Abstract 2140: Differential Efficacy and Safety of Drug-Eluting Stents With Short Versus Long Term Follow-up: A Meta-Analysis of Randomized Clinical Trials
Introduction: Drug eluting stents (DES) significantly reduce target lesion revascularization (TLR) compared to bare metal stents (BMS) within 1 year of follow-up, however they increase late stent thrombosis. The effect of DES on the need for late revascularization is unclear.
Hypothesis: We sought to evaluate the safety and efficacy of DES compared to BMS early after intervention (< 1 year) and late (> 1 year) among both stable patients and acute coronary syndromes.
Methods: We searched the Medline database for randomized clinical trials with long-term follow-up, from 2000 to 2007. We also searched relevant journal supplements for abstracts and obtained trial presentations from cardiology meetings.
Results: We identified 24 trials (17% acute coronary syndrome patients) with a total of 10,278 patients. The weighted mean duration of follow-up was 28 months. For early outcomes (< 1 year); the incidence of all-cause mortality for DES vs. BMS was 2% vs. 2.1%, RR=0.95, 95%CI (0.70–1.27), p=0.7, cardiovascular mortality was 1.4% vs. 1.5%, RR=0.95 (0.73–1.24), p=0.72, Q-wave myocardial infarction (MI) was 0.8% vs. 0.6%, RR= 1.24 (0.7–2.2), p=0.45, non-Q-wave MI was 3% vs. 4%, RR=0.73 (0.55–0.96), p=0.024, TLR was 5.9% vs. 17.8%, RR=0.29 (0.24–0.34), p<0.001, and stent thrombosis was 0.94% vs. 1.1%, RR=0.83 (0.55–1.27), p=0.4. For late outcomes (>1 year); the incidence of all-cause mortality for DES vs. BMS was 3.9% vs. 3.8%, RR=1.04 (0.79–1.38), p=0.7, cardiovascular mortality 1.4% vs. 1.5%, RR=0.95 (0.73–1.24), p=0.72, Q-wave MI was 0.7% vs.0.6%, RR=1.05 (0.54–2.05), p=0.87, non-Q-wave MI was 1.6% vs. 1.2%, RR=1.39 (0.87–2.21), p=0.16, TLR was 2.6% vs. 3.2%, RR=0.82 (0.59–1.13), p=0.23, and stent thrombosis was 0.59% vs. 0.15%, RR=3.2 (1.22–8.36), p=0.018.
Conclusions: Within 1 year of follow-up, DES appears to be safe and efficacious with similar mortality, similar stent thrombosis, decreased TLR, and decreased non-Q-wave MI compared to BMS. After 1 year, DES still has similar mortality compared to BMS, however TLR, while low, is no longer reduced, stent thrombosis is increased, and there is a numerical excess of non-Q-wave MI.