What's Going to Be Hot at ESC Congress 2009?

Shelley Wood

August 27, 2009

August 27, 2009 (Barcelona, Spain) — Late-breaking trials at this year's European Society of Cardiology (ESC) Congress contain a mix of large-scale comparisons of new and old drugs and devices, plus a smattering of smaller studies looking at optimizing care with approved or existing therapies and strategies. As previously reported by heartwire , a growing trend toward the early release of some of the most eagerly anticipated studies--in this case, MADIT-CRT and PLATO--may have taken the edge off some of the excitement for this year's line-up, although as program committee members for the meeting hastened to point out to heartwire , attendees are keen to hear key details from these and other trials.

Dominating the "hotline" session on Sunday, the opening day of the meeting, are new and old antiplatelet drugs, plus one trial of a new, intravenous, selective factor Xa inhibitor, otamixaban, and another of dabigatran, a direct thrombin inhibitor of the same drug class as ximelagatran, which was discontinued due to liver toxicity. The dabigatran trial is RE-LY, an 18 000-patient comparison of warfarin and dabigatran in atrial-fibrillation patients at high risk for stroke. The otamixaban trial is SEPIA-ACS1, a 3200-patient comparison of otamixaban with unfractionated heparin (UFH) and eptifibatide in ACS patients being conducted by the TIMI group.

Full PLATO results, looking at ticagrelor, the first reversible oral P2Y12-receptor antagonist, vs clopidogrel in ACS patients, will be presented on day 1 by Dr Lars Wallentin (Uppsala Clinical Research Center, Sweden); preliminary results for the study were released early by the sponsor, as reported by heartwire . According to Dr Fausto Pinto (Lisbon University, Portugal), program chair for the ESC 2009 Congress, both PLATO and RE-LY, as well as MADIT-CRT, presented on Tuesday, can be expected to have a major impact on clinical practice. Preliminary results for MADIT-CRT were also released early and reported by heartwire at the time.

Program committee member and ESC vice president Dr Steen Dalby Kristensen (Aarhus University Hospital, Denmark) reminded heartwire that the results from PLATO remain "exciting" despite their early release.

"This is a study of more than 18 000 people, and it's focusing on the whole broad group of ACS patients from non-STEMI to STEMI, treated both invasively and noninvasively. It's important to see if this reversible drug with a strong and fast antithrombotic action will be associated with more bleeding, because this is clearly the problem that you could have with a stronger drug."

Kristensen also highlighted CURRENT-OASIS 7, comparing standard and high loading and maintenance doses of clopidogrel and aspirin in 25 000 patients with ACS. "In the US, they've been using a 325- to 350-mg dose of aspirin, whereas in Europe we tend to use between 75 and 150 mg. The same thing with clopidogrel--traditionally, we've used 300 mg for loading, and here [in this trial] they are using a higher dose." Moreover, current practice is to use a 75-mg maintenance dose of clopidogrel. "It will be interesting to see whether using a higher maintenance dose, like 150 mg daily, gives better results. This has always been something we've been discussing, and maybe we'll get an answer from this trial."

Days 2 and 3

Day 2's hotline sessions are focused on elective and primary PCI, with an emphasis on process and management issues in a range of small studies, including NORDISTEMI, PRAGUE-7, and TRIANA, plus a left main stenting analysis from the GRACE registry. For the first time in years, new drug-eluting-stent (DES) technology is conspicuously absent from the ESC Congress hotline sessions. Only one of the late-breaking trials, the ISAR-TEST-4 study, is focused on new DES, in this case a three-way randomization comparing different "limus" drugs on stents with and without permanent polymers.

The third and final hotline session, on Tuesday, features heart-failure, hypertension, and heart-rhythm studies. These include the 9000-patient ACTIVE I trial, looking at irbesartan in AF patients; the 3000-patient KYOTO Heart Study, looking at the effects of valsartan in uncontrolled-hypertension patients; and PROTECT, assessing rolofylline in acute heart-failure patients with renal impairment. On the device front, investigators will present new data from the European CRT Survey and the German PreSCD II registry; Dr Arthur Moss (University of Rochester, New York) will present the full MADIT-CRT results.

Asked whether attendees could expect any surprises in the program, Pinto was noncommittal. "Let's wait for the final results," he said.

Outside the Hotlines

To heartwire , Pinto also highlighted some important program elements outside the late-breaking-trial sessions.

  • Clinical-trial-update sessions, spread over three days (Sunday, Monday, and Wednesday) providing attendees with information on hot topics such as clopidogrel or prasugrel and proton-pump inhibitors; statins for atrial fibrillation; fractional flow reserve; as well as new and old drugs: ivabradine, rosiglitazone, and bivalirudin.

  • A range of sessions dedicated to new ESC guidelines on everything from hypertension to syncope.

  • Overviews of "the fastest-moving areas in the field of cardiovascular medicine" that are immediately relevant to clinical practice.

  • A new translational tract with over 20 sessions dedicated to the clinical implications of basic science.

  • New joint sessions with sibling societies, such as the European Society of Medical Oncology, looking at issues such as the cardiovascular effects of oncology drugs.

  • A new session called "Meet the Editors," where the Editors Network of ESC will address the most challenging issues in publishing national cardiovascular journals.

  • A special lecture on heart failure, honoring the memory of Dr Philip Poole Wilson, who was a former president of the

Referring to the clinical-trial-update sessions, Pinto noted: "For the first time the European Heart Journal will consider these trials for fast-track review and simultaneous online publication."


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