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Previous Volume 360:1606-1617 April 16, 2009 Number 16 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set CME Exam Editorial by Gillis, A. M. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear Related Article PubMed Citation

ABSTRACT

Background Atrial fibrillation is the most common cardiac arrhythmia, and no current therapy is ideal for control of this condition. Experimental studies suggest that angiotensin II–receptor blockers (ARBs) can influence atrial remodeling, and some clinical studies suggest that they may prevent atrial fibrillation.

Methods We conducted a large, randomized, prospective, placebo-controlled, multicenter trial to test whether the ARB valsartan could reduce the recurrence of atrial fibrillation. We enrolled patients who were in sinus rhythm but had had either two or more documented episodes of atrial fibrillation in the previous 6 months or successful cardioversion for atrial fibrillation in the previous 2 weeks. To be eligible, patients also had to have underlying cardiovascular disease, diabetes, or left atrial enlargement. Patients were randomly assigned to receive valsartan or placebo. The two primary end points were the time to a first recurrence of atrial fibrillation and the proportion of patients who had more than one recurrence of atrial fibrillation over the course of 1 year.

Results A total of 1442 patients were enrolled in the study. Atrial fibrillation recurred in 371 of the 722 patients (51.4%) in the valsartan group, as compared with 375 of 720 (52.1%) in the placebo group (adjusted hazard ratio, 0.97; 96% confidence interval [CI], 0.83 to 1.14; P=0.73). More than one episode of atrial fibrillation occurred in 194 of 722 patients (26.9%) in the valsartan group and in 201 of 720 (27.9%) in the placebo group (adjusted odds ratio, 0.89; 99% CI, 0.64 to 1.23; P=0.34). The results were similar in all predefined subgroups of patients, including those who were not receiving angiotensin-converting–enzyme inhibitors.

Conclusions Treatment with valsartan was not associated with a reduction in the incidence of recurrent atrial fibrillation. (ClinicalTrials.gov number, NCT00376272 [ClinicalTrials.gov] .)

Source Information

The members of the writing committee (Marcello Disertori, M.D., Department of Cardiology, Santa Chiara Hospital, Trento; Roberto Latini, M.D., Simona Barlera, M.Sci., Maria Grazia Franzosi, Pharm.D., and Lidia Staszewsky, M.D., Department of Cardiovascular Research, Istituto di Ricerche Farmacologiche Mario Negri, Milan; Aldo Pietro Maggioni, M.D., and Donata Lucci, M.Sci., Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence; Giuseppe Di Pasquale, M.D., Cardiology Unit, Maggiore Hospital, Bologna; and Gianni Tognoni, M.D., Consorzio Mario Negri Sud, S. Maria Imbaro, Chieti — all in Italy) assume responsibility for the overall content and integrity of the article.

This article (10.1056/NEJMoa0805710) was updated on May 27, 2009, at NEJM.org.

Address reprint requests to Dr. Maggioni at the GISSI-AF Coordinating Center, ANMCO Research Center, Via La Marmora, 34, 50121 Florence, Italy, or at gissiaf{at}anmco.it.

Full Text of this Article

Related Letters:

Valsartan and Recurrent Atrial Fibrillation
Smit M. D., Van Gelder I. C., Tomoda H., Disertori M., Latini R., Maggioni A. P., the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico–Atrial Fibrillation (GISSI-AF) Investigators
Extract | Full Text | PDF  
N Engl J Med 2009; 361:532-533, Jul 30, 2009. Correspondence

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