Transesophageal echocardiography guided enoxaparin antithrombotic strategy for cardioversion of atrial fibrillation: the ACUTE II pilot study.
BACKGROUND
Patients with atrial fibrillation >2 days' duration for whom immediate cardioversion is desired or required are commonly hospitalized for 4 or more days of antithrombotic therapy with intravenous unfractionated heparin and commencement of oral warfarin. For these early cardioversion patients, self-administered low-molecular-weight heparin (enoxaparin sodium) as "bridge" therapy to warfarin may obviate the need for hospitalization and activated partial thromboplastin time monitoring and thus potentially lower costs and enhance utility.


OBJECTIVE
To compare feasibility and safety of a transesophageal echocardiography (TEE)-guided enoxaparin strategy with those of a TEE-guided unfractionated heparin strategy in patients with atrial fibrillation of >2 days' duration undergoing early electrical or chemical cardioversion.


METHODS
This is a randomized, multicenter clinical trial at 11 hospitals in the United States.


METHODS
Two hundred patients with atrial fibrillation >2 days' duration requiring early chemical or electric cardioversion will be enrolled. TEE-guided intravenous unfractionated heparin bridge therapy will be compared with TEE-guided subcutaneous enoxaparin bridge therapy.


METHODS
Feasibility outcomes are time to hospital discharge, patient quality of life/utility, treatment costs, and sinus rhythm. Safety outcomes are ischemic stroke, transient ischemic attack, systemic embolization, major and minor bleeding, clinical hemodynamic instability, and cardiac and cardioversion-related death for a 5-week period from enrollment.


CONCLUSIONS
The results of this pilot study will have important clinical and economic implications for the antithrombotic management of patients with atrial fibrillation undergoing TEE-guided cardioversion.
Murray
R D
RD
Steering and Publications Committee of ACUTE II, Cleveland, Ohio, USA.
Shah
A
A
Jasper
S E
SE
Goodman
A
A
Deitcher
S R
SR
Katz
W E
WE
Malouf
J F
JF
Stoddard
M F
MF
Grimm
R A
RA
Klein
A L
AL
D000925:Anticoagulants / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy / Q000628:therapy*; D017548:Echocardiography, Transesophageal; D004554:Electric Countershock / Q000379:methods*; D017984:Enoxaparin / Q000627:therapeutic use*; D005240:Feasibility Studies; D006493:Heparin / Q000627:therapeutic use*; D006801:Humans; D010865:Pilot Projects; D012107:Research Design
D000925:Anticoagulants; D017984:Enoxaparin; D006493:Heparin