Shelley Wood

November 08, 2011

November 8, 2011 (Orlando, Florida) — If some of the trials taking the stage at this year's American Heart Association 2011 Scientific Sessions sound familiar, that's because much of the hottest data to be released in full at this year's meeting have already made headlines after trials were stopped early or had their top-line results released early to the public for Securities and Exchange Commission (SEC) reasons.

In that lineup are TRACER, PALLAS, ATLAS-ACS 2, SATURN, and AIM-HIGH. Speaking with heartwire , Dr Elliott Antman (Brigham and Women's Hospital, Boston, MA), insisted that the early glimpse at how these studies turned out has not dampened enthusiasm for the full results--quite the opposite.

"I think there is actually more enthusiasm [among AHA attendees], because their interest has been piqued." In a perfect world, there would be no need to prerelease top-line information, he said, but "we're in an environment where there is all this concern about making a statement to satisfy the SEC. So we make every effort to advise investigators as to how to be as qualitative and nonquantitative in their preliminary presentation of the information as possible."

The "chatter" he's heard is that people are more excited than ever to see results in detail. "People know that we live in an evidenced-based medicine era, and they want to see the evidence in full, and more important, they want to hear the discussion around the results."

Sunday Late-Breakers

In fact, Antman's top picks from the opening late-breaking clinical-trial session, at 3:45 pm on Sunday, focused on thrombosis, are two of these earlier-glimpsed studies, TRACER, testing the protease-activated receptor 1 (PAR-1) inhibitor vorapaxar in ACS patients, and ATLAS ACS 2. As previously reported by heartwire , TRACER was stopped in January on the recommendations of the data safety and monitoring board (DSMB). By contrast, ATLAS results were released in top-line form after the trial met its primary end point of reducing a composite of cardiovascular death, MI, and stroke with rivaroxaban vs placebo. The drug was also associated with a significant increase in major bleeding events not associated with coronary artery bypass surgery. The magnitude of these safety and efficacy findings, however, remains to be seen.

Antman also singled out a third trial from that first session as "a close second"--ADOPT, addressing the prevention of thrombotic events using apixaban in patients hospitalized for acute illness.

Monday Late-Breakers

Monday actually includes two separate late-breaking clinical-trial sessions, one at 10:45 in the morning and one at 3:45 in the afternoon. This was necessitated by the sheer number of high-quality late-breaking results submitted to the AHA for consideration, Antman said.

The morning session is dedicated to health services research tackling a range of pressing questions, Antman said. "I can't decide which one is the 'best'--they're all important," he said. The Monday afternoon session is dedicated to heart rhythm disorders. Here, Antman singled out the PALLAS trial, stopped by the DSMB after seeing an increase in major cardiovascular events--a composite of stroke, MI, systemic embolism, or cardiovascular death--among patients with permanent atrial fibrillation randomized to dronedarone (Multaq, Sanofi).

Tuesday Late-Breakers

The Tuesday morning late-breaking session at 10:45 am includes a study looking at a new cholesteryl ester transfer protein (CETP) inhibitor, evacetrapib and the completed SATURN high-dose statin comparison, previously reported by heartwire . But the trial that Antman believes will "attract the most attention" in this session is AIM-HIGH.

As the sponsoring National Heart Lung and Blood Institute (NHLBI) announced when it stopped the study back in May, niacin appeared to offer no benefits on top of a statin for secondary prevention and was associated with a small increase in ischemic stroke.

"What we want to know is, was the study underpowered? Was niacin not working? Or does the concept of raising HDL not help?" This is a set of "robust questions" that we hope we'll get some answers to, Antman said.

Dr Bill Boden (University at Buffalo Schools of Medicine, NY), who will present AIM-HIGH, also spoke with heartwire last week and hinted that Antman and others will have their wishes granted. "The final data will show why the study turned out the way it did--there will be new information as to why we didn't see a benefit of niacin. There has been a lot of controversy about whether this is another nail in the coffin of the HDL-raising strategy or not, but I am still of the view that a low HDL is a bad thing and the patients we enrolled were just not high risk enough for us to show that. So I don't think we should give up on the idea of raising HDL yet."

Wednesday Late-Breakers

On Wednesday, the fifth and final day of late-breaking trials, starting at 10:45 am, is focused on what Antman called "common clinical problems that we see every day in cardiology."

Of the four, Antman highlighted ELEVATE-TIMI 56, looking at the utility of escalating clopidogrel dose based on genetic makeup. Acknowledging that a range of other trials have looked at this issue of clopidogrel responsiveness, Antman emphasized: "None of these are going to be the definitive answer on the clopidogrel story--it's going to take an outcomes study to do that, but each of these provides additional information that informs clinical practice."

A "large number" of the late-breaking trials are being published simultaneously in medical journals, Antman noted.

Beyond the Late-Breaking Clinical Trials

With five, "jam-packed" late-breaking clinical-trial sessions to go to--featuring a total of 21 trials--AHA attendees may need to be reminded about just how much other new data will be presented in oral and poster sessions at the meeting. In total, there will be 742 sessions, including 447 devoted to new research, with more than 4200 abstracts chosen from over 9000 submitted. Beyond those are seven plenary sessions and 19 "special sessions."

Of these, Antman highlighted a special NHBLI session, Monday, devoted to updating health professionals on the progress being made in new guidelines for management of hypertension (JNC 8), cholesterol (ATP 4), obesity (Obesity 2), and new child/adolescent CVD risk-reduction guidelines. Another special session, Tuesday, is focused on the PARTNER cohort A and cohort B trials of the Edwards Sapien valve--particularly germane in the wake of the FDA's approval decision last week.

Antman also pointed to the program-within-the-program for the International Congress on Global Cardiovascular Disease Prevention, a combination of plenary sessions, symposia, and seminars covering epidemiology, prevention, medical care, policy, and public health worldwide.

For those with no place to go come nightfall, Antman highlighted content that the AHA has brought back in recent years--evening sessions, hosted on Sunday, Monday, and Tuesday at the Peabody Hotel with a light dinner served. These are AHA core programs, he stressed, that give attendees "someplace to go in the evening that isn't a satellite session." The AHA program, however, notes that these events are supported by unrestricted educational grants from Merck, Genentech, and Pfizer.

Finally, Antman urged AHA attendees to avail themselves of some of the digital bells and whistles the AHA has launched. He pointed to the addition of QR codes on all the posters, allowing smart-phone users to download information about the poster to their phones, including a PDF of the poster itself, if available; email questions to the authors; and even listen to a prerecorded presentation of the data. "This is the way we need to start thinking about using new technology," he said.

Navigating the Program

This year's program can be perused on smart phones, on an online flip book, downloaded as an e-book, or in old-fashioned PDF.

As with last year, the 2011 program is organized by seven multidisciplinary cardiovascular cores: cardiovascular imaging; epidemiology and prevention; genetics, genomics and congenital CV disorders; heart rhythm disorders and resuscitation science; myocardium function and failure; catheter-based and surgical interventions; and vascular disease biology and clinical science.

Each core will include topics tagged as clinical, basic, population, or translational science, and content will also be grouped by clinical "tracks."

According to Antman, the meeting is on track to see the same number of attendees who typically come to the AHA meeting when it's held in Orlando, although he couldn't provide specific numbers. This year's meeting starts just one day after TCT 2011 wraps up in San Francisco, but so far, according to Antman, 900 interventional cardiologists have already registered for AHA, "and that's close to what we see every year," he added.