Incidence of adverse cardiac events 5 years after polymer-free sirolimus eluting stent implantation: Results from the prospective Bad Berka Yukon Choice™ registry.
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.
['Ohlow|Marc-Alexander|MA|', 'von Korn|Hubertus|H|', 'Gunkel|Oliver|O|', 'Farah|Ahmed|A|', 'Fuhrmann|Joerg T|JT|', 'Lauer|Bernward|B|']
D000368:Aged D017023:Coronary Angiography D003324:Coronary Artery Disease D023903:Coronary Restenosis D054855:Drug-Eluting Stents D005260:Female D005500:Follow-Up Studies D005858:Germany D006801:Humans D015994:Incidence D008297:Male D011108:Polymers D011446:Prospective Studies D012042:Registries D020123:Sirolimus D015996:Survival Rate D013997:Time Factors
sirolimus eluting stent Yukon choice outcome 5-year results