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ARCACHON

To evaluate the non-inferiority of a clinical follow-up as compared to a systematic stress testing strategy after coronary revascularization

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objectif

To demonstrate the non-inferiority of a strategy of simple clinical follow-up (without non-invasive stress testing) in asymptomatic CAD patients with a prior history of coronary revascularization compared to a strategy of systematic screening for myocardial ischemia using non-invasive stress testing.

date de réalisation

2021

nombre de patients

2664

nombre de centres participants

45 french sites

type de financement

Public (Assistance Publique – Hôpitaux de Paris)

Référence

NCT04566497

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)

Coronary artery revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) are commonly used for the management strategy of patients with coronary artery disease (CAD). However, the patients with previous coronary artery intervention remain at increased risk of recurrence of myocardial ischemia and death. This reflects the progression of CAD as well as the potential degradation of the initial results of revascularization procedures.
In the follow-up years after revascularization, the current guidelines recommend evaluation with stress tests when patients are symptomatic (Class I, evidence level C). The evaluation of asymptomatic patients is even more controversial (Class IIb, evidence level C) and accordingly there is a wide variation in routine follow-up strategies in these patients. Considering the absence of randomized trials evaluating different strategies for the routine follow-up of patients with stable CAD the guidelines are based on expert opinion only (evidence level C).
Silent ischemia identified by stress imaging is a frequent finding reaching up to 70% of patients during the following years after a complete coronary revascularization and is associated with adverse outcomes. Thus, a follow-up managing strategy based on systematic screening of myocardial ischemia may help prevent a major acute cardiac event in these patients. On the other hand, systematic screening of myocardial ischemia is costly and two retrospective studies did not found that repeat revascularization improve survival in asymptomatic patients with history of myocardial revascularization and silent ischemia on systematic follow-up stress imaging testing. Moreover, stress testing per se or additional procedures which can be performed with regard of stress testing results (ie, especially coronary angiograms and revascularizations) can cause unexpected complications.
Thus, we hypothesized that clinical follow-up alone would be non-inferior to systematic stress testing screening strategy during the regular follow-up of asymptomatic CAD patients with prior coronary revascularization.

Study 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.

source clinicaltrials.gov

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