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PROTECT – TIMI 30 Trial

PROTECT – TIMI 30 Trial. Randomized Trial to Evaluate the Relative PROTECT ion against Post-PCI Microvascular Dysfunction and Post-PCI Ischemia among Anti-Platelet and Anti-Thrombotic Agents. Unresolved Issues Among UA / NSTEMI Patients Undergoing PCI.

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PROTECT – TIMI 30 Trial

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  1. PROTECT – TIMI 30 Trial Randomized Trial to Evaluate the Relative PROTECTion against Post-PCI Microvascular Dysfunction and Post-PCI Ischemia among Anti-Platelet and Anti-Thrombotic Agents

  2. Unresolved Issues Among UA / NSTEMI Patients Undergoing PCI • What is the magnitude of the incremental benefit provided by the addition of an intravenous antiplatelet agent (a GP IIb-IIIa inhibitor) to antithrombotic agents? • What is the magnitude and importance of ongoing ischemia, myonecrosis and inflammation following PCI and how do antiplatelet and antithrombin agents affect these processes? • How do we balance the risks (bleeding) and benefits (reduced myonecrosis) of these agents?

  3. PROTECT: Goals (Continued) • Efficacy: • Myocardial perfusion • Myonecrosis • Recurrent ischemia • Inflammation • Rebound thrombin production • Clinical outcomes • Safety: • Bleeding

  4. TIMI 30: The PROTECT Trial High-risk UA/NSTEMI for PCI of a native coronary artery with either DM; or + Troponin; or ST 0.5 mm; or TRS > 3 N = 857 TRANSFER TO CATH LAB, DIAGNOSTIC ANGIOGRAM CONFIRM ELIGIBLE FOR PCI OF CULPRIT IN NATIVE ARTERY Eptifibatide 180/180 mg/kg + 2 mg/kg/min + + Bivalirudin 0.75 mg/kg IVB + 1.75 mg/kg/h Low Dose Enoxaparin 0.5 mg/kg IV Low Dose UFH 50 U/kg IVBACT 200-250 Randomization stratified by Clopidogrel pretreatment >6 h and ≤6 h If not pretreated, then 300 mg Clopidogrel immediately prior to stenting. All tx’d with ASA

  5. Primary Efficacy Endpoint • Primary Efficacy Endpoint: • Coronary Flow Reserve (CFR) • The acceleration in blood flow after adenosine TIMI Frame Count PRE-adenosine TIMI Frame Count POST-adenosine • Interpreted by TIMI Angiographic Core Lab • Blinded to treatment and clinical outcomes Higher CFR means greater improvement in blood flow after adenosine e.g. a CFR of 2 would mean blood flow was twice as fast after adenosine

  6. Other Angiographic Efficacy Endpoint: TIMI Myocardial Perfusion (TMP) Grades TMP Grade 3 TMP Grade 2 TMP Grade 1 TMP Grade 0 Normal ground glass appearance of blush Dye mildly persistent at end of washout Dye strongly persistent at end of washout Gone by next injection Stain present Blush persists on next injection No or minimal blush 6.2% 5.1% p = 0.05 Mortality (%) 4.4% 2.0% n = 79 n = 434 n = 46 n = 203 Gibson et al, Circulation 2000

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