The American Heart Association scientific sessions, which start next weekend in Los Angeles, will be bigger than ever, with 853 separate sessions– 111 more than last year– and 27 late-breaking clinical trials– 6 more than last year. Elliott Antman, chair of the scientific sessions program committee, provided a preview of some of the highlights of this year’s late-breakers.
Two of the most interesting trials will be presented at the first late-breaking session on Sunday afternoon. Perhaps the most eagerly anticipated trial of the entire meeting is the NIH’s FREEDOM (Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease) trial, which will be presented by Valentin Fuster. The trial will evaluate the relative worth of CABG and PCI in patients with diabetes.
Immediately preceding FREEDOM on the program is another NIH-sponsored trial, TACT (The Trial to Assess Chelation Therapy), testing the potential value of chelation therapy, a controversial alternative therapy. “We ought to take our hat off to the NIH for doing this trial, since industry was never going to fund this trial,” said Antman. Although most physicians have a skeptical view of chelation therapy, patients often express interest in it. TACT will finally provide real data about this approach.
Directly following the first session, the second late-breaking session will focus on economic and quality-of-life studies, including a quality of life TACT substudy and a cost-effectiveness FREEDOM substudy.
On Monday, two Italian trials will look at the role of omega-3 fatty acids for recurrent atrial fibrillation (FORWARD) and for the prevention of post-operative AF (OPERA). The Physicians Health Study II will examine the effect of multivitamins for cardiovascular endpoints. The UMPIRE study will test the feasibility of giving the polypill in 2,000 patients for a period of 15 months.
The second late-breaker session on Monday will present the results of three phase 2 trials of PCSK9 inhibitors. The session will include a panel discussion and an overview of this fast-moving and much-anticipated new therapeutic area. Also at this session will be the results of the dal-OUTCOMES phase 3 trial of the CETP inhibitor dalceptrapib. Although the drug is no longer in clinical development, many observers are eager to see if the results will have implications for other CETP inhibitors.
A Tuesday morning session will be entirely devoted to stem cell regeneration trials. Antman said this was a “promising avenue of investigation” but acknowledged that we still don’t know if this whole approach might fail.
Later on Tuesday, Arthur Moss will present the results of the MADIT Randomized Trial to Reduce Inappropriate Therapy, comparing customized programming to standard programming for the reduction of ICD-induced inappropriate shocks. At the same session the results of RELAX-AHF will be presented, testing the novel agent relaxin in acute heart failure. Finally, the CARRESS-HF study will offer insight into the role of ultrafiltration in patients with acute decompensated heart failure and worsening renal function.