RESUMO
To assess the efficacy of the direct thrombin inhibitor bivalirudin relative to heparin during contemporary coronary intervention, 1,056 patients who underwent elective or urgent revascularization were randomized in a large-scale pilot study to receive heparin (70 U/kg initial bolus) or bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg/hour infusion during the procedure). All patients received aspirin; pretreatment with clopidogrel was encouraged, and glycoprotein (GP) IIb/IIIa blockade was at the physician's discretion. Stents were placed in 85% of patients; 72% received a GP IIb/IIIa inhibitor, and 56% were pretreated with clopidogrel. Activated clotting times were higher among patients randomized to bivalirudin than among those given heparin before device activation (median 359 vs 293 seconds, p <0.001). The composite efficacy end point of death, myocardial infarction, or repeat revascularization before hospital discharge or within 48 hours occurred in 5.6% and 6.9% of patients in the bivalirudin and heparin groups, respectively (p = 0.40). Major bleeding occurred in 2.1% versus 2.7% of patients randomized to bivalirudin or heparin, respectively (p = 0.52). This trial represents the largest prospective dataset of bivalirudin administered concomitantly with planned GP IIb/IIIa blockade and provides evidence of the safety and efficacy of this combined antithrombotic approach.
Assuntos
Angioplastia Coronária com Balão , Anticoagulantes/uso terapêutico , Antitrombinas/uso terapêutico , Heparina/uso terapêutico , Hirudinas/análogos & derivados , Cuidados Intraoperatórios , Fragmentos de Peptídeos/uso terapêutico , Proteínas Recombinantes/uso terapêutico , Idoso , Anticoagulantes/efeitos adversos , Antitrombinas/efeitos adversos , Relação Dose-Resposta a Droga , Feminino , Heparina/efeitos adversos , Hirudinas/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Fragmentos de Peptídeos/efeitos adversos , Projetos Piloto , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/uso terapêutico , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/mortalidade , Hemorragia Pós-Operatória/induzido quimicamente , Proteínas Recombinantes/efeitos adversos , Resultado do Tratamento , Estados Unidos/epidemiologia , Tempo de Coagulação do Sangue TotalRESUMO
The direct antithrombin, bivalirudin, did not reduce angiographic restenosis measured either as the dichotomous restenosis rate of 62% for bivalirudin and 58% for heparin (p = 0.70), or as the late loss in lumen diameter of 0.44 +/- 0.47 mm for bivalirudin and 0.39 +/- 0.53 mm for heparin (p = 0.62). Direct thrombin inhibition with bivalirudin neither reduces angiographic restenosis nor alters the impact of several established risk factors for restenosis.
