Shelley Wood

March 20, 2012

March 19, 2012 (Chicago, Illinois) — Anticoagulant drugs? Cardiac surgery? Valves? CT imaging? The lineup of late-breaking clinical trials at this year's American College of Cardiology (ACC) 2012 Scientific Sessions/i2 Summit has a little something for everyone, although whether one or more trials emerge as blockbusters remains to be seen.

Included in the late-breaking line-up are a smattering of novel therapies, but also longer-term data from trials that already debuted at other meetings and others looking at products or approaches that have been around for years or decades.

ACC president Dr David Holmes (Mayo Clinic, Rochester, MN) was, not surprisingly, effusive about the range of topics.

"This is an amazing menu of late-breaking clinical trials [LBCTs] that are aimed at broad different ideas and broad different patient groups," he told reporters last week during a pre-ACC conference call for the press. "It's the sort of thing where you want to get there early and stay late, because they are going to be hugely great."

Hottest hot lines of ACC/i2 2012?

Headliner trials generating the most premeeting buzz include the full results from the TRA 2°P TIMI-50 trial and two-year results from PARTNER cohort A. Merck released preliminary results from TRA 2°P, looking at Merck's novel protease-activated receptor 1 (PAR-1) antagonist antiplatelet agent vorapaxar in secondary prevention among stable patients with MI, ischemic stroke, or peripheral vascular disease, showing that the product reduced the primary ischemic end point of the study, but at the cost of increased bleeding, including intracranial hemorrhage (ICH). Vorapaxar was also in the limelight at last year's AHA meeting in TRACER, where it failed to reduce the risk of ischemic events in ACS patients already on dual antiplatelet therapy and here, too, increased the risk of bleeding.

With over 26 000 patients enrolled, the results of TRA 2°P "will be very impactful in clinical medicine," ACC program committee cochair Dr Patrick O'Gara (Brigham and Women's Hospital, Boston, MA) predicted. "We're looking forward to seeing [how the drug performs] in the nonacute/chronic setting."

One-year results for PARTNER A, presented at ACC 2011, showed transcatheter valve implantation (TAVI) using the Sapien valve to be noninferior to surgery among patients eligible for both procedures; however, deaths were numerically higher in the surgery-treated patients (a nonsignificant difference) and strokes were statistically increased in the TAVI group.

This year, there is "tremendous" excitement about these longer-term results, chair of the "ACC/i2 with TCT" program committee, Dr Murat Tuzcu (Cleveland Clinic, OH), told reporters, with Holmes chiming in that these data also are of "huge interest from a regulatory standpoint."

While the FDA has approved the Sapien for use in patients who are not surgical candidates, the agency has yet to announce what day its advisors will be reviewing the PARTNER A data--these two-year results will be part of their deliberations.

Other late-breakers of note

There are a total of 18 studies across five ACC LBCT sessions during the four-day meeting, meaning one session every day at 8 am, plus an extra on Monday at 10:30. Each session contains four trials, with the exception of Saturday's, which has just two: the TRA 2°P trial, along with FOCUS, a new autologous bone-marrow stem-cell study in chronic heart failure.

New this year, several of the LBCT sessions are jointly sponsored by the ACC and a prominent journal, expected to simultaneously publish at least some of the presentations. So Monday's early LBCT session has the New England Journal of Medicine as a cosponsor, while the Tuesday morning LBCT session is jointly sponsored with the Journal of the American Medical Association.

Sunday's LBCT session includes final outcomes from the C-PORT E trial, for which six-week follow-up was presented at the AHA 2011 meeting. That's followed by a trial of thrombus aspiration in STEMI (INFUSE AMI), a study of triple antiplatelet therapy and drug-eluting stents (HOST-ASSURE), and then a treatment-gap analysis in acute coronary syndromes (BRIDGE-ACS).

Feeling lucky? Leave early

Best of luck to anyone hoping to sleep in on Sunday and still make it to the late-breakers: the annual Shamrock Shuffle 8K makes its way through downtown Chicago on Sunday, with major road closures and congestion between 8am and noon. Meeting organizers are advising attendees to plan on leaving early for the convention center Sunday morning to avoid frustration and a lot of green people.

The Monday LBCT sessions generated the most enthusiasm from Holmes, Tuzcu, and O'Gara on the press preview call. The morning line-up includes the PARTNER A results at 9:06; new rivaroxaban data from EINSTEIN PE (in symptomatic pulmonary embolism); CORONARY, comparing on- and off-pump CABG; and ACRIN PA 4005. This last is the first of two late-breaking studies looking at the role of CT coronary angiography, the second being an analysis from ROMICAT II on Tuesday morning.

In Monday's 10:30 session, Holmes and O'Gara highlighted a study looking at a monoclonal antibody used in the treatment of hypercholesterolemia. Acknowledging to the media that the program was light on LBCTs looking at investigational drugs, they said that this particular trial looking at REGN727/SAR236553 (Regeneron) is a standout. Other trials in this session include the STAMPEDE results, comparing bariatric surgery with medical therapy for the treatment of diabetes, as well as a pacemaker in syncope study and a "Mendelian randomized controlled trial of long-term LDL lowering."

Finally, Tuesday's 8 am late-breakers include new data from the American College of Cardiology Foundation/ Society of Thoracic Surgeons (ACCF-STS) ASCERT database comparing PCI and CABG in high-risk patients (previous results were presented at the STS 2012 meeting in January), ROMICAT II, the IMMEDIATE trial, studying glucose, insulin, and potassium (GIK) in ACS, and MOPETT, looking at the use of alteplase in moderate pulmonary embolism.

Interventional trials and stargazing

Attendees looking for interventional-trial highlights can check out two featured interventional clinical sessions on Saturday at 8 AM and 2 PM, offering a range of studies on transcatheter valves, platelet responsiveness, new-generation stents, and dual antiplatelet drug discontinuation.

Others coming to Chicago for a glimpse of celebrity cardiologists will have their mission made easier for them this year by a series called "Legends of Cardiovascular Medicine." Dr Eugene Braunwald (Brigham and Women's Hospital) leads off the first of the five sessions in the opening plenary, with a talk on the treatment of AMI into the next century. Other "legends" speaking and answering questions about their life and work during the meeting are Drs Magdi H Yacoub (Harefield Hospital, Middlesex, UK), Jane Somerville (Royal Brompton Hospital, London, UK), Valentin Fuster (Mount Sinai School of Medicine, New York, NY), and Antonio Colombo (Columbus Hospital, Milan, Italy). The ACC is even encouraging meeting attendees to text, tweet, or email questions to a specific legend before March 20.

Other bells and whistles

On the ACC/i2 Summit home page, organizers are showcasing some new bells and whistles added to this year's experience. One is a new eMeeting Planner app, available for iPad, iPhone, and Android. Others are a "learning lab," "industry-expert theater," and a spate of talks given by many of the world's top cardiologists, taking place in the "thought-leader theater" in the exhibit hall--a joint collaboration of the ACC and Phillips. Traffic to the expo hall at many meetings has flagged somewhat in the no-giveaways era: having some of the leading lights of cardiology speak in the heart of the exposition area appears to be an innovative attempt to boost circulation through this area. Another good reason, of course, is theheart.org booth, 12073. Stop by to read or print our breaking-news coverage, and tell us what you like, don't like, or would like to see more of at theheart.org. A tagline on the schedule states that the "Heart of Innovation" session and other learning destinations are not part of the official ACC annual scientific sessions and will not qualify for CME, CNE, or CE credit.

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