Heart-lung Transplant Rejection
Conditions
Keywords
Heart transplant, Coronary artery disease, Allograft vascular disease, Coronary stent, Optimal medical therapy, Prognosis
Brief 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.
Detailed description
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.
Interventions
DEVICEStent
Coronary revascularization
DRUGoptimal medical therapy
Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame |
|---|---|
| myocardial infarction at 1 year | at 1 year |
| Retransplantation at 1 year | at 1 year |
| Death 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 |
| implantation of transitory or definitive ventricular assist devices at 1 year | at 1 year |
Countries
France
Outcome results
None listed