PMID- 14967716
OWN - NLM
STAT- MEDLINE
DCOM- 20040601
LR  - 20131121
IS  - 1524-4539 (Electronic)
IS  - 0009-7322 (Linking)
VI  - 109
IP  - 8
DP  - 2004 Mar 2
TI  - Safety and efficacy of enoxaparin compared with unfractionated heparin and oral 
      anticoagulants for prevention of thromboembolic complications in cardioversion of 
      nonvalvular atrial fibrillation: the Anticoagulation in Cardioversion using 
      Enoxaparin (ACE) trial.
PG  - 997-1003
AB  - BACKGROUND: Anticoagulation in cardioversion of atrial fibrillation is currently 
      performed with unfractionated heparin (UFH) and oral anticoagulants, with or 
      without guidance by transesophageal echocardiography (TEE). Low-molecular-weight 
      heparins may reduce the risk of bleeding, may obviate the need for intravenous 
      access, and do not require frequent anticoagulation monitoring. METHODS AND 
      RESULTS: In a randomized, prospective multicenter trial, we compared the safety 
      and efficacy of enoxaparin administered subcutaneously with intravenous UFH 
      followed by the oral anticoagulant phenprocoumon in 496 patients scheduled for 
      cardioversion of atrial fibrillation of >48 hours' and < or =1 year's duration. 
      Patients were stratified to cardioversion with (n=431) and without (n=65) 
      guidance by TEE. The study aimed to demonstrate noninferiority of enoxaparin 
      compared with UFH+phenprocoumon with regard to the incidence of embolic events, 
      all-cause death, and major bleeding complications. Secondary end points included 
      successful cardioversion, maintenance of sinus rhythm until study end, and minor 
      bleeding complications. Of 496 randomized patients, 428 were analyzed per 
      protocol. Enoxaparin was noninferior to UFH+phenprocoumon with regard to the 
      incidence of the composite primary end point in a per-protocol analysis (7 of 216 
      patients versus 12 of 212 patients, respectively; P=0.016) and in an 
      intention-to-treat analysis (7 of 248 patients versus 12 of 248 patients, 
      respectively; P=0.013). There was no significant difference between the 2 groups 
      in the number of patients reverted to sinus rhythm. CONCLUSIONS: Enoxaparin is 
      noninferior to UFH+phenprocoumon for prevention of ischemic and embolic events, 
      bleeding complications, and death in TEE-guided cardioversion of atrial 
      fibrillation. Its easier application and more stable anticoagulation may make it 
      the preferred drug for initiation of anticoagulation in this setting.
FAU - Stellbrink, Christoph
AU  - Stellbrink C
AD  - Medizinische Klinik I, Rheinisch-Westfalische Technische Hochschule Aachen, 
      Aachen, Germany. cstellbrink@ukaachen.de
FAU - Nixdorff, Uwe
AU  - Nixdorff U
FAU - Hofmann, Thomas
AU  - Hofmann T
FAU - Lehmacher, Walter
AU  - Lehmacher W
FAU - Daniel, Werner Gunther
AU  - Daniel WG
FAU - Hanrath, Peter
AU  - Hanrath P
FAU - Geller, Christoph
AU  - Geller C
FAU - Mugge, Andreas
AU  - Mugge A
FAU - Sehnert, Walter
AU  - Sehnert W
FAU - Schmidt-Lucke, Caroline
AU  - Schmidt-Lucke C
FAU - Schmidt-Lucke, Jan-Andre
AU  - Schmidt-Lucke JA
CN  - ACE (Anticoagulation in Cardioversion using Enoxaparin) Study Group
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20040216
PL  - United States
TA  - Circulation
JT  - Circulation
JID - 0147763
RN  - 0 (Anticoagulants)
RN  - 0 (Enoxaparin)
RN  - 9005-49-6 (Heparin)
RN  - Q08SIO485D (Phenprocoumon)
SB  - IM
MH  - Administration, Oral
MH  - Aged
MH  - Anticoagulants/administration & dosage/adverse effects/*therapeutic use
MH  - Atrial Fibrillation/complications/*therapy
MH  - Cardiovascular Diseases/mortality
MH  - Drug Therapy, Combination
MH  - *Electric Countershock/adverse effects
MH  - Enoxaparin/administration & dosage/adverse effects/*therapeutic use
MH  - Female
MH  - Hemorrhage/chemically induced
MH  - Heparin/administration & dosage/adverse effects/*therapeutic use
MH  - Humans
MH  - Incidence
MH  - Infusions, Intravenous
MH  - Injections, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - Phenprocoumon/administration & dosage/adverse effects/*therapeutic use
MH  - Safety
MH  - Thromboembolism/epidemiology/*prevention & control
MH  - Treatment Outcome
EDAT- 2004/02/18 05:00
MHDA- 2004/06/02 05:00
CRDT- 2004/02/18 05:00
PHST- 2004/02/18 05:00 [pubmed]
PHST- 2004/06/02 05:00 [medline]
PHST- 2004/02/18 05:00 [entrez]
AID - 01.CIR.0000120509.64740.DC [pii]
AID - 10.1161/01.CIR.0000120509.64740.DC [doi]
PST - ppublish
SO  - Circulation. 2004 Mar 2;109(8):997-1003. doi: 10.1161/01.CIR.0000120509.64740.DC. 
      Epub 2004 Feb 16.