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Word of the Day

6-month clopidogrel better than 24 after stent placement (PRODIGY)

Clinical Question:
What is the optimal duration of dual antiplatelet therapy following cardiac stent placement?

Bottom Line:
The evidence is clear that long-term clopidogrel following stent placement does more harm than good, regardless of the indication or type of stent. (LOE = 1b)

Reference:
Valgimigli M, Campo G, Monti M, et al, for the Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study (PRODIGY) Investigators. Short versus long-term duration of dual-antiplatelet therapy after coronary artery stenting: a randomized multicenter trial. Circulation 2012;125(16):2015-2026.  [PMID:22438530]

Study Design:
Randomized controlled trial (single-blinded)

Funding:
Self-funded or unfunded

Allocation:
Uncertain

Setting:
Inpatient (any location) with outpatient follow-up

Synopsis:
Two previous Korean studies found no benefit to 24 months instead of 6 months of clopidogrel following coronary stent placement, but were somewhat underpowered. This study randomized a broad spectrum of 2013 patients to receive a bare-metal stent or 1 of 3 drug-eluting stents. The authors then randomized the 1970 patients who were still alive 1 month later (and who provided consent) to receive 6 months or 24 months of dual antiplatelet therapy with aspirin 160 mg to 325 mg once daily plus clopidogrel 75 mg once daily. All patients received aspirin for the entire duration of the study, and patients who were randomized to receive a bare-metal stent had the option of a shorter duration of dual therapy (but not less than 30 days). Groups were balanced, analysis was by intention to treat, and there were few patients lost to follow-up. Of the patients enrolled in the trial, 25.7% had stable angina, 74% had acute coronary syndrome, 18% had unstable angina, 23% had non-ST elevation myocardial infarction (MI), and 32% had ST elevation MI. Their mean age was 68 years. The likelihood of the composite outcome (death due to any cause, MI, or cerebrovascular accident) was similar between groups (10.1% vs 10.0%; P = .91). However, major bleeds were more likely in the 24-month clopidogrel group (1.6% vs 0.6%; P = .041; number needed to treat = 100). All-cause mortality was identical between groups (6.6%). Subgroup analyses showed no significant difference in outcomes by age or indication for stent placement.

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