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A D M I R A L

ADMIRAL. ADMIRAL Study. A D M I R A L. Abciximab before Direct Angioplasty and Stenting in Myocardial Infarction Regarding Acute and Long term follow-up. Aim of the Study.

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A D M I R A L

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  1. ADMIRAL ADMIRAL Study A D M I R A L Abciximab before Direct Angioplasty and Stenting in Myocardial Infarction Regarding Acute and Long term follow-up

  2. Aim of the Study To demonstrate the superiority of abciximab over placebo in primary PTCA with stenting in acute myocardial infarction ESC

  3. Design-Inclusion Criteria • Multicenter • Randomized • Double-Blind • Placebo Controlled • 2 x 150 patients included-July 1997-Dec.1998 • > 18 years old • Clinical Diagnosis of AMI ( ischemic pain > 30 min. ) • Onset of symptoms < 12 hours • ST elevation > 1 mm in at least 2 contiguous leads • Referred for Urgent Primary PTCA • Written informed consent before randomization ESC

  4. Design-Exclusion Criteria • Major Exclusion Criteria • Hemorrhagic risk factors • Current episode previously treated by thrombolytics • Cardiogenic shock • Life expectancy < 1 year • Contraindications to PTCA • Stenosis < 50% and TIMI 3 Flow in the IRA • Occluded vessel of minor angiographic importance • Culprit lesion not visualized ESC

  5. Criteria for Stent Implantation • Coronary artery diameter > 2.5 mm • Accessible by a stent • No massive calcification ESC

  6. Study Drugs • Abciximab or Placebo0.25 mg/kg bolus plus 0.125 mg/kg/min 12-hour infusion,as soon as AMI is diagnosed and before any sheath insertion,administered either in • the ambulance (MICU) • the emergency room • the catherization laboratory • Unfractionated heparin • Prior to intervention : 70 U/kg as a bolus (<7000 U) • Maintain ACT > 200 seconds pre and post PTCA until the second angiogram • Infusion rate of 7 U/kg/hour • Aspirin : 100-325 mg once daily during 6 months • Ticlopidine : 250 mg twice daily during 30 days if stent is used ESC

  7. Design AMI < 12 hours randomization Abciximab + Heparin, ASA, Ticlopidine Placebo + Heparin, ASA, Ticlopidine First Coronary Angiography PTCA + Stent First Coronary Angiography PTCA + Stent Coronary Angiography at 24 h and 6 Months Coronary Angiography at 24 h and 6 Months Clinical evaluation (24 h, 30 Days and 6 Months ESC

  8. Demographics Abciximab n = 150 Placebo n = 150 Male (%) 85.2 78.7 Age (years) 59.6 + 13.062.1 + 12.8 Weight (kg) 75.9 + 12.5 76.5 + 15.1 Prior MI (%) 14.1 7.3* Prior UA (%) 8.7 7.3 Prior Stable Angina (%) 4.7 4.7 Prior PTCA (%) 6.7 2.7* Prior Stent (%) 0.1 0.1 Prior CABG (%) 2.0 2.7 CAD Family History (%) 28.9 28.7 * p < 0.05 ESC

  9. Demographics Abciximab n = 150 Placebo n = 150 Smoker (%) 45.0 39.3 Hypertension (%) 39.3 41.3 Diabetes (%) 15.4 20.0 Hyperlipidemia (%) 39.6 37.3 Killip I (%) 89.9 89.3 ESC

  10. Procedures Abciximab n = 150 Placebo n = 150 Initial coronary angiogram (%) 98.7 99.3 Balloon angioplasty (%) 90.6 94.0 Stent placed (%) 83.9 86.0 24-hour Coronary Angiogram (%) 84.6 87.3 ESC

  11. Procedures Abciximab n = 150 Placebo n = 150 Stent placed (%) 83.9 86.0 Saint-Come stent placed (%) 65.1 64.6 Number of stent(s) / patient (%) 1 70.4 65.9 2 21.6 24.8 3 or more 8.0 9.3 Primary Success Rate (%) 94.4 94.6 ˆ ESC

  12. Medications Abciximab n = 150 Placebo n = 150 Aspirin (%) 96.6 96.0 Ticlopidine (%) 83.2 84.7 Received Study Drug Agent (%) • Bolus 100.0 99.3 • Bolus + Infusion 99.0 96.7 Prehospital administration (MICU) 10.7 11.3 Emergency Room administration 14.1 15.3 CCU or Cath Lab administration 75.2 73.4 ESC

  13. Time to Treatments Abciximab n = 150 Placebo n = 150 • Time from onset of chest pain: • to treatment (hrs) 3.2 + 2.5 3.5 + 2.4 • to bolus (hrs) 3.7 + 2.1 4.1 + 2.5 • to coronary angiogram (hrs) 3.9 + 2.1 4.4 + 2.6 • to PTCA (hrs) 4.1 + 2.1 4.6 + 2.6 ESC

  14. AMI Characteristics Abciximab n = 150 Placebo n = 150 Anterior AMI (%) 35.8 40.7 Inferior AMI (%) 50.7 46.7 Other AMI (%) 14.5 12.6 Right Coronary Artery (%) 38.0 35.3 Left Anterior Desc. Artery (%) 33.3 34.0 Circumflex Coronary Artery (%) 9.3 10.0 Other Coronary Arteries (%) 18.7 19.4 Vein Graft (%) 0.7 1.3 ESC

  15. Primary Endpoint • Percentage of ischemic events within the first 30 days: • Death • Recurrent MI • Urgent target vessel revascularization (PTCA or CABG) • Urgent TVR: performed within 24 hours from the onset of a new acute ischemic episode • Recurrent MI • within 24 hours of study entry: CK or CK-MB definitions • between 24 h and 7 days: ECG or CK-MB definitions • > 7 days: ECG or CK-MB definitions ESC

  16. 100 p < 0.02 92.0 90.4 89.9 80 84.4 83.7 82.5 60 % of Patients 40 p < 0.01 20 21.0 10.3 0 Initial After Balloon After stent 24-hours Placebo Abciximab ESC Angiographic Results: TIMI 3 flow rates

  17. 75 p < 0.05 p < 0.05 54.6 51.4 50 24-hour LVEF (%) 25 0 Abciximab n = 150 Placebo n = 150 ESC Left Ventricular Function

  18. Death, Recurrent MI, Urgent TVR 20 p = 0.02 15.3 - 52.3 % 15 % of Patients 10 7.3 5 0 Placebo n = 150 Abciximab n = 150 ESC Primary Endpoint (30 days)

  19. 10 p = 0.33 p = 0.02 7.3 6.7 - 54.8% - 80.0% % of Patients 5 3.3 p = 0.65 - 35.0% 2.0 1.3 1.3 0 Death Recurrent MI Urgent TVR Placebo Abciximab ESC Primary Endpoint Components (30 days)

  20. Death, Recurrent MI, Any Revascularization 30 p = 0.03 22.0 - 39.5 % 20 % of Patients 13.3 10 0 Placebo n = 150 Abciximab n = 150 ESC Secondary Endpoint (30 days)

  21. 10 p = 0.02 p = 0.50 8 6.7 6 % of Patients 4.0 4 2.6 1.3 2 0 Major Minor Placebo Abciximab ESC Bleeding Events

  22. - Preliminary Results Major Bleeding Events 10 8 6 % of Patients 4.0 4 2.6 2.0 2.0 1.7 2 0.9 0 Total CABG related Non-CABG related Placebo Abciximab ACC

  23. 6 4 % of Patients 2.0 2 1.4 1.3 0.7 0.6 0.6 0 Cerebral Blood Transfusions Other Major Placebo Abciximab ACC - Preliminary Results Major Bleeding Events

  24. Conclusions • In patients with acute myocardial infarction, abciximab in conjunction with primary stenting positively improved: • early TIMI 3 flow rate • left ventricular function • 30-day clinical results • The excess in minor bleeding may be due to the24-hour arterial sheath ESC

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