Incidence of adverse cardiac events 5 years after polymer-free sirolimus eluting stent implantation: Results from the prospective Bad Berka Yukon Choice™ registry

• Published in: Catheterization and cardiovascular interventions Vol. 84; no. 7; pp. 1080 - 1086
• Main Authors: Ohlow, Marc-Alexander, von Korn, Hubertus, Gunkel, Oliver, Farah, Ahmed, Fuhrmann, Joerg T., Lauer, Bernward
• Format: Journal Article
• Language: English
• Published: United States Blackwell Publishing Ltd 01-12-2014; Wiley Subscription Services, Inc
• Subjects: 5-year results; Acute coronary syndromes; Aged; Cardiology; Coronary Angiography; Coronary Artery Disease - surgery; Coronary Restenosis - diagnostic imaging; Coronary Restenosis - epidemiology; Diabetes; Drug-Eluting Stents; Female; Follow-Up Studies; Germany - epidemiology; Heart attacks; Humans; Incidence; Male; outcome; Polymers; Prospective Studies; Registries; Sirolimus - pharmacology; sirolimus eluting stent; Stents; Survival Rate - trends; Time Factors; Yukon choice; 5-year results; sirolimus eluting stent; outcome; Yukon choice
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.25272

Objectives
Drug‐eluting stents (DES) constitute a major achievement in preventing re‐stenosis, concerns remain regarding the increased inflammatory responses associated with the polymers used. This analysis focuses on outcomes in patients receiving the polymer‐free sirolimus‐eluting stent system YUKON‐Choice (Yukon‐DES, Translumina, Germany).
Methods
From 01/2006‐09/2008 all patients receiving Yukon‐DES (≥2.5 mm diameter) were prospectively enrolled in our registry. The primary endpoint was long‐term major adverse cardiac events (MACE).
Results
701 patients were included in our registry. Mean age was 65.7 ± 10 years (73% male gender, 35.5% diabetes, and 32.2% acute coronary syndrome). 76% of the lesions were of Type B2/C. Lesion length was 24.6 ± 5.2 mm and mean stent diameter was 2.8 ± 0.4 mm. A total of 511 pts (72%) underwent 6‐months angiographic follow‐up, target vessel revascularization was noted in 23.5%. At 5 years clinical outcomes were: cardiac death 5.8%; myocardial infarction 3.4%; and TVR 24.6%. The incidence of MACE differed significantly between “on‐label” and “off‐label” indications (14.8% vs. 40.8% MACE; P < 0.001). Incidence of definitive/probable stent thrombosis (ST) was 1.14% (8/701); very late (>1 year) ST occurred in 0.29%.
Conclusion
Our data suggests that the implantation of the sirolimus‐coated polymer‐free YUKON‐DES is safe and feasible with a very low incidence of ST in this real world patient cohort with high percentage of diabetes and small vessels. © 2013 Wiley Periodicals, Inc.