1 / 24

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.

jewel
Télécharger la présentation

A D M I R A L

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related