PMID- 24184894
OWN - NLM
STAT- MEDLINE
DCOM- 20140617
LR  - 20161125
IS  - 1557-2501 (Electronic)
IS  - 1042-3931 (Linking)
VI  - 25
IP  - 11
DP  - 2013 Nov
TI  - Safety of very early sheath removal in patients treated with REG1 for acute 
      coronary syndromes: insights from the RADAR trial.
PG  - 593-9
AB  - BACKGROUND: RADAR compared REG1 (25%, 50%, 75%, 100% reversal) with 
      unfractionated heparin (UFH) in 640 acute coronary syndrome (ACS) patients (479 
      REG1 patients, 161 UFH patients) undergoing an invasive management strategy. We 
      sought to determine whether the REG1 anticoagulation system allows for safer 
      early arterial sheath removal following cardiac catheterization. METHODS: REG1 
      patients had arterial sheath removal immediately post catheterization. We 
      measured arterial sheath management outcomes and vascular access complications in 
      patients who had sheath removal without vascular closure device implantation; 461 
      patients were included (349 REG1 patients, 112 UFH patients). RESULTS: The median 
      (25th, 75th) time from end of catheterization to arterial sheath removal was 
      shorter in REG1 arms regardless of reversal strategy (26 minutes [18, 46]) 
      compared with UFH (210 minutes [102, 342]). There was no increase in median time 
      from sheath removal to hemostasis (10 minutes [10, 20] and 10 minutes [10, 20]; 
      P=.60); vascular access-site bleeding complications were numerically fewer with 
      REG1 than UFH (6% vs 11%; odds ratio [OR], 0.57; 95% CI, 0.27-1.18; P=.14). There 
      were no differences in time to ambulation or hospital length of stay between the 
      groups. CONCLUSIONS: REG1 allows for very early arterial sheath removal following 
      cardiac catheterization without increasing the time to hemostasis or vascular 
      access-site bleeding complications. Further studies are needed to determine 
      whether anticoagulation with REG1 will translate into shorter hospital lengths of 
      stay and reduced costs in ACS patients.
FAU - Vavalle, John P
AU  - Vavalle JP
AD  - Department of Medicine, Box 31356, Durham, NC 27710 USA. john.vavalle@duke.edu.
FAU - Povsic, Thomas J
AU  - Povsic TJ
FAU - Aberle, Laura H
AU  - Aberle LH
FAU - Zelenkofske, Steven L
AU  - Zelenkofske SL
FAU - Mehran, Roxana
AU  - Mehran R
FAU - Kasprzak, Jaroslaw D
AU  - Kasprzak JD
FAU - Bode, Christoph
AU  - Bode C
FAU - Buller, Christopher E
AU  - Buller CE
FAU - Montalescot, Gilles
AU  - Montalescot G
FAU - Cornel, Jan H
AU  - Cornel JH
FAU - Becker, Richard C
AU  - Becker RC
FAU - Alexander, John H
AU  - Alexander JH
FAU - Cohen, Mauricio G
AU  - Cohen MG
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Invasive Cardiol
JT  - The Journal of invasive cardiology
JID - 8917477
RN  - 0 (Anticoagulants)
RN  - 9005-49-6 (Heparin)
SB  - IM
MH  - Acute Coronary Syndrome/blood/diagnostic imaging/*surgery
MH  - Aged
MH  - Anticoagulants/administration & dosage
MH  - Cardiac Catheterization/adverse effects/*instrumentation
MH  - Device Removal/adverse effects/*methods
MH  - Female
MH  - Follow-Up Studies
MH  - Heparin/administration & dosage
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Percutaneous Coronary Intervention/adverse effects/*instrumentation
MH  - Postoperative Hemorrhage/etiology/*prevention & control
MH  - Radiography
MH  - Single-Blind Method
MH  - Thrombosis/prevention & control
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2013/11/05 06:00
MHDA- 2014/06/18 06:00
CRDT- 2013/11/05 06:00
PHST- 2013/11/05 06:00 [entrez]
PHST- 2013/11/05 06:00 [pubmed]
PHST- 2014/06/18 06:00 [medline]
PST - ppublish
SO  - J Invasive Cardiol. 2013 Nov;25(11):593-9.