Cited by 441Atrial Fibrillation Management and OutcomesCardiac electrophysiology and arrhythmiasCardiac Arrhythmias and Treatments

Valsartan for prevention of recurrent atrial fibrillation

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The GISSI-AF Investigators·2009·New England Journal of Medicine

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.)

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  1. Wijffels MC, Kirchhof CJ, Dorland R, 11. Allessie MA. Atrial fibrillation begets atri- al fibrillation: a study in awake chronically instrumented goats. Circulation 1995;92: 1954-68.

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Authors
The GISSI-AF Investigators
Affiliations
Ospedale Santa Chiara (IT)
Corresponding author
The GISSI-AF Investigators
Venue
New England Journal of Medicine
Published
2009-04-16
Volume
360
Issue
16
Pages
1606-1617
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W1492717268
Cited by
441
References
34
Citations by year
2026: 5 · 2025: 1 · 2024: 11 · 2023: 9 · 2022: 14 · 2021: 13 · 2020: 20 · 2019: 9 · 2018: 18 · 2017: 15 · 2016: 25 · 2015: 21 · 2014: 32 · 2013: 35 · 2012: 51
FWCI
45.93
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Archivio Istituzionale della Ricerca (Universita Degli Studi Di Milano) (submittedVersion, other-oa)
  • ArTS Archivio della ricerca di Trieste (University of Trieste https://www.units.it/) (submittedVersion)
  • Florence Research (University of Florence) (submittedVersion)
  • IRIS UNIMORE (University of Modena and Reggio Emilia) (submittedVersion, cc-by)
  • IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
  • Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion)
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac electrophysiology and arrhythmias
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiac Arrhythmias and Treatments
Keywords
valsartan, atrial fibrillation recurrence, angiotensin receptor blockers, atrial remodeling, cardioversion, left atrial enlargement, diabetes mellitus, cardiovascular disease
MeSH terms
Valsartan, Aged, Atrial Fibrillation, Cardiovascular Diseases, Diabetes Mellitus, Double-Blind Method, Female, Cardiomegaly, Humans, Male, Middle Aged, Prospective Studies, Recurrence, Tetrazoles, Valine, Comorbidity, Proportional Hazards Models, Angiotensin II Type 1 Receptor Blockers

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