Comparison of Drug-Eluting Stents With Bare Metal Stents in Patients With ST-Segment Elevation Myocardial Infarction
How safe and effective are early-generation drug-eluting stents (DES) compared with bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI)?
The investigators performed a meta-analysis of 15 randomized controlled trials enrolling a total of 7,867 patients comparing first-generation Food and Drug Administration-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 prespecified 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% confidence interval [CI], 0.82-1.43). However, there were time-dependent effects, with an 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). The authors derived numbers-needed-to-treat and numbers needed-to-harm to prevent or cause one additional event per year when compared with BMS from baseline event rates in BMS arms and the pooled RR comparing DES and BMS.
The authors concluded that there is an early benefit of DES in primary PCI for STEMI with a reduction in TVR, and a trend toward less definite ST is offset in subsequent years by an increased risk of very late ST.
This meta-analysis of patients who underwent primary PCI for STEMI suggests time-dependent clinical effects of DES compared with BMS for definite ST, definite or probable ST, TVR, and MI. A large reduction in TVR and a trend toward less definite ST during the first year is somewhat offset by an increased risk of very late ST and accompanying clinical outcomes during subsequent years. Based on an overall favorable benefit-to-risk ratio, current American College of Cardiology/American Heart Association PCI guidelines give DES for STEMI a Class I recommendation, provided the patient has the ability to comply with and tolerate dual antiplatelet therapy.
Clinical Topics: Invasive Cardiovascular Angiography and Intervention
Keywords: Myocardial Infarction, United States Food and Drug Administration, Drug-Eluting Stents
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