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Incidence of adverse cardiac events 5 years after polymer‐free sirolimus eluting stent implantation: Results from the prospective Bad Berka Yukon Choice™ registry
Author(s) -
Ohlow MarcAlexander,
Korn Hubertus,
Gunkel Oliver,
Farah Ahmed,
Fuhrmann Joerg T.,
Lauer Bernward
Publication year - 2014
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.25272
Subject(s) - medicine , mace , myocardial infarction , sirolimus , stent , incidence (geometry) , surgery , clinical endpoint , drug eluting stent , cohort , acute coronary syndrome , prospective cohort study , restenosis , cardiology , clinical trial , percutaneous coronary intervention , physics , optics
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.