Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction

• Status: Terminated
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to compare optimal medical therapy alone versus percutaneous coronary intervention on top of medical therapy in the setting of heart transplant recipient coronary artery disease in a randomized trial.The primary endpoint assessed at 1 year is the composite of death, myocardial infarction, need for transitory or permanent ventricular assist device implantation, myocardial revascularization, occurrence or worsening of heart failure, any graft dysfunction and/or a decrease of left ventricular ejection fraction of at least 25% compared to baseline. The hypothesis of the study is the superiority of the interventional management over medical therapy alone in preventing the occurrence of the primary endpoint of the study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Criteria

Inclusion Criteria:

• Patients ≥ 18 years old

• Heart transplant recipient

• Stable clinical situation

• One or several non-critical coronary stenoses (≥ 50% et ≤ 75% visually or QCA-assessed diameter stenosis) considered as adequate for coronary stenting by the operator

• Left ventricular ejection fraction ≥ 40%

• Informed consentement signed by the patient

Exclusion Criteria:

• Acute coronary syndrome

• In-stent restenosis

• Proof of an extensive myocardial ischemia (≥ 7/17 segments ASE model)

• Coronary stenosis considered as critical by the operators with slow flow

• ACC/AHA Class IA indication for revascularization :

• vessel disease with left ventricular dysfunction

• Left main stenosis

• Severe proximal LAD stenosis

• Contra-indication to dual antiplatelet therapy

• Decompensated heart failure at the time of randomization

• Pregnant or breast-feeding women- Patients participating to another clinical research within 30 days before randomization- life expectancy < 1 y

• Patients unable to observe strict medical therapy and follow-up within 1 year after randomization