

“I’d much rather prevent cardiovascular deaths, MIs, and strokes even at the expense of causing reversible, nonfatal bleeding events,” said Dr. Sabatine, professor of medicine at Harvard Medical School in Boston and chairman of the TIMI Study Group at Brigham and Women’s Hospital.

Another notable adverse effect from ticagrelor treatment was a roughly threefold increased incidence of dyspnea, which led to drug discontinuation in 5%-7% of patients, depending on whether they received ticagrelor at 60 mg b.i.d. or 90 mg b.i.d. The study results showed a reduced rate of both bleeding and dyspnea in patients randomized to receive the 60-mg b.i.d. dosage, compared with those who received the 90-mg b.i.d. dosage, which is the standard ticagrelor dosage and the formulation now sold. At the same time, the efficacy of the 60-mg b.i.d. dosage for preventing ischemic events equaled that of the higher dosage. But as of today, it is impossible for a physician to prescribe a 60-mg formulation of ticagrelor because the manufacturer does not sell it.

Mitchel L. Zoler/Frontline Medical News

Several cardiologists PEGASUS-TIMI 54 at the meeting said that they agreed with Dr. Sabatine and felt that the benefits from prolonged DAPT with ticagrelor outweighed the downside of an increased bleeding risk.

“I think that the benefit is greater than the risk. None of us wants to see patients experience bleeding, but I was encouraged that fatal bleeds and intracranial hemorrhages were no different,” commented Dr. Elliott M. Antman, a professor of medicine at Harvard.

“The benefits outweigh the bleeding risk, but I wouldn’t trivialize the bleeding risk. Assessing a patient’s bleeding risk is really important,” commented Dr. Robert Harrington, professor of medicine at Stanford (Calif.) University.

But others at the meeting said that the elevated bleeding risk gave them pause. “There clearly is a price to be paid even if extended-duration DAPT reduces MI and stent thrombosis. I believe only the highest risk patients – those with acute coronary syndrome and ST-elevation MI – are the ones for whom I’d even consider it. Unless we can reduce bleeding risk, maybe with even lower doses [of ticagrelor], stopping aspirin, or using a reversal agent, we will be causing bleeds that are very relevant to patients,” commented Dr. Ajay J. Kirtane, an interventional cardiologist at Columbia University in New York.

Mitchel L. Zoler/Frontline Medical News

Dr. Kirtane also questioned whether TIMI major bleeds was the appropriate measure of bleeding risk in the context of a study like PEGASUS-TIMI 54. “Historically, TIMI major bleeding was derived from studies of acute heart attack patients getting fibrinolytic therapy. That is a very different population from this one. In my mind, the combination of TIMI major and minor bleeding would be more encompassing, and for patients the bleeding risks of these therapies are real and have been associated with bad sequelae,” he said in an interview.

When placed in the context of prior reports the new findings also raise the possibility that the generic, and hence much cheaper, thienopyridine clopidogrel might provide roughly the same long-term benefit as more expensive ticagrelor, especially for patients without a genetic profile that makes them poor clopidogrel metabolizers. This may be an attractive option for patients who have a problem paying for ticagrelor long term.

“I’d rather prescribe a patient a cheaper medication that might be a bit less effective than create an economic hardship,” Dr. Harrington said in an interview. The results from the DAPT trial, which included some post-PCI patients who received long-term DAPT with clopidogrel plus aspirin “give you a certain comfort” with the idea of substituting clopidogrel for ticagrelor when affordability is a major concern, Dr. Harrington noted.

PEGASUS-TIMI 54 enrolled 21, 162 patients who were 1-3 years out from a prior myocardial infarction at 1,161 sites in 31 countries. Enrolled patients also had to be at least 50 years old, and have at least one additional risk factor for ischemic events such as age 65 years or older, diabetes, multivessel coronary artery disease, or chronic renal dysfunction. The enrolled patients averaged 1.7 years out from their index MI. Randomization assigned patients to treatment with 90 mg ticagrelor b.i.d., 60 mg ticagrelor b.i.d., or placebo, and all patients also received daily treatment with 75-150 mg aspirin.

After a median follow-up of 33 months on treatment, the combined rate of cardiovascular death, myocardial infarction, or stroke – the study’s primary endpoint – occurred in 7.85% of patients on the 90-mg ticagrelor dosage, 7.77% of those on the 60-mg dosage, and in 9.04% of patients on placebo receiving aspirin only, statistically significant differences for the study’s primary endpoint for each of the two ticagrelor dosages. Concurrent with the report at the meeting the results also appeared online (N. Engl. J. Med. 2015; [doi:10.1056/nejmoa1500857]). This translated into hazard ratios of 0.85 for the 90 mg dosage and 0.84 for the 60 mg dosage compared with placebo.

The study’s primary safety outcome was the incidence of TIMI major bleeding events, which occurred in 2.60% of patients on the higher ticagrelor dosage, 2.30% of those on the 60 mg dosage, and in 1.06% of those on placebo, which converted into hazard ratios of 2.69 for the 90-mg dosage and 2.32 for the lower dosage for TIMI major bleeds compared with aspirin alone.

[email protected]

On Twitter @mitchelzoler

SAN DIEGO– The risk of developing cancer is significantly higher in survivors of an acute MI compared to the general population, according to a large Danish national registry study.

“Greater focus on long-term cancer risk is warranted in MI survivors. This could potentially have implications on future patient care for MI patients, outpatient follow-up strategies, and distribution of health care resources,” Morten Winther Malmborg said at the annual meeting of the American College of Cardiology.

He presented a nationwide cohort study including 3,005,734 Danish adults with no baseline history of MI or cancer who were followed for up to 17 years in the comprehensive Danish National Patient Registry. During the study period, 125,926 of these individuals had a nonfatal MI.

The subsequent incidence of cancer in the MI survivors was 167 cases per 10,000 person-years compared with 95 per 10,000 person-years in the control group, reported Mr. Malmborg, a fourth-year medical student at the University of Copenhagen.

Cancer diagnoses of all types were highest by far in the first 6 months post-MI, which he attributed to surveillance bias, since that was a period of increased medical contact. However, after he and his coinvestigators excluded the cancers diagnosed during that initial 6-month period, the post-MI group still had a highly significant 11% increased relative risk for cancer overall during the period from 6 months through 17 years post-MI.

The younger a patient was when the MI occurred, the greater the subsequent cancer risk. Individuals who had a nonfatal MI at age 30-54 had a 44% greater risk of cancer overall at 6 months–17 years post-MI compared, with the control group. Those who had an MI at age 55-69 had a 19% increased cancer risk compared to controls, while those whose MI occurred at age 70-99 had a modest but still statistically significant 5% increase in cancer risk.

Particularly striking, according to Mr. Malmborg, was the MI survivors’ 44% increased relative risk for lung cancer and 31% increase in bladder cancer during the period from 6 months–17 years post-MI compared with the general population. In contrast, rates of breast, prostate, and colon cancer weren’t significantly different between MI survivors and the general population with no history of MI.

This observational study didn’t address the mechanisms involved in MI survivors’ increased cancer risk. Although the Danish registry didn’t include information of smoking status, Mr. Malmborg speculated that smoking may figure prominently, since it is a major shared risk factor for cardiovascular disease as well as lung and bladder cancer in particular. Other shared risk factors for cardiovascular disease and cancer include obesity, sedentary lifestyle, and excessive alcohol use.

This is the first large-scale study to look at cancer risk post-MI. It’s an increasingly relevant issue because the advances in cardiac care that have brought improved long-term survival following acute MI means more patients with a history of MI are likely to die from noncardiac causes, Mr. Malmborg observed.

He and his coinvestigators are now performing a number-needed-to-screen analysis to help them determine whether structured, formal creening for cancer following an MI should be done routinely.

The study was supported by Danish national medical research funds. The presenter reported having no financial conflicts.

[email protected]

SAN DIEGO– The risk of developing cancer is significantly higher in survivors of an acute MI compared to the general population, according to a large Danish national registry study.

“Greater focus on long-term cancer risk is warranted in MI survivors. This could potentially have implications on future patient care for MI patients, outpatient follow-up strategies, and distribution of health care resources,” Morten Winther Malmborg said at the annual meeting of the American College of Cardiology.

He presented a nationwide cohort study including 3,005,734 Danish adults with no baseline history of MI or cancer who were followed for up to 17 years in the comprehensive Danish National Patient Registry. During the study period, 125,926 of these individuals had a nonfatal MI.

The subsequent incidence of cancer in the MI survivors was 167 cases per 10,000 person-years compared with 95 per 10,000 person-years in the control group, reported Mr. Malmborg, a fourth-year medical student at the University of Copenhagen.

Cancer diagnoses of all types were highest by far in the first 6 months post-MI, which he attributed to surveillance bias, since that was a period of increased medical contact. However, after he and his coinvestigators excluded the cancers diagnosed during that initial 6-month period, the post-MI group still had a highly significant 11% increased relative risk for cancer overall during the period from 6 months through 17 years post-MI.

The younger a patient was when the MI occurred, the greater the subsequent cancer risk. Individuals who had a nonfatal MI at age 30-54 had a 44% greater risk of cancer overall at 6 months–17 years post-MI compared, with the control group. Those who had an MI at age 55-69 had a 19% increased cancer risk compared to controls, while those whose MI occurred at age 70-99 had a modest but still statistically significant 5% increase in cancer risk.

Particularly striking, according to Mr. Malmborg, was the MI survivors’ 44% increased relative risk for lung cancer and 31% increase in bladder cancer during the period from 6 months–17 years post-MI compared with the general population. In contrast, rates of breast, prostate, and colon cancer weren’t significantly different between MI survivors and the general population with no history of MI.

This observational study didn’t address the mechanisms involved in MI survivors’ increased cancer risk. Although the Danish registry didn’t include information of smoking status, Mr. Malmborg speculated that smoking may figure prominently, since it is a major shared risk factor for cardiovascular disease as well as lung and bladder cancer in particular. Other shared risk factors for cardiovascular disease and cancer include obesity, sedentary lifestyle, and excessive alcohol use.

This is the first large-scale study to look at cancer risk post-MI. It’s an increasingly relevant issue because the advances in cardiac care that have brought improved long-term survival following acute MI means more patients with a history of MI are likely to die from noncardiac causes, Mr. Malmborg observed.

He and his coinvestigators are now performing a number-needed-to-screen analysis to help them determine whether structured, formal creening for cancer following an MI should be done routinely.

The study was supported by Danish national medical research funds. The presenter reported having no financial conflicts.

[email protected]

SAN DIEGO– The risk of developing cancer is significantly higher in survivors of an acute MI compared to the general population, according to a large Danish national registry study.

“Greater focus on long-term cancer risk is warranted in MI survivors. This could potentially have implications on future patient care for MI patients, outpatient follow-up strategies, and distribution of health care resources,” Morten Winther Malmborg said at the annual meeting of the American College of Cardiology.

He presented a nationwide cohort study including 3,005,734 Danish adults with no baseline history of MI or cancer who were followed for up to 17 years in the comprehensive Danish National Patient Registry. During the study period, 125,926 of these individuals had a nonfatal MI.

The subsequent incidence of cancer in the MI survivors was 167 cases per 10,000 person-years compared with 95 per 10,000 person-years in the control group, reported Mr. Malmborg, a fourth-year medical student at the University of Copenhagen.

Cancer diagnoses of all types were highest by far in the first 6 months post-MI, which he attributed to surveillance bias, since that was a period of increased medical contact. However, after he and his coinvestigators excluded the cancers diagnosed during that initial 6-month period, the post-MI group still had a highly significant 11% increased relative risk for cancer overall during the period from 6 months through 17 years post-MI.

The younger a patient was when the MI occurred, the greater the subsequent cancer risk. Individuals who had a nonfatal MI at age 30-54 had a 44% greater risk of cancer overall at 6 months–17 years post-MI compared, with the control group. Those who had an MI at age 55-69 had a 19% increased cancer risk compared to controls, while those whose MI occurred at age 70-99 had a modest but still statistically significant 5% increase in cancer risk.

Particularly striking, according to Mr. Malmborg, was the MI survivors’ 44% increased relative risk for lung cancer and 31% increase in bladder cancer during the period from 6 months–17 years post-MI compared with the general population. In contrast, rates of breast, prostate, and colon cancer weren’t significantly different between MI survivors and the general population with no history of MI.

This observational study didn’t address the mechanisms involved in MI survivors’ increased cancer risk. Although the Danish registry didn’t include information of smoking status, Mr. Malmborg speculated that smoking may figure prominently, since it is a major shared risk factor for cardiovascular disease as well as lung and bladder cancer in particular. Other shared risk factors for cardiovascular disease and cancer include obesity, sedentary lifestyle, and excessive alcohol use.

This is the first large-scale study to look at cancer risk post-MI. It’s an increasingly relevant issue because the advances in cardiac care that have brought improved long-term survival following acute MI means more patients with a history of MI are likely to die from noncardiac causes, Mr. Malmborg observed.

He and his coinvestigators are now performing a number-needed-to-screen analysis to help them determine whether structured, formal creening for cancer following an MI should be done routinely.

The study was supported by Danish national medical research funds. The presenter reported having no financial conflicts.

[email protected]

SAN DIEGO – Current guidelines call for treating acute coronary syndrome patients with dual antiplatelet therapy (aspirin plus a thienopyridine) for at least 1 year following their event, but results from recent large, randomized trials suggest that many patients continue to benefit from treatment that extends beyond the first year, Dr. Richard C. Becker said during an interview at the annual meeting of the American College of Cardiology.

New results reported at the meeting from the PEGASUS-TIMI (Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction) 54 trial highlight the long-term risk for ischemic events faced by patients following an acute coronary syndrome (N. Engl. J. Med. 2025;[doi: 10.1056/NEJMoa0904327]. The results also underscore the importance of risk assessment, and the importance of tailoring treatment to ACS patients based not only on their long-term risk from their cardiovascular disease but also their risk for adverse bleeding events secondary to prolonged, aggressive antiplatelet therapy. The PEGASUS-TIMI 54 results complement the findings reported last year from the DAPT (Dual Antiplatelet Therapy) trial (N. Engl. J. Med. 2014;371:2155-66), he said.

Based on the accumulated evidence, ACS patients who have done well clinically on DAPT after 1 year and are deemed at low risk for bleeding and other complications are good candidates for more prolonged DAPT treatment, said Dr. Becker, professor and director of the University of Cincinnati Heart, Lung & Vascular Institute.

PEGASUS-TIMI 54 ws sponsored by AstraZeneca, which markets ticagrelor (Brilinta). Dr. Becker has been a consultant to and received research support from AstraZeneca.

[email protected]

On Twitter @mitchelzoler

SAN DIEGO – Current guidelines call for treating acute coronary syndrome patients with dual antiplatelet therapy (aspirin plus a thienopyridine) for at least 1 year following their event, but results from recent large, randomized trials suggest that many patients continue to benefit from treatment that extends beyond the first year, Dr. Richard C. Becker said during an interview at the annual meeting of the American College of Cardiology.

New results reported at the meeting from the PEGASUS-TIMI (Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction) 54 trial highlight the long-term risk for ischemic events faced by patients following an acute coronary syndrome (N. Engl. J. Med. 2025;[doi: 10.1056/NEJMoa0904327]. The results also underscore the importance of risk assessment, and the importance of tailoring treatment to ACS patients based not only on their long-term risk from their cardiovascular disease but also their risk for adverse bleeding events secondary to prolonged, aggressive antiplatelet therapy. The PEGASUS-TIMI 54 results complement the findings reported last year from the DAPT (Dual Antiplatelet Therapy) trial (N. Engl. J. Med. 2014;371:2155-66), he said.

Based on the accumulated evidence, ACS patients who have done well clinically on DAPT after 1 year and are deemed at low risk for bleeding and other complications are good candidates for more prolonged DAPT treatment, said Dr. Becker, professor and director of the University of Cincinnati Heart, Lung & Vascular Institute.

PEGASUS-TIMI 54 ws sponsored by AstraZeneca, which markets ticagrelor (Brilinta). Dr. Becker has been a consultant to and received research support from AstraZeneca.

[email protected]

On Twitter @mitchelzoler

SAN DIEGO – Current guidelines call for treating acute coronary syndrome patients with dual antiplatelet therapy (aspirin plus a thienopyridine) for at least 1 year following their event, but results from recent large, randomized trials suggest that many patients continue to benefit from treatment that extends beyond the first year, Dr. Richard C. Becker said during an interview at the annual meeting of the American College of Cardiology.

New results reported at the meeting from the PEGASUS-TIMI (Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction) 54 trial highlight the long-term risk for ischemic events faced by patients following an acute coronary syndrome (N. Engl. J. Med. 2025;[doi: 10.1056/NEJMoa0904327]. The results also underscore the importance of risk assessment, and the importance of tailoring treatment to ACS patients based not only on their long-term risk from their cardiovascular disease but also their risk for adverse bleeding events secondary to prolonged, aggressive antiplatelet therapy. The PEGASUS-TIMI 54 results complement the findings reported last year from the DAPT (Dual Antiplatelet Therapy) trial (N. Engl. J. Med. 2014;371:2155-66), he said.

Based on the accumulated evidence, ACS patients who have done well clinically on DAPT after 1 year and are deemed at low risk for bleeding and other complications are good candidates for more prolonged DAPT treatment, said Dr. Becker, professor and director of the University of Cincinnati Heart, Lung & Vascular Institute.

PEGASUS-TIMI 54 ws sponsored by AstraZeneca, which markets ticagrelor (Brilinta). Dr. Becker has been a consultant to and received research support from AstraZeneca.

[email protected]

On Twitter @mitchelzoler

SAN DIEGO – Digoxin increases the risk of death by 27% in patients with atrial fibrillation, a meta-analysis of 19 studies showed.

Patients with AF and kidney failure faced a 60% to 70 % increase in mortality compared to their counterparts not taking digoxin, according to a press release on the study.

A weaker association between digoxin and death was observed in AF patients who also had heart failure, a finding the authors suggest warrants further investigation.

“Until further research can be done, I would suggest physicians use caution when prescribing digoxin for patients with atrial fibrillation, especially given that there are alternative drugs available that might be safer,” lead author Dr. Waqas Qureshi said in a statement.

The results were released in advance of their March 15 presentation at the annual meeting of the American College of Cardiology in San Diego.

About 5.6 million Americans have atrial fibrillation (AF) and roughly 1 in 5 are prescribed digoxin for heart rate control.

Current guidelines recommend digoxin as first-line therapy in patients who aren’t physically active and as a second-line drug for more active patients.

“Based on consistent results coming out of many studies, our results suggest digoxin should be downgraded from its position as a front-line agent for certain patients with atrial fibrillation,” Dr. Qureshi, a clinical and research cardiology fellow at Wake Forest School of Medicine in Winston-Salem, N.C., recommended.

The authors reviewed 19 studies including five cohort and randomized controlled trials involving 501,681 patients. Of these, 458,311 patients had AF and 111,978 were prescribed digoxin.

In a random effects model, digoxin was associated with an increased risk of mortality, with a pooled hazard ratio of 1.27 (95% confidence interval 1.19-1.36; P value < .001).

Several studies in the meta-analysis suggest that higher blood levels of digoxin increase the risk of death. The mechanism behind the increased mortality is not known, although previous studies have suggested digoxin increases the risk of thromboembolism.

The meta-analysis accounted for risk factors and co-morbidities reported in the various studies, but it’s possible that some confounding factors may not have been accounted for, the authors acknowledge.

“The study points to the need for a well-structured, targeted trial to investigate digoxin’s safety,” Dr. Qureshi stated.

[email protected]

SAN DIEGO – Digoxin increases the risk of death by 27% in patients with atrial fibrillation, a meta-analysis of 19 studies showed.

Patients with AF and kidney failure faced a 60% to 70 % increase in mortality compared to their counterparts not taking digoxin, according to a press release on the study.

A weaker association between digoxin and death was observed in AF patients who also had heart failure, a finding the authors suggest warrants further investigation.

“Until further research can be done, I would suggest physicians use caution when prescribing digoxin for patients with atrial fibrillation, especially given that there are alternative drugs available that might be safer,” lead author Dr. Waqas Qureshi said in a statement.

The results were released in advance of their March 15 presentation at the annual meeting of the American College of Cardiology in San Diego.

About 5.6 million Americans have atrial fibrillation (AF) and roughly 1 in 5 are prescribed digoxin for heart rate control.

Current guidelines recommend digoxin as first-line therapy in patients who aren’t physically active and as a second-line drug for more active patients.

“Based on consistent results coming out of many studies, our results suggest digoxin should be downgraded from its position as a front-line agent for certain patients with atrial fibrillation,” Dr. Qureshi, a clinical and research cardiology fellow at Wake Forest School of Medicine in Winston-Salem, N.C., recommended.

The authors reviewed 19 studies including five cohort and randomized controlled trials involving 501,681 patients. Of these, 458,311 patients had AF and 111,978 were prescribed digoxin.

In a random effects model, digoxin was associated with an increased risk of mortality, with a pooled hazard ratio of 1.27 (95% confidence interval 1.19-1.36; P value < .001).

Several studies in the meta-analysis suggest that higher blood levels of digoxin increase the risk of death. The mechanism behind the increased mortality is not known, although previous studies have suggested digoxin increases the risk of thromboembolism.

The meta-analysis accounted for risk factors and co-morbidities reported in the various studies, but it’s possible that some confounding factors may not have been accounted for, the authors acknowledge.

“The study points to the need for a well-structured, targeted trial to investigate digoxin’s safety,” Dr. Qureshi stated.

[email protected]

SAN DIEGO – Digoxin increases the risk of death by 27% in patients with atrial fibrillation, a meta-analysis of 19 studies showed.

Patients with AF and kidney failure faced a 60% to 70 % increase in mortality compared to their counterparts not taking digoxin, according to a press release on the study.

A weaker association between digoxin and death was observed in AF patients who also had heart failure, a finding the authors suggest warrants further investigation.

“Until further research can be done, I would suggest physicians use caution when prescribing digoxin for patients with atrial fibrillation, especially given that there are alternative drugs available that might be safer,” lead author Dr. Waqas Qureshi said in a statement.

The results were released in advance of their March 15 presentation at the annual meeting of the American College of Cardiology in San Diego.

About 5.6 million Americans have atrial fibrillation (AF) and roughly 1 in 5 are prescribed digoxin for heart rate control.

Current guidelines recommend digoxin as first-line therapy in patients who aren’t physically active and as a second-line drug for more active patients.

“Based on consistent results coming out of many studies, our results suggest digoxin should be downgraded from its position as a front-line agent for certain patients with atrial fibrillation,” Dr. Qureshi, a clinical and research cardiology fellow at Wake Forest School of Medicine in Winston-Salem, N.C., recommended.

The authors reviewed 19 studies including five cohort and randomized controlled trials involving 501,681 patients. Of these, 458,311 patients had AF and 111,978 were prescribed digoxin.

In a random effects model, digoxin was associated with an increased risk of mortality, with a pooled hazard ratio of 1.27 (95% confidence interval 1.19-1.36; P value < .001).

Several studies in the meta-analysis suggest that higher blood levels of digoxin increase the risk of death. The mechanism behind the increased mortality is not known, although previous studies have suggested digoxin increases the risk of thromboembolism.

The meta-analysis accounted for risk factors and co-morbidities reported in the various studies, but it’s possible that some confounding factors may not have been accounted for, the authors acknowledge.

“The study points to the need for a well-structured, targeted trial to investigate digoxin’s safety,” Dr. Qureshi stated.

[email protected]

SNOWMASS, COLO. – New-onset brain lesions arising after transcatheter aortic valve replacement are the largely unacknowledged elephant in the room with regard to the boomingly popular procedure.

Multiple studies utilizing diffusion-weighted MRI have shown roughly a 70% incidence of new brain lesions following transcatheter aortic valve replacement (TAVR). And studies employing full neurocognitive test batteries have consistently shown a relationship between small brain infarcts much like these, cognitive decline, and dementia, Dr. David R. Holmes Jr. said at the Annual Cardiovascular Conference at Snowmass.

Bruce Jancin/Frontline Medical News

“This is an incredibly alarming piece of information. People should be aware of this. There is interest in doing TAVR in younger and younger patients. But there is indeed an issue with unintended consequences. If we take younger and less and less symptomatic patients, their chance of dementia in 20 years is probably going to be increased. We’re going to have to follow these patients for a long period of time to look at that specific endpoint,” noted Dr. Holmes of the Mayo Clinic in Rochester, Minn.

Speaking of unintended consequences, there is also the issue of TAVR-related stroke. Among the more than 27,000 patient records submitted to the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry through December 2014, the periprocedural stroke rate was 2.4%. One-year outcomes included 26.2% mortality and a 3.6% stroke rate.

Given that two-thirds of TAVR cases submitted to the TVT registry in 2014 involved patients age 80 or older, with New York Heart Association class III/IV symptoms present in 82%, and 50% of patients rated as being at extreme risk with a predicted 1-year mortality of 50% without intervention, a 3.6% stroke rate can be considered tolerable. But not so in the sort of younger asymptomatic patients with significant aortic stenosis increasingly under discussion as potential candidates for the procedure.

“Stroke rates are the real deal in patients undergoing TAVR. Maybe you’re going to take an asymptomatic person and give them a stroke rather than wait or give a surgical valve replacement,” the cardiologist said.

He predicted that within 10 years, the use of cerebral protection devices will be considered mandatory, not just during TAVR, but during percutaneous coronary intervention, CABG surgery, and probably during atrial fibrillation ablation as well. All of these procedures have been linked to new-onset brain lesions on diffusion-weighted MRI.

Promising new neuroprotection devices include Keystone Heart’s TriGuard, a filter-deflector that covers all three cerebral arteries, has no impact on cerebral blood flow, doesn’t require an additional access site, is supported by excellent safety data, and is approved in Europe but investigational in the United States, Dr. Holmes observed. Efficacy data are coming soon, when the results of the DETECT III (A Prospective Randomized Evaluation of The TriGuard HDH Embolic Deflection Device During Transcatheter Aortic Valve Replacement) will be presented at the ACC scientific sessions on March 15. In that study, 70 patients underwent neurocognitive testing before and 30 days after their TAVR procedure.

“We’re going to be using something – a filter or filter-deflector – in every single patient to prevent the abnormal brain hits that are seen with all of these procedures. The need for brain protection is not going away,” he forecast.

Dr. Holmes, who played a pivotal role in creating the TVT registry during his term as ACC president, pointed out an intriguing registry finding: Through 2014, only 36% of the procedures have been done percutaneously.

“When you go to meetings everybody says, ‘We do them all percutaneously with a dual Perclose.’ But when you look at the data, out of those 27,000 patients only about one-third were done percutaneously. Is that going to be different in the future? Probably. But it’s important to remember that we’re still not doing all that many percutaneous procedures,” the cardiologist said.

He reported serving as a consultant to Boston Scientific.

[email protected]

SNOWMASS, COLO. – New-onset brain lesions arising after transcatheter aortic valve replacement are the largely unacknowledged elephant in the room with regard to the boomingly popular procedure.

Multiple studies utilizing diffusion-weighted MRI have shown roughly a 70% incidence of new brain lesions following transcatheter aortic valve replacement (TAVR). And studies employing full neurocognitive test batteries have consistently shown a relationship between small brain infarcts much like these, cognitive decline, and dementia, Dr. David R. Holmes Jr. said at the Annual Cardiovascular Conference at Snowmass.

Bruce Jancin/Frontline Medical News

“This is an incredibly alarming piece of information. People should be aware of this. There is interest in doing TAVR in younger and younger patients. But there is indeed an issue with unintended consequences. If we take younger and less and less symptomatic patients, their chance of dementia in 20 years is probably going to be increased. We’re going to have to follow these patients for a long period of time to look at that specific endpoint,” noted Dr. Holmes of the Mayo Clinic in Rochester, Minn.

Speaking of unintended consequences, there is also the issue of TAVR-related stroke. Among the more than 27,000 patient records submitted to the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry through December 2014, the periprocedural stroke rate was 2.4%. One-year outcomes included 26.2% mortality and a 3.6% stroke rate.

Given that two-thirds of TAVR cases submitted to the TVT registry in 2014 involved patients age 80 or older, with New York Heart Association class III/IV symptoms present in 82%, and 50% of patients rated as being at extreme risk with a predicted 1-year mortality of 50% without intervention, a 3.6% stroke rate can be considered tolerable. But not so in the sort of younger asymptomatic patients with significant aortic stenosis increasingly under discussion as potential candidates for the procedure.

“Stroke rates are the real deal in patients undergoing TAVR. Maybe you’re going to take an asymptomatic person and give them a stroke rather than wait or give a surgical valve replacement,” the cardiologist said.

He predicted that within 10 years, the use of cerebral protection devices will be considered mandatory, not just during TAVR, but during percutaneous coronary intervention, CABG surgery, and probably during atrial fibrillation ablation as well. All of these procedures have been linked to new-onset brain lesions on diffusion-weighted MRI.

Promising new neuroprotection devices include Keystone Heart’s TriGuard, a filter-deflector that covers all three cerebral arteries, has no impact on cerebral blood flow, doesn’t require an additional access site, is supported by excellent safety data, and is approved in Europe but investigational in the United States, Dr. Holmes observed. Efficacy data are coming soon, when the results of the DETECT III (A Prospective Randomized Evaluation of The TriGuard HDH Embolic Deflection Device During Transcatheter Aortic Valve Replacement) will be presented at the ACC scientific sessions on March 15. In that study, 70 patients underwent neurocognitive testing before and 30 days after their TAVR procedure.

“We’re going to be using something – a filter or filter-deflector – in every single patient to prevent the abnormal brain hits that are seen with all of these procedures. The need for brain protection is not going away,” he forecast.

Dr. Holmes, who played a pivotal role in creating the TVT registry during his term as ACC president, pointed out an intriguing registry finding: Through 2014, only 36% of the procedures have been done percutaneously.

“When you go to meetings everybody says, ‘We do them all percutaneously with a dual Perclose.’ But when you look at the data, out of those 27,000 patients only about one-third were done percutaneously. Is that going to be different in the future? Probably. But it’s important to remember that we’re still not doing all that many percutaneous procedures,” the cardiologist said.

He reported serving as a consultant to Boston Scientific.

[email protected]

SNOWMASS, COLO. – New-onset brain lesions arising after transcatheter aortic valve replacement are the largely unacknowledged elephant in the room with regard to the boomingly popular procedure.

Multiple studies utilizing diffusion-weighted MRI have shown roughly a 70% incidence of new brain lesions following transcatheter aortic valve replacement (TAVR). And studies employing full neurocognitive test batteries have consistently shown a relationship between small brain infarcts much like these, cognitive decline, and dementia, Dr. David R. Holmes Jr. said at the Annual Cardiovascular Conference at Snowmass.

Bruce Jancin/Frontline Medical News

“This is an incredibly alarming piece of information. People should be aware of this. There is interest in doing TAVR in younger and younger patients. But there is indeed an issue with unintended consequences. If we take younger and less and less symptomatic patients, their chance of dementia in 20 years is probably going to be increased. We’re going to have to follow these patients for a long period of time to look at that specific endpoint,” noted Dr. Holmes of the Mayo Clinic in Rochester, Minn.

Speaking of unintended consequences, there is also the issue of TAVR-related stroke. Among the more than 27,000 patient records submitted to the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry through December 2014, the periprocedural stroke rate was 2.4%. One-year outcomes included 26.2% mortality and a 3.6% stroke rate.

Given that two-thirds of TAVR cases submitted to the TVT registry in 2014 involved patients age 80 or older, with New York Heart Association class III/IV symptoms present in 82%, and 50% of patients rated as being at extreme risk with a predicted 1-year mortality of 50% without intervention, a 3.6% stroke rate can be considered tolerable. But not so in the sort of younger asymptomatic patients with significant aortic stenosis increasingly under discussion as potential candidates for the procedure.

“Stroke rates are the real deal in patients undergoing TAVR. Maybe you’re going to take an asymptomatic person and give them a stroke rather than wait or give a surgical valve replacement,” the cardiologist said.

He predicted that within 10 years, the use of cerebral protection devices will be considered mandatory, not just during TAVR, but during percutaneous coronary intervention, CABG surgery, and probably during atrial fibrillation ablation as well. All of these procedures have been linked to new-onset brain lesions on diffusion-weighted MRI.

Promising new neuroprotection devices include Keystone Heart’s TriGuard, a filter-deflector that covers all three cerebral arteries, has no impact on cerebral blood flow, doesn’t require an additional access site, is supported by excellent safety data, and is approved in Europe but investigational in the United States, Dr. Holmes observed. Efficacy data are coming soon, when the results of the DETECT III (A Prospective Randomized Evaluation of The TriGuard HDH Embolic Deflection Device During Transcatheter Aortic Valve Replacement) will be presented at the ACC scientific sessions on March 15. In that study, 70 patients underwent neurocognitive testing before and 30 days after their TAVR procedure.

“We’re going to be using something – a filter or filter-deflector – in every single patient to prevent the abnormal brain hits that are seen with all of these procedures. The need for brain protection is not going away,” he forecast.

Dr. Holmes, who played a pivotal role in creating the TVT registry during his term as ACC president, pointed out an intriguing registry finding: Through 2014, only 36% of the procedures have been done percutaneously.

“When you go to meetings everybody says, ‘We do them all percutaneously with a dual Perclose.’ But when you look at the data, out of those 27,000 patients only about one-third were done percutaneously. Is that going to be different in the future? Probably. But it’s important to remember that we’re still not doing all that many percutaneous procedures,” the cardiologist said.

He reported serving as a consultant to Boston Scientific.

[email protected]