Background There is a lack of evidence regarding the benefits of β-blocker treatment after invasively managed acute myocardial infarction (MI) without reduced left ventricular ejection fraction (LVEF). Methods and results TREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fraction (REBOOT) trial is a pragmatic, controlled, prospective, randomized, open-label blinded endpoint (PROBE design) clinical trial testing the benefits of β-blocker maintenance therapy in patients discharged after MI with or without ST-segment elevation. Patients eligible for participation are those managed invasively during index hospitalization (coronary angiography), with LVEF >40%, and no history of heart failure (HF). At discharge, patients will be randomized 1:1 to β-blocker therapy (agent and dose according to treating physician) or no β-blocker therapy. The primary endpoint is a composite of all-cause death, nonfatal reinfarction, or HF hospitalization over a median follow-up period of 2.75 years (minimum 2 years, maximum 3 years). Key secondary endpoints include the incidence of the individual components of the primary composite endpoint, the incidence of cardiac death, and incidence of malignant ventricular arrhythmias or resuscitated cardiac arrest. The primary endpoint will be analyzed according to the intention-to-treat principle. Conclusion The REBOOT trial will provide robust evidence to guide the prescription of β-blockers to patients discharged after MI without reduced LVEF.
The Trifecta aortic valve has excellent hemodynamics characteristics. Moreover, the Perceval prosthesis may achieve better hemodynamics than the conventional valves; therefore, it has been proposed to reduce the incidence of patient–prosthesis mismatch. Our aim was to compare the prevalence of this complication between both prostheses. All patients who underwent valve replacement with a Perceval or a Trifecta from 2016 to 2020 at our institution were included. We calculated the prevalence of patient–prosthesis mismatch for each prosthesis and size and performed a multinomial logistic regression model to investigate the impact of choosing one prosthesis over the other. A total of 516 patients were analyzed. Moderate mismatch was present in 33 (8.6%) in the Trifecta group and 28 (21.4%) in the Perceval group, p < 0.001. Severe mismatch was present in 8 (2.1%) patients with Trifecta and 5 (3.8%) patients with Perceval, p = 0.33. Compared with the Perceval, the Trifecta prosthesis was shown to reduce moderate patient–prosthesis mismatch: OR = 0.5 (95% CI 0.3–0.9, p = 0.02). Both prostheses led to a similar risk of severe patient–prosthesis mismatch: OR = 0.9 (95% CI 0.3–2.8, p = 0.79). Both prostheses provide a very low risk of severe patient–prosthesis mismatch. Compared with the Perceval prothesis, the Trifecta prosthesis is able to reduce by 50% the risk of moderate mismatch.
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