Prise en charge du SCA ST + en urgence. 9803mo01, 1

Transcription

1 Prise en charge du SCA ST + en urgence 9803mo01, 1

2 9803mo01, 2

3 Trial of Routine ANgioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction The TRANSFER-AMI trial Warren J. Cantor, David Fitchett, Bjug Borgundvaag, Michael Heffernan, Eric A. Cohen, Laurie J. Morrison, John Ducas, Anatoly Langer, Shamir Mehta, Charles Lazzam, Brian Schwartz, Vladimir Dzavik, Amparo Casanova, Paramjit Singh, Shaun G. Goodman on behalf of the TRANSFER-AMI Investigators 9803mo01, 3

4 High Risk ST Elevation MI within 12 hours of symptom onset Community Hospital Emergency Department TNK + ASA + Heparin / Enoxaparin + Clopidogrel Pharmacoinvasive Strategy Urgent Transfer to PCI Centre Standard Treatment Assess chest pain, ST resolution at minutes after randomization Failed Reperfusion* Successful Reperfusion PCI Centre Cath Lab Cath / PCI within 6 hrs Cath and Rescue Elective Cath regardless of PCI ± GP IIb/IIIa ± PCI reperfusion status Inhibitor > 24 hrs later Repatriation of stable patients within 24 hrs of PCI * ST segment resolution < 50% & persistent chest pain, or hemodynamic instability Randomization stratified by age ( 75( vs. > 75) and by enrolling site 9803mo01, 4

5 Procedures Cardiac Cath performed (%) Time- TNK to Cath (hrs) PCI performed (%) Stent used (% of PCI cases) Time- TNK to PCI (hrs) PCI within 6 hrs of TNK (%) PCI within 12 hrs of TNK (%) GP IIb/IIIa inhibitor use (%) Time- TNK to GP IIb/IIIa inhib.. (hrs) IABP use (%) CABG performed (%) Standard Treatment (n=508) (4, 69) (4, 73) (4, 63) 6 8 Pharmacoinvasive Strategy (n=522) 97 3 (2, 4) (3, 5) (3, 5) mo01, 5

6 % of Patients n=496 n=508 Primary Endpoint: 30-Day Death, re-mi, CHF, Severe Recurrent Ischemia, Shock OR=0.537 (0.368, 0.783); p= Days from Randomization Standard (n=496) Pharmacoinvasive (n=508) mo01, 6

7 Components of Primary Endpoint Death Reinfarction Recurrent Ischemia Death/MI/Ischemia New / worsening CHF Cardiogenic Shock Standard Treatment (n=498) Pharmacoinvasive Strategy P-Value (n=512) mo01, 7

8 9803mo01, 8

9 ClinicalTrials.gov Identifier: NCT Abciximab in Patients with AMI Undergoing Primary PCI After Clopidogrel Pretreatment BRAVE-3 Trial Bavarian Reperfusion AlternatiVes Evaluation-3 Trial J. Mehilli, A. Kastrati, K. Huber, S. Schulz, J. Pache, C.Markwardt, S. Kufner, F. Dotzer, K. Schlotterbeck, J. Dirschinger, A. Schömig 9803mo01, 9

10 Study Therapy (randomized, double-blind) Clopidogrel 600 mg oral Aspirin 500 mg i.v. or oral Unfractionated Heparin 5000 IU Abciximab n=401 Bolus: 0.25 mg/kg Infusion: µg/kg/min/12h Placebo n=399 Additional UFH bolus of 70U/kg Placebo infusion for 12h Aspirin 200mg/day indefinitely Clopidogrel 2 x 75mg/day for 3 days Clopidogrel 75mg/day for at least 4 weeks 9803mo01, 10

11 Time Intervals Symptom to admission Abciximab (n=401) 210[110;420] Placebo (n=399) 216[110;467] Admission to study drug 25[15;43] 20[14;40] Clopidogrel loading to PCI 73[54;104] 75[53;105] Admission to PCI 78[59;109] 80[58;110] Median [25 th, 75 th percentiles] in minutes 9803mo01, 11

12 Primary Endpoint % LV 20 Final infarct size Mean P =.47 15,7 16,6 40 % LV Final infarct size Median [25th; 75th percentile] P = Abciximab Placebo 0 Abciximab Placebo 9803mo01, 12

13 Clinical Adverse Events - 30 days - 6 % P =.46 P =.48 P = Death/MI Death/MI/Stroke Death/MI/Stroke/uTVR Abciximab Placebo 9803mo01, 13

14 Conclusion In patients with acute STEMI undergoing primary PCI after pre-treatment with a 600mg loading dose of clopidogrel, the additional use of abciximab is not associated with further reduction in infarct size 9803mo01, 14

15 Time Intervals Symptom to admission Admission to study drug Clopidogrel loading to PCI Admission to PCI 290 min for PCI Abciximab (n=401) 210[110;420] 25[15;43] 73[54;104] 78[59;109] Placebo (n=399) 216[110;467] 40% d IDM ant. 20[14;40] 75[53;105] 80[58;110] Median [25 th, 75 th percentiles] in minutes 9803mo01, 15

16 Discussion Importance de l organisation à «l avance» Réseau du SCA ST+ Traitement précoce Orientation adaptée Nouvelles recommandations européennes pour octobre mo01, 16