Gregg W Stone1, Tim Clayton2, Efthymios N Deliargyris3, Jayne Prats3, Roxana Mehran4, Stuart J Pocock2. 1. Columbia University Medical Center, New York, New York; The Cardiovascular Research Foundation, New York, New York. Electronic address: gs2184@columbia.edu. 2. London School of Hygiene and Tropical Medicine, London, United Kingdom. 3. The Medicines Company, Parsippany, New Jersey. 4. The Cardiovascular Research Foundation, New York, New York; Mount Sinai Medical Center, New York, New York.
Abstract
OBJECTIVES: The purpose of this study was to determine whether, in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primarypercutaneous coronary intervention (PCI), the reduction in cardiac mortality in those taking bivalirudin compared with unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (UFH+GPI) can be fully attributed to reduced bleeding. BACKGROUND: The association between hemorrhagic complications and mortality may explain the survival benefit with bivalirudin. METHODS: A total of 3,602 STEMI patients undergoing primary PCI were randomized to bivalirudin versus UFH+GPI. Three-year cardiac mortality was analyzed in patients with and without major bleeding. RESULTS: When compared with UFH+GPI, bivalirudin resulted in lower 3-year rates of major bleeding (6.9% vs. 10.5%, hazard ratio [HR]: 0.64 [95% confidence interval (CI): 0.51 to 0.80], p < 0.0001) and cardiac mortality (2.9% vs. 5.1%, HR: 0.56 [95% CI: 0.40 to 0.80], p = 0.001). Three-year cardiac mortality was reduced in bivalirudin-treated patients with major bleeding (20 fewer deaths with bivalirudin; 5.8% vs. 14.6%, p = 0.025) and without major bleeding (18 fewer deaths with bivalirudin; 2.6% vs. 3.8%, p = 0.048). In a fully-adjusted multivariable model accounting for major bleeding and other adverse events, bivalirudin was still associated with a 43% reduction in 3-year cardiac mortality (adjusted HR: 0.57 [95% CI: 0.39 to 0.83], p = 0.003). CONCLUSIONS:Bivalirudin reduces cardiac mortality in patients with STEMI undergoing primary PCI, an effect that can only partly be attributed to prevention of bleeding. Further studies are required to identify the nonhematologic benefits of bivalirudin. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction; NCT00433966).
RCT Entities:
OBJECTIVES: The purpose of this study was to determine whether, in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), the reduction in cardiac mortality in those taking bivalirudin compared with unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (UFH+GPI) can be fully attributed to reduced bleeding. BACKGROUND: The association between hemorrhagic complications and mortality may explain the survival benefit with bivalirudin. METHODS: A total of 3,602 STEMI patients undergoing primary PCI were randomized to bivalirudin versus UFH+GPI. Three-year cardiac mortality was analyzed in patients with and without major bleeding. RESULTS: When compared with UFH+GPI, bivalirudin resulted in lower 3-year rates of major bleeding (6.9% vs. 10.5%, hazard ratio [HR]: 0.64 [95% confidence interval (CI): 0.51 to 0.80], p < 0.0001) and cardiac mortality (2.9% vs. 5.1%, HR: 0.56 [95% CI: 0.40 to 0.80], p = 0.001). Three-year cardiac mortality was reduced in bivalirudin-treated patients with major bleeding (20 fewer deaths with bivalirudin; 5.8% vs. 14.6%, p = 0.025) and without major bleeding (18 fewer deaths with bivalirudin; 2.6% vs. 3.8%, p = 0.048). In a fully-adjusted multivariable model accounting for major bleeding and other adverse events, bivalirudin was still associated with a 43% reduction in 3-year cardiac mortality (adjusted HR: 0.57 [95% CI: 0.39 to 0.83], p = 0.003). CONCLUSIONS: Bivalirudin reduces cardiac mortality in patients with STEMI undergoing primary PCI, an effect that can only partly be attributed to prevention of bleeding. Further studies are required to identify the nonhematologic benefits of bivalirudin. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction; NCT00433966).
Authors: Tim Kinnaird; Goran Medic; Gianni Casella; Francois Schiele; Upendra Kaul; Peter W Radke; Indra Eijgelshoven; Gert Bergman; Derek P Chew Journal: J Blood Med Date: 2013-10-02
Authors: Sukhdeep Bhogal; Debabrata Mukherjee; Jayant Bagai; Huu T Truong; Hemang B Panchal; Ghulam Murtaza; Mustafa Zaman; Rajesh Sachdeva; Timir K Paul Journal: Cardiovasc Hematol Disord Drug Targets Date: 2020
Authors: Ping Li; Hongyan Zhang; Caidong Luo; Zheng Ji; Zeqi Zheng; Zhenyong Li; Fan Wu; Jinlong Li; Lang Hong Journal: Front Cardiovasc Med Date: 2022-04-29
Authors: Gregor Fahrni; Mathias Wolfrum; Giovanni Luigi De Maria; Adrian P Banning; Umberto Benedetto; Rajesh K Kharbanda Journal: J Am Heart Assoc Date: 2016-07-22 Impact factor: 5.501