Cryoballoon Versus Open Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: The Prospective, Randomized, Controlled, Noninferiority FreezeAF Study.
BACKGROUND
There is a lack of data on the comparative efficacy and procedural safety of open irrigated radiofrequency (RF) and cryoballoon catheter (CB) ablation for pulmonary vein isolation in patients with paroxysmal atrial fibrillation.


RESULTS
In a prospective, noninferiority study, 315 patients were randomly assigned to RF (n=159) or CB (n=156) ablation. The primary end point was freedom from atrial arrhythmia with absence of persistent complications. Patients were largely comparable between groups with more vascular disease in the RF group (8.2% versus 2.6% for CB; P=0.028). The primary end point at 12 months was achieved by 70.7% with RF and 73.6% with CB (multiple procedure success), including 31 redo procedures in each group (19.5% of RF versus 19.9% of CB; P=0.933). For the intention-to-treat population, noninferiority of CB was revealed for the predefined inferiority margin (risk difference, 0.029; 95% confidence interval, -0.074 to 0.132; P<0.001). Rates at 6 months were 63.1% and 64.1% for the RF and CB groups (single procedure success), and noninferiority was confirmed (risk difference, 0.010; 95% confidence interval, -0.097 to 0.116; P=0.002). Periprocedural complications for the index procedure were more frequent in the CB group (5.0% RF, 12.2% CB; P=0.022) with a significant difference in phrenic nerve palsies (0% RF, 5.8% CB; P=0.002).


CONCLUSIONS
This large, prospective, randomized, controlled study demonstrates noninferiority of CB ablation versus RF ablation for treating patients with paroxysmal atrial fibrillation.


BACKGROUND
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00774566.
From Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.). armin.luik@klinikum-karlsruhe.de.
Armin
A
Luik
From Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Andrea
A
Radzewitz
From Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Meinhard
M
Kieser
From Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Marlene
M
Walter
From Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Peter
P
Bramlage
From Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Patrick
P
Hörmann
From Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Kerstin
K
Schmidt
From Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Nicolas
N
Horn
From Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Maria
M
Brinkmeier-Theofanopoulou
From Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Kevin
K
Kunzmann
From Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Tobias
T
Riexinger
From Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Gerhard
G
Schymik
From Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Matthias
M
Merkel
From Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany (A.L., A.R., M.W., P.H., K.S., N.H., M.B.-T., T.R., G.S., M.M., C.S.); Institute of Medical Biometry and Informatics, University of Heidelberg, Germany (M.K., K.K.); and Institute for Pharmacology and Preventive Medicine, Mahlow, Germany (P.B.).
Claus
C
Schmitt
D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use; D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000188:drug therapy / Q000453:epidemiology / Q000601:surgery*; D002318:Cardiovascular Diseases / Q000453:epidemiology; D017115:Catheter Ablation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D003131:Combined Modality Therapy; D015897:Comorbidity; D003452:Cryosurgery / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D003920:Diabetes Mellitus / Q000453:epidemiology; D015716:Electrocardiography, Ambulatory; D005260:Female; D006801:Humans; D021621:Imaging, Three-Dimensional; D007431:Intraoperative Complications / Q000453:epidemiology / Q000209:etiology; D008297:Male; D008875:Middle Aged; D010490:Pericardial Effusion / Q000453:epidemiology / Q000209:etiology; D010791:Phrenic Nerve / Q000293:injuries; D019106:Postoperative Hemorrhage / Q000139:chemically induced; D011446:Prospective Studies; D011667:Pulmonary Veins / Q000601:surgery*; D018570:Risk Assessment; D018401:Sample Size; D019851:Thrombophilia / Q000188:drug therapy / Q000209:etiology; D016896:Treatment Outcome
D000319:Adrenergic beta-Antagonists; D000925:Anticoagulants
arrhythmias, cardiac; atrial fibrillation; catheter ablation