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Safety and efficacy of drug-eluting and bare metal stents. Comprehensive meta-analysis of randomized trials and observational studies
Circulation, 06/17/09

Kirtane AJ et al. – Results of randomized controlled trials (RCTs) show no significant differences in long-term rates of death or myocardial infarction after drug-eluting (DES) or bare metal stent (BMS) use for either off- or on-label indications. In real-world nonrandomized observational studies with more pts but potential selection bias, DES use associated with reduced death and myocardial infarction. Both RCTs and observational studies showed marked and comparable reductions in target vessel revascularization with DES vs BMS.

• Meta-analysis of DES studies to estimate relative impact of DES vs BMS on safety and efficacy endpoints
• Focus on non–Food and Drug Administration–labeled indications
• Report on comparative DES vs BMS studies with ≥100 total pts and mortality data with cumulative follow-up of ≥1 yr

• Data review for 9470 pts in 22 RCTs and 182,901 pts in 34 observational studies
• In RCTs, DES (vs BMS) associated with no detectable differences in overall mortality or myocardial infarction, with significant 55% reduction in target vessel revascularization
• Point estimates slightly lower in off- vs on-label analyses
• In observational studies, DES associated with significant reductions in mortality, myocardial infarction, and target vessel revascularization vs BMS

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