The leadership of the American College of Cardiology (ACC) selected new clinical research to be unveiled at the 60th annual scientific sessions of the American College of Cardiology (ACC) and the 2011 i2 Summit in New Orleans, April 2 to 5, during a press conference this week.
On Sunday, April 3, further evaluation of the randomized controlled PARTNER trial, which assessed the utilization of transcatheter aortic valve implantation (TAVI) in patients who were not surgical candidates, will make up the late breaking clinical trials. First, Craig R. Smith, MD, from Columbia University in New York City, will present the results of the findings of TAVI vs. surgical aortic valve replacement in “high-risk” patients with aortic stenosis (cohort A of the trial).
Edward J. McNulty, MD, co-chair of ACC.11, and assistant professor of medicine at University of California, San Francisco (UCSF) and interventional cardiologist at Kaiser Permanente in San Francisco, explained that this is the first presentation of the “much-anticipated results” of cohort A of the PARTNER trial. “Cohort A included patients who were eligible, but at high risk for traditional surgery, while cohort B included patients too high risk for surgery,” he said. Cohort B of the PARTNER trial was presented at last year’s TCT.10, but McNulty added that depending on results, cohort A could have “substantial implications for a great number of patients suffering from aortic stenosis in the U.S., compared with the less common patient population in cohort B.”
The cohort A results will be followed by a presentation by Matthew R. Reynolds, MD, from Beth Israel Deaconess Medical Center in Boston, on the lifetime cost-effectiveness of TAVI compared with standard care among inoperable patients with aortic stenosis (cohort B of the trial). At AHA.10, David J. Cohen, MD, touched upon the potential financial complications of TAVI, after presenting the cohort B quality-of-life results. The PARTNER trial is sponsored by Edwards Lifesciences.
In addition, on April 3, there will be one study that is particularly relevant to the venue of the conference this year. It will assess the MI rates of residents of New Orleans before and after Hurricane Katrina. ACC President Ralph G. Brindis, MD, from UCSF Medical Center, also pointed out another study that may be one of the first to examine restless leg syndrome “for its association with poorer cardiovascular outcomes, beyond the nuisance of the condition.”
On Monday, April 4, the two-year outcomes for the EVEREST II randomized, controlled trial results will be presented. The trial compared the MitraClip valve repair system (Abbott) with surgery for the repair of leaky mitral valves. While the initial safety and effectiveness outcomes were positive, “there have been concerns about the durability of the less invasive procedure,” said McNulty, who added that the late Elizabeth Taylor underwent this procedure.
Also, on April 4, Eric J. Velaquez, MD, from Duke University Medical Center in Durham, N.C., will present the results of the STITCH trial, which evaluated intensive medical therapy with or without CABG surgery in patients. “In recent years, medical therapy has improved dramatically, and this is the first trial comparing bypass surgery to medical therapy in the contemporary era,” said McNulty, who called the trial one of the “blockbusters of the conference, as it has the potential to change practice in a similar manner to the COURAGE trial.”
The PRECOMBAT trial, also to be presented on April 4, is a randomized comparison of bypass surgery vs. angioplasty using sirolimus-eluting stents (Cypher, Cordis) in patients with left main coronary artery disease.
On Tuesday, April 5, meeting attendees can learn about the MAGELLAN trial, which evaluated how the anticoagulant rivaroxaban (Xarelto, Bayer HealthCare) compares with standard therapy of enoxaparin (Lovenox, Sanofi-Aventis) for the prevention of venous thromboembolism in 8,000 randomized, acutely ill medical patients. “This trial will have tremendous relevance for contemporary hospital practice,” McNulty said.
Also on April 5, the EXCELLENT trial will be presented. This study addresses the longevity with which patients should be taking dual-antiplatelet therapy (six months vs. one year) after the implantation of a drug-eluting stent (everolimus- [Xience, Abbott] vs. sirolimus-eluting stents) for coronary revascularization.