Ultrathin-strut biodegradable polymer versus durable polymer drug-eluting stents: a meta-analysis

Abstract

Objectives: Determine whether an ultrathin biodegradable polymer sirolimus-eluting stent ('Orsiro'-BP-SES) has clinical benefits over second-generation durable polymer drug-eluting stents (DP-DES).

Methods: We conducted a prospective systematic review and meta-analysis of randomised clinical trials comparing Orsiro BP-SES against DP-DES (PROSPERO Registration: CRD42019147136). The primary outcome was target lesion failure (TLF): composite of cardiac death, target vessel myocardial infarction (TVMI) and clinically indicated target lesion revascularisation (TLR)) evaluated at the longest available follow-up.

Results: Nine trials randomised 11 302 patients to either Orsiro BP-SES or DP-DES. At mean weighted follow-up of 2.8 years, the primary outcome (TLF) occurred in 501 of 6089 (8.2%) participants with BP-SES compared with 495 of 5213 (9.5%) participants with DP-DES. This equates to an absolute risk reduction of 1.3% in TLF in favour of Orsiro BP-SES (OR 0.82; 95% CI 0.69 to 0.98; p=0.03). This was driven by a reduction in TVMI (OR 0.80; 95% CI 0.65 to 0.98; p=0.03). There were no significant differences in other clinical endpoints: cardiac death, TLR and stent thrombosis.

Conclusion: The Orsiro BP-SES shows promising clinical outcomes in patients undergoing percutaneous coronary intervention compared with contemporary second-generation DES at a short to medium term follow-up. More research is warranted to evaluate performance over a longer follow-up period and in different clinical and lesion subsets.

Keywords: acute coronary syndrome; coronary artery disease; coronary intervention (PCI); coronary stenting; interventional cardiology.

Figure 1

Risk-of-bias summary for trials included in the meta-analysis.

Figure 2

PRISMA flow chart for studies included in the meta-analysis. BP-EES, biodegradable polymer everolimus-eluting stent; DP-DES, durable polymer drug-eluting stents; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses; RCT, randomised controlled trial; SES, sirolimus-eluting stent.

Figure 3

Target lesion failure and secondary end points. BP-SES, biodegradable polymer sirolimus-eluting stent; DP-DES, durable polymer drug-eluting stents; TLR, target lesion revascularisation.

Figure 4

Forest plots of primary outcome (A) and secondary outcomes (B–E) for Orsiro BP-SES versus DP-DES. BP-SES, biodegradable polymer sirolimus-eluting stent; DP-DES, durable polymer drug-eluting stents.

Figure 5

11 302 participants randomised across 9 RCTs between the Orsiro BP-SES and DP-DES groups showed a significant reduction in TLF in participants with the Orsiro BP-SES. BP-SES, biodegradable polymer sirolimus-eluting stent (Odds ratio 0.82; 95% CI 0.69-0.98; P=0.03); DP-DES, durable polymer drug-eluting stents; RCTs, randomised controlled trials; TLF, target lesion failure.

Figure 6

Interaction of ACS and treatment effect (TLF) at study level between BP-SES and DP-DES groups. ACS, acute coronary syndrome; BP-SES, biodegradable polymer sirolimus-eluting stent; DP-DES, durable polymer drug-eluting stents; TLF, target lesion failure.