Key result
Sirolimus-eluting stents cut reintervention ~26% compared to paclitaxel-eluting stents.
Why the study?
It was not known whether late outcomes differ between the two most commonly used drug-eluting stents, sirolimus-eluting stents and paclitaxel-eluting stents, in patients with coronary artery disease.
Does the sirolimus-eluting stent reduce the need for reintervention and stent thrombosis compared to the paclitaxel-eluting stent in patients with coronary artery disease?
Meta-Analysis (n=8,695)
Randomized trials
Does the sirolimus-eluting stent reduce the need for reintervention and stent thrombosis compared to the paclitaxel-eluting stent in patients with coronary artery disease?
Hazard Ratio: 0.74 (95% CI 0.63–0.87)
p-value: p=<0.001
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“While each trial was randomized, they are mostly single-center, unblinded (investigators were aware of which device was being deployed) studies in which the clinical end points under analysis were determined by the investigators rather than being adjudicated by an independent clinical events committee.”
In patients with coronary artery disease, sirolimus-eluting stents are superior to paclitaxel-eluting stents in significantly reducing the risks of target lesion revascularization and stent thrombosis without significantly altering mortality.
OBJECTIVES Our purpose was to make a synthesis of the available evidence on the relative efficacy and safety of 2 drug-eluting stents (DES)--sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES)--in patients with coronary artery disease. BACKGROUND It is not known whether there are differences in late outcomes between the 2 most commonly used DES: SES and PES. METHODS Sixteen randomized trials of SES versus PES with a total number of 8,695 patients were included in this meta-analysis. A full set of individual outcome data from 5,562 patients was also available. Mean follow-up period ranged from 9 to 37 months. The primary efficacy end point was the need for reintervention (target lesion revascularization). The primary safety end point was stent thrombosis. Secondary end points were death and recurrent myocardial infarction (MI). RESULTS No significant heterogeneity was found across trials. Compared with PES, SES significantly reduced the risk of reintervention (hazard ratio [HR] 0.74; 95% confidence interval [CI] 0.63 to 0.87, p < 0.001) and stent thrombosis (HR 0.66; 95% CI 0.46 to 0.94, p = 0.02) without significantly impacting on the risk of death (HR 0.92; 95% CI 0.74 to 1.13, p = 0.43) or MI (HR 0.84; 95% CI 0.69 to 1.03, p = 0.10). CONCLUSIONS Sirolimus-eluting stents are superior to PES in terms of a significant reduction of the risk of reintervention and stent thrombosis. The risk of death was not significantly different between the 2 DES, but there was a trend toward a higher risk of MI with PES, especially after the first year from the procedure.
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Schömig et al. (2007) conducted a meta-analysis in Coronary artery disease (n=8,695). Sirolimus-eluting stent (SES) vs. Paclitaxel-eluting stent (PES) was evaluated on Need for reintervention (target lesion revascularization) (HR 0.74, 95% CI 0.63-0.87, p=<0.001). Sirolimus-eluting stents were superior to paclitaxel-eluting stents in reducing reintervention (HR 0.74; 95% CI 0.63-0.87; p<0.001) and stent thrombosis (HR 0.66; p=0.02).
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