Prognostic Impact of Sinus Rhythm in Atrial Fibrillation Patients: Separating Rhythm Outcomes From Randomized Strategy Findings From the CABANA Trial

T Jared Bunch; Jeanne E Poole; Adam P Silverstein; Kerry L Lee; Hussein R Al-Khalidi; Gerhard Hindricks; Alexander Romanov; Evgeny Pokushalov; Tristram D Bahnson; Melanie Daniels; Jonathan P Piccini; Daniel B Mark; Douglas L Packer; CABANA Investigators

doi:10.1161/CIRCEP.123.012697

Prognostic Impact of Sinus Rhythm in Atrial Fibrillation Patients: Separating Rhythm Outcomes From Randomized Strategy Findings From the CABANA Trial

Circ Arrhythm Electrophysiol. 2024 Apr 17:e012697. doi: 10.1161/CIRCEP.123.012697. Online ahead of print.

Affiliations

¹ University of Utah School of Medicine, Salt Lake City (T.J.B.).
² University of Washington Medical Center, Seattle (J.E.P.).
³ Duke Clinical Research Institute, Duke University, Durham, NC (A.P.S., K.L.L., H.R.A.-K., T.D.B., M.D., J.P.P., D.B.M.).
⁴ Leipzig Heart Center, Leipzig, DE (G.H.).
⁵ E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation (G.H.).
⁶ Novosibirsk State Medical University, Russian Federation (A.R., E.P.).
⁷ Intermountain Heart Institute, Salt Lake City, UT (D.L.P.).

PMID: 38629286
DOI: 10.1161/CIRCEP.123.012697

Abstract

Background: Clinically detected atrial fibrillation (AF) is associated with a significant increase in mortality and other adverse cardiovascular events. Since the advent of effective methods for AF rhythm control, investigators have attempted to determine how much these adverse prognostic AF effects could be mitigated by the restoration of sinus rhythm (SR) and whether the method used mattered.

Methods: The CABANA trial (Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) randomized 2204 AF patients to ablation versus drug therapy, of which 1240 patients were monitored in follow-up using the CABANA ECG rhythm monitoring system. To assess the prognostic benefits of SR, we performed a prespecified analysis using Cox survival modeling with heart rhythm as a time-dependent variable and a randomized treatment group as a stratification factor.

Results: In the 1240 patient study cohort, 883 (71.2%) had documented AF at some point during their postblanking follow-up. Among the 883 patients, 671 (76.0%) experienced AF within the first year of postblanking follow-up, and 212 (24.0%) experienced their first AF after ≥1 year of postblanking follow-up. The primary CABANA end point (death, disabling stroke, serious bleeding, or cardiac arrest) occurred in 95 (10.8%) of the 883 patients with documented AF and in 29 (8.1%) of the 357 patients with no AF recorded during follow-up. In multivariable time-dependent analysis, the presence of SR (compared with non-SR) was associated with a significantly reduced risk of the primary end point (adjusted hazard ratio, 0.57 [95% CI, 0.38-0.85]; P=0.006; independent of treatment strategy [ablation versus drugs]). Corresponding results for all-cause mortality were adjusted hazard ratio of 0.59 [95% CI, 0.35-1.01]; P=0.053).

Conclusions: In patients in the CABANA trial with detailed long-term rhythm follow-up, increased time in SR was associated with a clinically consequential decreased in mortality and other adverse prognostic events. The predictive value of SR was independent of the therapeutic approach responsible for reducing the burden of detectable AF.

Registration: URL: https://clinicaltrials.gov; Unique Identifier: NCT00911508.

Keywords: anti-arrhythmia agents; atrial fibrillation; catheter ablation; follow-up studies; prognosis.

Associated data

ClinicalTrials.gov/NCT00911508