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Heart Care Centers of Illinois

Heart Care Centers of Illinois. Design. Single arm, open label, 13 U.S. centers Patients with ST-segment elevation myocardial infarction (STEMI) Less than 12 hours duration No prior thrombolytic therapy Primary PCI required

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Heart Care Centers of Illinois

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  1. Heart Care Centers of Illinois

  2. Design • Single arm, open label, 13 U.S. centers • Patients with ST-segment elevation myocardial infarction (STEMI) • Less than 12 hours duration • No prior thrombolytic therapy • Primary PCI required • Patient population matched to CADILLAC by inclusion and exclusion criteria • Comparable efficacy endpoints

  3. Design (cont.) • Treatment: Bivalirudin 0.75mg/kg bolus, 1.75mg/kg/hr infusion for duration of procedure • Optional post-procedure infusion: 0.25mg/kg/hr • Abciximab if TIMI flow <3 at end of procedure • Primary endpoints of safety and efficacy evaluated at 7 days/hospital discharge, 30 days and 6 months

  4. Inclusion Criteria • Symptoms of STEMI for at least 30 min within previous 12 hours AND • ST-segment elevation in at least 2 contiguous leads or new LBBB or existing LBBB with positive troponin • Residual high grade stenosis and associated abnormalities in regional wall motion. • Planned primary PCI in native coronary vessel

  5. Exclusion Criteria • Prior LMWH, Thrombolytics, GP IIb/IIIa inhibitors • Cardiogenic shock (SBP <80 for >30 min or a need for intravenous pressors) • Stroke or neurosurgery within 3 months • Severe hypertension not adequately controlled by antihypertensive therapy at the time of study entry (BP >180/110 mm Hg) • Life expectancy <1 year • Heparin only therapy allowed prior to PCI • 30 minute washout, or • ACT <250

  6. Primary Endpoints • EfficacyEvaluated at 7 days/hospital discharge, at 30 days, and 6 months composite and individual components of: • Death (cardiac and unknown cause) • Reinfarction • Repeat intervention/revascularization of target lesion as a result of ischemia • Disabling stroke • Rate of subacute thrombosis at 7 days/hospital discharge and at 30 days

  7. Primary Endpoints • SafetyEvaluated at 7 days/hospital discharge: • Clinically significant bleeding defined as: • Intracranial, retroperitoneal, or ocular bleeding • Access site hemorrhage requiring surgical intervention or a >5cm diameter hematoma • Reduction in Hgb concentration of >3g/dL with overt bleeding • Any blood transfusion • Any reoperation for bleeding • Thrombocytopenia (<100,000 cells/L with a fall of >50% from baseline)

  8. BIAMI Sites

  9. Enrollment and Follow-up Patients Enrolled 201 ITT 201 PCI successful 194 Cath Only 4 PCI unsuccessful 3 Safety 201 7-day 201 30-day 197 4 patients lost to f/u 6-month 190 11 patients lost to f/u Ed. 4/19

  10. CADILLAC • Comparison with CADILLAC entry criteria and efficacy prespecified in protocol • CADILLAC, 2082 AMI patients, 2x2 factorial design (PTCA or stent with and without abciximab) • Abciximab/stent group (n=524) used as comparison • Highest % TIMI 3 flow rate end of procedure • Lowest composite endpoint at 30 days and 6 months G. Stone M.D., C. Grines M.D., D. Cox M.D. N Engl J Med, Vol. 346, No. 13 March 28, 2002

  11. Patient Characteristics CADILLAC Comparison

  12. Target Vessel/Lesion Characteristics Ed 5/9

  13. PCI Therapy Stentsn • Drug Eluting Stents 123 • Cypher 69 • Taxus 64 • Bare Metal Stents 54 • Drug Eluting and Bare Metal 10 • Thrombectomy 16

  14. Anticoagulation • All patients received bivalirudin during their PCI • 60% of patients received UFH before their intervention • 40% of patients received NO UFH, only bivalirudin • NO significant bleeding occurred in the patient population that received BOTH UFH and bivalirudin • Mean ACT 189 seconds in patients who received UFH.

  15. Concomitant Meds

  16. Concomitant Meds n/N 20/197 12/20 % 10.1 60.0 • Abciximab bolus and infusion • Administration for less than TIMI-3 flow post procedure • TIMI-3 flow achieved post-Abcixmab

  17. Of the 194 patients with a successful PCI, 86 required post-procedure anticoagulation: Angiomax® 64 patients Heparin 14 patients Both 8 patients

  18. Post Procedure Heparin (non CABG) • Reasons for heparin continuation • IABP • Transition to Warfarin • DVT / PE prophylaxis • Other

  19. Post Procedure Angiomax® (non CABG) * Only 25 patients had greater than 30 minutes Angiomax

  20. Pre/Post-Procedure TIMI Flow * Visible Thrombus present prior to procedure in 61.2% of patients. Ed 4/21

  21. Primary Endpoint * Both strokes post CABG** SAT not collected to 6 months Ed. 5/9

  22. Efficacy 30 days: Patient Details 03/23

  23. Efficacy 30 days: Patient Details contd. 03/23

  24. Deaths at 30 days : Patient Details

  25. Bleeding Endpoint • All bleeds had post procedural anticoagulation Ed 5/9

  26. Clinically Significant Bleeding : Details All bleeds had post procedural anticoagulation/antiplatelet Ed 04/21

  27. 30-Day Clinical Outcomes Comparison to CADILLAC * Two Strokes Post CABG Ed. 5/9

  28. 6-Month Clinical Outcomes Comparison to CADILLAC * Two Strokes Post CABG Ed. 4/18

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