Meta-analysis of the Effects of Paclitaxel-Eluting Stents Versus Bare Metal Stents on Volumetric Intravascular Ultrasound in Patients With Versus Without Diabetes Mellitus
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摘要
We searched relevant sources from inception to March, 2007, and contacted investigators and manufacturers to identify randomised controlled trials in patients with coronary artery disease that compared drug-eluting with bare-metal stents, or that compared sirolimus-eluting stents head-to-head with paclitaxel-eluting stents. Safety outcomes included mortality, myocardial infarction, and definite stent thrombosis; the effectiveness outcome was target lesion revascularisation. We included 38 trials (18 023 patients) with a follow-up of up to 4 years. Trialists and manufacturers provided additional data on clinical outcomes for 29 trials. We did a network meta-analysis with a mixed-treatment comparison method to combine direct within-trial comparisons between stents with indirect evidence from other trials while maintaining randomisation.

Findings

Mortality was similar in the three groups: hazard ratios (HR) were 1·00 (95%credibility interval 0·82–1·25) for sirolimus-eluting versus bare-metal stents, 1·03 (0·84–1·22) for paclitaxel-eluting versus bare-metal stents, and 0·96 (0·83–1·24) for sirolimus-eluting versus paclitaxel-eluting stents. Sirolimus-eluting stents were associated with the lowest risk of myocardial infarction (HR 0·81, 95%credibility interval 0·66–0·97, p=0·030 vs bare-metal stents; 0·83, 0·71–1·00, p=0·045 vs paclitaxel-eluting stents). There were no significant differences in the risk of definite stent thrombosis (0 days to 4 years). However, the risk of late definite stent thrombosis (>30 days) was increased with paclitaxel-eluting stents (HR 2·11, 95%credibility interval 1·19–4·23, p=0·017 vs bare-metal stents; 1·85, 1·02–3·85, p=0·041 vs sirolimus-eluting stents). The reduction in target lesion revascularisation seen with drug-eluting stents compared with bare-metal stents was more pronounced with sirolimus-eluting stents than with paclitaxel-eluting stents (0·70, 0·56–0·84; p=0·0021).

Interpretation

The risks of mortality associated with drug-eluting and bare-metal stents are similar. Sirolimus-eluting stents seem to be clinically better than bare-metal and paclitaxel-eluting stents.


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