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Is CURE a cure for acute coronary syndromes? Statistical versus clinical significance
Umesh N Khot1, Steven E Nissen
1Department of Cardiology, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland Heights, OH 44195, USA. unkhot@bigfoot.com
Insights
Clopidogrel offers limited benefits for acute coronary syndromes, primarily preventing myocardial infarction but not reducing mortality. Increased bleeding risks, especially during cardiac surgery, warrant caution with its widespread use.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Clopidogrel is approved for non-ST-elevation acute coronary syndromes.
- The Clopidogrel in Unstable Angina to Prevent Recurrent Events (CURE) trial supports its use.
- Concerns exist regarding the trial's methodology and clinical significance.
Purpose of the Study:
- To critically evaluate the clinical significance of clopidogrel based on the CURE trial.
- To assess the benefits and risks of clopidogrel in acute coronary syndromes.
Main Methods:
- Analysis of findings from the Clopidogrel in Unstable Angina to Prevent Recurrent Events (CURE) trial.
- Review of clopidogrel's impact on mortality, myocardial infarction, and bleeding events.
- Assessment of bleeding risk, particularly in patients undergoing cardiac surgery.
Main Results:
- Clopidogrel did not demonstrate a reduction in mortality.
- Benefits were confined to preventing myocardial infarction, with less stringent diagnostic criteria used.
- A significant increase in both major and minor bleeding events was observed.
- Clopidogrel use was associated with elevated bleeding risk in early cardiac surgery.
Conclusions:
- The clinical benefits of clopidogrel in acute coronary syndromes appear limited.
- Increased bleeding risks, especially in surgical settings, outweigh the observed benefits.
- Widespread clopidogrel use, particularly with early revascularization strategies, may offer minimal clinical advantage with substantial risk.
Abstract:
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.