Key result
Biodegradable polymer sirolimus-eluting stents showed comparable 5-year rates of cardiac death, MI, or revascularization versus everolimus-eluting stents (20.5% vs 19.5%; HR 1.04; p=0.71).
Why the study?
Do biodegradable polymer sirolimus-eluting stents or permanent polymer sirolimus-eluting stents improve clinical outcomes compared to permanent polymer everolimus-eluting stents in patients with coronary artery disease?
RCT (n=2,603)
randomized
Do biodegradable polymer sirolimus-eluting stents or permanent polymer sirolimus-eluting stents improve clinical outcomes compared to permanent polymer everolimus-eluting stents in patients with coronary artery disease?
Hazard Ratio: 1.04 (95% CI 0.84–1.29)
Absolute Event Rate: 20.5% vs 19.5%
p-value: p=0.71
Biodegradable polymer sirolimus-eluting stents and permanent polymer everolimus-eluting stents provide comparable long-term efficacy and safety at 5 years in patients with coronary artery disease.
Supports interchangeable use of biodegradable polymer sirolimus-eluting stents; confirms long-term equivalence to everolimus-eluting stents.
AIMS: Both biodegradable polymer sirolimus-eluting stents and permanent polymer everolimus-eluting stents offer potential for enhanced late outcomes in comparison with earlier-generation permanent polymer sirolimus-eluting stents. However, long-term comparative efficacy data among these devices remain a scientific gap. We aimed to compare the efficacy and safety of biodegradable polymer sirolimus-eluting stents (Yukon Choice PC) versus permanent polymer everolimus-eluting stents (XIENCE) versus permanent polymer sirolimus-eluting stents (CYPHER) at five-year follow-up. METHODS AND RESULTS: Overall, 2,603 patients were randomised to treatment with the Yukon Choice PC (n=1,299), XIENCE (n=652) or CYPHER (n=652) stents. The primary endpoint was the device-oriented composite of cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularisation (TLR). The main secondary endpoint was definite/probable stent thrombosis (ST). Follow-up was performed up to five years. Concerning the primary endpoint, there was no significant difference between Yukon Choice PC and XIENCE stents (20.5% vs. 19.5%, HR=1.04, 95% CI: 0.84-1.29; p=0.71) or between CYPHER and XIENCE stents (23.5% vs. 19.5%, HR=1.21, 95% CI: 0.95-1.53; p=0.12). In terms of safety, rates of ST were similar with both Yukon Choice PC and XIENCE (1.2% vs. 1.4%; HR=0.83, 95% CI: 0.37-1.91; p=0.67) but numerically higher with CYPHER as compared to XIENCE (2.4% vs. 1.4%, HR=1.67, 95% CI: 0.73-3.82; p=0.22). CONCLUSIONS: Biodegradable polymer Yukon Choice PC and permanent polymer XIENCE stents showed comparable clinical outcomes at five years. Permanent polymer CYPHER stents showed numerically higher rates of device-related adverse events. Trials registration: ClinicalTrials.gov (identifier: NCT00598676).
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Kufner et al. (2016) conducted an RCT in coronary artery disease (n=2,603). Biodegradable polymer sirolimus-eluting stents (Yukon Choice PC) vs. Permanent polymer everolimus-eluting stents (XIENCE) or permanent polymer sirolimus-eluting stents (CYPHER) was evaluated on Device-oriented composite of cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularisation (TLR) (HR 1.04, 95% CI 0.84-1.29, p=0.71). Biodegradable polymer sirolimus-eluting stents showed comparable 5-year rates of cardiac death, MI, or revascularization versus everolimus-eluting stents (20.5% vs 19.5%; HR 1.04; p=0.71).
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