Beta-Blockers after Myocardial Infarction in Patients without Heart Failure.
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Munkhaugen John, Kristensen Anna Meta D, Halvorsen Sigrun, Holmager Therese, Olsen Michael Hecht, Bakken Arnhild, Sehested Thomas S G, Ruddox Vidar, Mæng Michael, Vikenes Kjell, Jensen Svend E, Steigen Terje, Lambrechtsen Jess, Jortveit Jarle, Bovin Ann, Schirmer Henrik, Christiansen Morten Krogh, Wiseth Rune, Mikkelsen Dennis, Larsen Alf Inge, Lyngby Kjærgaard Camilla, Andresen Kristoffer, Gustafsson Ida, Tuseth Vegard, Larsen Mogens Lytken, Deeg Peter Stefan, Veien Karsten, Bøhmer Ellen, Bøtker Hans Erik, Brattrud Anja Otrebska, Brønnum-Schou Jens, Pettersen Alf-Åge Reistad, Bang Lia Evi, Øie Erik, Engstrøm Thomas, Borg Eva Bostad, Kristensen Kjeld, Nymo Ståle Haugset, Gislason Gunnar, Vethe Nils Tore, Abdulla Jawdat Abdul Majid, Dammen Toril, Mouridsen Mette Rauhe, Bendz Bjørn, Bertelsen Mette Lykke Norgaard, Hove Jens Dahlgaard, Schierbeck Louise, Snoer Martin, Davidsen Cedric, Egholm Gro, Thomsen Kristian Korsgaard, Jadou Ghassan, Poenaru Monica, Krarup Nikolaj Thure, Böttcher Morten, Stæhr Peter Bisgaard, Zwisler Ann-Dorthe, Edvardsen Thor, Torp-Pedersen Christian, Otterstad Jan Erik, Lange Theis, Fagerland Morten W, Atar Dan, Prescott Eva, BETAMI–DANBLOCK Investigators
Аннотация
METHODS: In an open-label, randomized trial with blinded end-point evaluation, conducted in Denmark and Norway, we assigned patients who had had a myocardial infarction and who had a left ventricular ejection fraction of at least 40%, in a 1:1 ratio, to receive long-term beta-blocker therapy within 14 days after the event or no beta-blocker therapy. The primary end point was a composite of death from any cause or major adverse cardiovascular events (new myocardial infarction, unplanned coronary revascularization, ischemic stroke, heart failure, or malignant ventricular arrhythmias).
RESULTS: A total of 5574 patients underwent randomization and were included in the main analyses - 2783 in the beta-blocker group and 2791 in the no-beta-blocker group. After a median follow-up of 3.5 years (interquartile range, 2.2 to 4.6), a primary end-point event had occurred in 394 patients (14.2%) in the beta-blocker group and in 454 patients (16.3%) in the no-beta-blocker group (hazard ratio, 0.85; 95% confidence interval [CI], 0.75 to 0.98; P = 0.03). Death from any cause occurred in 4.2% of the patients in the beta-blocker group and in 4.4% of those in the no-beta-blocker group; myocardial infarction occurred in 5.0% and 6.7%, respectively (hazard ratio, 0.73; 95% CI, 0.59 to 0.92), unplanned coronary revascularization in 3.9% and 3.9%, ischemic stroke in 1.6% and 1.3%, heart failure in 1.5% and 1.9%, and malignant ventricular arrhythmias in 0.5% and 0.6%. No apparent differences in safety outcomes were observed between the groups.
CONCLUSIONS: Among patients with a myocardial infarction and a left ventricular ejection fraction of at least 40%, beta-blocker therapy led to a lower risk of death or major adverse cardiovascular events than no beta-blocker therapy. (Funded by the Health South-East research program in Norway and others; BETAMI-DANBLOCK ClinicalTrials.gov numbers, NCT03646357 and NCT03778554.).