Abstract | BACKGROUND: OBJECTIVES: The goal of this study was to examine the outcomes of procedural anticoagulation with bivalirudin versus heparin ± GPI for primary PCI, given the evolution in primary PCI. METHODS: Databases from HORIZONS-AMI and EUROMAX were pooled for patient-level analysis. The Breslow-Day test evaluated heterogeneity between trials. RESULTS: A total of 5,800 patients were randomized to bivalirudin (n = 2,889) or heparin ± GPI (n = 2,911). The radial approach was used in 21.3% of patients, prasugrel/ ticagrelor was used in 18.1% of patients, and GPI was used in 84.8% of the control group. Bivalirudin compared with heparin ± GPI resulted in reduced 30-day rates of major bleeding (4.2% vs. 7.8%; relative risk [RR]: 0.53; 95% confidence interval [CI]: 0.43 to 0.66; p < 0.0001), thrombocytopenia (1.4% vs. 2.9%, RR: 0.48; 95% CI: 0.33 to 0.71; p = 0.0002), and cardiac mortality (2.0% vs. 2.9%; RR: 0.70; 95% CI: 0.50 to 0.97; p = 0.03), with nonsignificantly different rates of reinfarction, ischemia-driven revascularization, stroke, and all-cause mortality. Bivalirudin resulted in increased acute (<24 h) stent thrombosis rates (1.2% vs. 0.2%; RR: 6.04; 95% CI: 2.55 to 14.31; p < 0.0001), with nonsignificantly different rates of subacute stent thrombosis. Composite net adverse clinical events were lower with bivalirudin (8.8% vs. 11.9%; RR: 0.74; 95% CI: 0.63 to 0.86; p < 0.0001). There was no significant heterogeneity between the 2 trials for these outcomes, and results were consistent across major subgroups. CONCLUSIONS:
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Authors | Gregg W Stone, Roxana Mehran, Patrick Goldstein, Bernhard Witzenbichler, Arnoud Van't Hof, Giulio Guagliumi, Christian W Hamm, Philippe Généreux, Peter Clemmensen, Stuart J Pocock, Bernard J Gersh, Debra Bernstein, Efthymios N Deliargyris, Philippe Gabriel Steg |
Journal | Journal of the American College of Cardiology
(J Am Coll Cardiol)
Vol. 65
Issue 1
Pg. 27-38
(Jan 06 2015)
ISSN: 1558-3597 [Electronic] United States |
PMID | 25572507
(Publication Type: Comparative Study, Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Antithrombins
- Hirudins
- Peptide Fragments
- Platelet Glycoprotein GPIIb-IIIa Complex
- Recombinant Proteins
- Heparin
- bivalirudin
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Topics |
- Aged
- Antithrombins
(adverse effects, therapeutic use)
- Drug Therapy, Combination
- Female
- Heparin
(therapeutic use)
- Hirudins
(adverse effects)
- Humans
- Male
- Middle Aged
- Myocardial Infarction
(mortality, therapy)
- Peptide Fragments
(adverse effects, therapeutic use)
- Percutaneous Coronary Intervention
- Platelet Glycoprotein GPIIb-IIIa Complex
(antagonists & inhibitors)
- Recombinant Proteins
(adverse effects, therapeutic use)
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