Comparison of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation A Randomized Controlled Trial

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dc.contributor.author Wilber, David J.
dc.contributor.author Pappone, Carlo
dc.contributor.author Neuzil, Petr
dc.contributor.author De Paola, Angelo [UNIFESP]
dc.contributor.author Marchlinski, Frank
dc.contributor.author Natale, Andrea
dc.contributor.author Macle, Laurent
dc.contributor.author Daoud, Emile G.
dc.contributor.author Calkins, Hugh
dc.contributor.author Hall, Burr
dc.contributor.author Reddy, Vivek
dc.contributor.author Augello, Giuseppe
dc.contributor.author Reynolds, Matthew R.
dc.contributor.author Vinekar, Chandan
dc.contributor.author Liu, Christine Y.
dc.contributor.author Berry, Scott M.
dc.contributor.author Berry, Donald A.
dc.contributor.author ThermoCool AF Trial Investigators
dc.date.accessioned 2016-01-24T13:59:11Z
dc.date.available 2016-01-24T13:59:11Z
dc.date.issued 2010-01-27
dc.identifier http://dx.doi.org/10.1001/jama.2009.2029
dc.identifier.citation Jama-Journal of the American Medical Association. Chicago: Amer Medical Assoc, v. 303, n. 4, p. 333-340, 2010.
dc.identifier.issn 0098-7484
dc.identifier.uri http://repositorio.unifesp.br/handle/11600/32181
dc.description.abstract Context Antiarrhythmic drugs are commonly used for prevention of recurrent atrial fibrillation (AF) despite inconsistent efficacy and frequent adverse effects. Catheter ablation has been proposed as an alternative treatment for paroxysmal AF.Objective To determine the efficacy of catheter ablation compared with antiarrhythmic drug therapy (ADT) in treating symptomatic paroxysmal AF.Design, Setting, and Participants A prospective, multicenter, randomized (2: 1), unblinded, Bayesian-designed study conducted at 19 hospitals of 167 patients who did not respond to at least 1 antiarrhythmic drug and who experienced at least 3 AF episodes within 6 months before randomization. Enrollment occurred between October 25, 2004, and October 11, 2007, with the last follow-up on January 19, 2009.Intervention Catheter ablation (n = 106) or ADT (n = 61), with assessment for effectiveness in a comparable 9-month follow-up period.Main Outcome Measures Time to protocol-defined treatment failure. the proportion of patients who experienced major treatment-related adverse events within 30 days of catheter ablation or ADT was also reported.Results At the end of the 9-month effectiveness evaluation period, 66% of patients in the catheter ablation group remained free from protocol-defined treatment failure compared with 16% of patients treated with ADT. the hazard ratio of catheter ablation to ADT was 0.30 (95% confidence interval, 0.19-0.47; P < .001). Major 30-day treatment-related adverse events occurred in 5 of 57 patients (8.8%) treated with ADT and 5 of 103 patients (4.9%) treated with catheter ablation. Mean quality of life scores improved significantly in patients treated by catheter ablation compared with ADT at 3 months; improvement was maintained during the course of the study.Conclusion Among patients with paroxysmal AF who had not responded to at least 1 antiarrhythmic drug, the use of catheter ablation compared with ADT resulted in a longer time to treatment failure during the 9-month follow-up period.Trial Registration clinicaltrials.gov Identifier: NCT00116428 JAMA. 2010;303(4):333-340 en
dc.description.sponsorship Biosense Webster
dc.description.sponsorship Boston Scientific
dc.description.sponsorship Medtronic
dc.description.sponsorship St Jude Medical
dc.description.sponsorship Blackwell/Futura
dc.description.sponsorship Johnson Johnson
dc.description.sponsorship Cardiofocus
dc.description.sponsorship Cyrocath Technologies
dc.description.sponsorship Hansen Medical
dc.description.sponsorship NIH
dc.description.sponsorship Bristol-Myers Squibb
dc.description.sponsorship GE Healthcare
dc.description.sponsorship BARD
dc.description.sponsorship Atritech
dc.description.sponsorship CryoCath Technologies
dc.description.sponsorship Endosense Hansen Medical
dc.format.extent 333-340
dc.language.iso eng
dc.publisher Amer Medical Assoc
dc.relation.ispartof Jama-Journal of the American Medical Association
dc.rights Acesso restrito
dc.title Comparison of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation A Randomized Controlled Trial en
dc.type Artigo
dc.contributor.institution Loyola Univ
dc.contributor.institution Hosp San Raffaele
dc.contributor.institution Na Homolce Hosp
dc.contributor.institution Universidade Federal de São Paulo (UNIFESP)
dc.contributor.institution Hosp Univ Penn
dc.contributor.institution Cleveland Clin Fdn
dc.contributor.institution Montreal Heart Inst
dc.contributor.institution Ohio State Univ
dc.contributor.institution Johns Hopkins Univ Hosp
dc.contributor.institution Univ Rochester
dc.contributor.institution Harvard Clin Res Inst
dc.contributor.institution Biosense Webster
dc.contributor.institution Berry Consultants
dc.contributor.institution Univ Texas MD Anderson Canc Ctr
dc.description.affiliation Loyola Univ, Med Ctr, Dept Med, Cardiovasc Inst, Maywood, IL 60153 USA
dc.description.affiliation Hosp San Raffaele, Dept Med, I-20132 Milan, Italy
dc.description.affiliation Na Homolce Hosp, Dept Med, Prague, Czech Republic
dc.description.affiliation Hosp São Paulo, UNIFESP, Dept Med, São Paulo, Brazil
dc.description.affiliation Hosp Univ Penn, Dept Med, Philadelphia, PA 19104 USA
dc.description.affiliation Cleveland Clin Fdn, Dept Med, Cleveland, OH 44195 USA
dc.description.affiliation Montreal Heart Inst, Dept Med, Montreal, PQ H1T 1C8, Canada
dc.description.affiliation Ohio State Univ, Dept Med, Columbus, OH 43210 USA
dc.description.affiliation Johns Hopkins Univ Hosp, Dept Med, Baltimore, MD 21287 USA
dc.description.affiliation Univ Rochester, Med Ctr, Dept Med, Rochester, NY 14642 USA
dc.description.affiliation Harvard Clin Res Inst, Boston, MA USA
dc.description.affiliation Biosense Webster, Diamond Bar, CA USA
dc.description.affiliation Berry Consultants, College Stn, TX USA
dc.description.affiliation Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA
dc.description.affiliationUnifesp Hosp São Paulo, UNIFESP, Dept Med, São Paulo, Brazil
dc.description.sponsorshipID NIH: BARI 2D
dc.identifier.doi 10.1001/jama.2009.2029
dc.description.source Web of Science
dc.identifier.wos WOS:000273952800021



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