Clinical trials update from the American Heart Association: REPAIR‐AMI, ASTAMI, JELIS, MEGA, REVIVE‐II, SURVIVE, and PROACTIVE

Abstract

This article provides information and a commentary on trials presented at the American Heart Association meeting held in November 2005, relevant to the pathophysiology, prevention and treatment of heart failure. All reports should be considered as preliminary data, as analyses may change in the final publication. In REPAIR-AMI an improvement in ejection fraction was observed in post-MI patients following infusion of bone marrow stem cells. However, the ASTAMI study showed no benefit of stem cell implantation in a similar patient cohort. The JELIS study reported a reduction in major coronary events in patients receiving statins plus fish oil compared to statins alone. MEGA showed that low dose statins in a low risk population reduce the incidence of major cardiovascular events. Two studies of levosimendan in acute heart failure gave conflicting results, in the REVIVE-II study levosimendan was reported to have a superior effect on the composite primary outcome compared to placebo, however, in SURVIVE despite a trend to early benefit with levosimendan, there was no difference in effect on long-term outcome versus dobutamine. The PROACTIVE study showed encouraging results for the use of pioglitazone in post-myocardial infarction patients with concomitant type 2 diabetes.

Limited plasticity of mesenchymal stem cells cocultured with adult cardiomyocytes

“…However, a recent clinical trials update from the American Heart Association [Cleland et al, 2006] reports no benefit of stem cells implantation in the ASTAMI study and a small but significant benefit in REPAIR-AMI.…”

Current treatment options for early management in acute decompensated heart failure

“…Other vasodilators, such as calcium sensitizers, were received initially with much promise, although subsequent properly controlled studies did not duplicate the initial small randomized studies (45).…”

Canadian Cardiovascular Society Consensus Conference recommendations on heart failure update 2007: Prevention, management during intercurrent illness or acute decompensation, and use of biomarkers

“…There are no placebo-controlled trials assessing dobutamine efficacy in AHF, but it is clearly associated with increased incidence of arrhythmias (168). Levosimendan, a calcium-sensitizing inodilator, has been reported to reduce mortality compared with dobutamine and placebo (169). In the Randomized Multicenter Evaluation of Intravenous Levosimendan Efficacy II (REVIVE-II) trial (169), levosimendan showed modest benefit over placebo, but there was more hypotension and atrial fibrillation, and mortality at 90 days was higher.…”

“…In the Randomized Multicenter Evaluation of Intravenous Levosimendan Efficacy II (REVIVE-II) trial (169), levosimendan showed modest benefit over placebo, but there was more hypotension and atrial fibrillation, and mortality at 90 days was higher. In the Survival of Patients with Acute Heart Failure in Need of Intravenous Inotropic Support (SURVIVE) study (169), there was a trend to early benefit with levosimendan over dobutamine that was not evident past the period of hemodynamic efficacy of the drug; there was more atrial fibrillation, and mortality was comparable at the end of the study (169). Because there was no placebo-treated arm in this study, although levosimendan appeared to have better efficacy and safety than dobutamine, this is not to say that it is superior to placebo.…”