title: Safety and efficacy of prasugrel use in patients undergoing percutaneous coronary intervention and anticoagulated with bivalirudin.
abstract: The randomized TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel-Thrombolysis In Myocardial Infarction (TRITON-TIMI) 38 trial compared prasugrel and clopidogrel in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). Patients treated with prasugrel had fewer ischemic events but more procedure-related bleeding. In the present study, we aimed to determine the effect of bivalirudin on bleeding in patients treated with prasugrel. A total of 692 patients with consecutive acute coronary syndrome underwent PCI with stent implantation and were anticoagulated with bivalirudin. The patients were divided into 2 groups according to the antiplatelet regimen (clopidogrel or prasugrel) chosen during or just after PCI. The bleeding complications during hospitalization were tabulated. Ischemic events were analyzed during hospitalization and at 30 days. Prasugrel was used in 96 patients (13.9%) and clopidogrel in 596 (86.1%). The clinical and procedural characteristics were similar, although the clopidogrel patients more often reported systemic hypertension (p = 0.01), previous PCI (p <0.001), and chronic renal insufficiency (p = 0.05). During hospitalization, the bleeding and ischemic complication rates were similar and low in both groups (major in-hospital complications 4.2% for clopidogrel vs 2.1% for prasugrel, p = 0.6; Thrombolysis In Myocardial Infarction major bleeding 2.5% vs 2.1%, p = 1.00; Thrombolysis In Myocardial Infarction minor bleeding 4.2% vs 5.2%, p = 0.6). At 30 days, no differences were found in ischemic events between both groups (target vessel revascularization/major adverse cardiac events 5.4% vs 2.1%, p = 0.2). In conclusion, prasugrel, when given after bivalirudin as the intraprocedural antithrombin agent for patients with acute coronary syndrome undergoing PCI, is as safe and effective as clopidogrel.
authors.affiliation: Division of Cardiology, Department of Internal Medicine, MedStar Washington Hospital Center, Washington, DC, USA.
authors.forename: Ana
authors.initials: A
authors.lastname: Laynez
authors.forename: Gabriel
authors.initials: G
authors.lastname: Sardi
authors.forename: Rebecca
authors.initials: R
authors.lastname: Torguson
authors.forename: Zhenyi
authors.initials: Z
authors.lastname: Xue
authors.forename: William O
authors.initials: WO
authors.lastname: Suddath
authors.forename: Lowell F
authors.initials: LF
authors.lastname: Satler
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Kent
authors.forename: Augusto D
authors.initials: AD
authors.lastname: Pichard
authors.forename: Joseph
authors.initials: J
authors.lastname: Lindsay
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
mesh_terms: D054058:Acute Coronary Syndrome / Q000000981:diagnostic imaging / Q000628:therapy*; D000991:Antithrombins / Q000008:administration & dosage / Q000627:therapeutic use; D017023:Coronary Angiography; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006629:Hirudins; D006801:Humans; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments; D062645:Percutaneous Coronary Intervention; D010879:Piperazines / Q000008:administration & dosage* / Q000627:therapeutic use; D000068799:Prasugrel Hydrochloride; D011300:Preoperative Care / Q000379:methods*; D058921:Purinergic P2Y Receptor Antagonists / Q000008:administration & dosage / Q000627:therapeutic use; D011994:Recombinant Proteins; D012189:Retrospective Studies; D013876:Thiophenes / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D010879:Piperazines; D058921:Purinergic P2Y Receptor Antagonists; D011994:Recombinant Proteins; D013876:Thiophenes; D000068799:Prasugrel Hydrochloride; C074619:bivalirudin