Heparin manufacturing Characteristics of ufh and lmwh chains



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Heparin manufacturing




Characteristics of UFH and LMWH Chains



Sites of Anti-thrombotic Drug Action





Treatment—LMWH: Enoxaparin for Non ST  ACS TIMI 11B/ESSENCE Meta-Analysis of Death/MI



Enoxaparin Outcomes



TESSMA: TIMI 11B + ESSENCE Meta-Analysis 1 Yr Follow-up



Study Design and Protocol







Enoxaparin Meta-analysis Triple Composite Event Rates



Superior

  • Superior

  • Yield of the

  • New strategy of

  • Enoxaparin,

  • Revascularization &

  • GlYcoprotein IIb/IIIa Inhibitors







Enoxaparin UFH Unadjusted (n = 4993) (n = 4985) P-value

  • Enoxaparin UFH Unadjusted (n = 4993) (n = 4985) P-value

  • Death and MI (%) 14.0 14.5 0.396

  • Death (%) 3.2 3.1 0.705

  • MI (%) 11.7 12.7 0.135











LMWH in ACS/AMI and PCI

  • Pre-Treatment +/- GP IIb/IIIa

    • ESSENCE/TIMI-11b (n = 239)
    • PEPCI (n = 48)
    • NICE – 3 (n = 661)
    • Collet Trial (n = 132)
  • No Pre-Treatment +/- GP IIb/IIIa

    • NICE – 1 (n = 828)
    • NICE – 4 (n = 818)
    • CRUISE (n = 129)
    • Choussat Trial (n = 242)
  • Post-Thrombolysis for AMI

    • ASSENT – 3 (n = 590)
    • ENTIRE / TIMI – 23 (n = 121 )


Performing angioplasty is like

  • Performing angioplasty is like

  • flying a jet airplane –



Enoxaparin in PCI



NICE 1 and NICE 4

  • NICE 1 (n = 828)

    • Enoxaparin
    • 1 mg/kg IV
    • without GP IIb/IIIa


NICE-1 and 4: Enoxaparin in PCI



NICE 1 and NICE 4



NICE 3 Protocol



NICE 3



CRUISE: Enoxaparin vs UFH in PCI with Eptifibatide











Anti-Xa Activity With LMW Heparin Administration



Enoxaparin pK Modeling 1 mg/kg sc



Enoxaparin in PCI in Patients with ACS

  • 451 pts with UA/NQWMI rx’d with enoxaparin for 48 hrs.

  • 293 underwent cath within 8 hrs of AM enox. dose

  • 132 ad hoc PCI, no additional UFH/LMWH

  • 30d: Death=1.5%, MI=3.0%, Maj. Bleeding = 0.8%

  • Mean anti-Xa at PCI=0.98+0.03 IU/ml,



Enoxaparin in PCI



Monitoring of the anticoagulant effect

  • Monitoring of the anticoagulant effect

  • (anti-Xa effect) of enoxaparin on clotting



RapidPoint











Enoxaparin Key Principles

  • Subcutaneous dosing

    • delay between dose and effect (peak 3-4h)
    • not therapeutic from dose 1
    • steady-state only after 3-4 doses
    • ~5% of patients still <0.6 anti-Xa IU/ml
  • Cath lab considerations

    • no monitoring available
    • t½ of subq enox ~8h (sheath pull)
    • adverse interactions between enox + UFH, enox + GP IIb/IIIa (↑ anticoagulation → bleeding, adverse events)
    • pharmacodynamics of IV enox = IV UFH


Enoxaparin ED to Diagnostic Cardiac Catheterization

  • ED (AMI, ACS):

    • 1.0 mg/kg subq (0.75 mg/kg if age >75)
    • (optional 30 mg IV bolus if age <75)
  • inpatient: 1.0 mg/kg subq q12°

  • dx cath:

    • <12h since subq dose: no additional anticoagulation
    • >12h since subq dose: manage anticoag as de novo
  • sheath pull timing:

    • ~4 hrs after 1 subq dose
    • ~6 hrs after 2 subq doses
    • ~8 hrs after >2 subq doses


Enoxaparin Percutaneous Coronary Intervention

  • PCI:

    • 1 dose subq enoxaparin <8h: 0.3 mg/kg IV
    • >2 doses subq, last dose <8h: 0.1 mg/kg IV
    • last subq enoxaparin 8-12h: 0.3 mg/kg IV
    • >12h, or de novo:
      • with GP IIb/IIIa: 0.5-0.6 mg/kg IV
      • without GP IIb/IIIa: 0.75-1.0 mg/kg IV
  • sheath pull timing (whichever is greater):

    • IV enoxaparin only: ~4h after dose
    • 1-2 doses of subq enoxaparin: ~6h after dose
    • >3 doses of subq enoxaparin: ~8h after dose


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