Efficacy Study of Drug-eluting and Bare Metal Stents in Bypass Graft Lesions (ISAR-CABG)

German Heart Center Munich

Status and phase: Completed; Phase 4

Conditions: Arteriosclerosis of Arterial Coronary Artery Bypass Graft

Treatments: Device: biodegradable-polymer-based sirolimus-eluting stent; Device: bare metal stents; Device: paclitaxel-eluting stent; Device: sirolimus-eluting stent

Study type: Interventional

Funder types: Other

Identifiers

NCT00611910

GE IDE No. S02707

Details and patient eligibility

About

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

Full 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.

Enrollment: 610 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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610 participants in 2 patient groups

DES

Experimental group

Description:

drug-eluting stents

Treatment:

Device: sirolimus-eluting stent

Device: paclitaxel-eluting stent

Device: biodegradable-polymer-based sirolimus-eluting stent

BMS

Active Comparator group

Description:

bare metal stents

Treatment:

Device: bare metal stents