title: Thromboembolic event rate in paroxysmal and persistent atrial fibrillation: data from the GISSI-AF trial.
abstract: BACKGROUND
  Few data on the thromboembolic (TE) risk of paroxysmal and persistent atrial fibrillation (AF) are available. This study aimed to assess the incidence of TE events in paroxysmal and persistent AF.
  
  
  METHODS
  We performed a subset post hoc analysis of 771 patients with paroxysmal and 463 with persistent AF enrolled in the multicenter, prospective, randomized, double-blind, placebo-controlled GISSI-AF trial - comparing the efficacy of valsartan versus placebo in preventing AF recurrences - where the choice of antithrombotic treatment was left to the judgment of the referring physician. TE and major outcome events were centrally validated. AF recurrences were detected by frequent clinic visits and a transtelephonic monitoring device with weekly and symptomatic transmissions.
  
  
  RESULTS
  Eighty-five percent of patients had a history of hypertension, and the 7.7% had heart failure, left ventricular dysfunction, or both. The mean CHADS2 score was 1.41±0.84. TE and major bleeding events were observed at a low incidence among the overall population at 1-year follow-up (0.97% and 0.81%, respectively). The univariate and multivariable analyses revealed no statistically significant differences in the incidence of TE, major bleeding events or mortality in paroxysmal and persistent AF patients. TE events were more common among women than men (p=0.02). The follow-up examination showed under- or overtreatment with warfarin in many patients, according to guideline suggestions. Warfarin was more frequently prescribed to patients with persistent AF (p<0.0001) and patients with AF recurrences (p<0.0001). AF recurrences were noninvasively detected in 632 (51.2%) patients. In patients without AF recurrences, the TE event rate was 0.5% versus 1.74%, 1.28%, and 1.18% for those with only symptomatic, only asymptomatic or both symptomatic and asymptomatic AF recurrences, respectively, but the difference was not statistically significant, even after adjusting for warfarin treatment and the CHADS2 score (HR 2.93; CI 95%; 0.8-10.9; p=0.11).
  
  
  CONCLUSIONS
  TE and major bleeding events showed a very low incidence in the GISSI-AF trial population, despite under- or overtreatment with warfarin in many patients. TE events had a similar rate in paroxysmal and persistent AF.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  NCT00376272.
authors.affiliation: Department of Cardiology, Santa Chiara Hospital, Trento, Italy. gissiaf@anmco.it
authors.forename: Marcello
authors.initials: M
authors.lastname: Disertori
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Franzosi
authors.forename: Simona
authors.initials: S
authors.lastname: Barlera
authors.forename: Franco
authors.initials: F
authors.lastname: Cosmi
authors.forename: Silvia
authors.initials: S
authors.lastname: Quintarelli
authors.forename: Chiara
authors.initials: C
authors.lastname: Favero
authors.forename: Glauco
authors.initials: G
authors.lastname: Cappellini
authors.forename: Gianna
authors.initials: G
authors.lastname: Fabbri
authors.forename: Aldo Pietro
authors.initials: AP
authors.lastname: Maggioni
authors.forename: Lidia
authors.initials: L
authors.lastname: Staszewsky
authors.forename: Luigi Andrea
authors.initials: LA
authors.lastname: Moroni
authors.forename: Roberto
authors.initials: R
authors.lastname: Latini
mesh_terms: D000368:Aged; D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology*; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects; D019983:Guideline Adherence; D006470:Hemorrhage / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians'; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012008:Recurrence; D018570:Risk Assessment; D012307:Risk Factors; D013686:Telemetry; D013777:Tetrazoles / Q000627:therapeutic use; D013923:Thromboembolism / Q000175:diagnosis / Q000453:epidemiology* / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome; D014633:Valine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000068756:Valsartan; D014859:Warfarin / Q000627:therapeutic use
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000889:Anti-Arrhythmia Agents; D005343:Fibrinolytic Agents; D013777:Tetrazoles; D014859:Warfarin; D000068756:Valsartan; D014633:Valine