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 - Journal of the American Medical Association

Volumn 321, Issue 13, 2019, Pages 1261-1274

  Packer, Douglas L ^a   Mark, Daniel B ^b   Robb, Richard A ^a   Monahan, Kristi H ^a   Bahnson, Tristram D ^b   Poole, Jeanne E ^c   Noseworthy, Peter A ^a   Rosenberg, Yves D ^d   Jeffries, Neal ^d   Mitchell, L Brent ^e   Flaker, Greg C ^f   Pokushalov, Evgeny ^g   Romanov, Alexander ^g   Bunch, T Jared ^h   Noelker, Georg ⁱ   Ardashev, Andrey ^j   Revishvili, Amiran ^k   Wilber, David J ^l   Cappato, Riccardo ^m   Kuck, Karl Heinz ⁿ   Hindricks, Gerhard ^o   Davies, D Wyn ^p   Kowey, Peter R ^q   Naccarelli, Gerald V ^r   Reiffel, James A ^s   Piccini, Jonathan P ^b   Silverstein, Adam P ^b   Al Khalidi, Hussein R ^b   Lee, Kerry L ^b   more..

^a MAYO CLINIC   (United States)

^b DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^c UNIVERSITY OF WASHINGTON MEDICAL CENTER   (United States)

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

^e LIBIN CARDIOVASCULAR INSTITUTE OF ALBERTA   (Canada)

^f UNIVERSITY OF MISSOURI   (United States)

^g N N BLOKHIN NATIONAL MEDICAL RESEARCH CENTER OF ONCOLOGY   (Russian Federation)

^h INTERMOUNTAIN HEALTHCARE   (United States)

ⁱ RUHR UNIVERSITY BOCHUM   (Germany)

^j MOSCOW STATE UNIVERSITY   (Russian Federation)

^k Bakoulev Center for Cardiovascular Surgery   (Russian Federation)

^l LOYOLA UNIVERSITY MEDICAL CENTER   (United States)

^m HUMANITAS UNIVERSITY   (Italy)

ⁿ DEPARTMENT OF CARDIOLOGY   (Germany)

^o UNIVERSITY OF LEIPZIG HEART CENTER   (Germany)

^p ST MARY S HOSPITAL   (United Kingdom)

^q THOMAS JEFFERSON UNIVERSITY   (United States)

^r PENN STATE COLLEGE OF MEDICINE   (United States)

^s Howard Hughes Medical Institute   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIARRHYTHMIC AGENT;

AGED; ALL CAUSE MORTALITY; ATRIAL FIBRILLATION; BLEEDING; CARDIOVASCULAR MORTALITY; CATHETER ABLATION; CEREBROVASCULAR ACCIDENT; CLINICAL EFFECTIVENESS; COMPARATIVE STUDY; CONFERENCE PAPER; CONTROLLED STUDY; DRUG CONTROL; FALSE ANEURYSM; FEMALE; FOLLOW UP; HEART ARREST; HEART PROARRHYTHMIA; HEART TAMPONADE; HEMATOMA; HOSPITALIZATION; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PAROXYSMAL ATRIAL FIBRILLATION; PERSISTENT ATRIAL FIBRILLATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; PULMONARY VEIN ISOLATION; RANDOMIZED CONTROLLED TRIAL; RECURRENT DISEASE; RISK FACTOR; THERAPY EFFECT; THYROID DISEASE; TREATMENT OUTCOME; CLINICAL TRIAL; COMPLICATION; INTENTION TO TREAT ANALYSIS; KAPLAN MEIER METHOD; MIDDLE AGED; MORTALITY; REGISTER; STATISTICS AND NUMERICAL DATA;

AGED; ANTI-ARRHYTHMIA AGENTS; ATRIAL FIBRILLATION; CATHETER ABLATION; FEMALE; HEART ARREST; HEMORRHAGE; HOSPITALIZATION; HUMANS; INTENTION TO TREAT ANALYSIS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; RECURRENCE; REGISTRIES; RISK FACTORS; STROKE;

EID: 85062970753     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2019.0693     Document Type: Conference Paper

References (34)

1. Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998; 98 (10): 946-952. doi: 10.1161/01.CIR.98.10.946 9737513
2. Miyasaka Y, Barnes ME, Gersh BJ, Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation. 2006; 114 (2): 119-125. doi: 10.1161/CIRCULATIONAHA.105.595140 16818816
3. Bunch TJ, Crandall BG, Weiss JP, Patients treated with catheter ablation for atrial fibrillation have long-term rates of death, stroke, and dementia similar to patients without atrial fibrillation. J Cardiovasc Electrophysiol. 2011; 22 (8): 839-845. doi: 10.1111/j.1540-8167.2011.02035.x 21410581
4. Calkins H, Reynolds MR, Spector P, Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses. Circ Arrhythm Electrophysiol. 2009; 2 (4): 349-361. doi: 10.1161/CIRCEP.108.824789 19808490
5. Jaïs P, Cauchemez B, Macle L, Catheter ablation versus antiarrhythmic drugs for atrial fibrillation: the A4 study. Circulation. 2008; 118 (24): 2498-2505. 19029470
6. Pappone C, Augello G, Sala S, A randomized trial of circumferential pulmonary vein ablation versus antiarrhythmic drug therapy in paroxysmal atrial fibrillation: the APAF Study. J Am Coll Cardiol. 2006; 48 (11): 2340-2347. doi: 10.1016/j.jacc.2006.08.037 17161267
7. Packer DL, Kowal RC, Wheelan KR,; STOP AF Cryoablation Investigators. 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. 2013; 61 (16): 1713-1723. doi: 10.1016/j.jacc.2012.11.064 23500312
8. Wilber DJ, Pappone C, Neuzil P,; ThermoCool AF Trial Investigators. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA. 2010; 303 (4): 333-340. doi: 10.1001/jama.2009.2029 20103757
9. Mont L, Bisbal F, Hernandez-Madrid A,; SARA investigators. Catheter ablation vs antiarrhythmic drug treatment of persistent atrial fibrillation: a multicentre, randomized, controlled trial (SARA study). Eur Heart J. 2014; 35: 505-507. doi: 10.1093/eurheartj/eht457
10. Marrouche NF, Brachmann J, Andresen D,; CASTLE-AF Investigators. Catheter ablation for atrial fibrillation with heart failure. N Engl J Med. 2018; 378 (5): 417-427. doi: 10.1056/NEJMoa1707855 29385358
11. Packer DL, Mark DB, Robb RA,; CABANA Investigators. Catheter ablation versus antiarrhythmic drug therapy for atrial fibrillation (CABANA) trial: study rationale and design. Am Heart J. 2018; 199: 192-199. doi: 10.1016/j.ahj.2018.02.015 29754661
12. Calkins H, Hindricks G, Cappato R, 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017; 14 (10): e275-e444. doi: 10.1016/j.hrthm.2017.05.012 28506916
13. Fuster V, Rydén LE, Cannom DS,; 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. 2006; 114 (7): e257-e354. 16908781
14. Fuster V, Rydén LE, Cannom DS, 2011 ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in partnership with the European Society of Cardiology and in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. J Am Coll Cardiol. 2011; 57 (11): e101-e198. doi: 10.1016/j.jacc.2010.09.013 21392637
15. Calkins H, Brugada J, Packer DL,; European Heart Rhythm Association (EHRA); European Cardiac Arrhythmia Society (ECAS); American College of Cardiology (ACC); American Heart Association (AHA); Society of Thoracic Surgeons (STS). HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up: a report of the Heart Rhythm Society (HRS) Task Force on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2007; 4 (6): 816-861. doi: 10.1016/j.hrthm.2007.04.005 17556213
16. Calkins H, Kuck K, Cappato R,; Heart Rhythm Society Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. 2012 HRS/EHRA/ECAS/ACC/AHA/APHRS/STS/ESC expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendation for patient selection, procedural techniques, patient management, and follow up, definitions, endpoints, and research trial design: a report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. Heart Rhythm. 2012; 9 (4): 632-696.e21. doi: 10.1016/j.hrthm.2011.12.016 22386883
17. Mark DB, Anstrom KJ, Sheng S,; CABANA Investigators. Effect of catheter ablation vs medical therapy on quality of life among patients with atrial fibrillation: the CABANA randomized clinical trial [published online March 15, 2019]. JAMA. doi: 10.1001/jama.2019.0692
18. Kalbfleisch J, Prentice R. The Statistical Analysis of Failure Time Data. 2nd ed. Hoboken, NJ: John Wiley & Sons; 2002. doi: 10.1002/9781118032985
19. Kaplan E, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958; 53: 457-481. doi: 10.1080/01621459.1958.10501452
20. Cox D. Regression models and life-tables (with discussion). J R Stat Soc B. 1972; 34: 187-220.
21. Schoenfeld D. Partial residuals for the proportional hazards regression model. Biometrika. 1982; 69 (1): 239-241. doi: 10.1093/biomet/69.1.239
22. Fine J, Gray R. A proportional hazards model for the subdistribution of a competing risk. J Am Stat Assoc. 1999; 94: 496-509. doi: 10.1080/01621459.1999.10474144
23. O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979; 35 (3): 549-556. doi: 10.2307/2530245 497341
24. Lan K, DeMets L. Discrete sequential boundaries for clinical trials. Biometrika. 1983; 70: 659-663. doi: 10.2307/2336502
25. Liao JM, Stack CB, Goodman S. Annals understanding clinical research: interpreting results with large P values. Ann Intern Med. 2018; 169 (7): 485-486. doi: 10.7326/M18-2003 30208404
26. Sheiner LB, Rubin DB. Intention-to-treat analysis and the goals of clinical trials. Clin Pharmacol Ther. 1995; 57 (1): 6-15. doi: 10.1016/0009-9236(95)90260-0 7828382
27. Hunter RJ, Berriman TJ, Diab I, A randomized controlled trial of catheter ablation versus medical treatment of atrial fibrillation in heart failure (the CAMTAF trial). Circ Arrhythm Electrophysiol. 2014; 7 (1): 31-38. doi: 10.1161/CIRCEP.113.000806 24382410
28. Di Biase L, Mohanty P, Mohanty S, Ablation versus amiodarone for treatment of persistent atrial fibrillation in patients with congestive heart failure and an implanted device: results from the AATAC multicenter randomized trial. Circulation. 2016; 133 (17): 1637-1644. doi: 10.1161/CIRCULATIONAHA.115.019406 27029350
29. Friberg L, Tabrizi F, Englund A. Catheter ablation for atrial fibrillation is associated with lower incidence of stroke and death: data from Swedish health registries. Eur Heart J. 2016; 37 (31): 2478-2487. doi: 10.1093/eurheartj/ehw087 26984861
30. Noseworthy P, Gersh B, Kent D, Atrial fibrillation ablation in practice: assessing CABANA generalizability [published March 15, 2019]. Eur Heart J. doi: 10.1093/eurheartj/ehz085
31. Morillo CA, Verma A, Connolly SJ,; RAAFT-2 Investigators. Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of paroxysmal atrial fibrillation (RAAFT-2): a randomized trial. JAMA. 2014; 311 (7): 692-700. doi: 10.1001/jama.2014.467 24549549
32. Cosedis Nielsen J, Johannessen A, Raatikainen P, Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation. N Engl J Med. 2012; 367 (17): 1587-1595. doi: 10.1056/NEJMoa1113566 23094720
33. Cappato R, Calkins H, Chen SA, Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010; 3 (1): 32-38. doi: 10.1161/CIRCEP.109.859116 19995881
34. Cappato R, Calkins H, Chen SA, Worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circulation. 2005; 111 (9): 1100-1105. doi: 10.1161/01.CIR.0000157153.30978.67 15723973