Important valve replacement data expected at ACC.13

Two major studies on transfemoral aortic valve replacement technologies will be among the late-breaking clinical trials presented at the annual meeting of the American College of Cardiology March 9-11.

The results come at a key time, when surgeons are starting to consider transfemoral aortic valve replacement (TAVR) for low-risk as well as high-risk patients, said ACC.13 Cochair Dr. Mark G. Davies.

Other highlights among the late-breakers at the meeting include studies on biodegradable versus durable stents, statins to prevent kidney injury during percutaneous coronary intervention (PCI), short-acting antiplatelet therapy, new drugs that may reduce the size or long-term effects of heart attacks, ranolazine therapy to reduce angina in patients with diabetes, using digitalis in older patients with heart failure, and more.

He and a roster of other ACC officials provided these highlights:

• PARTNER trial: Two-year data from the Placement of Aortic Transcatheter Valve (PARTNER) trial already have suggested that results with TAVR were reasonably comparable to results with surgical aortic valve replacement (SAVR), though perhaps with increased risk of early stroke after TAVR. "But the one Achilles heel that everyone is worried about is that there will be more early strokes in TAVR," said Dr. Davies, a senior member at the Methodist Hospital Research Institute, Houston.

Three-year data from the PARTNER trial, to be presented at the meeting, should show whether the level of valvular regurgitation is increasing or not – important findings that will change practices, he said. "This is significant because we’re entering an era of entertaining these technologies for what’s considered normal or low-risk patients who might avoid a surgical aortic revascularization," said Dr. Davies. For hospitals, "it will be interesting to see if the cost-effectiveness is carried out to 3 years," he added.

• PARTNER II: This trial used a second-generation Edwards Sapien XT transcatheter heart valve and delivery system, which has a lower profile compared with the first-generation device.

The Food and Drug Administration required the Sapien and Edwards investigators to compare the newer version against SAVR before taking it to market, according to ACC Vice President Dr. Patrick T. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital, Boston.

"Most investigators and clinicians in this area are keen to hear the results of this trial, and I think most anticipate that a lower-profile device will be an improvement," he said.

• NEXT trial: Enthusiasm for a potential future of biodegradable stent products rides on hopes that biodegradable polymers might cause less arterial injury and stent thrombosis, "although it seems to me very difficult to beat very low rates of stent thrombosis with present-generation drug-eluting stents," Dr. O’Gara said. This large Japanese trial comparing a biodegradable stent polymer and a durable stent polymer in more than 3,000 patients is a major data source. The NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent (NEXT) trial likely will contribute "very important information in this growing field," he said.

• DKCRUSH-III trial: A highly technical and impressively large study in China compared two interventional strategies in more than 400 patients with unprotected left main bifurcation lesions. Historically, interventionalists have been challenged by management of lesions at the distal end of the left main coronary artery and extending to the origins of the left anterior descending (LAD) artery and the circumflex artery, he said. "Manipulation of the left main in this particular area is fraught with complications and relatively high rates of recurrent events."

The prospective, multicenter Comparison of Double Kissing Crush Versus Culotte Stenting for Unprotected Distal Left Main Bifurcation Lesions (DKCRUSH-III) study randomized patients to intervention with stents placed in the LAD and circumflex arteries or to high-pressure balloons being placed in those arteries and inflated simultaneously.

• CHAMPION PHOENIX trial: Results of previous studies of the experimental antiplatelet drug cangrelor have been neutral or positive, but none of the studies were as large as the Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (CHAMPION PHOENIX), which boasts nearly 11,000 patients. Preliminary results of the phase III trial suggested that this intravenously administered P2Y2-receptor inhibitor outperformed clopidogrel in patients requiring PCI in a composite endpoint of death, MI, ischemia-driven revascularization, and stent thrombosis at 48 hours.

The potential advantage of cangrelor is its very rapid onset and rapid offset of effects. "I think there is very keen expectation to hear the results of this trial as to whether or not this medication should be considered in the armamentarium at the time of PCI," Dr. O’Gara said.

• PRATO-ACS trial: The open-label Statin Contrast Induced Neuropathy Prevention (PRATO-ACS) trial randomized patients with non–ST-elevation acute coronary syndrome who are undergoing PCI to usual care or to taking a 40-mg dose of rosuvastatin at admission and then 20 mg/day for 1 month, to see if the statin will reduce acute kidney injury from the angiographic contrast medium.

"This is a very interesting look at the efficacy of a medication which, in this context, is likely to be extremely safe," Dr. O’Gara said.

Dr. Gary S. Mintz, chief medical officer at the Cardiovascular Research Foundation, New York, added, "This is an important problem. When you have a patient presenting acutely, you really don’t have much of a choice" but to send the patient to a catheterization lab, where almost invariably a stent is implanted, a procedure requiring angiographic contrast, which can induce acute renal insufficiency or worsen preexisting renal insufficiency. "Patients who develop significant renal insufficiency have an awful outcome, both acutely and long-term. If there’s any safe way, any easy, efficacious way to prevent acute renal insufficiency in this setting, this will become the standard of care."

• MASS COMM trial: The use of PCI is increasing in smaller hospitals as more of them develop non-open coronary artery based practices, and there’s controversy over whether these practices should have the backup of on-site cardiac surgery services, Dr. Davies said. The PCI Outcomes in Community Versus Tertiary Settings (MASS COMM) trial randomized nearly 4,000 Massachusetts residents undergoing elective PCI to one of 10 hospitals without on-site surgical backup or one of 7 hospitals with on-site backup.

• REMINDER trial: Despite all the advances in treating acute MI, a subgroup of patients still suffer enough heart damage that they go on to develop heart failure. The large, multicenter Impact of Eplerenone on Cardiovascular in Patients Post Myocardial Infarction (REMINDER) trial randomized more than 1,000 patients who’d had heart attacks within 24 hours to treatment with placebo or the aldosterone-blocker eplerenone. Outcomes to be reported include some clinical signs of worsening heart function, clinical signs that predict heart failure, and some biomarkers of worsening cardiac function.

• Select ACS trial: This multicenter, randomized, double-blind, placebo-controlled study looks at whether or not giving the investigational drug inclacumab to patients with non–ST-elevation MI who are undergoing PCI reduces short-term markers of infarct size. Inclacumab is a fully human antibody targeting P-selectin, a molecule that plays a role in sending white blood cells to the site of injury during inflammation.

"If, in fact, this agent reduces the size of the heart attack in this subgroup of patients, it potentially could have benefits long term," said ACC.13 Chairman Dr. Miguel A. Quiñones, chair of the department of cardiology in the Methodist Hospital System, Houston, and professor of medicine at Weill Cornell Medical College, New York.

• ASTRONAUT trial: Can add-on therapy with the potent direct renin inhibitor aliskiren improve outcomes in patients presenting with acute heart failure? Results of a trial in roughly 1,600 patients – the Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients with Acute Decompensated Heart Failure (ASTRONAUT) trial – may tell us.

• TERISA trial: The Type 2 Diabetes Evaluation of Ranolazine in Subjects with Chronic Stable Angina (TERISA) trial looked at whether the drug reduced the weekly average frequency of angina in patients with diabetes, coronary artery disease, and chronic stable angina. Revascularization procedures can be challenging in diabetics, who often have small vessels, so a helpful medical therapy would be a boon, said ACC.13 Cochair Dr. Christie M. Ballantyne, director of the Center for Cardiovascular Disease Prevention at Methodist DeBakey Heart Center, Houston.

• DIG trial: An analysis of data from the Digitalis Investigation Group (DIG) trial will report whether giving the inexpensive drug digoxin to patients aged 65 years or older who have heart failure reduced hospitalizations and mortality.

• STOP-HF trial: The St. Vincent’s Screening To Prevent Heart Failure (STOP-HF) study took a "very creative approach" to try and reduce the impact of the current epidemic of heart failure by catching patients before they develop symptoms, Dr. Ballantyne said. They screened people over age 40 who had risk factors for heart failure using a blood test for natriuretic peptide; those with high levels of the peptide were sent for echocardiography and were comanaged by their primary care physician with recommendations from a specialty cardiology service. The control group of patients with risk factors for heart failure received usual care without the blood test screening or collaborative management. Results will compare the prevalence and severity of left ventricular dysfunction over 5 years in the two groups.

A list of these and other late-breaking presentations can be found on the ACC.13 website.

Dr. Quinones and Dr. Davies reported having no financial disclosures. Dr. Ballantyne reported receiving speaker and consulting fees and research funds from many pharmaceutical companies. Dr. Mintz has received fees for consulting or speaking from Boston Scientific, Volcano, Medtronic, LightLab, and Pfizer. Dr. O’Gara has been on the Data and Safety Monitoring Board of Lantheus Medical Imaging.

[email protected]

On Twitter @sherryboschert

Two major studies on transfemoral aortic valve replacement technologies will be among the late-breaking clinical trials presented at the annual meeting of the American College of Cardiology March 9-11.

The results come at a key time, when surgeons are starting to consider transfemoral aortic valve replacement (TAVR) for low-risk as well as high-risk patients, said ACC.13 Cochair Dr. Mark G. Davies.

Other highlights among the late-breakers at the meeting include studies on biodegradable versus durable stents, statins to prevent kidney injury during percutaneous coronary intervention (PCI), short-acting antiplatelet therapy, new drugs that may reduce the size or long-term effects of heart attacks, ranolazine therapy to reduce angina in patients with diabetes, using digitalis in older patients with heart failure, and more.

He and a roster of other ACC officials provided these highlights:

• PARTNER trial: Two-year data from the Placement of Aortic Transcatheter Valve (PARTNER) trial already have suggested that results with TAVR were reasonably comparable to results with surgical aortic valve replacement (SAVR), though perhaps with increased risk of early stroke after TAVR. "But the one Achilles heel that everyone is worried about is that there will be more early strokes in TAVR," said Dr. Davies, a senior member at the Methodist Hospital Research Institute, Houston.

Three-year data from the PARTNER trial, to be presented at the meeting, should show whether the level of valvular regurgitation is increasing or not – important findings that will change practices, he said. "This is significant because we’re entering an era of entertaining these technologies for what’s considered normal or low-risk patients who might avoid a surgical aortic revascularization," said Dr. Davies. For hospitals, "it will be interesting to see if the cost-effectiveness is carried out to 3 years," he added.

• PARTNER II: This trial used a second-generation Edwards Sapien XT transcatheter heart valve and delivery system, which has a lower profile compared with the first-generation device.

The Food and Drug Administration required the Sapien and Edwards investigators to compare the newer version against SAVR before taking it to market, according to ACC Vice President Dr. Patrick T. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital, Boston.

"Most investigators and clinicians in this area are keen to hear the results of this trial, and I think most anticipate that a lower-profile device will be an improvement," he said.

• NEXT trial: Enthusiasm for a potential future of biodegradable stent products rides on hopes that biodegradable polymers might cause less arterial injury and stent thrombosis, "although it seems to me very difficult to beat very low rates of stent thrombosis with present-generation drug-eluting stents," Dr. O’Gara said. This large Japanese trial comparing a biodegradable stent polymer and a durable stent polymer in more than 3,000 patients is a major data source. The NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent (NEXT) trial likely will contribute "very important information in this growing field," he said.

• DKCRUSH-III trial: A highly technical and impressively large study in China compared two interventional strategies in more than 400 patients with unprotected left main bifurcation lesions. Historically, interventionalists have been challenged by management of lesions at the distal end of the left main coronary artery and extending to the origins of the left anterior descending (LAD) artery and the circumflex artery, he said. "Manipulation of the left main in this particular area is fraught with complications and relatively high rates of recurrent events."

The prospective, multicenter Comparison of Double Kissing Crush Versus Culotte Stenting for Unprotected Distal Left Main Bifurcation Lesions (DKCRUSH-III) study randomized patients to intervention with stents placed in the LAD and circumflex arteries or to high-pressure balloons being placed in those arteries and inflated simultaneously.

• CHAMPION PHOENIX trial: Results of previous studies of the experimental antiplatelet drug cangrelor have been neutral or positive, but none of the studies were as large as the Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (CHAMPION PHOENIX), which boasts nearly 11,000 patients. Preliminary results of the phase III trial suggested that this intravenously administered P2Y2-receptor inhibitor outperformed clopidogrel in patients requiring PCI in a composite endpoint of death, MI, ischemia-driven revascularization, and stent thrombosis at 48 hours.

The potential advantage of cangrelor is its very rapid onset and rapid offset of effects. "I think there is very keen expectation to hear the results of this trial as to whether or not this medication should be considered in the armamentarium at the time of PCI," Dr. O’Gara said.

• PRATO-ACS trial: The open-label Statin Contrast Induced Neuropathy Prevention (PRATO-ACS) trial randomized patients with non–ST-elevation acute coronary syndrome who are undergoing PCI to usual care or to taking a 40-mg dose of rosuvastatin at admission and then 20 mg/day for 1 month, to see if the statin will reduce acute kidney injury from the angiographic contrast medium.

"This is a very interesting look at the efficacy of a medication which, in this context, is likely to be extremely safe," Dr. O’Gara said.

Dr. Gary S. Mintz, chief medical officer at the Cardiovascular Research Foundation, New York, added, "This is an important problem. When you have a patient presenting acutely, you really don’t have much of a choice" but to send the patient to a catheterization lab, where almost invariably a stent is implanted, a procedure requiring angiographic contrast, which can induce acute renal insufficiency or worsen preexisting renal insufficiency. "Patients who develop significant renal insufficiency have an awful outcome, both acutely and long-term. If there’s any safe way, any easy, efficacious way to prevent acute renal insufficiency in this setting, this will become the standard of care."

• MASS COMM trial: The use of PCI is increasing in smaller hospitals as more of them develop non-open coronary artery based practices, and there’s controversy over whether these practices should have the backup of on-site cardiac surgery services, Dr. Davies said. The PCI Outcomes in Community Versus Tertiary Settings (MASS COMM) trial randomized nearly 4,000 Massachusetts residents undergoing elective PCI to one of 10 hospitals without on-site surgical backup or one of 7 hospitals with on-site backup.

• REMINDER trial: Despite all the advances in treating acute MI, a subgroup of patients still suffer enough heart damage that they go on to develop heart failure. The large, multicenter Impact of Eplerenone on Cardiovascular in Patients Post Myocardial Infarction (REMINDER) trial randomized more than 1,000 patients who’d had heart attacks within 24 hours to treatment with placebo or the aldosterone-blocker eplerenone. Outcomes to be reported include some clinical signs of worsening heart function, clinical signs that predict heart failure, and some biomarkers of worsening cardiac function.

• Select ACS trial: This multicenter, randomized, double-blind, placebo-controlled study looks at whether or not giving the investigational drug inclacumab to patients with non–ST-elevation MI who are undergoing PCI reduces short-term markers of infarct size. Inclacumab is a fully human antibody targeting P-selectin, a molecule that plays a role in sending white blood cells to the site of injury during inflammation.

"If, in fact, this agent reduces the size of the heart attack in this subgroup of patients, it potentially could have benefits long term," said ACC.13 Chairman Dr. Miguel A. Quiñones, chair of the department of cardiology in the Methodist Hospital System, Houston, and professor of medicine at Weill Cornell Medical College, New York.

• ASTRONAUT trial: Can add-on therapy with the potent direct renin inhibitor aliskiren improve outcomes in patients presenting with acute heart failure? Results of a trial in roughly 1,600 patients – the Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients with Acute Decompensated Heart Failure (ASTRONAUT) trial – may tell us.

• TERISA trial: The Type 2 Diabetes Evaluation of Ranolazine in Subjects with Chronic Stable Angina (TERISA) trial looked at whether the drug reduced the weekly average frequency of angina in patients with diabetes, coronary artery disease, and chronic stable angina. Revascularization procedures can be challenging in diabetics, who often have small vessels, so a helpful medical therapy would be a boon, said ACC.13 Cochair Dr. Christie M. Ballantyne, director of the Center for Cardiovascular Disease Prevention at Methodist DeBakey Heart Center, Houston.

• DIG trial: An analysis of data from the Digitalis Investigation Group (DIG) trial will report whether giving the inexpensive drug digoxin to patients aged 65 years or older who have heart failure reduced hospitalizations and mortality.

• STOP-HF trial: The St. Vincent’s Screening To Prevent Heart Failure (STOP-HF) study took a "very creative approach" to try and reduce the impact of the current epidemic of heart failure by catching patients before they develop symptoms, Dr. Ballantyne said. They screened people over age 40 who had risk factors for heart failure using a blood test for natriuretic peptide; those with high levels of the peptide were sent for echocardiography and were comanaged by their primary care physician with recommendations from a specialty cardiology service. The control group of patients with risk factors for heart failure received usual care without the blood test screening or collaborative management. Results will compare the prevalence and severity of left ventricular dysfunction over 5 years in the two groups.

A list of these and other late-breaking presentations can be found on the ACC.13 website.

Dr. Quinones and Dr. Davies reported having no financial disclosures. Dr. Ballantyne reported receiving speaker and consulting fees and research funds from many pharmaceutical companies. Dr. Mintz has received fees for consulting or speaking from Boston Scientific, Volcano, Medtronic, LightLab, and Pfizer. Dr. O’Gara has been on the Data and Safety Monitoring Board of Lantheus Medical Imaging.

[email protected]

On Twitter @sherryboschert

Two major studies on transfemoral aortic valve replacement technologies will be among the late-breaking clinical trials presented at the annual meeting of the American College of Cardiology March 9-11.

The results come at a key time, when surgeons are starting to consider transfemoral aortic valve replacement (TAVR) for low-risk as well as high-risk patients, said ACC.13 Cochair Dr. Mark G. Davies.

Other highlights among the late-breakers at the meeting include studies on biodegradable versus durable stents, statins to prevent kidney injury during percutaneous coronary intervention (PCI), short-acting antiplatelet therapy, new drugs that may reduce the size or long-term effects of heart attacks, ranolazine therapy to reduce angina in patients with diabetes, using digitalis in older patients with heart failure, and more.

He and a roster of other ACC officials provided these highlights:

• PARTNER trial: Two-year data from the Placement of Aortic Transcatheter Valve (PARTNER) trial already have suggested that results with TAVR were reasonably comparable to results with surgical aortic valve replacement (SAVR), though perhaps with increased risk of early stroke after TAVR. "But the one Achilles heel that everyone is worried about is that there will be more early strokes in TAVR," said Dr. Davies, a senior member at the Methodist Hospital Research Institute, Houston.

Three-year data from the PARTNER trial, to be presented at the meeting, should show whether the level of valvular regurgitation is increasing or not – important findings that will change practices, he said. "This is significant because we’re entering an era of entertaining these technologies for what’s considered normal or low-risk patients who might avoid a surgical aortic revascularization," said Dr. Davies. For hospitals, "it will be interesting to see if the cost-effectiveness is carried out to 3 years," he added.

• PARTNER II: This trial used a second-generation Edwards Sapien XT transcatheter heart valve and delivery system, which has a lower profile compared with the first-generation device.

The Food and Drug Administration required the Sapien and Edwards investigators to compare the newer version against SAVR before taking it to market, according to ACC Vice President Dr. Patrick T. O’Gara, director of clinical cardiology at Brigham and Women’s Hospital, Boston.

"Most investigators and clinicians in this area are keen to hear the results of this trial, and I think most anticipate that a lower-profile device will be an improvement," he said.

• NEXT trial: Enthusiasm for a potential future of biodegradable stent products rides on hopes that biodegradable polymers might cause less arterial injury and stent thrombosis, "although it seems to me very difficult to beat very low rates of stent thrombosis with present-generation drug-eluting stents," Dr. O’Gara said. This large Japanese trial comparing a biodegradable stent polymer and a durable stent polymer in more than 3,000 patients is a major data source. The NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent (NEXT) trial likely will contribute "very important information in this growing field," he said.

• DKCRUSH-III trial: A highly technical and impressively large study in China compared two interventional strategies in more than 400 patients with unprotected left main bifurcation lesions. Historically, interventionalists have been challenged by management of lesions at the distal end of the left main coronary artery and extending to the origins of the left anterior descending (LAD) artery and the circumflex artery, he said. "Manipulation of the left main in this particular area is fraught with complications and relatively high rates of recurrent events."

The prospective, multicenter Comparison of Double Kissing Crush Versus Culotte Stenting for Unprotected Distal Left Main Bifurcation Lesions (DKCRUSH-III) study randomized patients to intervention with stents placed in the LAD and circumflex arteries or to high-pressure balloons being placed in those arteries and inflated simultaneously.

• CHAMPION PHOENIX trial: Results of previous studies of the experimental antiplatelet drug cangrelor have been neutral or positive, but none of the studies were as large as the Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (CHAMPION PHOENIX), which boasts nearly 11,000 patients. Preliminary results of the phase III trial suggested that this intravenously administered P2Y2-receptor inhibitor outperformed clopidogrel in patients requiring PCI in a composite endpoint of death, MI, ischemia-driven revascularization, and stent thrombosis at 48 hours.

The potential advantage of cangrelor is its very rapid onset and rapid offset of effects. "I think there is very keen expectation to hear the results of this trial as to whether or not this medication should be considered in the armamentarium at the time of PCI," Dr. O’Gara said.

• PRATO-ACS trial: The open-label Statin Contrast Induced Neuropathy Prevention (PRATO-ACS) trial randomized patients with non–ST-elevation acute coronary syndrome who are undergoing PCI to usual care or to taking a 40-mg dose of rosuvastatin at admission and then 20 mg/day for 1 month, to see if the statin will reduce acute kidney injury from the angiographic contrast medium.

"This is a very interesting look at the efficacy of a medication which, in this context, is likely to be extremely safe," Dr. O’Gara said.

Dr. Gary S. Mintz, chief medical officer at the Cardiovascular Research Foundation, New York, added, "This is an important problem. When you have a patient presenting acutely, you really don’t have much of a choice" but to send the patient to a catheterization lab, where almost invariably a stent is implanted, a procedure requiring angiographic contrast, which can induce acute renal insufficiency or worsen preexisting renal insufficiency. "Patients who develop significant renal insufficiency have an awful outcome, both acutely and long-term. If there’s any safe way, any easy, efficacious way to prevent acute renal insufficiency in this setting, this will become the standard of care."

• MASS COMM trial: The use of PCI is increasing in smaller hospitals as more of them develop non-open coronary artery based practices, and there’s controversy over whether these practices should have the backup of on-site cardiac surgery services, Dr. Davies said. The PCI Outcomes in Community Versus Tertiary Settings (MASS COMM) trial randomized nearly 4,000 Massachusetts residents undergoing elective PCI to one of 10 hospitals without on-site surgical backup or one of 7 hospitals with on-site backup.

• REMINDER trial: Despite all the advances in treating acute MI, a subgroup of patients still suffer enough heart damage that they go on to develop heart failure. The large, multicenter Impact of Eplerenone on Cardiovascular in Patients Post Myocardial Infarction (REMINDER) trial randomized more than 1,000 patients who’d had heart attacks within 24 hours to treatment with placebo or the aldosterone-blocker eplerenone. Outcomes to be reported include some clinical signs of worsening heart function, clinical signs that predict heart failure, and some biomarkers of worsening cardiac function.

• Select ACS trial: This multicenter, randomized, double-blind, placebo-controlled study looks at whether or not giving the investigational drug inclacumab to patients with non–ST-elevation MI who are undergoing PCI reduces short-term markers of infarct size. Inclacumab is a fully human antibody targeting P-selectin, a molecule that plays a role in sending white blood cells to the site of injury during inflammation.

"If, in fact, this agent reduces the size of the heart attack in this subgroup of patients, it potentially could have benefits long term," said ACC.13 Chairman Dr. Miguel A. Quiñones, chair of the department of cardiology in the Methodist Hospital System, Houston, and professor of medicine at Weill Cornell Medical College, New York.

• ASTRONAUT trial: Can add-on therapy with the potent direct renin inhibitor aliskiren improve outcomes in patients presenting with acute heart failure? Results of a trial in roughly 1,600 patients – the Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients with Acute Decompensated Heart Failure (ASTRONAUT) trial – may tell us.

• TERISA trial: The Type 2 Diabetes Evaluation of Ranolazine in Subjects with Chronic Stable Angina (TERISA) trial looked at whether the drug reduced the weekly average frequency of angina in patients with diabetes, coronary artery disease, and chronic stable angina. Revascularization procedures can be challenging in diabetics, who often have small vessels, so a helpful medical therapy would be a boon, said ACC.13 Cochair Dr. Christie M. Ballantyne, director of the Center for Cardiovascular Disease Prevention at Methodist DeBakey Heart Center, Houston.

• DIG trial: An analysis of data from the Digitalis Investigation Group (DIG) trial will report whether giving the inexpensive drug digoxin to patients aged 65 years or older who have heart failure reduced hospitalizations and mortality.

• STOP-HF trial: The St. Vincent’s Screening To Prevent Heart Failure (STOP-HF) study took a "very creative approach" to try and reduce the impact of the current epidemic of heart failure by catching patients before they develop symptoms, Dr. Ballantyne said. They screened people over age 40 who had risk factors for heart failure using a blood test for natriuretic peptide; those with high levels of the peptide were sent for echocardiography and were comanaged by their primary care physician with recommendations from a specialty cardiology service. The control group of patients with risk factors for heart failure received usual care without the blood test screening or collaborative management. Results will compare the prevalence and severity of left ventricular dysfunction over 5 years in the two groups.

A list of these and other late-breaking presentations can be found on the ACC.13 website.

Dr. Quinones and Dr. Davies reported having no financial disclosures. Dr. Ballantyne reported receiving speaker and consulting fees and research funds from many pharmaceutical companies. Dr. Mintz has received fees for consulting or speaking from Boston Scientific, Volcano, Medtronic, LightLab, and Pfizer. Dr. O’Gara has been on the Data and Safety Monitoring Board of Lantheus Medical Imaging.

[email protected]

On Twitter @sherryboschert