a1 National Evidence-based Healthcare Collaborating Agency
a2 Severance Cardiovascular Hospital, Yonsei University College of Medicine
a3 National Evidence-based Healthcare Collaborating Agency Severance Cardiovascular Hospital, Yonsei University College of Medicine
Objectives: Recent concerns have been raised for the safety after drug-eluting stents (DES) implantation compared with the use of bare-metal stents (BMS) in patients with ST-elevation acute myocardial infarction (STEMI). The objective of this study was to estimate the relative impact of DES versus BMS on mortality, myocardial infarction (MI), target vessel revascularization (TVR), and stent thrombosis (ST) in STEMI patients by performing comprehensive meta-analyses of randomized controlled trials (RCTs) and observational studies.
Methods: We performed an electronic search and manual search of studies presented through September 2009, without language restrictions. An approach of “using systematic reviews” was used. Two independent reviewers extracted prespecified data from each study. A random-effects model was used to combine trials and to perform stratified analyses based on study designs and the duration of follow-up.
Results: Fourteen RCTs were identified (N = 7,654). Compared with BMS, DES significantly reduced TVR (risk ratio [RR], 0.48; 95 percent confidence interval [CI], 0.41–0.56) and MI (RR, 0.77; 95 percent CI, 0.61–0.97), without increasing mortality (RR, 0.88; 95 percent CI, 0.70–1.10) and ST (RR, 0.93; 95 percent CI, 0.72–1.21). Among 35 observational studies (N = 44,849), the use of DES was associated with a significant reduction in mortality (RR, 0.85; 95 percent CI, 0.79–0.91) and TVR (RR, 0.61; 95 percent CI, 0.48–0.77). MI and ST were significantly lower in the DES group within 1-year follow-up, but there were no differences within 2 years of follow-up. There was no evidence of statistical heterogeneity and publication bias.
Conclusions: These data in aggregate suggest that using DES in STEMI patients is safe and efficacious, but there are differences between RCT and observational data comparing DES and BMS.
This study was completed as part of the health technology assessment report (project no. NA2009-015) funded by the National Evidence-based Healthcare Collaborating Agency (NECA) in Korea. The results of this project underwent the appraisal process involving cardiologists, methodologists, and governmental officials.