1 / 9

J. Mehilli , A. Kastrati, K. Huber, S. Schulz, J. Pache, C.Markwardt, S. Kufner, F. Dotzer, K. Schlotterbeck, J. Dirsc

ClinicalTrials.gov Identifier: NCT00133250. Abciximab in Patients with AMI Undergoing Primary PCI After Clopidogrel Pretreatment. BRAVE-3 Trial B avarian R eperfusion A lternati V es E valuation-3 Trial.

nusa
Download Presentation

J. Mehilli , A. Kastrati, K. Huber, S. Schulz, J. Pache, C.Markwardt, S. Kufner, F. Dotzer, K. Schlotterbeck, J. Dirsc

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. ClinicalTrials.gov Identifier: NCT00133250 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.

  2. Background • Glycoprotein IIb/IIIa inhibitors (GPI) may improve the results of primary PCI in acute STEMI • Pretreatment with a 300mg loading dose of clopidogrel improved the outcome of patients undergoing PCI in the setting of the CLARITY trial • A higher, 600mg loading dose of clopidogrel further enhances and accelerates platelet inhibition

  3. Objective ..to assess whether abciximab further reduces the infarct size in patients with acute ST-elevation myocardial infarction undergoing PCI after pretreatment with 600 mg clopidogrel

  4. Myocardial perfusion % 0% 100% 50% Endpoints Primary endpoint: • SPECT study (5-7days after • randomization) • Final infarct size • (% of the left ventricle) Secondary endpoints: • Death • Myocardial reinfarction • Urgent revascularization • Stroke • Major and minor bleedings (TIMI criteria) • Profound thrombocytopenia

  5. Study Therapy (randomized, double-blind, multicenter) Clopidogrel 600 mg oral Aspirin 500 mg i.v. or oral Unfractionated Heparin 5000 IE Abciximab n=401 Placebo n=399 Aspirin 200mg/day indefinitely Clopidogrel 2 x 75mg/day for 3 days Clopidogrel 75mg/day for at least 4 weeks

  6. Reperfusion Strategy P =.80 100 Drug-eluting stents % Bare metal stents PTCA 60 Medical treatment 20 Abciximab Placebo

  7. Primary Endpoint Final infarct size Mean Final infarct size Median[25th; 75th percentile] 40 P =.76 P = .47 % LV % LV 30 20 10 10 9 0 Abciximab Placebo Abciximab Placebo

  8. 30-Day Mortality P= .53 6 % Abciximab 4 Cumulative Incidence Placebo 2 0 0 5 10 15 20 25 30 Days after randomization

  9. 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 notassociated with further reduction in infarct size

More Related