EXPEDITED REVIEW
A novel point-of-care enoxaparin monitor for use during percutaneous coronary intervention
Results of the Evaluating Enoxaparin Clotting Times (ELECT) Study
David J. Moliterno, MD, FACC*,*,
James B. Hermiller, MD, FACC ,
Dean J. Kereiakes, MD, FACC ,
Eric Yow, MS ,
Robert J. Applegate, MD, FACC||,
Gregory A. Braden, MD, FACC¶,
Eric J. Dippel, MD, FACC#,
Mark I. Furman, MD, FACC**,
Cindy L. Grines, MD, FACC ,
Neal S. Kleiman, MD, FACC ,
Glenn N. Levine, MD, FACC ,
Tift Mann, III, MD, FACC||||,
Ravi N. Nair, MD, FACC¶¶,
Ronald A. Stine, MD, FACC,##,
Steven J. Yacubov, MD, FACC*** and
James E. Tcheng, MD, FACC
* Departments of Cardiovascular Medicine, The Cleveland Clinic Foundation, Cleveland, Ohio, USA
St. Vincent's Hospital, Indianapolis, Indiana, USA
The Linder Center-Ohio Heart Health Center, Cincinnati, Ohio, USA
Duke Clinical Research Institute, Durham, North Carolina, USA
|| Wake Forest University, Winston-Salem, North Carolina, USA
¶ Forsythe Medical Center, Winston-Salem, North Carolina, USA
# Genesis Medical Center, Davenport, Iowa, USA
** University of Massachusetts, Worcester, Massachusetts, USA
 William Beaumont Hospital, Royal Oak, Michigan, USA
 Baylor College of Medicine and the Methodist DeBakey Heart Center, Houston, Texas, USA
 VA Medical Center-Houston, Houston, Texas, USA
|||| Wake Medical Center, Raleigh, North Carolina, USA
¶¶ University Hospitals-Case Western Reserve University, Cleveland, Ohio, USA
## Sentara Norfolk General, Norfolk, Virginia, USA
*** Riverside Methodist Hospital, Columbus, Ohio, USA
* Reprint requests and correspondence: Dr. David J. Moliterno, Department of Cardiovascular Medicine, The Cleveland Clinic Foundation, 9500 Euclid Avenue, F-25, Cleveland, Ohio 44195. molited{at}ccf.org
OBJECTIVES: The aim of this study was to discern a target range of anticoagulation for enoxaparin during percutaneous coronary intervention (PCI) as measured by the Rapidpoint ENOX (Pharmanetics Inc., Morrisville, North Carolina), a new point-of-care test.
BACKGROUND: In the U.S., enoxaparin has been used in only a small proportion of PCI procedures, partly because a rapid enoxaparin-specific assay was unavailable.
METHODS: We analyzed data from 445 enrolled patients receiving subcutaneous or intravenous enoxaparin in a prospective, multicenter study. Serial anticoagulation measurements and clinical outcomes were recorded.
RESULTS: The in-hospital composite occurrence of death, myocardial infarction, and urgent target vessel revascularization was 5.4%, and Thrombolysis In Myocardial Infarction (TIMI) major bleeding, minor bleeding, and any reported bleeding occurred in 0.2%, 1.3%, and 7.9% of patients, respectively. No significant association between procedural ENOX times and ischemic events was observed (p = 0.222), although the event rate was 4.0% among those with ENOX times between 250 to 450 s versus 7.2% for those outside this range (p = 0.134). Increasing ENOX time at sheath removal was correlated with any bleeding (p = 0.010) with a 1% increase for every 30-s rise.
CONCLUSIONS: Ischemic events were infrequent, and the rate appeared lowest in the mid-range of ENOX times. Bleeding events increased with increasing ENOX times. These observations, combined with a suggested procedural anti-Xa level of 0.8 to 1.8 IU/ml, translate into a recommended ENOX time range of 250 to 450 s for PCI and <200 to 250 s for sheath removal.
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Abbreviations and Acronyms
| | ACS | | acute coronary syndrome | | ACT | | activated clotting time | | FDA | | Food and Drug Administration | | GP | | glycoprotein | | IV | | intravenous | | LMWH | | low-molecular-weight heparin | | MI | | myocardial infarction | | PCI | | percutaneous coronary intervention | | SC | | subcutaneous | | TIMI | | Thrombolysis In Myocardial Infarction | | TVR | | target vessel revascularization | | UFH | | unfractionated heparin |
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