title: Angiotensin II-antagonist in paroxysmal atrial fibrillation (ANTIPAF) trial.
abstract: BACKGROUND
  Unlike antiarrhythmic drugs, the safety and beneficial effects of angiotensin II receptor blockade (ARB) in patients with structural heart disease is well established. The clinical efficacy of ARBs to prevent atrial fibrillation (AF) so far only has been shown in patients with structural heart disease. Here, we report the primary outcome of the Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation (ANTIPAF) trial, which investigated the effect of olmesartan medoxomil compared with placebo on AF burden in patients with paroxysmal AF without structural heart disease.
  
  
  RESULTS
  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 end point. Four hundred thirty patients with documented paroxysmal AF without structural heart disease were randomized to placebo or 40 mg olmesartan per day. Concomitant therapy with ARBs, angiotensin-converting enzyme inhibitors, and antiarrhythmic drugs was prohibited. Patients were followed using daily transtelephonic ECG (tele-ECG) recordings independent of symptoms. The intention-to-treat population of the trial encompassed 425 patients (placebo group, n=211; olmesartan group, n=214). A total of 87 818 tele-ECGs were analyzed in these patients during follow-up (placebo group, 44 888 ECGs; olmesartan group, 42 930 ECGs). Thus, a mean of 207 tele-ECGs were recorded per patient. The primary end point (AF burden) was not different between the 2 groups (P=0.770). Secondary outcome parameters, including quality of life, also were not different. In particular, time to first AF recurrence, time to persistent AF, and number of hospitalizations were not different between the 2 groups. The time to prescription of recovery medication (amiodarone) was the only parameter showing an intergroup difference, with earlier prescription of amiodarone in the placebo group (P=0.022).
  
  
  CONCLUSIONS
  One year of ARB therapy per se does not reduce the number of AF episodes in patients with documented paroxysmal AF without structural heart disease. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00098137.
authors.affiliation: University Hospital Magdeburg, Magdeburg, Germany. andreas.goette@med.ovgu.de
authors.forename: Andreas
authors.initials: A
authors.lastname: Goette
authors.forename: Norbert
authors.initials: N
authors.lastname: Schön
authors.forename: Paulus
authors.initials: P
authors.lastname: Kirchhof
authors.forename: Günter
authors.initials: G
authors.lastname: Breithardt
authors.forename: Thomas
authors.initials: T
authors.lastname: Fetsch
authors.forename: Karl Georg
authors.initials: KG
authors.lastname: Häusler
authors.forename: Helmut U
authors.initials: HU
authors.lastname: Klein
authors.forename: Gerhard
authors.initials: G
authors.lastname: Steinbeck
authors.forename: Karl
authors.initials: K
authors.lastname: Wegscheider
authors.forename: Thomas
authors.initials: T
authors.lastname: Meinertz
mesh_terms: D047228:Angiotensin II Type 1 Receptor Blockers / Q000008:administration & dosage*; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004562:Electrocardiography / Q000187:drug effects; D005260:Female; D005500:Follow-Up Studies; D005858:Germany / Q000453:epidemiology; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013614:Tachycardia, Paroxysmal / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D013777:Tetrazoles / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D007093:Imidazoles; D013777:Tetrazoles; C437965:olmesartan