AIMS: To evaluate safety and effectiveness of early generation drug-eluting stents (DES) compared with bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), and to determine whether benefits and risks vary over time. METHODS AND RESULTS: We performed a meta-analysis of 15 randomized controlled trials enrolling a total of 7867 patients comparing first-generation FDA-approved DES with BMS in patients with STEMI. Random effect models were used to assess differences in outcomes between DES and BMS among different time periods with regard to the pre-specified primary outcomes stent thrombosis (ST) and target vessel revascularization (TVR). The overall risk of definite ST was similar for DES and BMS [risk ratio (RR) = 1.08, 95% CI 0.82-1.43]. However, there were time-dependent effects, with a RR of 0.80 during the first year (95% CI 0.58-1.12) and 2.10 during subsequent years (95% CI 1.20-3.69), with a positive test for interaction between RR of ST and time (P for interaction = 0.009). Results were similar for definite or probable ST (P for interaction = 0.015). In the overall analysis, TVR was performed less frequently in patients with DES when compared with BMS (RR 0.51, 95% CI 0.43-0.61), with a greater benefit in the first year (RR 0.46, 95% CI 0.38-0.55) when compared with subsequent years (RR 0.75, 95% CI 0.59-0.94; P for interaction = 0.007). CONCLUSION: An early benefit of early generation DES in primary PCI for STEMI with a reduction in TVR and a trend towards less definite ST is offset in subsequent years by an increased risk of very late ST.
AIMS: To evaluate safety and effectiveness of early generation drug-eluting stents (DES) compared with bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), and to determine whether benefits and risks vary over time. METHODS AND RESULTS: We performed a meta-analysis of 15 randomized controlled trials enrolling a total of 7867 patients comparing first-generation FDA-approved DES with BMS in patients with STEMI. Random effect models were used to assess differences in outcomes between DES and BMS among different time periods with regard to the pre-specified primary outcomes stent thrombosis (ST) and target vessel revascularization (TVR). The overall risk of definite ST was similar for DES and BMS [risk ratio (RR) = 1.08, 95% CI 0.82-1.43]. However, there were time-dependent effects, with a RR of 0.80 during the first year (95% CI 0.58-1.12) and 2.10 during subsequent years (95% CI 1.20-3.69), with a positive test for interaction between RR of ST and time (P for interaction = 0.009). Results were similar for definite or probable ST (P for interaction = 0.015). In the overall analysis, TVR was performed less frequently in patients with DES when compared with BMS (RR 0.51, 95% CI 0.43-0.61), with a greater benefit in the first year (RR 0.46, 95% CI 0.38-0.55) when compared with subsequent years (RR 0.75, 95% CI 0.59-0.94; P for interaction = 0.007). CONCLUSION: An early benefit of early generation DES in primary PCI for STEMI with a reduction in TVR and a trend towards less definite ST is offset in subsequent years by an increased risk of very late ST.
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