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

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.

Study Overview

• Status: Terminated
• Conditions: Heart-lung Transplant Rejection
• Intervention / Treatment: Device: Stent; Drug: optimal medical therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Pitié Salpetriere university Hospital - Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Farzin BEYGUI, MD, PhD, Assistance Publique - Hôpitaux de Paris; Principal Investigator: Pascal LEPRINCE, MD, PhD, Assistance Publique - Hôpitaux de Paris; Principal Investigator: Saida VARNOUS, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: February 19, 2013
• First Submitted That Met QC Criteria: February 20, 2013
• First Posted (Estimate): February 21, 2013

Study Record Updates

• Last Update Posted (Estimate): October 14, 2015
• Last Update Submitted That Met QC Criteria: October 13, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Prognosis; Coronary artery disease; Heart transplant; Optimal medical therapy; Coronary stent; Allograft vascular disease
• Other Study ID Numbers: P081262; 2010-A01516-33 (Other Identifier: IDRCB)