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Health See other Health Articles Title: AHA Sessions Preview: Highlights Include Long-Awaited Controversial Lipid, Stent Trials CHICAGO, IL — Mark Twain once wrote that the host city for this year's American Heart Association (AHA) 2014 Scientific Sessions is "always a novelty; for she is never the Chicago you saw when you passed through the last time." That could be said about cardiology practice itself, which should emerge from the sessions' 4 days of original research, dialog, and expert discussion with a bounty of insights expected to take the management of patients with heart disease to higher levels. If there's anyone who exemplifies what the field's advances over the past decades can do for patients with heart disease, it may be Dick Cheney, who will present his take on "Living with Heart Failure" on Monday morning of the sessions. The former vice president's odyssey has included at least five MIs, the first at age 38, followed by coronary stenting, CABG surgery, an implantable cardioverter-defibrillator, a left-ventricular-assist device in July 2010, and, 20 months later, heart transplantation. He has been a one-man test case for best contemporary cardiovascular care throughout most of his adult life and generous about publicly sharing his story. Antiplatelets, LDL-Lowering Agents: Long-Awaited Answers at Hand? Primary results from at least two major clinical trials, the Dual Antiplatelet Therapy Study (DAPT) and the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), will be presented at different late-breaking clinical-trials sessions, program chair Dr Robert Harrington (Stanford University, CA) told heartwire . "These are two trials that the community has waited for a long time." Both studies will be analyzed and discussed from different angles at not only the late-breaking sessions but also the separate Clinical Trials: Special Reports, Harrington observed. A number of controversies surrounding the trials—for example, the variety of stents used in DAPT and protracted patient enrollment in IMPROVE-IT, as long covered by heartwire —are certain to be addressed at one venue or another. The first late-breaking session on Sunday is devoted entirely to trials of antiplatelet therapy in the setting of coronary stenting and especially to nailing down the most effective but safest duration for treatment with primarily clopidogrel or prasugrel. Should it be given for 6 months, or 12, or 24, or longer after the procedure? The DAPT study along with ISAR-SAFE and two other trials should shed some light on one of interventional cardiology's biggest questions. Instead of a discussant following each of the presentations, Harrington said, "In this session we shortened the presentations a bit, and then we asked a single commentator to put the entire field in perspective in light of these four trials. [Dr] Gilles Montalescot [Hôpital Pitié-Salpêtrière, Paris, France] will be doing that." The schedule then calls for Montalescot, the presenters, and others to join in a panel discussion. IMPROVE IT is "the anchor" of Monday's second late-breaking session, observed Harrington. Launched 9 years ago, the trial asked whether adding ezetimibe to simvastatin (the combination drug Vytorin, Merck), which can knock low-density lipoprotein (LDL) cholesterol levels down further than is possible with simvastatin alone, make a difference to clinical outcomes. Vytorin is often used in clinical practice, but without the kind of clinical-outcomes studies that established statins as the go-to solo drug therapy for dyslipidemia. Harrington noted, "As a community, we're looking forward to this. Prevention: From Aspirin to PCSK9 Inhibition Also in that session: primary results of the Japanese Primary Prevention Project, a randomized trial of open-label aspirin at 100 mg/day for primary prevention, which enrolled >14 000 patients aged 60 to 85 years (58% were women) with cardiovascular risk factors including, in one-third of cases, diabetes. Not only is primary-prevention aspirin a critical public-health question, Harrington said, "Just the fact that somebody did a trial with 60- to 85-year-olds is really important." Next will be the FACTOR-64 trial, a trial planned for 900 patients with diabetes but asymptomatic for coronary disease to undergo screening with computed tomography (CT) angiography vs standard therapy. Not only does it have lots of patients for an imaging study, said Harrington, it's special for being an imaging study with clinical outcomes. Last in that session: the primary data presentation of ODYSSEY Alternative, a randomized trial of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab (Sanofi/Regeneron) in statin-intolerant patients with primary hypercholesterolemia and moderate to high cardiovascular risk. The placebo-controlled trial separately compared the drug with ezetimibe and atorvastatin in a projected 314 patients for changes in LDL cholesterol over 24 weeks. A Wednesday morning Clinical Trials: Special Reports is devoted to other alirocumab trials in the ODYSSEY family, including a comparison of the drug with other statins or ezetimibe in high-CV-risk patients, a trial in severe heterozygous familial hypercholesterolemia, one in patients not well controlled on maximal statins, and another of alirocumab vs placebo in a projected 2100 high-CV-risk patients followed for up to 20 months. "We're starting the session with an overview of PCSK9-inhibitor therapy, then the four other ODYSSEY studies, and then we have a biostatistician talking about LDL as a surrogate," Harrington said. "We're hoping he's provocative." Familiar Drugs for Special Populations The third late-breaking clinical-trial session on Tuesday begins with presentations on two studies that may be remarkable more for their populations, seldom seen in large clinical trials, than for the newness of the tested therapies. One is a randomized comparison of the beta-blocker atenolol with the angiotensin-receptor blocker (ARB) losartan in young people with Marfan syndrome, and the other a randomized trial of losartan in hypertrophic cardiomyopathy (HCM). "These are trials we don't have a lot of in cardiology," Harrington said. "Six hundred kids and young adults with Marfan's—that's extraordinary! And HCM is another where we've not done a lot of multicenter clinical trials." He said beta-blockers are standard therapy for patients with Marfan syndrome, "based on literature from a long time ago. And there are some mechanistic data as well as pilot data suggesting that losartan may be beneficial. So this comparison of atenolol and losartan looks at aortic enlargement in these patients." An accompanying presentation looks at the epidemiology of infective endocarditis in the UK and "raises questions about what the recommendations should be for antibiotic prophylaxis for those with structural heart disease when they get their teeth cleaned." Two trials leading off the fourth late-breaking clinical-trials session on Wednesday morning look at biodegradable drug-eluting stents (DES). The BASKET-PROVE II and EVOLVE II clinical trials will then be discussed as a pair by Dr Roxana Mehran (Mount Sinai School of Medicine, New York, NY). "By going with these new types of stents, do you lose anything on the restenosis/repeat-revascularization front, and do you reduce the long-term risk of stent thrombosis? That's part of the question," Harrington said. "We're pretty excited to have these two trials, frankly, because these are the kind of studies that frequently go to the TCT." A Classic Statin Trial Revisited There are four other Clinical Trials: Special Reports sessions, besides the one dedicated to the ODYSSEY trials, running Monday, Tuesday, and Wednesday. Among the noteworthy individual presentations, Harrington noted for Tuesday, is a 20-year follow-up on a randomized trial that helped launch the era of statins for primary prevention, the West of Scotland Coronary Prevention Study (WOSCOPS). Poster Comment: If there's anyone who exemplifies what the field's advances over the past decades can do for patients with heart disease, it may be Dick Cheney, who will present his take on "Living with Heart Failure" Sometimes it's best to let nature take its course; thousands of people would still be alive. Post Comment Private Reply Ignore Thread
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