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Efficacy

Efficacy

Background Biodegradable polymer drug-eluting stents (DES) offer potential for enhanced late outcomes in comparison with permanent polymer stents. In addition, there is increasing interest in comparison of everolimus-eluting stents (Xience) against sirolimus-eluting stents (Cypher).

Objectives To compare the 3-year efficacy and safety of biodegradable polymer with permanent polymer stents and of everolimus-eluting with sirolimus-eluting stents.

Methods ISAR-TEST 4 (Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting Stents) was a randomized clinical trial with broad inclusion criteria enrolling 2603 patients at 2 clinics in Munich, Germany. Patients were randomized to either biodegradable polymer (n=1299)(YUKON CHOICE PC) or permanent polymer stents (n=1304) (CYPHER and XIENCE); patients treated with permanent polymer stents were randomly allocated to everolimus-eluting (n=652) or sirolimus-eluting stents (n=652). The primary endpoint was the composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization.

Results Clinical events continued to accrue at a low rate out to 3 years in all groups. Overall there was no significant difference between YUKON Choice PC and XIENCE & CYPHER concerning the primary endpoint (20.1% versus 20.9%, hazard ratio = 0.95, 95% CI, 0.80-1.13; P=0.59). Rates of definite/probable stent thrombosis were also similar in both groups. (1.2% versus 1.7% respectively; HR = 0.71, CI, 0.37-1.39; P=0.32). In patients treated with permanent polymer stents, everolimus-eluting stents were comparable to sirolimus-eluting stents concerning the primary endpoint (19.6% vs. 22.2%, HR, 0.87; CI, 0.68-1.11; P=0.26) as well as definite/probable stent thrombosis (1.4% vs. 1.9%, HR, 0.75; CI, 0.32-1.78; P=0.51).

Conclusion: YUKON Choice PC and XIENCE & CYPHER  are associated with similar clinical outcomes at 3 years. In addition, Xience results are comparable to Cypher in terms of overall clinical efficacy and safety.

 


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