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Abstract
BackgroundThe Orsiro biodegradable polymer sirolimus-eluting stent (O-SES) is a new-generation biodegradable polymer drug-eluting stent with the thinnest strut thickness to date developed to improve the percutaneous treatment of patients with coronary artery disease. We perform a meta-analysis of randomized clinical trials (RCTs) comparing the efficacy and safety of an ultra-thin, Orsiro biodegradable polymer sirolimus-eluting stent (O-SES) compared with durable polymer drug-eluting stents (DP-DESs).MethodsMedline, Embase, and CENTRAL databases were searched for randomized controlled trials comparing the safety and efficacy of O-SES versus DP-DES. Paired reviewers independently screened citations, assessed risk of bias of included studies, and extracted data. We used the Mantel-Haenszel method to calculate risk ratio (RR) by means of a random-effects model.ResultsSix RCTs with a total of 6949 patients were selected. All included trials were rated as low risk of bias. The O-SES significantly reduced the risk of myocardial infarction (RR 0.78, 95% confidence interval [CI] 0.62–0.98; I2 = 0%; 10 fewer per 1000 [from 1 fewer to 18 fewer]; high quality) compared with the DP-DES. There was no significant difference between O-SES and DP-DES in the prevention of stent thrombosis (RR: 0.75; 95% CI: 0.52–1.08), cardiac death (RR: 0.93; 95% CI: 0.63–1.36), target lesion revascularization (RR 1.10, 95% CI 0.86–1.42) and target vessel revascularization (RR 0.97, 95% CI 0.78–1.21).ConclusionAmong patients undergoing percutaneous coronary intervention, O-SES resulted in significantly lower rates of myocardial infarction than DP-DES and had a trend toward reduction in stent thrombosis.
Highlights
The Orsiro biodegradable polymer sirolimus-eluting stent (O-SES) is a new-generation biodegradable polymer drug-eluting stent with the thinnest strut thickness to date developed to improve the percutaneous treatment of patients with coronary artery disease
The Orsiro biodegradable polymer sirolimus-eluting stent (O-SES; Biotronik, Bülach, Switzerland) is a novel drug-eluting stent (DES) consisting of an ultrathin strut cobalt chromium design with a bioresorbable, poly-Llactic acid polymer coating that releases sirolimus [9]
All the included studies presented outcomes of Target vessel revascularization (TVR) and Target lesion revascularization (TLR), showing that there was no statistically significant difference between O-SES and durable polymer (DP)-DES regarding TVR (RR 0.97, 95% confidence intervals (CI) 0.78–1.21) and TLR (RR 1.10, 95% CI 0.86–1.42). (Fig. 4)
Summary
The Orsiro biodegradable polymer sirolimus-eluting stent (O-SES) is a new-generation biodegradable polymer drug-eluting stent with the thinnest strut thickness to date developed to improve the percutaneous treatment of patients with coronary artery disease. The implantation of a drug-eluting stent (DES) that prevent restenosis by the release of antiproliferative agents from polymers is considered the standard approach for percutaneous coronary intervention [1]. The Orsiro biodegradable polymer sirolimus-eluting stent (O-SES; Biotronik, Bülach, Switzerland) is a novel DES consisting of an ultrathin strut cobalt chromium design with a bioresorbable, poly-Llactic acid polymer coating that releases sirolimus [9]. The reduced strut thickness of 40% has been reported to improve outcomes compared with early generation drug-eluting stents [12]. The use of thin struts might reduce the risk of potentially fatal complications, such as ST and MI [10]
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