Low molecular weight heparin for prevention of thromboembolic complications in cardioversion--rationale and design of the ACE study (Anticoagulation in Cardioversion using Enoxaparin).
The modality and duration of anticoagulation before, during, and after cardioversion of atrial fibrillation--either with or without guidance by transesophageal echocardiography (TEE)--is still an unresolved issue. Intravenous infusion of unfractionated heparin until effective anticoagulation with phenprocoumon or warfarin is used as the standard therapy. However, this approach may be associated with several days of hospitalization because of the necessity for intravenous heparin administration. Moreover, there may be an increased risk of bleeding complications or, conversely, episodes of undercoagulation. Low-molecular weight heparin is an attractive alternative as it not only provide a safe and predictable level of anticoagulation with fewer side effects but can also be administered safely on an outpatient basis. In addition, no anticoagulation monitoring is needed. The ACE study (Anticoagulation in Cardioversion using Enoxaparin) is a randomized, prospective, open-label multicenter trial comparing the safety and efficacy of subcutaneous enoxaparin with intravenous heparin/oral phenprocoumon before and after cardioversion (stratified to TEE guidance or no TEE guidance). This article presents the rationale, design and status of the ACE study.
Stellbrink
C
C
Medizinische Klinik I, RWTH Aachen Pauwelsstrasse 30, 52057 Aachen, Germany. cste@pcserver.mk1.rwth-aachen.de
Hanrath
P
P
Nixdorff
U
U
Hofmann
T
T
Lehmacher
W
W
Kühle
K
K
Fetsch
T
T
Grewe
R
R
Schmidt-Lucke
J A
JA
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D001281:Atrial Fibrillation / Q000000981:diagnostic imaging / Q000628:therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D017548:Echocardiography, Transesophageal; D004554:Electric Countershock / Q000009:adverse effects*; D017984:Enoxaparin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006493:Heparin / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D010644:Phenprocoumon / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000000981:diagnostic imaging / Q000517:prevention & control*; D012307:Risk Factors; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000000981:diagnostic imaging / Q000517:prevention & control*
D017984:Enoxaparin; D006493:Heparin; D010644:Phenprocoumon