Prevention of Atrial Fibrillation After Atrial Flutter Ablation With Ramipril (from the PREFACE Study)

Area of Science:

• Cardiology
• Pharmacology
• Clinical Trials

Background:

• The role of renin-angiotensin-aldosterone system (RAAS) inhibitors in preventing atrial fibrillation (AF) after atrial flutter (AFL) ablation is not well-established.
• Previous studies on RAAS inhibitors for AF prevention have yielded controversial results.

Purpose of the Study:

• To investigate the efficacy of ramipril compared to placebo in preventing AF occurrence in patients undergoing AFL ablation.
• To assess the impact of ramipril on secondary endpoints such as supraventricular arrhythmias, heart failure, stroke, and death.

Main Methods:

• Prospective, multicenter, randomized, double-blind, double-dummy trial (PREFACE trial).
• 198 patients hospitalized for AFL ablation were randomized to receive either ramipril 5 mg/day or placebo.
• Follow-up included 1-week Holter ECGs at 3, 6, 9, and 12 months post-ablation.

Main Results:

• No significant difference in AF occurrence between the ramipril and placebo groups during the 12-month follow-up (p=0.96).
• Secondary endpoints, including supraventricular arrhythmia, heart failure, stroke, and death, were also not significantly different between groups.
• Safety outcomes, such as serious adverse events, hypotension, renal impairment, and hyperkalemia, showed no significant differences.

Conclusions:

• Ramipril, a RAAS inhibitor, does not reduce AF occurrence in patients undergoing AFL ablation.
• RAAS inhibition is not an effective strategy for preventing AF in this patient population within a 1-year follow-up period.