AntiThrombotic Therapy in the Cath Lab

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AntiThrombotic Therapy in the Cath Lab: Preliminary Results from the NICE TrialsCindy L. Grines, M.D. William Beaumont Hospital Royal Oak, Michigan

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Karsh, JACC 1996;28:1437

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*30% of PTCA pts required additional heparin boluses†††††† p < .001TFPI = tissue factor pathway inhibitorACT (s)aPTT (s)TFPI (ng/ml)Anticoagulation Effect: IV Enoxaparin vs IV Heparin

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CharacteristicEnoxaparin (n=30)Unfractionated Heparin (n=30)p ValuePost-PTCA stenosis (%) TIMI 3 flow (% pts) Major dissection post-PTCA (% pts) Ischemic complications (% pts) Bleeding events (% pts) Vascular events (% pts)14 ± 18.2 97 3 0 1 016 ± 18.1 93 0 3 0 10.70 1.00 0.24 0.24 0.49 1.00

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IV Enoxaparin For Elective PTCAConclusions: Compared to conventional unfractionated heparin, a single bolus of IV enoxaparin was safe achieved more consistent antithrombotic effect with less anticoagulant effect may eliminate need for hematologic monitoring

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LMWH For Interventional ProceduresWhat is Yet To Be Determined? Is IV LMWH clinically superior to conventional heparin? Are higher doses (greater anti-Xa effect) necessary to be superior to heparin? What is the appropriate dose of LMWH if a SQ dose has been given, or if IIb/IIIa agents are given?

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Ongoing Studies Of IV Enoxaparin Instead Of Conventional Heparin For Coronary InterventionStudyPInDoseGoalNICE 1 NICE 4Grines Kereiakes810 (complete) 818 (complete)1 mg/kg 0.75 mg/kg plus abciximabSafety Safety

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Goals of NICE 1 and NICE 4Safety - major bleeding, MACE Large non-randomized data set  compare to recent historical controls (EPILOG and EPISTENT) Inclusion criteria - similar to EPILOG

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NICE 1 and 4: Preliminary ResultsNICE 1NICE 4Complete data Enoxaparin dose (mg) Abciximab bolus (mg) infusion (g/min) # Vessels PCI 1 (%) 2 (%) 3 (%) 4 (%) 5 (%) Stent utilization (%) (any lesion)309 (38%) 86 0 0 50.2 30.7 13.3 3.2 1.9 84.8310 (38%) 65 21.5 10.0 47.4 31.9 16.5 2.6 1.0 85.5

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Safety DataNICE 1NICE 4Major bleeding, 30d (%) Non CABG bleed (%) Any transfusion (%) > 30%  in platelets (%) Platelets < 50,0000.6 0.3 1.6 2.6 00.3 0 1.3 8.9 1.6EPI- LOG (Abciximab/ Low dose heparin)EPI- STENT (Stent/ abciximab)2.0 1.1 1.6 NR NR1.4 0.6 3.1 NR NR

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NICE 1 and 4: Clinical Outcomes at 30 DaysNICE 1 (Enoxaparin) (n=309)NICE 4 (Enoxaparin/Abciximab) (n=310)Death (%) MI (%)* Urgent Revasc. (%) Death + MI (%) Death, MI, Urgent Revasc. (%)1.3 2.6 1.9 3.6 4.90.3 1.9 0.6 2.3 2.3* Investigator defined

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NICE 1 and 4: Myocardial InfarctionNICE 1 (Enoxaparin) (n=309)NICE 4 (Enoxaparin/Abciximab) (n=310)Clinical infarction (%) Any CK  3 x normal Any MB  3 x normal (CK may be normal)2.6 3.3 7.81.9 4.2 12.4

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Conclusions Based on Preliminary NICE ResultsIV enoxaparin, used instead of UFH for coronary interventions: Is associated with low rate of major bleeding Slightly higher rates of CKMB release may represent more aggressive PCI (paradoxically higher with abciximab) Appears safe and effective

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Last Updated: 8th March 2018

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