November 10th, 2011
The AHA in Orlando: A Preview
Larry Husten, PHD
The AHA 2011 Scientific Sessions start this weekend in Orlando. CardioExchange received a preview of some of the many expected highlights of the meeting from Program Chair Elliott Antman. (Click here to view AHA videos of Antman’s meeting previews.)
Antman stressed the sheer size and magnitude of the meeting: 742 individual sessions, 4238 abstracts selected out of more than 9000 submitted, 295 invited sessions, and 5 late-breaking clinical trial sessions.
Here are a few of the late-breaking clinical trials highlighted by Antman:
ADOPT (Apixaban Dosing to Optimize Protection from Thrombosis) will be the first of several trials evaluating the newer anticoagulants. The ADOPT Trial randomized 6,528 hospitalized, medically ill patients to evaluate apixaban 2.5 mg twice daily for 30 days compared to enoxaparin for at least 6 days to reduce the incidence of venous thromboembolism.
TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) is a large new trial investigating the novel agent vorapaxar, which is a thrombin receptor antagonist, in the setting of ACS. Merck, the trial’s sponsor, announced earlier this year that the trial had been stopped prematurely by the data and safety monitoring board, but few details have been available until now.
ATLAS ACS 2-TIMI 51 (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome-Thrombolysis in Myocardial Infarction 51) is a large trial testing whether the addition of rivaroxaban to standard care in patients with ACS can reduce major cardiovascular events. The sponsor of the trial announced that the trial was positive for the primary endpoint but that there were also more bleeding complications in the rivaroxaban arm. Antman noted that “many important questions remain open,” including whether the trial shows an impact on mortality.
PALLAS, which tested the role of dronedarone in patients with permanent atrial fibrillation, was stopped early because of harm. Many observers are keen to learn the details of this trial, and whether it will have implications for the use of dronedarone in other indications.
AIM-HIGH tested the effect of extended-release niacin in patients with CV disease and low HDL cholesterol and high triglycerides. The trial was stopped for futility. “We don’t know if that means if the trial was underpowered, if niacin doesn’t work, or if HDL therapies don’t work,” said Antman. “There will be lots of implications for the future of HDL.”
Antman also pointed to a plenary session on Monday morning that will feature a status report from the NHLBI on 3 major new guidelines for blood pressure (JNC 8), lipids (ATP 4), and obesity that are expected to be published in 2012. In addition, a separate symposium will focus on the PARTNER trial and the integration of percutaneous aortic valve implantation into clinical practice.
Click here for a complete list of the AHA late-breaking clinical trials.