Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. (ARCACHON)

Assessment in a Randomized Controlled Trial of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.

Due to the lack of randomized controlled trials, the best follow-up strategy of asymptomatic patients after coronary artery revascularization is controversial. A systematic screening of silent myocardial ischemia may help prevent a major acute cardiac event. However, systematic screening strategy is costly and there is currently no evidence that repeated revascularization improve survival. Moreover, stress testing per se or additional procedures which can be performed with regard of stress testing results can cause unexpected complications.

ARCACHON is a national, multicenter, randomized, open label trial, that will evaluate the non-inferiority of a clinical follow-up as compared to a systematic stress testing strategy after coronary revascularization.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Coronary Artery Bypass Grafting
• Intervention / Treatment: Other: No stress testing; Procedure: stress testing

Detailed Description

Coronary artery revascularization is commonly used for the management strategy of patients with coronary artery disease (CAD).

In the following years after revascularization, the current guidelines recommend evaluation with stress tests when patients are symptomatic. Due to the lack of randomized trials, the evaluation of asymptomatic patients is controversial and accordingly there is a wide variation in routine follow-up strategies in these patients. A systematic screening of silent myocardial ischemia may help prevent a major acute cardiac event. However, systematic screening strategy is costly and there is currently no evidence that repeated revascularization improve survival We hypothesized that clinical follow-up alone would be non-inferior to systematic stress testing screening strategy during follow-up of asymptomatic CAD patients with prior coronary revascularization.

The primary objective of ARCACHON trial is to demonstrate the non-inferiority of a strategy of clinical follow-up (without non-invasive stress testing) in asymptomatic patients with a history of coronary revascularization compared to a strategy of systematic screening for myocardial ischemia using non-invasive stress testing by the primary endpoint as the composite of: all-cause death, myocardial infarction, stroke or any cardiovascular event leading to unplanned hospitalization.

• Study Type: Interventional
• Enrollment (Anticipated): 2664
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadjib Hammoudi, MD PHD; Phone Number: +33 01 42 16 55 35; Email: nadjib.hammoudi@aphp.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • Pitie Salpetriere

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:

1. Prior coronary revascularization (PCI or CABG) at any time before randomization.
2. Asymptomatic at the time of randomization (defined as a Canadian Cardiovascular Society score ≤ 1, stable on the current medical treatment).
3. Patient affiliated to Social Security
4. Informed, written consent from the patient

Exclusion Criteria:

1. Age < 18years
2. Any acute coronary syndrome in the previous 3 months

3. Symptoms suggestive of angina pectoris at the time of randomization:

   • Angina is characterized by ischemic chest pain occurring on exertion or stress relieved by rest and/or nitroglycerine.
   • Angina equivalents are defined as dyspnea, fatigue, or diaphoresis on exertion evaluated by the principal investigator as abnormal and attributable to myocardial ischemia.
4. Any severe valvular disease
5. Prior heart transplantation
6. Class III or IV symptomatic heart failure (NYHA classification).
7. Persons whose occupations impact on public safety (e.g. airline pilots, lorry or bus drivers) in whom systematic stress testing could be required for medico-legal reasons
8. Malignancies and other comorbid conditions with a life expectancy < 2 years
9. Pregnancy or nursing women
10. Women of childbearing age without effective birth control or intention to become pregnant during the course of the trial
11. Contemporaneous enrollment in a different clinical trial
12. Inability to sign an informed consent. Patient under legal protection (guardianship, curatorship) or mental condition (psychiatric or organ cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the trial or mental retardation or language barrier such that the patient is unable to give informed consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; no systematic stress testing during follow-up	Other: No stress testing; No stress testing during the patient follow up (up to 48 months) if the patient remains asymptomatic; Other Names: Arm1
Active Comparator: Active Comparator; systematic annual stress testing during follow-up	Procedure: stress testing; Systematic annual stress testing during the patient follow up (up to 48 months); Other Names: Arm 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
demonstrate the non-inferiority of a strategy of clinical follow-up	The primary outcomes measured at longest follow-up (minimum 24 months) the number of All-cause death in each arm	minimum 24 months to 48 months
demonstrate the non-inferiority of a strategy of clinical follow-up	The primary outcomes measured at longest follow-up (minimum 24 months) is the number of Myocardial infarction in each arm	minimum 24 months to 48 months
demonstrate the non-inferiority of a strategy of clinical follow-up	The primary outcomes measured at longest follow-up (minimum 24 months) is the number of Stroke in each arm hospitalization.	minimum 24 months to 48 months
demonstrate the non-inferiority of a strategy of clinical follow-up	The primary outcomes measured at longest follow-up (minimum 24 months) is the number of any cardiovascular event leading to unplanned hospitalization in each arm	minimum 24 months to 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compare the clinical follow-up strategy to a systematic screening of myocardial ischemia	Hierarchical assessment of the following criteria at longest follow-up (minimum 24 months) All-cause death, myocardial infarction	minimum 24 months to 48 months
compare the clinical follow-up strategy to a systematic screening of myocardial ischemia	Hierarchical assessment of the following criteria at longest follow-up (minimum 24 months): Angina control per Seattle Angina Questionnaire	minimum 24 months to 48 months
compare the clinical follow-up strategy to a systematic screening of myocardial ischemia	Hierarchical assessment of the following criteria at longest follow-up (minimum 24 months): Quality of life in each arm	minimum 24 months to 48 months
compare the clinical follow-up strategy to a systematic screening of myocardial ischemia	Hierarchical assessment of the following criteria at longest follow-up (minimum 24 months): Urgent or unscheduled revascularizations in each arm	minimum 24 months to 48 months
compare the clinical follow-up strategy to a systematic screening of myocardial ischemia	Hierarchical assessment of the following criteria at longest follow-up (minimum 24 months): Any cardiovascular event leading to unplanned hospitalization in each arm	minimum 24 months to 48 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Nadjib Hammoudi, MD PHD, APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Anticipated): September 30, 2025
• Study Completion (Anticipated): September 30, 2025

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Coronary artery disease; Myocardial ischemia; coronary revascularization; Stress testing
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: P170908J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No