{"id":34305,"date":"2013-01-22T16:23:04","date_gmt":"2013-01-22T21:23:04","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&p=34305"},"modified":"2013-01-22T16:23:04","modified_gmt":"2013-01-22T21:23:04","slug":"trials-of-niacin-and-af-device-will-headline-american-college-of-cardiology-program","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2013\/01\/22\/trials-of-niacin-and-af-device-will-headline-american-college-of-cardiology-program\/","title":{"rendered":"Trials of Niacin and AF Device Will Headline American College of Cardiology Program"},"content":{"rendered":"

\"\"<\/a>Two big trials will highlight this year’s American College of Cardiology (ACC) meeting in March in\u00a0San Francisco. First is the PREVAIL trial testing\u00a0Boston Scientific’s long-anticipated Watchman left atrial appendage closure device for stroke prevention in patients with atrial fibrillation (AF).\u00a0Second is the detailed presentation of the controversial failed HPS2-THRIVE trial of extended-release niacin and laropiprant.\u00a0The final list of trials has been posted on the ACC website.<\/a><\/p>\n

Boston Scientific’s Watchman device has been the subject of intense interest since the\u00a0PROTECT AF trial<\/a>\u00a0in 2009. However,\u00a0the FDA raised numerous questions about the device<\/a>\u00a0and, despite\u00a0a positive recommendation from the Circulatory Systems Devices panel<\/a>, required the company to perform\u00a0a new pivotal trial<\/a>. That trial,\u00a0PREVAIL<\/a>\u00a0(Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy), will be presented on Saturday, March 9, at the ACC. The trial was designed to confirm the overall finding of the earlier trial that Watchman was noninferior to standard warfarin therapy (PROTECT) and to address lingering safety and efficacy issues raised by that trial.<\/p>\n

In December, Merck\u00a0disclosed<\/a>\u00a0that the\u00a0HPS2-THRIVE\u00a0<\/a>(Heart\u00a0Protection\u00a0Study 2-Treatment of\u00a0HDL to\u00a0Reduce the\u00a0Incidence of\u00a0Vascular\u00a0Events) had failed to meet its primary endpoint. The trial, which was the\u00a0largest-ever study of niacin, found no benefit, and a signal of harm, for the combination of a statin and the combination of\u00a0extended-release niacin and laropiprant when compared to statin therapy alone in 25,673 patients at high risk for cardiovascular events. Interest in the detailed results of the trial is keen. Experts will sift the tea leaves for any clues the trial may provide about the viability of the HDL hypothesis, while\u00a0some experts believe that niacin may yet prove to be found beneficial<\/a>.<\/p>\n

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\"English:<\/a><\/p>\n<\/div>\n

Also of particular interest will be the\u00a0PARTNER 2, Cohort B trial<\/a>, testing the next generation of Edwards’ transcatheter aortic valve replacement (TAVR) system in patients with aortic stenosis who are not candidates for surgery. Partner 2, however, is not expected to attract the same attention as the original PARTNER trials, as TAVR this year has started to enter clinical practice in the U.S. and is no longer the subject of much controversy.<\/p>\n

Another trial of interest is the\u00a0CHAMPION PHOENIX Trial<\/a>.\u00a0According to the Medicines Company, which\u00a0released top line results earlier this month<\/a>, the trial found that the new antiplatelet drug\u00a0cangrelor was superior to clopidogrel in reducing ischemic events at 48 hours in PCI patients.\u00a0Nearly 11,000 patients scheduled for PCI for either stable angina or an acute coronary syndrome were enrolled in the study.<\/p>\n

The\u00a0REMINDER Trial<\/a>\u00a0tested the effect of the early adminstration of eplerenone in approximately 1,000 patients with acute MI but without heart failure. The primary endpoint is the time to cardiovascular mortality, rehospitalization, or extended initial hospital stay due to diagnosis of heart failure or sustained VT\/VF.<\/p>\n

Following the highly controversial presentation of\u00a0the initial results<\/a>\u00a0of TACT<\/a>\u00a0(Trial to Assess Chelation Therapy) last year at the AHA, which raised the possibility that chelation therapy might be beneficial, the TACT investigators will present the results of the second part of the trial, in which patients were randomized to an\u00a0oral high-dose vitamin and mineral supplement or placebo.<\/p>\n

Here is the ACC’s complete list of late-breaking clinical trials:
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Late-Breaking Clinical Trials I<\/strong><\/p>\n

Saturday, March 9, 8 \u2013 10 a.m.<\/p>\n