COMPARATIVE EFFECTIVENESS REVIEW- DRUG-ELUTING STENTS VERSUS BARE-METAL STENTS FOR ACUTE MYOCARDIAL INFARCTION

Author(s)

Suh HS1, Song H1, Choi J1, Jang EJ1, Son HJ1, Kim JS2, Choi DH2, Lee SM11National Evidence-based Healthcare Collaborating Agency (NECA), Seoul, South Korea, 2Yonsei University College of Medicine, Seoul, South Korea

OBJECTIVES: To estimate the relative impact of drug-eluting stents(DES) versus bare-metal stents(BMS) on death, myocardial infarction(MI), target vessel revascularization(TVR), and stent thrombosis(ST) in patients with ST-elevation acute myocardial infarction(STEMI) by performing comprehensive meta-analyses of randomized controlled trials(RCTs) and observational studies METHODS: We searched Ovid-Medline, EMBASE, the Cochrane Library, and conference proceedings for articles comparing outcomes between DES and BMS among STEMI patients presented through September 2009. The quality of studies was evaluated by using the Cochrane’s risk of bias for RCTs and MINORS(Methodological Index for Non-Randomized Studies) for observational studies. The relative risk(RR) using the inverse variance random-effects method for each study outcome was calculated. RCT and observational data were analyzed separately. To assess heterogeneity of RRs across trials, we used the Cochrane-Q-statistic and I2-statistic. Subgroup-analyses were performed by length of follow-up and meta-regression was used to evaluate predictors of outcomes by stent-type. Funnel plots, the Egger-test, and the Begg-test were used to assess publication-bias. To assess the quality of the evidence, we used GRADEpro.RESULTS: Fifteen RCTs were identified(N=7654, kappa-statistic=0.90). Compared with BMS, DES significantly reduced TVR(RR:0.48; 95% confidence interval[CI]:0.41-0.56) and MI(RR:0.76; 95%CI:0.60-0.96), without increasing death(RR=0.88; 95%CI:0.70-1.11) and ST(RR:0.93; 95%CI:0.72-1.21). Among 35 observational studies(N=44,849), DES significantly reduced death(RR:0.85; 95%CI:0.79-0.91) and TVR(RR:0.61; 95%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 follow-up. There was no evidence of statistical heterogeneity and publication-bias. Among RCTs, the quality of the evidence of TVR was assessed as “High”, death and MI as “moderate”, and ST as “low”. The quality of the evidence from observational studies was assessed as “very low” or “low”. CONCLUSIONS: These data in aggregate suggest that using DES in STEMI patients are safe and efficacious but there are differences between RCT and observational data comparing DES and BMS.

Conference/Value in Health Info

2010-05, ISPOR 2010, Atlanta, GA, USA

Value in Health, Vol. 13, No. 3 (May 2010)

Code

PCV142

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Cardiovascular Disorders

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