1. Prevention of Atrial Fibrillation After Atrial Flutter Ablation With Ramipril (from the PREFACE Study).
- Author
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Guichard JB, Anselme F, Defaye P, Mansourati J, Pavin D, Pasquié JL, Saludas Y, Barthélémy JC, Roche F, Laporte S, Chapelle C, Garcin A, Romeyer C, Isaaz K, and Da Costa A
- Subjects
- Aged, Atrial Fibrillation diagnosis, Double-Blind Method, Electrocardiography, Ambulatory, Female, Follow-Up Studies, Hospitalization, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Prospective Studies, Recurrence, Treatment Outcome, Angiotensin-Converting Enzyme Inhibitors therapeutic use, Atrial Fibrillation prevention & control, Atrial Flutter drug therapy, Atrial Flutter surgery, Catheter Ablation, Ramipril therapeutic use
- Abstract
The clinical efficacy of the inhibitors of the renin-angiotensin-aldosterone system (RAAS) as an upstream therapy for atrial fibrillation (AF) prevention is controversial. No study has itemized so far the role of RAAS inhibitors in AF prevention after atrial flutter (AFL) ablation. This trial aims to investigate the effect of ramipril compared with placebo on AF occurrence in patients hospitalized for AFL ablation without structural heart disease. The Prevention of Atrial Fibrillation by Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter (PREFACE) trial was a prospective, multicenter, randomized, double-blind, double-dummy trial depicting the AF occurrence during a 12-month follow-up as the primary end point. A total of 198 patients hospitalized for AFL ablation were enrolled in the trial and randomized to placebo or ramipril 5 mg/day. Patients were followed up during 1 year after AFL ablation using 1-week Holter electrocardiogram at 3, 6, 9, and 12 months. The intention-to-treat population encompassed 97 patients in the ramipril group and 101 patients in the placebo group. The primary end point, such as AF occurrence during the 1-year follow-up, was not different between the 2 groups (p = 0.96). Secondary end points, including the occurrence of supraventricular arrhythmia (p = 0.50), heart failure, stroke, and death, were not different between the 2 groups. Safety outcome parameters, including serious adverse events leading to treatment disruption (p = 0.10), hypotension, impairment of renal function, and elevated serum potassium level, also were not different between the 2 groups. In conclusion, RAAS inhibition using ramipril does not reduce AF occurrence in patients facing AFL ablation during the 1-year follow-up., Competing Interests: Disclosures The authors have no conflicts of interest to disclose., (Copyright © 2021 Elsevier Inc. All rights reserved.)
- Published
- 2022
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