Hot or Not, This Year’s Trials Offer Food for Thought: My Takeaways From ACC 2016
Somehow, heading into this year’s American College of Cardiology 2016 Scientific Sessions, I had the Easter-morning attitude that despite knowing everything slated for delivery, I was still hoping to stumble across some hidden treats. This gets harder and harder every year.
The number of “late-breaking trials” at the major cardiology conferences seems to grow ever larger, even as the sum total of study participants shrinks smaller and smaller. And naturally, the unblinking beam of the media spotlight at annual meetings is trained on these studies, making them almost impossible to ignore. As a journalist, this means press conferences, press releases, media availabilities, embargoed slides, and, more often than not, embargoed papers that will be published simultaneously. Try as I might to turn a blind eye and hunt for smaller, potentially more novel things in the program that may be of interest to our readers, it feels a bit like bumping around in the props closet while the large-cast musical is belting it out on the big stage.
This year, 18 of the 23 late breakers and at least 22 other studies presented elsewhere at the meeting were published simultaneously in major medical journals. The McMaster University investigators who presented the three HOPE-3 late breakers in the opening session endured some good-natured ribbing from colleagues for managing to milk three separate New England Journal of Medicine publications out of a single—albeit large and international—study. Our coverage on TCTMD went in the opposite direction, seeking to encapsulate the lipid results, the blood pressure results, and the overall “polypill concept” in a single story. However you slice it, five ‘breaking’ sessions comprised of four or five trials each makes for a lot of news, leaving little time to check out the smaller rooms a 10-minute tromp from the Main Tent.
TAVR Trials Stand out Among ‘Neutral’ STEMI Studies
For interventionalists heading to ACC, the program looked promising: a major TAVR study in the opening showcase, one entire late-breaking clinical trial session devoted to interventional therapies, and a smattering of related topics—chest pain admissions, contrast nephropathy, vagus nerve stimulation for heart failure, stem cell delivery—elsewhere in the late-breaking lineup.
Things got off to a good start. Saturday’s PARTNER 2A randomized trial, showing the older generation Sapien-XT device to be noninferior to surgical valve replacement in intermediate-risk patients (with a tantalizing signal of superior results for transfemoral TAVR versus surgery) seemed to serve as a teaser for a second study, using the latest-generation device, slated for presentation the next day.
Come Sunday, however, a slate of trials addressing long-standing questions in STEMI care came up short or, as DANAMI 3 investigator Henning Kelbæk, MD (Roskilde Hospital, Roskilde, Denmark), chided me, “neutral.”
EARLY-BAMI showed no reduction in infarct size for STEMI patients who received IV metoprolol prior to PCI. Two late-breaking presentations from DANAMI3 found no benefit for deferred stenting or ischemic postconditioning in STEMI interventions. As one moderator put it, the session was starting to feel “a bit depressing.” Others seeing the silver lining, however, pointed out that a failed strategy in a STEMI trial merely underscores the already excellent care that patients today are receiving. Neil Moat, MD (Royal Brompton Hospital, London, England), put this succinctly in the latest episode of On Record, discussing the ACC interventional trials: “With the STEMI trials the results are so good that to find an additional, incremental, statistically significant benefit is very difficult to do.”
The fourth presentation, however, appeared to turn the mood around. This was SAPIEN 3, a prospective registry testing the latest generation transcatheter valve in intermediate-risk patients whose results were compared to the surgical results of PARTNER 2A via a complex, quintile-based propensity score analysis. Here, Sapien 3 emerged as a clear winner. While moderators and commentators highlighted the shortcomings of a nonrandomized trial, the results were widely lauded as (to quote press conference participant, David Kandzari, MD, of Piedmont Heart Center in Georgia, Atlanta) “some of the best observed outcomes we’ve ever seen with a transcatheter valve therapy.”
A fifth presentation in this session, looking at TAVR volumes and outcomes, underscored the need for centers to maintain minimum procedural volumes—an intuitive but provocative finding which prompts the inevitable question of just how many hospitals should be offering TAVR.
Beyond the Late-Breaking Trials
TCTMD reporters hustled between the Main Tent, the press conferences, and the media room, ducking out whenever possible to check out other studies—the hidden gems I’d hoped to discover in the program. If you haven’t already done so, check out our coverage of a (nonrandomized) comparison of the novel oral anticoagulants; the choice of radial over femoral; gender discrimination in the cardiology profession; morphine’s effect on antiplatelet drugs; marijuana and AMI; the MitraClip and the Watchman, postapproval; a sneak preview of changes afoot for revascularization AUC; sex-based differences in diagnostic testing; late benefit of revascularization in severe HF from STICH, and much, much more.
Regrettably overlooked in our coverage were lifestyle and prevention. That’s despite the impressive efforts by ACC program planners to ramp up their focus on these issues with a video address by First Lady Michelle Obama; a showcase lecture by David Nash, MD, the founding dean of the Jefferson College of Population Health in Philadelphia, PA; and an “intensive” half-day program dedicated to “less drugs, more sex, and a little more rock-and-roll”.
Part of the problem is the lack of a news angle. From a cardiovascular fitness standpoint, we’re collectively getting sicker. But while that makes for a great headline, the big trial lineups at these meetings never include the massive randomized, controlled prevention trial that will make for a great data-driven story on TCTMD. If these are buried somewhere in the oral abstracts or posters, we dash right past them, trying to get to the late breakers. The last story we ran on TCTMD before our pages started teeming with ACC 2016 news was an analysis predicting that one in five people worldwide will be obese by 2025. As best as I can tell, this got fewer page views than most of our ACC coverage. During the ACC late breaker devoted to lipids and cholesterol-lowering drugs, a lone study reported positive results for a massive, mobile-based physical activity and weight-loss initiative. Yet as we noted in our coverage, physicians who’d showed up to see the drug-therapy studies left the Main Tent en masse before the STEPATHLON results were revealed.
Prevention and Interventions: The Place In-between
My whole career in medical journalism, I’ve loved covering interventions. I’ve gotten a kick out of the visionary and often colorful characters who dream up new cardiovascular devices and techniques, and the inevitable squabbling that ensues over pricing, coverage, and appropriate use. But the prevention piece nibbles away at me, even more so following the sad news today that the European Society of Cardiology has cancelled its EuroPREVENT meeting in Istanbul, citing security concerns.
Like everyone else, I’m sure, I came home from ACC 2016 exhausted: four days’ worth of science packed into three, on a half night’s worth of sleep. Sore-footed, undernourished by a hodgepodge of irregular, calorie-dense meals, and eager to get back to some outdoor activity, I took a week to feel normal again. And yet, what a treat to see old friends and colleagues, to feel the rush of covering breaking news, on-site, and to understand what science will move forward while other niggling questions got satisfying answers. If nothing else, I’m reminded of all the treatments I personally hope to avoid, down the road, by adopting all the behaviors we didn’t get around to writing about.