Impactful Clinical Trials of 2012: What Clinicians Need to Know

Abstract

The results of clinical trials serve to inform cardiovascular (CV) practice. In 2012, a number of clinical trials were reported that have an immediate effect on patient management. We highlight the results of key trials in several areas: interventional cardiology, acute coronary syndromes (ACS), and pharmacologic therapy. The FREEDOM trial, which demonstrated a significant benefit on hard outcomes of coronary artery bypass grafting vs multivessel percutaneous coronary intervention (PCI) in patients with diabetes, answered a long-debated question. The MADIT-RIT trial demonstrated an impressive reduction in inappropriate shocks and mortality in stable implantable cardioverter defibrillator (ICD) patients by altering ICD programming variables. In ACS, prolonged dual antiplatelet therapy (DAPT) with acetylsalicylic acid (ASA) and prasugrel in medically managed patients was not superior to ASA plus clopidogrel, and ongoing trials will assess if there are benefits to use of DAPT beyond 1 year. The WOEST trial compared warfarin plus DAPT vs warfarin plus ASA alone in PCI patients who had an indication for ongoing anticoagulation. Not surprisingly, the major bleeding rate was lower with double compared with triple therapy. However, major CV events were unexpectedly lower with double therapy as well, a finding that warrants confirmation in larger studies. One of the most exciting developments in 2012 was with PCSK9 inhibitors, injectable monoclonal antibodies, that were shown to lower low-density lipoprotein cholesterol by 40%-70% above the effects of maximal dose statin therapy. We now await the results of large outcome trials with this promising class of drugs.