Five-year outcomes from a trial of three limus-eluting stents with different polymer coatings in patients with coronary artery disease: final results from the ISAR-TEST 4 randomised trial.

Abstract

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).

• Authors: Sebastian Kufner, Robert A Byrne, Marco Valeskini, Stefanie Schulz, Tareq Ibrahim, Petra Hoppmann, Simon Schneider, Karl-Ludwig Laugwitz, Heribert Schunkert, Adnan Kastrati, Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents (ISAR-TEST4) Investigators
• Journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology (EuroIntervention) Vol. 11 Issue 12 Pg. 1372-9 (Mar 2016) ISSN: 1969-6213 [Electronic] France
• PMID: 25405657 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Cardiovascular Agents
• Coated Materials, Biocompatible
• Polymers
• Everolimus
• Sirolimus

Topics

• Absorbable Implants
• Aged
• Cardiovascular Agents (administration & dosage, adverse effects)
• Coated Materials, Biocompatible
• Coronary Artery Disease (diagnostic imaging, mortality, therapy)
• Coronary Thrombosis (etiology)
• Drug-Eluting Stents
• Everolimus (administration & dosage, adverse effects)
• Female
• Germany
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Percutaneous Coronary Intervention (adverse effects, instrumentation, mortality)
• Polymers (chemistry)
• Proportional Hazards Models
• Prosthesis Design
• Risk Factors
• Sirolimus (administration & dosage, adverse effects)
• Time Factors
• Treatment Outcome