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

被引：891

作者：

Wilber, David J. ^{[1
]}

Pappone, Carlo ^{[2
]}

Neuzil, Petr ^{[3
]}

De Paola, Angelo ^{[4
]}

Marchlinski, Frank ^{[5
]}

Natale, Andrea ^{[6
]}

Macle, Laurent ^{[7
]}

Daoud, Emile G. ^{[8
]}

Calkins, Hugh ^{[9
]}

Hall, Burr ^{[10
]}

Reddy, Vivek ^{[3
]}

Augello, Giuseppe ^{[2
]}

Reynolds, Matthew R. ^{[11
]}

Vinekar, Chandan ^{[12
]}

Liu, Christine Y. ^{[12
]}

Berry, Scott M. ^{[13
]}

Berry, Donald A. ^{[14
]}

机构：

[1] Loyola Univ, Med Ctr, Dept Med, Cardiovasc Inst, Maywood, IL 60153 USA

[2] Hosp San Raffaele, Dept Med, I-20132 Milan, Italy

[3] Na Homolce Hosp, Dept Med, Prague, Czech Republic

[4] Hosp Sao Paulo, UNIFESP, Dept Med, Sao Paulo, Brazil

[5] Hosp Univ Penn, Dept Med, Philadelphia, PA 19104 USA

[6] Cleveland Clin Fdn, Dept Med, Cleveland, OH 44195 USA

[7] Montreal Heart Inst, Dept Med, Montreal, PQ H1T 1C8, Canada

[8] Ohio State Univ, Dept Med, Columbus, OH 43210 USA

[9] Johns Hopkins Univ Hosp, Dept Med, Baltimore, MD 21287 USA

[10] Univ Rochester, Med Ctr, Dept Med, Rochester, NY 14642 USA

[11] Harvard Clin Res Inst, Boston, MA USA

[12] Biosense Webster, Diamond Bar, CA USA

[13] Berry Consultants, College Stn, TX USA

[14] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA

来源：

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2010年 / 303卷 / 04期

关键词：

QUALITY-OF-LIFE; PULMONARY VEIN ABLATION; FOLLOW-UP; CLINICAL-TRIALS; SINUS RHYTHM; MANAGEMENT; RISK; AMIODARONE; MORTALITY; OUTCOMES;

D O I：

10.1001/jama.2009.2029

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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

引用

页码：333 / 340

页数：8

共 28 条

[1] Impact of atrial fibrillation on the risk of death [J].

Benjamin, EJ ;

Wolf, PA ;

D'Agostino, RB ;

Silbershatz, H ;

Kannel, WB ;

Levy, D .

CIRCULATION, 1998, 98 (10) :946-952

[2] Bayesian clinical trials [J].

Berry, DA .

NATURE REVIEWS DRUG DISCOVERY, 2006, 5 (01) :27-36

[3] Introduction to Bayesian methods III: use and interpretation of Bayesian tools in design and analysis [J].

Berry, DA .

CLINICAL TRIALS, 2005, 2 (04) :295-300

[4] Bayesian statistics and the efficiency and ethics of clinical trials [J].

Berry, DA .

STATISTICAL SCIENCE, 2004, 19 (01) :175-187

[5] Effect of radiofrequency catheter ablation an health-related quality of life and activities of daily living in patients with recurrent arrhythmias [J].

Bubien, RS ;

KnottsDolson, SM ;

Plumb, VJ ;

Kay, GN .

CIRCULATION, 1996, 94 (07) :1585-1591

[6] HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: Recommendations for personnel, policy, procedures and follow-up [J].

Calkins, Hugh ;

Brugada, Josep ;

Packer, Douglas L. ;

Cappato, Riccardo ;

Chen, Shih-Ann ;

Crijns, Harry J. G. ;

Damiano, Ralph J., Jr. ;

Davies, D. Wyn ;

Haines, David E. ;

Haissaguerre, Michel ;

Iesaka, Yoshito ;

Jackman, Warren ;

Jais, Pierre ;

Kottkamp, Hans ;

Kuck, Karl Heinz ;

Lindsay, Bruce D. ;

Marchlinski, Francis E. ;

McCarthy, Patrick M. ;

Mont, J. Lluis ;

Morady, Fred ;

Nademanee, Koontawee ;

Natale, Andrea ;

Pappone, Carlo ;

Prystowsky, Eric ;

Raviele, Antonio ;

Ruskin, Jeremy N. ;

Shemin, Richard J. .

HEART RHYTHM, 2007, 4 (06) :816-861

[7] Worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation [J].

Cappato, R ;

Calkins, H ;

Chen, SA ;

Davies, W ;

Iesaka, Y ;

Kalman, J ;

Kim, YH ;

Klein, G ;

Packer, D ;

Skanes, A .

CIRCULATION, 2005, 111 (09) :1100-1105

[8] Clinical factors associated with abandonment of a rate-control or a rhythm-control strategy for the management of atrial fibrillation in the AFFIRM study [J].

Curtis, AB ;

Seals, AA ;

Safford, RE ;

Slater, W ;

Tullo, NG ;

Vidaillet, JH ;

Wilber, DJ ;

Slee, A .

AMERICAN HEART JOURNAL, 2005, 149 (02) :304-308

[9] Quality of life improves with treatment in the Canadian Trial of Atrial Fibrillation [J].

Dorian, P ;

Paquette, M ;

Newman, D ;

Green, M ;

Connolly, SJ ;

Talajic, M ;

Roy, D .

AMERICAN HEART JOURNAL, 2002, 143 (06) :984-990

[10] ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation - Executive summary [J].

Fuster, Valentin ;

Ryden, Lars E. ;

Cannom, David S. ;

Crijns, Harry J. ;

Curbs, Anne B. ;

Ellenbogen, Kenneth A. ;

Halperin, Jonathan L. ;

Le Heuzey, Jean-Yves ;

Kay, G. Neal ;

Lowe, James E. ;

Olsson, S. Bertil ;

Prystowsky, Eric N. ;

Tamargo, Juan Luis ;

Wann, Samuel ;

Smith, Sidney C., Jr. ;

Jacobs, Alice K. ;

Adams, Cynthia D. ;

Anderson, Jeffery L. ;

Antman, Elliott M. ;

Halperin, Jonathan L. ;

Hunt, Sharon Ann ;

Nishimura, Rick ;

Ornato, Joseph P. ;

Page, Richard L. ;

Riegel, Barbara ;

Priori, Silvia G. ;

Blanc, Jean-Jacques ;

Budaj, Andrzej ;

Camm, A. John ;

Dean, Veronica ;

Deckers, Jaap W. ;

Despres, Catherine ;

Dickstein, Kenneth ;

Lekakis, John ;

McGregor, Keith ;

Metra, Marco ;

Morais, Joao ;

Osterspey, Ady ;

Tamargo, Juan Luis ;

Zamorano, Jose Luis .

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2006, 48 (04) :854-906

← 1 2 3 →