Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial: Study Rationale and Design

American Heart Journal

Volumn 199, Issue , 2018, Pages 192-199

  Packer, Douglas L ^a   Mark, Daniel B ^b   Robb, Richard A ^a   Monahan, Kristi H ^a   Bahnson, Tristram D ^b   Moretz, Kathleen ^b   Poole, Jeanne E ^d   Mascette, Alice ^c   Rosenberg, Yves ^c   Jeffries, Neal ^c   Al Khalidi, Hussein R ^b   Lee, Kerry L ^b  

^a MAYO CLINIC   (United States)

^b DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^c NATIONAL HEART LUNG AND BLOOD INSTITUTE   (United States)

^d UNIVERSITY OF WASHINGTON MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRONEDARONE; HEPARIN; LOW MOLECULAR WEIGHT HEPARIN; WARFARIN; ANTIARRHYTHMIC AGENT;

ADULT; ARTICLE; ATRIAL FIBRILLATION; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; CATHETER ABLATION; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; FEMALE; HEALTH CARE POLICY; HEART ARREST; HOLTER MONITORING; HOSPITALIZATION; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; PILOT STUDY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; AMBULATORY ELECTROCARDIOGRAPHY; HEART MUSCLE CONDUCTION SYSTEM; HEART RATE; PATHOPHYSIOLOGY; PHYSIOLOGY; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC);

ANTI-ARRHYTHMIA AGENTS; ATRIAL FIBRILLATION; CATHETER ABLATION; ELECTROCARDIOGRAPHY, AMBULATORY; HEART CONDUCTION SYSTEM; HEART RATE; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 85046834221     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2018.02.015     Document Type: Article

References (50)

1. NCT00911508. https://clinicaltrials.gov/ct2/show/NCT00911508.
2. Go, A., Hylek, E., Phillip, K. et al., Prevalence of diagnosed AF in adults. Natonal implications for rhythm management and stroke prevention: the Anticoagulation and Risk Factors in AF (ATRIA). JAMA 285 (2001), 2370–2375.
3. Lloyd-Jones, D., Wang, T., Leip, E. et al., Lifetime risk for development of AF. The Framingham Heart Study. Circulation 110 (2004), 1042–1046.
4. Greenlee, R., Vidaillet, H., Recent progress in the epidemiology of atrial fibrillation. Curr Opin Cardiol 20 (2005), 7–14.
5. Maisel, W., Stevenson, L., AF in heart failure: epidemiology, pathophysiology, and rantionale for therapy. Am J Cardiol 91 (2003), 2D–8D.
6. Wang, T., Larson, M., Levy, D. et al., Temporal relations of AF and congestive heart failure and their joint influence on mortality: The Framingham Heart Study. Circulation 107 (2003), 2920–2925.
7. Cha, Y., Redfield, M., Shen, W. et al., AF and ventricular dysfunction: a vicious electromechanical cycle. Circulation 109 (2004), 2839–2843.
8. The AF Follow-up Investigation of Rhythm Management (AFFIRM) Investigators, A comparison of rate control and rhythm control n patients with atrial fibrillation. NEJM 347 (2002), 1825–1833.
9. Van Gelder, E., Hagens, V., Bosker, H. et al., A comparison of rate control and rhythm control in patients with recurrent persistent atrial fibrillation. NEJM 347 (2002), 1834–1840.
10. Carlsson, J., Miketic, S., Windeler, J. et al., Randomized trial of rate control versus rhythm control in persistent atria fibrillation. J Am Coll Cardiol 41 (2003), 1690–1696.
11. Hohnloser, S., Juck, K., Lilienthal JftPi, Rhythm or rate control in atrial fibrillation - pharmcological intervention in atrial fibrillation (PIAF): a randomized trial. Lancet 356 (2000), 1789–1794.
12. Roy, D., Talajic, M., Nattel, S. et al., Rhythm control versus rate control for atrial fibrillation and heart failure. NEJM 358 (2008), 2667–2677.
13. Prasad, S., Mania, H., Camillo, C. et al., The Cox Maze III procedure for atrial fibrillation: Long-term efficacy in patients undergoing lone vs. concomitant procedures. J Thorac Cardiovasc Surg 126 (2003), 1822–1828.
14. Cox, J., Boineau, J., Schuessler, R. et al., Five-year experience with the maze procedure for atrial fibrillation. Ann Thorac Surg 56 (1993), 814–823.
15. Cox, J., The surgical treatment of atrial fibrillation. IV. Surgical Technique. J Thorac Cardiovasc Surg 101 (1991), 584–592.
16. Stulak, J., Sundt, Tr, Dearani, J. et al., Ten-year experience with the Cox-maze procedure for atrial fibrillation: How do we define success?. Ann Thorac Surg 83 (2007), 1319–1324.
17. Schaff, H., Dearani, J., Daly, R. et al., Cox-maze procedure for atrial fibrillation: Mayo Clinic experience. Semin Thorac Cardiovasc Surg 12 (2000), 30–37.
18. Hand, N., Schaff, H., Morris, J. et al., Outcome of valve repair and the Cox maze procedure for mitral regurgitation and associated atrial fibrillation. J Thorac Cardiovasc Surg 118 (1999), 628–635.
19. Cox, J., Ad, N., Palazzo, T., Impact of the maze procedure on the stroke rate in patients with atrial fibrillation. J Thorac Cardiovasc Surg 118 (1999), 833–840.
20. Damiano, R.J., Gaynor, S., Bailey, M. et al., The long-term outcome in patients with coronary disease and atrial fibrillation undergoing the Cox maze procedure. J Thorac Cardiovasc Surg 126 (2003), 2016–2021.
21. Wijffels, M., Kirchhof, C., Dorland, R. et al., Atrial fibrillation begets atrial fibrillation: A study in awake chronically instrumented goats. Circulation 92 (1995), 1954–1968.
22. Morillo, C., Klein, G., Jones, D. et al., Chronic rapid atrial pacing. Structural, functional, and electrophysiological characteristics of a new model of sustained atrial fibrillation. Circulation 91 (1995), 1588–1595.
23. Haissaguerre, M., Jais, P., Shah, D. et al., Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. NEJM 339 (1998), 659–666.
24. Stabile, G., Bertaglia, E., Senatore, G. et al., Catheter ablation treatment in patients with drug-refractory atrial fibrillation: a prospective, multi-centre, randomized, controlled study (Catheter Ablation For the Cure of Atrial Fibrillation Study). Eur Heart J 27 (2006), 216–221.
25. Wazni, O., Marrouche, N., Martin, D. et al., Radiofrequency ablation versus antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation. JAMA 293 (2005), 2634–2640.
26. Pappone, C., Augello, G., Sala, S. et al., A controlled, randomized trial of circumferential pulmonary vein ablation versus antiarrhythmic drug therapy for curing paroxysmal atrial fibrillation. The APAF Study. J Am Coll Cardiol 48 (2006), 2340–2347.
27. Jais, P., Cauchemez, J., Haissaguerre, M., Atrial fibrillation ablation vs. anti-arrhythmic drugs: A multi-center, randomized trial. Circulation 118 (2008), 2498–2505.
28. How we approach AF ablation in our lab today - Patient selection, ablation strategies, and safety considerations. Tenth Annual International Symposium on Atrial Fibrillation, 2005.
29. Morillo, C., Verma, A., Connolly, S. et al., Radiofrequency ablation vs. antiarrhythmic drugs as first-line treatment of paroxysmal atrial fibrillation (RAAFT-2); a randomized trial. JAMA 311 (2014), 692–700.
30. Packer, D., Kowal, R., Wheelan, K. et al., Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: first results of the North American Arctic Front (STOP AF) pivotal trial. J Am Coll Cardiol 61 (2013), 1713–1723.
31. Wilber, D., Pappone, C., Neuzil, P. et al., Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA 303 (2010), 333–340.
32. Sox, H., Greenfield, S., Cassel, C. et al., Initial national priorities for comparative effectiveness research. 2009, National Academy of Sciences.
33. Packer, D., Lee, K., Mark, D. et al., Catheter ablation vs. antiarrhythmic drug therapy for atrial fibrillation. American College of Cardiology 59th Scientific Sessions Late Breaking Clin Trials, 2010.
34. Fuster, V., Ryden, L., Cannon, D. et al., American College of Cardiology/American Heart Association Task Force on Practice Guidelines. European Society of Cardiology Committee for Practice Guidelines. European Heart Rhythm Association. Heart Rhythm Society. 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 (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation 114 (2006), e257–e354.
35. Calkins, H., Brugada, J., Packer, D. et al., HRS/EHRA/ECAS Expert consensus statement on catheter and surgical ablation of atrial fibrillation: Recommendations for personnel, policy, procedures and follow-up. Heart Rhythm 4 (2007), 815–861.
36. Natale, A., Raviele, A., Arentz, T. et al., Venice chart international consensus document on atrial fibrillation ablation. J Cardiovasc Electrophysiol 18 (2007), 560–580.
37. Nademanee, K., McKenzie, J., Kosar, E. et al., A new approach for catheter ablaton of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol 43 (2004), 2044–2053.
38. Nakagaw, H., Scherlag, B., Lockwood, D. et al., Localization of left atrial autonomic ganglionated plexuses using endocardial and epicardial high frequency stimulation in patients with AF. Heart Rhythm, 2, 2005, S10.
39. Ware, J.J., Snow, K., Kosinski, M. et al., SF-36 Health Survey: manual & Interpretation Guide. 1993, The Health Institute, New England Medical Center, Boston.
40. Hlatky, M., Boineau, R., Higginbotham, M. et al., A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol 64 (1989), 651–654.
41. Spertus, J., Dorian, P., Bubien, R. et al., Development and validation of the Atrial Fibrillation Effect on QualiTy-of-LIfe (AFEQT) Questionnaire in patients with atrial fibrillation. Circ Arrhythm Electrophysiol 4 (2011), 15–25.
42. The EuroQol Group, EuroQol - a new facility for the measurement of health-related quality of life. Health Policy 16 (1990), 199–209.
43. Reilly, M., Zbrozek, A., Dukes, E., The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 4 (1993), 353–365.
44. Turpin, R., Ozminkowski, R., Sharda, C. et al., Realiability and validity of the Stanford Presenteeism Scale. J Occup Environ Med 46 (2004), 1123–1133.
45. Wokhlu, A., Monahan, K., Hodge, D. et al., Long-term quality of life after ablation of atrial fibrillation: The impact of recurrence, symptom relief, and placebo effect. J Am Coll Cardiol 55 (2010), 2308–2316.
46. Kaplan, E., Meier, P., Nonparametric estimation from incomplete observations. J Am Stat Assoc 53 (1958), 457–481.
47. Cox, D., Regression models and life-tables (with discussion). J R Stat Soc B 34 (1972), 187–220.
48. Fine, J., Gray, R., A proportional hazards model for the subdistribution of a competing risk. J Am Stat Assoc 94 (1999), 496–509.
49. Lan, K., DeMets, L., Discrete sequential boundaries for clinical trials. Biometrika 70 (1983), 659–663.
50. Bang, H., Tsiatis, A., Estimating medical costs with censored data. Biometrika 87 (2000), 329–343.