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


CONCLUSIONS
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.
Department of Cardiology, Zentralklinik Bad Berka, Germany.
Marc-Alexander
MA
Ohlow
Hubertus
H
von Korn
Oliver
O
Gunkel
Ahmed
A
Farah
Joerg T
JT
Fuhrmann
Bernward
B
Lauer
D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000601:surgery; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000453:epidemiology; D054855:Drug-Eluting Stents; D005500:Follow-Up Studies; D005858:Germany / Q000453:epidemiology; D015994:Incidence; D011108:Polymers; D011446:Prospective Studies; D012042:Registries; D020123:Sirolimus / Q000494:pharmacology; D015996:Survival Rate / Q000639:trends; D013997:Time Factors
D011108:Polymers; D020123:Sirolimus
5-year results; Yukon choice; outcome; sirolimus eluting stent