Clinical trials update from the American College of Cardiology 2008: Carisma, Trends, meta‐analysis of Cox‐2 studies, Hat, on‐Target, Hyvet, Accomplish, Momentum, Protect, Horizon‐hf and Reverse

Abstract

This article provides information and a commentary on trials relevant to the pathophysiology, prevention and treatment of heart failure, presented at the American College of Cardiology. Unpublished reports should be considered as preliminary data, as analyses may change in the final publication.CARISMA investigated the use of implantable loop recorders for detecting life-threatening arrhythmias in patients with LVSD after MI and found that brady-and ventricular tachy-arrhythmias predicted an adverse prognosis. The TRENDS study showed that the burden of atrial fibrillation detected by pacemakers or defibrillators predicted the risk of embolic events but not with sufficient precision to justify changes in anti-thrombotic management. A meta-analysis of six trials reported an increased cardiovascular risk associated with celecoxib, particularly for heart failure, which was related to dose and baseline cardiovascular risk. The HAT study failed to show a benefit of providing post-MI patients with a home defibrillator. MOMENTUM, a study of a device designed to augment aortic blood flow, was stopped early due to increased bleeding risk. Results from PROTECT support the use of rolofylline 30 mg/day in acute heart failure, a definitive study is now underway. Istaroxime, an agent that appears to have both inotropic and lusitropic effects, improved haemodynamics when added to standard therapy in patients stabilised after admission with heart failure in HORIZON-HF. The REVERSE study suggested that CRT improves ventricular function and reduces morbidity even in patients with few or no symptoms of heart failure and may delay or prevent worsening heart failure.

The Year in Heart Failure

“…Even though there is broader acceptance for the use of ultrafiltration for salt and fluid removal, a small but carefully performed randomized study (74) comparing intravenous diuretic therapy with ultrafiltration did not find significant differential impact on renal hemodynamics. Another trial using continuous aortic flow augmentation aimed at preserving renal function (75) also failed to demonstrate noticeable clinical benefits and was associated with increased bleeding. In contrast, clinical investigations regarding the role of adenosine A 1 receptor antagonism seem to be going in the right direction.…”

“…The results of the pilot phase of the large Phase III trial evaluating add-on intravenous rolofylline in AHFS were highlighted in the American College of Cardiology 2008 Scientific Sessions. Among the 301 patients with AHFS and impaired renal function (creatinine clearance 20 to 80 ml/min) and volume overload, increasing success/decreasing treatment failures (defined as death, rehospitalization, or worsening HF or renal function), as well as improving serum creatinine were associated with increasing rolofylline dosing (up to 30 mg/day) (75).…”

Reducing Stroke Rates in Patients With Atrial Fibrillation

“…The presumed, but unproven, mechanism was a reduction in atrial fibrillation burden, an interesting new and evolving marker of stroke risk in patients with atrial fibrillation. 21 It is also possible that the antihypertensive effect of dronedarone may play a role in stroke reduction, but in ATHENA, the difference in blood pressure was relatively small. Dronedarone also appears to be anti-ischemic with respect to coronary events and may have pleiotropic mechanisms, yet to be identified, similar to the neuroprotective effect of statins.…”

Sleep apnea in patients with heart failure: Could cardiac resynchronization therapy be the first line treatment?

“…The implantation of CRT was probably precluded by the low NYHA class of these patients (all but one were NYHA II). However, there is increasing evidence that CRT may be very effective in mildly symptomatic patients [17]. In addition, patients with atrial fibrillation [18] or narrow QRS [19], may soon be advocated to undergo CRT, which could result in a dramatic increase of the proportion of eligible patients.…”