Efficacy Study of Drug-eluting and Bare Metal Stents in Bypass Graft Lesions

Phase 4

Completed

• Conditions: Arteriosclerosis of Arterial Coronary Artery Bypass Graft
• Interventions: Device: bare metal stents; Device: sirolimus-eluting stent; Device: paclitaxel-eluting stent; Device: biodegradable-polymer-based sirolimus-eluting stent

• Registration Number: NCT00611910
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-01-29
• Study First Posted: 2008-02-11
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-12
• Last Update Posted: 2011-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 610

Inclusion Criteria

• Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in CABG
• Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
• In women with childbearing potential a negative pregnancy test is mandatory

Exclusion Criteria

• Cardiogenic shock
• Target lesion located in the native coronary vessels.
• In-stent restenosis of CABG
• Target lesion located at internal mammary artery graft or free arterial graft
• Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
• Known allergy to the study medications: clopidogrel, rapamycin, paclitaxel, stainless steel.
• Inability to take clopidogrel for at least 6 months.
• Pregnancy (present, suspected or planned) or positive pregnancy test.
• Previous enrollment in this trial.
• Patient's inability to fully cooperate with the study protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DES	paclitaxel-eluting stent	drug-eluting stents
BMS	bare metal stents	bare metal stents
DES	sirolimus-eluting stent	drug-eluting stents
DES	biodegradable-polymer-based sirolimus-eluting stent	drug-eluting stents

Primary Outcome Measures

Name	Time	Method
The primary end point of the study is composite of death, myocardial infarction and target lesion revascularization at one year after stent implantation	12 months

Secondary Outcome Measures

Name	Time	Method
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.	12 months
Myocardial infarction rate	12 months
All cause death	12 months
Stent thrombosis	12 months

Trial Locations

Locations (4)

Bad Segeberger Kliniken; 🇩🇪 Bad Segeberg, Germany

Medizinische Klinik, Klinikum rechts der Isar; 🇩🇪 Muenchen, Germany

Herzzentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Germany