Coronary Disease
Conditions
Keywords
drug eluting stent, left main disease
Brief summary
The purpose of this study is to evaluate the efficacy of two different drug-eluting stents (Everolimus and Zotarolimus-eluting) for treatment of unprotected left main coronary artery disease.
Detailed description
Restenosis in the left main coronary artery may have severe consequences given the large proportion of the myocardium compromised in this condition, and, in several studies, it has been linked to the 6-month mortality after the index procedure. Drug-eluting stents have reduced the restenosis rate and the need for target vessel revascularization not only in simple lesion but also in high risk subsets of patients and lesions such as diabetics, long lesions or bifurcations. There are no data about their efficacy in left main coronary artery disease. Thus, the aim of this study is to investigate the performance of two different drug-eluting stents (Everolimus and Zotarolimus-eluting) in left main coronary lesions.
Interventions
DEVICEEverolimus-eluting stent (Xience)
stent is implanted due to randomization
DEVICEZotarolimus-eluting stent (Endeavor Resolute)
stent is implanted due to randomization
Sponsors
Technical University of Munich
Deutsches Herzzentrum Muenchen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50 % stenosis located in unprotected LMCA who are unable to undergo CABG because of cardiac surgeons' refusal (poor surgical candidates) or their own unwillingness. * Pretreatment with a loading dose of 600 mg clopidogrel. * Informed, written consent by the patients or her/his legally-authorized representative for participation in the study.
Exclusion criteria
* Cardiogenic shock. * ST-segment elevation acute myocardial infarction (ST-segment ≥ 0.1 mV elevation in ≥ 2 contiguous ECG leads persisting for at least 20 minutes) within 48 hours from symptom onset. * In-stent restenosis. * Malignancies or other comorbid conditions with life expectancy less than one year or that may result in protocol non-compliance. * Prior coronary artery bypass surgery with revascularization of LAD and/or LCx. * Planned staged PCI procedure within 30 days from index procedure or prior PCI within the last 30 days. * An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first six months post enrollment. * Known allergy to the study medications: aspirin, clopidogrel, UHF; sirolimus, paclitaxel; true anaphylaxis after prior exposure to contrast media. * Pregnancy (present, suspected or planned). * Patient's inability to fully cooperate with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major adverse cardiac event defined as a composite of death, myocardial infarction and target lesion revascularization. | 1 year follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Angiographic restenosis at follow-up coronary angiography. | 6-9 months follow-up |
Countries
Germany, Italy
Outcome results
None listed