Drug-eluting Stents to Treat Unprotected Coronary Left Main Disease

Phase 4

Completed

• Conditions: Coronary Disease
• Interventions: Device: Everolimus-eluting stent (Xience); Device: Zotarolimus-eluting stent (Endeavor Resolute)

• Registration Number: NCT00598637
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-01-21
• Study First Posted: 2008-01-22
• Primary Completion: 2012-09
• Study Completion: 2013-02
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-01
• Last Update Posted: 2013-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 650

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EES	Everolimus-eluting stent (Xience)	Everolimus-eluting stent (Xience)
ZES	Zotarolimus-eluting stent (Endeavor Resolute)	Zotarolimus-eluting stent (Endeavor Resolute)

Primary Outcome Measures

Name	Time	Method
Incidence of major adverse cardiac event defined as a composite of death, myocardial infarction and target lesion revascularization.	1 year follow-up

Secondary Outcome Measures

Name	Time	Method
Angiographic restenosis at follow-up coronary angiography.	6-9 months follow-up

Trial Locations

Locations (4)

First Medizinische Klinik, Klinikum rechts der Isar; 🇩🇪 Munich, Germany

Bad Segeberger Kliniken; 🇩🇪 Bad Segeberg, Germany

Azienda Ospedaliero Universitaria di Ferrara; 🇮🇹 Ferrara, Italy

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Germany