John Munkhaugen, Anna Meta D Kristensen, Sigrun Halvorsen, Therese Holmager, Michael Hecht Olsen, Arnhild Bakken, Thomas S G Sehested, Vidar Ruddox, Michael Mæng, Kjell Vikenes, Svend E Jensen, Terje Steigen, Jess Lambrechtsen, Jarle Jortveit, Ann Bovin, Henrik Schirmer, Morten Krogh Christiansen, Rune Wiseth, Dennis Mikkelsen, Alf Inge Larsen, Camilla Lyngby Kjærgaard, Kristoffer Andresen, Ida Gustafsson, Vegard Tuseth, Mogens Lytken Larsen, Peter Stefan Deeg, Karsten Veien, Ellen Bøhmer, Hans Erik Bøtker, Anja Otrebska Brattrud, Jens Brønnum-Schou, Alf-Åge Reistad Pettersen, Lia Evi Bang, Erik Øie, Thomas Engstrøm, Eva Bostad Borg, Kjeld Kristensen, Ståle Haugset Nymo, Gunnar Gislason, Nils Tore Vethe, Jawdat Abdul Majid Abdulla, Toril Dammen, Mette Rauhe Mouridsen, Bjørn Bendz, Mette Lykke Norgaard Bertelsen, Jens Dahlgaard Hove, Louise Schierbeck, Martin Snoer, Cedric Davidsen, Gro Egholm, Kristian Korsgaard Thomsen, Ghassan Jadou, Monica Poenaru, Nikolaj Thure Krarup, Morten Böttcher, Peter Bisgaard Stæhr, Ann-Dorthe Zwisler, Thor Edvardsen, Christian Torp-Pedersen, Jan Erik Otterstad, Theis Lange, Morten W Fagerland, Dan Atar, Eva Prescott
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引用次数: 0
Abstract
Background: The evidence supporting beta-blocker therapy after myocardial infarction was established before the introduction of modern coronary reperfusion therapy and secondary prevention strategies.
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.).
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