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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

View larger version (31K): [in a new window]   Figure 1 The Rapidpoint ENOX coagulation monitor card technology. Within the device an oscillating magnet moves the paramagnetic iron oxide particles (PIOP) on the card once the dry reagent dissolves from the added whole blood. After Factor Xa activation, coagulation occurs and the reduced motion of the iron particles is detected by a change in reflected infrared light.

View larger version (16K): [in a new window]   Figure 2 Distribution of patients enrolled in ELECT according to anticoagulation received. GP = glycoprotein; IV = intravenous; PCI = percutaneous coronary intervention; Rx = treatment; SC = subcutaneous.

View larger version (32K): [in a new window]   Figure 3 Correlation of ENOX times with anti-Xa levels in the ELECT study. The ENOX test card reports clotting times to a maximum of 700 s.

View larger version (13K): [in a new window]   Figure 4 Kernel smoothing regression and 95% confidence interval lines assessing the occurrence of major adverse cardiac events (MACE) over the range of procedural ENOX times. For display purposes, several ENOX values <200 were truncated at 200 and several >600 were truncated at 600.

View larger version (14K): [in a new window]   Figure 5 Kernel smoothing regression and 95% confidence interval lines assessing the occurrence of any bleeding event over the range of ENOX times prior to sheath removal. For display purposes, several ENOX values <200 were truncated at 200 and several >600 were truncated at 600.