Drug-Eluting or Bare-Metal Stents for PCI
What are the efficacy and safety outcomes for new-generation drug-eluting stents (DES) compared with bare-metal stents (BMS)?
The investigators did an individual patient data meta-analysis of randomized clinical trials to compare outcomes after implantation of new-generation DES or BMS among patients undergoing percutaneous coronary intervention. The primary outcome was the composite of cardiac death or myocardial infarction. Data were pooled in a one-stage random-effects meta-analysis and examined at maximum follow-up and at 1-year landmark. Risk estimates are reported as hazard ratios (HRs) with 95% confidence intervals (CIs).
The authors obtained individual data for 26,616 patients in 20 randomized trials. Mean follow-up was 3.2 (standard deviation, 1.8) years. The risk of the primary outcome was reduced in DES recipients compared with BMS recipients (HR, 0.84; 95% CI, 0.78–0.90; p < 0.001) owing to a reduced risk of myocardial infarction (0.79, 0.71–0.88, p < 0.001) and a possible slight but nonsignificant cardiac mortality benefit (0.89, 0.78–1.01, p = 0.075). All-cause death was unaffected (HR with DES, 0.96; 95% CI, 0.88–1.05; p = 0.358), but risk was lowered for definite stent thrombosis (0.63, 0.50–0.80, p < 0.001) and target-vessel revascularization (0.55, 0.50–0.60, p < 0.001). There was a time-dependent treatment effect, with DES being associated with lower risk of the primary outcome than BMS up to 1 year after placement. While the effect was maintained in the longer-term, there was no further divergence from BMS after 1 year.
The authors concluded that performance of new-generation DES in the first year after implantation means that BMS should no longer be considered the gold standard for safety.
This study reports that use of DES reduced the risk of cardiac death or myocardial infarction compared with BMS at the mean follow-up time of 3.2 years and at 5 years. The use of DES was also associated with a significantly reduced risk of definite stent thrombosis and target-vessel revascularization at the longest available follow-up and at 5 years. These benefits accrued within the first year after treatment, even within 30 days, with no further incremental benefit or loss thereafter. Overall, these data suggest that BMS should no longer be considered the gold standard for safety and the focus of future DES technology should target clinical outcome improvements beyond 1 year.
Keywords: Acute Coronary Syndrome, Drug-Eluting Stents, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Risk, Secondary Prevention, Stents, Thrombosis
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