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Goette, Andreas (Germany)
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List of Authors: Andreas Goette, Norbert Schön Paulus Kirchhof, Günter Breithardt, Thomas Fetsch, Helmut U. Klein, Gerhard Steinbeck, Karl Wegscheider, Thomas Meinertz
Unlike antiarrhythmic drugs, the safety and beneficial effects of angiotensin II receptor blockade (ARBs) in patients with structural heart disease is well established. The clinical efficacy of ARBs to prevent atrial fibrillation (AF) has so far only been shown in patients with structural heart disease. Here, we report the primary outcome of the ANTIPAF trial, which investigated the effect of olmesartan medoxomil as compared to placebo on AF burden in patients with paroxysmal AF without structural heart disease. Methods: The ANTIPAF trial was a prospective, randomized, placebo-controlled, multicenter trial analyzing the AF burden (percentage of days with documented episodes of paroxysmal AF) during a 12-month follow-up as the primary study endpoint. 430 patients with documented paroxysmal AF without structural heart disease were randomized to placebo or 40mg olmesartan per day. Concomitant therapy with ARBs, ACE inhibitors, and antiarrhythmic drugs was prohibited. Patients were followed using daily trans-telephonic ECG recordings independent of symptoms. Results: The intension-to-treat population of the trial encompassed 425 patients (211 placebo group and 214 olmesartan group). A total of 87,818 tele-ECGs were analysed in these patients during follow-up (44,888 ECGs in the placebo group and 42,930 ECGs in the olmesartan group). Thus, a mean of 207 tele-ECGs were recorded per patient with an average of 1.12 tele-ECGs per patient and day of follow-up. The primary endpoint (AF burden) was not dif-ferent in the two groups (p=0.7702). Secondary outcome parameters including quality of life were also not different in both groups. In particular, time to first AF recurrence, time to persis-tent AF, and number of hospitalizations were identical in the two groups. The time to pre-scription of recovery medication (amiodarone) was the only parameter showing an intergroup difference with earlier prescription of amiodarone in the placebo group (p=0.0365). ARB therapy per se does not reduce the number of AF episodes in patients with documented paroxysmal AF without structural heart disease. Therefore, ARBs may not be recommended as first line treatment for paroxysmal AF if not indicated for other reasons.
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