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.

  • STATUS
    Recruiting
  • End date
    Sep 30, 2025
  • participants needed
    2664
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 28 November 2021
ischemia
cardiac event
exercise stress test
coronary revascularization
revascularisation

Summary

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.

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.

Details
Condition Coronary artery bypass graft, Myocardial Ischemia, coronary artery bypass, cabg, Coronary heart disease, coronary artery bypass surgery, coronary bypass, Coronary Artery Disease, Percutaneous Coronary Intervention, Cardiac Ischemia
Treatment No stress testing, stress testing, stress testing
Clinical Study IdentifierNCT04566497
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on28 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Age < 18years
Any acute coronary syndrome in the previous 3 months
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
Any severe valvular disease
Prior heart transplantation
Class III or IV symptomatic heart failure (NYHA classification)
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
Malignancies and other comorbid conditions with a life expectancy < 2 years
Pregnancy or nursing women
Women of childbearing age without effective birth control or intention to become pregnant during the course of the trial
Contemporaneous enrollment in a different clinical trial
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
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