Jean-Philippe Collet1, Guillaume Cayla2, Pierre-Vladimir Ennezat3, Florence Leclercq4, Thomas Cuisset5, Simon Elhadad6, Patrick Henry7, Loic Belle8, Ariel Cohen9, Johanne Silvain10, Olivier Barthelemy10, Farzin Beygui11, Abdourahmane Diallo12, Eric Vicaut12, Gilles Montalescot10. 1. Sorbonne Université Paris 6, ACTION Study Group, Institut de Cardiologie Hôpital Pitié-Salpêtrière (APHP), INSERM UMRS, 1166 Paris, France. Electronic address: jean-philippe.collet@psl.aphp.fr. 2. ACTION Study Group, Cardiologie, CHU Carémeau, Université de Montpellier, Nîmes, France. 3. Cardiologie, Pôle Thorax et Vaisseaux, CHU La Tronche, Grenoble, France. 4. Cardiologie, Hôpital Arnaud de Villeneuve-CHU Montpellier, France. 5. Department of Cardiology, CHU Timone and Aix-Marseille Univ, INSERM UMR1062, INRA UMR1260, Nutrition, Obesity and Risk of Thrombosis, Faculty of Medicine, F-13385 Marseille, France. 6. Cardiologie, CH de Lagny-Marne la Vallée, Jossigny, France. 7. Cardiologie, CHU Lariboisière (APHP), Paris, France. 8. Cardiologie, Centre Hospitalier d'Annecy, France. 9. Cardiologie, CHU Saint-Antoine (APHP), Paris, France. 10. Sorbonne Université Paris 6, ACTION Study Group, Institut de Cardiologie Hôpital Pitié-Salpêtrière (APHP), INSERM UMRS, 1166 Paris, France. 11. Cardiologie, Hôpital de la Côte de Nacre, Caen, France. 12. ACTION Study Group, Unité de Recherche Clinique-Hôpital Lariboisière (APHP), France and Université Denis Diderot, Paris, France.
Abstract
BACKGROUND: The prevalence and associated-risk of asymptomatic multisite artery disease (MSAD) in high risk coronary patients are unknown. Whether systematic identification and aggressive management of asymptomatic MSAD is clinically relevant in high risk coronary patients has not been evaluated. METHODS: We randomly assigned 521 high risk coronary patients defined by the presence of three-vessel coronary disease (n=304) or recent acute coronary syndrome beyond the age of 75years (n=215) to either a strategy of systematic detection of asymptomatic MSAD combined with an aggressive secondary prevention (n=263) or to a more conventional strategy based on treatment of coronary artery disease only with standard of care (n=258). The primary end point was the time to first occurrence of death, any organ failure or ischemic event leading to re-hospitalization through two years of follow-up. RESULTS: The pro-active strategy identified asymptomatic MSAD in 21.7% of patients with few revascularizations (3.6%); the pro-active pharmacological secondary prevention was obtained in >85% of patients and life-style changes in <60% of patients. At 2-year follow-up, the primary end point occurred in 44.9% of patients in the pro-active group and 43.0% of patients in the conventional group (HR 1.03; 95% confidence interval [CI], 0.80 to 1.34]. The rate of major bleeding did not differ significantly between groups (4.6% vs 5.0%; HR, 0.97; 95% CI, 0.40 to 1.91). CONCLUSION: In high risk coronary patients, there is no apparent benefit of a systematic detection of asymptomatic extra-coronary atherothrombotic disease and intensified treatment over a 2-year follow-up period. (Funded by the Academic Allies in Cardiovascular Trials Initiatives and Organized Networks and Institut de l'Athérothrombose; AMERICA ClinicalTrials.gov number, NCT00445835).
RCT Entities:
BACKGROUND: The prevalence and associated-risk of asymptomatic multisite artery disease (MSAD) in high risk coronary patients are unknown. Whether systematic identification and aggressive management of asymptomatic MSAD is clinically relevant in high risk coronary patients has not been evaluated. METHODS: We randomly assigned 521 high risk coronary patients defined by the presence of three-vessel coronary disease (n=304) or recent acute coronary syndrome beyond the age of 75years (n=215) to either a strategy of systematic detection of asymptomatic MSAD combined with an aggressive secondary prevention (n=263) or to a more conventional strategy based on treatment of coronary artery disease only with standard of care (n=258). The primary end point was the time to first occurrence of death, any organ failure or ischemic event leading to re-hospitalization through two years of follow-up. RESULTS: The pro-active strategy identified asymptomatic MSAD in 21.7% of patients with few revascularizations (3.6%); the pro-active pharmacological secondary prevention was obtained in >85% of patients and life-style changes in <60% of patients. At 2-year follow-up, the primary end point occurred in 44.9% of patients in the pro-active group and 43.0% of patients in the conventional group (HR 1.03; 95% confidence interval [CI], 0.80 to 1.34]. The rate of major bleeding did not differ significantly between groups (4.6% vs 5.0%; HR, 0.97; 95% CI, 0.40 to 1.91). CONCLUSION: In high risk coronary patients, there is no apparent benefit of a systematic detection of asymptomatic extra-coronary atherothrombotic disease and intensified treatment over a 2-year follow-up period. (Funded by the Academic Allies in Cardiovascular Trials Initiatives and Organized Networks and Institut de l'Athérothrombose; AMERICA ClinicalTrials.gov number, NCT00445835).
Authors: Vivianne L Jagt; Constantijn E V B Hazenberg; Jaap Kapelle; Maarten J Cramer; Frank L J Visseren; Jan Westerink Journal: PLoS One Date: 2022-03-10 Impact factor: 3.240