Author + information
- Received September 6, 2009
- Revision received November 16, 2009
- Accepted November 18, 2009
- Published online February 23, 2010.
- Sakis Themistoclakis, MD*,
- Andrea Corrado, MD*,
- Francis E. Marchlinski, MD†,
- Pierre Jais, MD‡,
- Erica Zado, PAC†,
- Antonio Rossillo, MD*,
- Luigi Di Biase, MD§,
- Robert A. Schweikert, MD∥,
- Walid I. Saliba, MD¶,
- Rodney Horton, MD§,
- Prasant Mohanty, MBBS, MPH§,
- Dimpi Patel, DO§,
- David J. Burkhardt, MD§,
- Oussama M. Wazni, MD¶,
- Aldo Bonso, MD*,
- David J. Callans, MD†,
- Michel Haissaguerre, MD‡,
- Antonio Raviele, MD*,* ( and )
- Andrea Natale, MD§
- ↵*Reprint requests and correspondence:
Dr. Antonio Raviele, Cardiovascular Department, Dell'Angelo Hospital, Via Paccagnella 11, 30174 Mestre-Venezia, Italy
Objectives The aim of this multicenter study was to evaluate the safety of discontinuing oral anticoagulation therapy (OAT) after apparently successful pulmonary vein isolation.
Background Atrial fibrillation (AF) is associated with an increased risk of thromboembolic events (TE) and often requires OAT. Pulmonary vein isolation is considered an effective treatment for AF.
Methods We studied 3,355 patients, of whom 2,692 (79% male, mean age 57 ± 11 years) discontinued OAT 3 to 6 months after ablation (Off-OAT group) and 663 (70% male, mean age 59 ± 11 years) remained on OAT after this period (On-OAT group). CHADS2(congestive heart failure, hypertension, age [75 years and older], diabetes mellitus, and a history of stroke or transient ischemic attack) risk scores of 1 and ≥2 were recorded in 723 (27%) and 347 (13%) Off-OAT group patients and in 261 (39%) and 247 (37%) On-OAT group patients, respectively.
Results During follow-up (mean 28 ± 13 months vs. 24 ± 15 months), 2 (0.07%) Off-OAT group patients and 3 (0.45%) On-OAT group patients had an ischemic stroke (p = 0.06). No other thromboembolic events occurred. No Off-OAT group patient with a CHADS2risk score of ≥2 had an ischemic stroke. A major hemorrhage was observed in 1 (0.04%) Off-OAT group patient and 13 (2%) On-OAT group patients (p < 0.0001).
Conclusions In this nonrandomized study, the risk–benefit ratio favored the suspension of OAT after successful AF ablation even in patients at moderate-high risk of TE. This conclusion needs to be confirmed by future large randomized trials.
Dr. Jaïs has received presentation fees from BW/Bard. Dr. Schweikert has received speaker honoraria from GlaxoSmithKline, Sanofi-Aventis, St. Jude Medical, and Boston Scientific. Dr. Saliba has received speaker honoraria from J&J, Medtronic, St. Jude Medical, and Boston Scientific. Dr. Horton is on the Speakers' Bureau of Medtronic, St. Jude Medical, and Boston Scientific; is a consultant for Hansen Medical and Atritech; and is on the clinical advisory panel of Biosense-Webster. Dr. Burkhardt is a chief medical advisor for Stereotaxis. Dr. Haissaguerre has received presentation fees from BW/Bard. Dr. Raviele is on the Speakers' Bureau of Biosense-Webster, and is a consultant to and advisory board member of Sanofi-Aventis. Dr. Natale has received a research grant from St. Jude Medicaland speaker honoraria from St. Jude Medical, Medtronic, Biosense-Webster, and Boston Scientific.
- Received September 6, 2009.
- Revision received November 16, 2009.
- Accepted November 18, 2009.
- American College of Cardiology Foundation