The aim of this study is to compare the efficacy of drug-eluting stents and bare metal stents to reduce reblockage of bypass grafts after coronary stenting
A large number of studies showed that drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare metal stents. Although this applies to the vast majority of patients, intimal hyperplasia and in-stent restenosis have not been completely eliminated and remain to occur in certain high risk subgroups. While there is a plenty of data about the efficacy of DES in complex lesions or diabetics, no randomized data exist about the efficacy of DES in coronary artery bypass graft lesions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
610
due to randomization Cypher stent will be implanted
due to randomization Taxus stent will be implanted
due to randomization a rapamycin-eluting stent with biodegradable polymer will be implanted
Herzzentrum Bad Krozingen
Bad Krozingen, Germany
Bad Segeberger Kliniken
Bad Segeberg, Germany
Deutsches Herzzentrum Muenchen
Munich, Germany
Medizinische Klinik, Klinikum rechts der Isar
München, Germany
The primary end point of the study is composite of death, myocardial infarction and target lesion revascularization at one year after stent implantation
Time frame: 12 months
Myocardial infarction rate
Time frame: 12 months
Need of target lesion revascularization (TLR), defined as any revascularization procedure involving the target lesion due to luminal re-narrowing in the presence of symptoms or objective signs of ischemia.
Time frame: 12 months
All cause death
Time frame: 12 months
Stent thrombosis
Time frame: 12 months
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Due to randomization one bare-metal stent will be implanted. The decision about the stent type will be up to the interventionalist