DOI: 10.1161/CIRCEP.113.000586

Incidence and Significance of Early Recurrences of Atrial Fibrillation after Cryoballoon Ablation: Insights From The Multicenter STOP AF Trial

Running title: Andrade et al.; Early recurrence in STOP AF

Jason G. Andrade, MD1,2, Paul Khairy, MD, PhD1; Laurent Macle, MD1; Doug Packer, MD3; emy N N.. Ru Rusk Ruskin, skin sk in,, MD6; in John W. Lehmann, MD, MPH4; Richard G. Holcomb, PhD5; Jeremy Marc Dubuc MD1

1

Montreal H Heart eaart Institutee & Department Deparrtm De ment off Medicine, Meddicine,, U Université nive ni verssitéé ddee M ve Montréal, onttréal, Montreal, on Mon ontrreall, Ca Canada; a 2 3 Department m ntt ooff Me ment Medi Medicine, d ci cine nee, Un Univ University iverrsiity ooff British Brit Br itis it ishh Columbia, is Colu Co lu umb m ia ia, Va Vancouver, V ncou nc ouve ou ver, ve r Ca r, C Canada; nada na daa; Ma Mayo yo Clinic, Cl Rochester,, MN MN; N; 4Me Medical Medi d ca di call Mo Moni Monitor, nito ni tor, to r, L r, Lehmann e ma eh mann nn C Consulting, onnsu s lt l in ing, g Wayland, g, Way yla land nd,, MA nd MA;; 5St Statistical S tat atis i ti is tica call Co ca Consu Consultant, u 6 Minn Mi nnea nn eapo ea pooliis, s MN; MN; Ma Massachusetts Mass sac achu huse hu s ttss Ge se Gene General n raal Ho ne H Hospital, sppittal a , Bo Boston, ostton o , MA Minneapolis,

Correspondence: Dr. Jason G. Andrade Montreal Heart Institute 5000 Belanger St. E. Montreal, QC, H1T 1C8 Canada Tel: (604) 875-5069 Fax: (604) 875-5874 E-mail: [email protected]

Journal Subject Codes: [22] Ablation/ICD/surgery, [106] Electrophysiology, [5] Arrhythmias, clinical electrophysiology, drugs 1 Downloaded from http://circep.ahajournals.org/ by guest on February 2, 2015

DOI: 10.1161/CIRCEP.113.000586

Abstract: Background - Early recurrences of atrial fibrillation (ERAF) are common after radiofrequency catheter ablation for atrial fibrillation (AF). We sought to determine the incidence and prognostic significance of ERAF after cryoballoon ablation. Moreover, the benefit of early reablation for ERAF after cryoballoon ablation is undetermined. Methods and Results - The STOP AF trial randomized 245 patients with paroxysmal AF to medical therapy versus cryoballoon-based pulmonary vein ablation. Patients were followed for 12 months. ERAF was defined as any recurrence of AF >30 seconds during the first 3 months of follow-up. Late recurrence (LR) was defined as any recurrence of AF >30 seconds between 3-12 months. Of the 163 patients randomized to cryoablation, 84 patients experienced ERAF xper xp erie er ienc ie nced nc ed E RAF RA F (51.5%). (51 The only significant factor associated with ERAF was male sex (HR 2.18; .18; 95%CI 95% 5%CI CI 11.03-4.61; .0033-44. 4.6 p=0.041). Late recurrence patients was related to rec ecur urre ur rencce was observed in 41 patient re ntss (25.1%), and w nt a significantly relate as ERAF (55.6% with without ERAF; Among with ERAF, 6% LR R wit th ERAF ER RAF vvs. s. 12.7% 12. 2.7% 2. 7% %w ithoout ERA it RAF;; p 30 30 after the index ablation procedure. Late recurrence defined recurrence AF >30 uration urati ion ffrom rom 3 to t 12 12 months h after aft f er th ft the he iindex nddex ablation abbl blattion procedure. p occed pr durre. R ep peat ab abla lati la t on aat any ti seconds duration Repeat ablation time was classified llassified a if ifiiedd as a recurrence. rec rrence No N patient ti t was as lost lostt to t follow-up ffollo oll ll p andd all ll underwent nder de entt th the required outpatient visits and monitoring. Statistical Analysis Continuous variables are expressed as the mean ± standard deviation (or median, first and third quartiles [Q1, Q3]) and categorical variables are expressed as frequency and percentage. Comparisons between baseline characteristics were performed by independent Student t, MannWhitney rank sum, Fisher exact, or Ȯ2 tests where appropriate. In order to analyze the association of baseline and procedural factors on ERAF and late recurrence (in the total population and subpopulation with ERAF), Cox regression modeling was used. A multivariable model was used to estimate hazard ratios (HRs) for recurrence while controlling for patient

5 Downloaded from http://circep.ahajournals.org/ by guest on February 2, 2015

DOI: 10.1161/CIRCEP.113.000586

demographic and clinical characteristics. The proportional hazards assumption was tested for each covariate using a model including a time varying covariate for the covariate of interest. The covariate of “early recurrence” violated the proportional hazards assumption (p=0.0046; p-value for the time-varying covariate). Therefore, to better assess the association of the other covariates of interest with late recurrence, a proportional hazards model stratified on early recurrence was employed. For each of the three study outcomes, the multivariable Cox model considered covariates with univariable p-values

Incidence and significance of early recurrences of atrial fibrillation after cryoballoon ablation: insights from the multicenter Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) Trial.

Early recurrence of atrial fibrillation (ERAF) is common after radiofrequency catheter ablation for AF. We sought to determine the incidence and progn...
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