Is CURE a cure for acute coronary syndromes? Statistical versus clinical significance.
Clopidogrel has been recently approved for treatment of non-ST-elevation acute coronary syndromes based on the Clopidogrel in Unstable Angina to Prevent Recurrent Events (CURE) trial. However, the trial's findings are confounded by issues that lessen its clinical significance. Clopidogrel did not reduce mortality; its benefit was limited to preventing myocardial infarction, which was defined less stringently than in previous trials. Clopidogrel led to an increase in major and minor bleeding. Furthermore, clopidogrel increased bleeding risk in early cardiac surgery. Thus, widespread usage of clopidogrel, especially in centers with an early revascularization strategy, will have limited clinical benefit with considerable risk.
Khot
Umesh N
UN
Department of Cardiology, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland Heights, OH 44195, USA. unkhot@bigfoot.com
Nissen
Steven E
SE
D000208:Acute Disease; D000789:Angina, Unstable / Q000188:drug therapy* / Q000503:physiopathology / Q000517:prevention & control*; D002986:Clinical Trials as Topic; D000077144:Clopidogrel; D006470:Hemorrhage / Q000139:chemically induced*; D006801:Humans; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012306:Risk; D055502:Secondary Prevention; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use*
D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine