CABANA trial: “beauty is in the eye of the beholder”

  • David Briceno
  • Prasant Mohanty
  • Luigi Di BiaseEmail author
  • Jorge Romero
  • Domenico Giovanni Della Rocca
  • Chintan Trivedi
  • Sanghamitra Mohanty
  • Andrea Natale


The CABANA trial reported that catheter ablation, when compared with drug therapy, did not significantly reduce the primary composite end point of death, disabling stroke, serious bleeding, or cardiac arrest in patients with atrial fibrillation. Despite multiple limitations in study design, the CABANA trial still confirmed that catheter ablation of atrial fibrillation led to clinically important and significant improvements in quality of life at 12 months without increasing the risk of complications.


Ablation Atrila fibrillation Mortality Outcomes 


Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.


  1. 1.
    Packer DL, Mark DB, Robb RA, Monahan KH, Bahnson TD, Poole JE, et al. Effect of catheter ablation vs antiarrhythmic drug therapy on mortality, stroke, bleeding, and cardiac arrest among patients with atrial fibrillation: the CABANA randomized clinical trial. Jama. 2019;321:1261.CrossRefGoogle Scholar
  2. 2.
    Mark DB, Anstrom KJ, Sheng S, Piccini JP, Baloch KN, Monahan KH, et al. Effect of catheter ablation vs medical therapy on quality of life among patients with atrial fibrillation: the CABANA randomized clinical trial. Jama. 2019;321:1275.CrossRefGoogle Scholar
  3. 3.
    Montori VM, Permanyer-Miralda G, Ferreira-Gonzalez I, et al. Validity of composite end points in clinical trials. Bmj. 2005;330:594–6.CrossRefGoogle Scholar
  4. 4.
    McCoy CE. Understanding the use of composite endpoints in clinical trials. West J Emerg Med. 2018;19:631–4.CrossRefGoogle Scholar
  5. 5.
    Bang H, Davis CE. On estimating treatment effects under non-compliance in randomized clinical trials: are intent-to-treat or instrumental variables analyses perfect solutions? Stat Med. 2007;26:954–64.CrossRefGoogle Scholar
  6. 6.
    Sheiner LB, Rubin DB. Intention-to-treat analysis and the goals of clinical trials. Clin Pharmacol Ther. 1995;57:6–15.CrossRefGoogle Scholar
  7. 7.
    Little RJ, Long Q, Lin X. A comparison of methods for estimating the causal effect of a treatment in randomized clinical trials subject to noncompliance. Biometrics. 2009;65:640–9.CrossRefGoogle Scholar
  8. 8.
    Ye C, Beyene J, Browne G, Thabane L. Estimating treatment effects in randomised controlled trials with non-compliance: a simulation study. BMJ Open. 2014;4:e005362.CrossRefGoogle Scholar
  9. 9.
    Shrier I, Verhagen E, Stovitz SD. The intention-to-treat analysis is not always the conservative approach. Am J Med. 2017;130:867–71.CrossRefGoogle Scholar
  10. 10.
    Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017;14:e275–444.CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical CenterAlbert Einstein College of MedicineNew YorkUSA
  2. 2.Texas Cardiac Arrhythmia InstituteSt. David’s Medical CenterAustinUSA

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