Clinical trial NCT01795729: Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction
Official title: Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction: THE ARCHER TRIAL
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heart-lung Transplant Rejection
Keywords: Heart transplant
Coronary artery disease
Allograft vascular disease
Coronary stent
Optimal medical therapy
Prognosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-02-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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%
timeFrame: at 1 year
Secondary outcomes:
measure: Death at 1 year
timeFrame: at 1 year
measure: myocardial infarction at 1 year
timeFrame: at 1 year
measure: Retransplantation at 1 year
timeFrame: at 1 year
measure: implantation of transitory or definitive ventricular assist devices at 1 year
timeFrame: at 1 year
measure: new or worsening heart failure at 1 year
timeFrame: at 1 year
measure: graft failure and/or a decrease of left ventricular ejection fraction of at least 25% at 1 year compared to baseline
timeFrame: at 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié Salpetriere university Hospital - Cardiology
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Farzin BEYGUI, MD, PhD
role: STUDY_DIRECTOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pascal LEPRINCE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Saida VARNOUS, MD
role: PRINCIPAL_INVESTIGATOR
References: