Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2013 Apr 15:13:28.
doi: 10.1186/1471-2261-13-28.

Thromboembolic event rate in paroxysmal and persistent atrial fibrillation: data from the GISSI-AF trial

Marcello Disertori  1 , Maria Grazia Franzosi, Simona Barlera, Franco Cosmi, Silvia Quintarelli, Chiara Favero, Glauco Cappellini, Gianna Fabbri, Aldo Pietro Maggioni, Lidia Staszewsky, Luigi Andrea Moroni, Roberto Latini; GISSI-AF investigators
Affiliations
Randomized Controlled Trial

Thromboembolic event rate in paroxysmal and persistent atrial fibrillation: data from the GISSI-AF trial

Marcello Disertori et al. BMC Cardiovasc Disord. .

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.

Trial registration number: NCT00376272.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Kaplan Meier curves for TE (panel A) and major bleeding events (panel B) during the follow-up period in paroxysmal and persistent AF patients.
Figure 2
Figure 2
The percentage of patients who used antithrombotic treatments at baseline and at the 6-month and 1-year follow-up (FU) examinations according to the type of AF (Px = paroxysmal AF; Ps = persistent AF), the presence of at least 1 AF recurrence (R) and the CHADS2 score. The warfarin group also includes patients receiving both warfarin and an antiplatelet agent.
See this image and copyright information in PMC

References

    1. Fuster V, Rydén LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association task force on practice guidelines and the European Society of Cardiology committee for practice guidelines: developed in collaboration with the European Heart Rhythm association and the Heart Rhythm Society. Circulation. 2006;114:e257–e354. - PubMed
    1. Hart RG, Pearce LA, Aguilar MI. Metanalysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007;146:857–867. doi: 10.7326/0003-4819-146-12-200706190-00007. - DOI - PubMed
    1. Singer DE, Chang Y, Fang MC, Borowsky LH, Pomernacki NK, Udaltsova N, Go AS. The net clinical benefit of warfarin in anticoagulation in atrial fibrillation. Ann Intern Med. 2009;151:297–305. doi: 10.7326/0003-4819-151-5-200909010-00003. - DOI - PMC - PubMed
    1. Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ. Validation of clinical classification schemes for predicting stroke. Results from the national registry of atrial fibrillation. JAMA. 2001;285:2864–2870. doi: 10.1001/jama.285.22.2864. - DOI - PubMed
    1. Fang MC, Go AS, Chang Y, Borowsky LH, Pomernacki, Singer DE. Comparison of risk stratification schemes to predict thromboembolism in people with nonvalvular atrial fibrillation. J Am Coll Cardiol. 2008;51:810–815. doi: 10.1016/j.jacc.2007.09.065. - DOI - PMC - PubMed

Publication types

MeSH terms

Associated data