Key result
Orsiro BP-SES reduces target lesion failure ~18% vs. DP-DES, driven by fewer target vessel MIs.
Why the study?
It was uncertain whether ultrathin biodegradable polymer sirolimus-eluting stents provide clinical benefits over second-generation durable polymer drug-eluting stents.
Does an ultrathin biodegradable polymer sirolimus-eluting stent reduce target lesion failure in patients undergoing percutaneous coronary intervention compared to second-generation durable polymer drug-eluting stents?
Meta-Analysis (n=11,302)
Does an ultrathin biodegradable polymer sirolimus-eluting stent reduce target lesion failure in patients undergoing percutaneous coronary intervention compared to second-generation durable polymer drug-eluting stents?
Odds Ratio: 0.82 (95% CI 0.69–0.98)
Absolute Event Rate: 8.2% vs 9.5%
Absolute Risk Reduction: 1.3%
p-value: p=0.03
Ultrathin biodegradable polymer sirolimus-eluting stents reduce target lesion failure, driven by fewer target vessel myocardial infarctions, compared to durable polymer drug-eluting stents at short to medium term follow-up.
Supports Orsiro BP-SES preference in PCI; extends prior trial findings via meta-analysis.
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.
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Monjur et al. (2020) conducted a meta-analysis in percutaneous coronary intervention (n=11,302). Orsiro biodegradable polymer sirolimus-eluting stent vs. second-generation durable polymer drug-eluting stents (DP-DES) was evaluated on target lesion failure (TLF): composite of cardiac death, target vessel myocardial infarction (TVMI) and clinically indicated target lesion revascularisation (TLR) (OR 0.82, 95% CI 0.69 to 0.98, p=0.03). The Orsiro BP-SES reduced target lesion failure compared with DP-DES (8.2% vs 9.5%; OR 0.82; 95% CI 0.69-0.98; p=0.03), driven by a reduction in target vessel myocardial infarction.
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