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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction: THE ARCHER TRIAL

Conditions
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Heart-lung Transplant Rejection

Intervention / Treatment
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* Device: Stent
* Drug: optimal medical therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: Coronary stent+optimal medical therapy<br>Coronary stent on top of optimal medical therapy | Device: Stent<br>* Coronary revascularization<br>* Other names: Any type of approved bare metal or drug-eluting coronary stent;Drug: optimal medical therapy<br>* Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated<br>* Other names: Any treatment required at the physicians discretion for the treatment of the patient;|
| Active Comparator: 2: Optimal medical therapy<br>Optimal medical therapy | Drug: optimal medical therapy<br>* Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated<br>* Other names: Any treatment required at the physicians discretion for the treatment of the patient;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composit of death, myocardial infarction, retransplantation, implantation of transitory or definitive ventricular assist devices, new or worsening heart failure, graft failure and/or a decrease of left ventricular ejection fraction of at least 25% | The composit of death, myocardial infarction, retransplantation, implantation of transitory or definitive ventricular assist devices, new or worsening heart failure, graft failure and/or a decrease of left ventricular ejection fraction of at least 25% at 1 year | at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death at 1 year |  | at 1 year | 
| myocardial infarction at 1 year |  | at 1 year | 
| Retransplantation at 1 year |  | at 1 year | 
| implantation of transitory or definitive ventricular assist devices at 1 year |  | at 1 year | 
| new or worsening heart failure at 1 year |  | at 1 year | 
| graft failure and/or a decrease of left ventricular ejection fraction of at least 25% at 1 year compared to baseline |  | at 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart transplant, Coronary artery disease, Allograft vascular disease, Coronary stent, Optimal medical therapy, Prognosis