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Review
. 2018 Aug 15;18(1):170.
doi: 10.1186/s12872-018-0902-5.

Safety and efficacy of ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer drug-eluting stents: a meta-analysis of randomized trials

Ping Zhu  1 , Xin Zhou  1 , Chenliang Zhang  1 , Huakang Li  1 , Zhihui Zhang  2 , Zhiyuan Song  3
Affiliations
Review

Safety and efficacy of ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer drug-eluting stents: a meta-analysis of randomized trials

Ping Zhu et al. BMC Cardiovasc Disord. .

Abstract

Background: 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. 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).

Methods: Medline, 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.

Results: Six 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).

Conclusion: Among 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.

Keywords: Biodegradable polymer; Durable polymer; Meta-analysis; Percutaneous coronary intervention.

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The authors declare that they have no competing interests.

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Figures

Fig. 1
Fig. 1
Search strategy and final included and excluded studies
Fig. 2
Fig. 2
Risk of bias summary
Fig. 3
Fig. 3
Forest plot assessing safety outcomes. A: myocardial infarction, B: definite or probable stent thrombosis, C: cardiac death. CI = confidence interval; M-H = Mantel-Haenszel; SE = standard error
Fig. 4
Fig. 4
Forest plot assessing efficacy outcomes. A: target vessel revascularization, B: target lesion revascularization (TLR). CI = confidence interval; M-H = Mantel-Haenszel; SE = standard error
Fig. 5
Fig. 5
Trial sequential analysis of myocardial infarction
Fig. 6
Fig. 6
Forest plot assessing myocardial infarction of subgroup analysis based on various DES types (everolimus and zotarolimus)
See this image and copyright information in PMC

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