Of the trials chosen for the six Late-Breaking Clinical Trial sessions, all being presented in the first 2 days of the American Heart Association scientific sessions in Chicago Nov. 10-12. Here are some of the most potentially practice-changing studies to look out for.
- REDUCE-IT: Relative to placebo, the fish oil derivative AMR101 (icosapent-ethyl) evaluated in the REDUCE-IT trial was associated with a 25% reduction in a primary composite endpoint of major adverse cardiovascular events (MACE), according top-line data released in September. A highly purified ethyl ester of eicosapentaenoic acid (EPA), AMR101 (Vascepa, Amarin) was studied on top of statin therapy in both primary and secondary prevention cohorts among the 8,000 patients randomized. Relative efficacy for primary and secondary prevention was not described in the initial release of data and will be of particular when the full results are released on Saturday, Nov. 10 at 2:00 p.m.
- DECLARE TIMI58: In top line results from DECLARE TIMI58, which randomized more than 17,000 participants with type 2 diabetes an experimental arm or placebo, the SGLT2 inhibitor dapagliflozin (Farxiga, AstraZeneca) was linked to a reduction in the composite endpoint of hospitalization for heart failure or cardiovascular death. In the early release of results, no mention was made of the effect of this agent on a composite of cardiovascular death, MI, or ischemic stroke, which was a secondary co-primary endpoint. This and the impact of dapagliflozin on an array of secondary endpoints will be revealed when the full results are made available in the Saturday late-breaker session at 2:00 p.m.
- VITAL: The relative effect of vitamin D, fish oil, or both on body composition was compared in the VITAL study, which randomized more than 20,000 patients. Fish oil plus vitamin D, fish oil plus placebo, vitamin D plus placebo, and two placebos were compared in a 2 x 2 factorial design. The primary outcome includes total body fat and lean mass as well as these components in the abdomen and other anatomic sites. Body mass index, waist circumference, and waist-to-hip ratio are among secondary outcomes. In addition, the relative effects of these treatments on lipids, blood glucose, and other aspects of metabolism were followed over the 2 years of the study, to presented at 2 p.m. on Saturday.
- CIRT: Responding to the evidence that inflammation is a crucial contributor to atherothrombosis, the CIRT trial tested whether the anti-inflammatory agent methotrexate reduces rates of MI, stroke, and cardiovascular death relative to placebo in patients with stable coronary artery disease and either type 2 diabetes or metabolic syndrome. The study enrolled about 7,000 patients and will have follow-up of nearly 6 years. Secondary endpoints, such as the impact of methotrexate on rates of coronary revascularization, peripheral artery disease, venous thromboembolism, and aortic stenosis, may provide insight about the ways in which control of inflammation affects vascular pathology. The presentation is at 2 p.m. on Saturday.
- Also on Saturday, diverse trial hypotheses are being tested. For example, the cost effectiveness of a PCSK9 inhibitor will be the focus of the ODYSSEY OUTCOMES economics study, presented at the 2:00 session. The results of YOGA-CaRe, a multicenter trial of a yoga-based cardiac rehabilitation program, will be presented in a subsequent Saturday late-breaking session. Of highlights of the third Saturday late-breaking session, ALERT-AF will determine whether a computerized decision protocol affected anticoagulation management in hospitalized patients with atrial fibrillation.