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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.

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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