Beta-Blocker Interruption or Continuation after Myocardial Infarction
Johanne Silvain1, Guillaume Cayla1, Emile Ferrari1
1From Sorbonne Université, ACTION Group, INSERM Unité Mixte de Recherche (UMRS) 1166, Hôpital Pitié-Salpêtrière Assistance Publique-Hôpitaux de Paris (AP-HP) (J.S., P.G., N.P., K.A., G.M.), the Department of Cardiology, Hôpital Européen Georges Pompidou, AP-HP, Université Paris Cité (E.P.), FACT (French Alliance for Cardiovascular Trials) (G.L.), the Department of Cardiology, Université Paris Cité, Hôpital Lariboisière, AP-HP, INSERM Unité 942 (J.-G.D.), the Cardiology Department, Hôpital Saint-Antoine, ACTION Group, Sorbonne Université, INSERM UMRS 938 (F. Boccara), the Cardiology Department Hôpital Bichat, AP-HP (M.S.), Unité de Recherche Clinique, ACTION Group, Hôpital Fernand Widal (AP-HP) (A.D., E.V.), and SAMM (Statistique, Analyse et Modélisation Multidisciplinaire) EA 4543, Université Paris 1 Panthéon Sorbonne (A.D., E.V.), Paris, the Cardiology Department, Nimes University Hospital, Montpellier University, ACTION Group, Nimes (G.C., B.L.), the Cardiology Department, Pasteur University Hospital, Nice (E.F., N.R.), the Cardiology Department, Hôpitaux de Chartres, ACTION Group, Hôpital Louis Pasteur, Chartres (G.R., C.T.), Cardiology Department, Hôpital Centre François Mitterrand de Pau, Pau (N.D.), Département de Cardiologie, Centre Hospitalo-Universitaire (CHU) La Timone, ACTION Group, Marseille University, INSERM, Marseille (T.C., P.D.), the Cardiology Department, CHU Tours, INSERM Unité 1327 ISCHEMIA, Université de Tours, Tours (F.I.), the Cardiology Department, CHU de Toulouse, Toulouse (T.L.), the Cardiology Department, Clinique du Pont de Chaume, Montauban (T. Petroni), the Heart and Lung Institute, University Hospital of Lille, and Institut Pasteur of Lille, INSERM Unité 1011-EGID, Lille (G.L.), the Cardiology Department, CHU d'Avignon, Avignon (F. Bresoles), the Cardiology Group of the Côte Basque, Bayonne (J.-N.L.), the Cardiology Department, CHU de Dijon Bourgogne, Dijon (T. Pommier), the Cardiology Department, CHU de Montpellier, Montpellier (F.L.), the Cardiology Department, CHU Henri Mondor, Créteil (P.L.), the Cardiology Department, Centre Hospitalier (CH) Métropole-Savoie (Hôpital Chambéry), Chambéry (T.B.H.), the Cardiology Department, Groupe Hospitalier Mutualiste (GHM) de Grenoble, Grenoble (T.F.), the Cardiology Department, CHU d'Auxerre, Auxerre (F.J.), Cardiology Department, CHU Angers et UMR Centre National de la Recherche Scientifique (CNRS) 6015, INSERM Unité 1083 Equipe Physiopathologie Cardiovasculaire, Unité de Formation et de Recherche (UFR) Santé, Angers (A.F.), Grands Prés Cardiac Rehabilitation Centre, St. Denis (R.D.), the Cardiology Department, General Hospital Yves Le Foll, Saint-Brieuc (L.P.), and the Cardiology Department, Grand Hôpital de l'Est Francilien Site Marne-La-Vallée, Jossigny (M.E.K.) - all in France.
Insights
Discontinuing beta-blocker treatment after myocardial infarction did not prove noninferior to continuing it. This study suggests that long-term beta-blocker therapy should be maintained for patients with a history of uncomplicated myocardial infarction.
Area of Science:
- Cardiology
- Clinical Trials
- Pharmacology
Background:
- The optimal duration for beta-blocker therapy post-myocardial infarction remains unclear.
- There is a need to evaluate the safety and efficacy of discontinuing long-term beta-blocker treatment to mitigate side effects and enhance patient quality of life following uncomplicated myocardial infarction.
Purpose of the Study:
- To determine if interrupting long-term beta-blocker treatment is noninferior to continuing it in patients with a history of uncomplicated myocardial infarction.
- To assess the impact of beta-blocker interruption on patient quality of life.
Main Methods:
- A multicenter, open-label, randomized, noninferiority trial involving 3698 patients.
- Patients with myocardial infarction history and left ventricular ejection fraction ≥40% were randomized to either interrupt or continue beta-blocker treatment.
- The primary endpoint was a composite of death, nonfatal myocardial infarction, stroke, or cardiovascular hospitalization, with a noninferiority margin of <3 percentage points.
Main Results:
- Interruption of beta-blocker treatment was not found to be noninferior to continuation. The primary outcome event rate was 23.8% in the interruption group versus 21.1% in the continuation group.
- The risk difference was 2.8 percentage points (95% CI, <0.1 to 5.5), with a hazard ratio of 1.16 (95% CI, 1.01 to 1.33).
- Beta-blocker interruption did not demonstrate an improvement in patient quality of life.
Conclusions:
- Interruption of long-term beta-blocker treatment following myocardial infarction was not noninferior to continuing the therapy.
- The findings suggest that continuation of beta-blocker treatment is a more appropriate strategy for patients with a history of uncomplicated myocardial infarction.
- Further research may be needed to explore alternative strategies for managing long-term beta-blocker therapy in this patient population.
Background:
The appropriate duration of treatment with beta-blocker drugs after a myocardial infarction is unknown. Data are needed on the safety and efficacy of the interruption of long-term beta-blocker treatment to reduce side effects and improve quality of life in patients with a history of uncomplicated myocardial infarction.
Methods:
In a multicenter, open label, randomized, noninferiority trial conducted at 49 sites in France, we randomly assigned patients with a history of myocardial infarction, in a 1:1 ratio, to interruption or continuation of beta-blocker treatment. All the patients had a left ventricular ejection fraction of at least 40% while receiving long-term beta-blocker treatment and had no history of a cardiovascular event in the previous 6 months. The primary end point was a composite of death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for cardiovascular reasons at the longest follow-up (minimum, 1 year), according to an analysis of noninferiority (defined as a between-group difference of <3 percentage points for the upper boundary of the two-sided 95% confidence interval). The main secondary end point was the change in quality of life as measured by the European Quality of Life-5 Dimensions questionnaire.
Results:
A total of 3698 patients underwent randomization: 1846 to the interruption group and 1852 to the continuation group. The median time between the last myocardial infarction and randomization was 2.9 years (interquartile range, 1.2 to 6.4), and the median follow-up was 3.0 years (interquartile range, 2.0 to 4.0). A primary-outcome event occurred in 432 of 1812 patients (23.8%) in the interruption group and in 384 of 1821 patients (21.1%) in the continuation group (risk difference, 2.8 percentage points; 95% confidence interval [CI], <0.1 to 5.5), for a hazard ratio of 1.16 (95% CI, 1.01 to 1.33; P = 0.44 for noninferiority). Beta-blocker interruption did not seem to improve the patients' quality of life.
Conclusions:
In patients with a history of myocardial infarction, interruption of long-term beta-blocker treatment was not found to be noninferior to a strategy of beta-blocker continuation. (Funded by the French Ministry of Health and ACTION Study Group; ABYSS ClinicalTrials.gov number, NCT03498066; EudraCT number, 2017-003903-23.).
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