Abstract 4096: The Role of Valsartan in the Prevention of Atrial Fibrillation Recurrence: The GISSI-AF Results
Prevention of atrial fibrillation (AF) recurrence with anti-arrhythmic agents is generally limited. Experimental studies suggest that angiotensin II receptor blockers (ARBs) can influence atrial remodelling. Some preliminary clinical data, mainly from retrospective analyses of trials testing ARBs with different aims, also show that ARBs can prevent AF. GISSI-AF trial is a randomized, prospective, placebo controlled, multicentre study designed to test whether valsartan can reduce AF recurrence, when used on top of recommended treatments (including ACE-I and amiodarone). 1442 pts (median age 68 years, females 38%) in sinus rhythm with symptomatic AF (at least two documented AF episodes in the previous 6 months or successful cardioversion in the last 2 weeks) with underlying cardiovascular diseases (HF/LV dysfunction 8%, prior stroke 4%, CAD 12%, hypertension 85%) were randomized to Valsartan (up to 320 mg) or placebo by 114 Italian cardiology centers. To improve the detection of episodes of AF, all pts have been provided with a transtelephonic monitoring device. The primary objectives of GISSI-AF were:
time to first recurrence of AF (Cox proportional hazards model) and
number of pts with more than one AF episode over 1-year follow-up.
All AF events have been centrally validated. AF reoccurred in 371/722 (51.4%) in the Valsartan group vs 375/720 (52.1%) in Placebo (Adjusted HR 0.99; 96%CI 0.85–1.15). The number of pts with more than one AF episode were 194/722 (26.9%) in the Valsartan group vs 201/720 (27.9%) in Placebo (OR 0.95; 99%CI 0.70 –1.29). The results were similar in all predefined subgroups of pts, including those not receiving ACE-I. A trend favoring valsartan was observed only in the small group of pts with HF and/or LV dysfunction (Adjusted HR 0.81; 95%CI 0.48 –1.35). More than 80% of the pts tolerated 320 mg/day of valsartan with a discontinuation rate at 1 year of 14.8%. Only 2 serious adverse reactions occurred in pts on Valsartan: 1 hypotension, 1 renal dysfunction plus hyperkalemia. In GISSI-AF, the largest trial ever conducted with RAAS blockers in pts with AF, Valsartan did not reduce AF recurrence.