Heart-lung Transplant Rejection Clinical Trial
Official title:
Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction: THE ARCHER TRIAL
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.
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 assessed 1
year after randomization.
Objectives: To demonstrate the superiority of the interventional management on top of
optimal medical therapy over optimal medical therapy alone in preventing the occurrence of
the primary endpoint of the study assessed 1 year after randomization
Design : Multicenter, prospective randomized 1 :1, open-label blinded endpoint study
Target population : Heart transplant recipients, aged ≥18 years, without coronary artery
disease-related symptoms, with angiographically significant coronary artery stenoses (≥50%
anatomically adequate for a revascularization by coronary angioplasty with stent
implantation, with no contraindication to dual antiplatelet therapy associating aspirin and
a P2Y12 inhibitorfor a duration of 12 monthsand with ni grade IA ACC/AHA indication for
revascularization
Inclusion period: 12 months (may be extended based on the inclusion rythme)
Maximum duration of participation for patients : 13 months
Total duration of the study : 37 months
Primary endpoint : The composit of death, myocardial infarction, retransplantation,
implantation of transitory or definitve ventricular assist devices, new or worsening heart
failure, graft failure and/or a decrease of left ventricular ejection fraction of at least
25% compared to baseline.The occurrence of any event qualifying for the primary endpoint
will be assessed by a Cox survival analysis stratified on center.The primary endpoint will
be assessed 12 months after randomization.
Secondary endpoints : Any of the individual events defining the primary outcome at 1 year
Number of patients to be included and power calculation : 80 patients per group. A 1 year
primary endpoint rate of 30% in the active and 50% in with an inclusion period of 24 months
and alpha=5% warants a 90% power using a cox model.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment