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8 záznamů v Medvik Filtry

Článek

Relative efficacy and safety of ticagelor vs clopidogrel as a function of time to invasive management in non-ST-segment elevation acute coronary syndrome in the PLATO trial

Pollack, Charles V
Autor Pollack, Charles V Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania
Davoudi, Farideh
Autor Davoudi, Farideh Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts
Diercks, Deborah B
Autor Diercks, Deborah B Department of Emergency Medicine, University of Texas Southwestern, Dallas
Becker, Richard C
Autor Becker, Richard C Division of Cardiovascular Health and Disease, Heart, Lung and Vascular Institute, University of Cincinnati College of Medicine, Ohio
James, Stefan K
Autor James, Stefan K Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Sweden
Lim, Soo Teik
Autor Lim, Soo Teik Department of Cardiology, National Heart Centre, Singapore
Schulte, Phillip J
Autor Schulte, Phillip J Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota former employee at Duke Clinical Research Institute, Duke University Medical Center, North Carolina
Spinar, Jindrich
Autor Spinar, Jindrich Department of Internal Medicine/Cardiology, Masaryk University, Brno, Czech Republic
Steg, Philippe Gabriel
Autor Steg, Philippe Gabriel Département Hospitalo-Universitaire FIRE, AP-HP, Hôpital Bichat, Paris, France Paris Diderot University, Sorbonne Paris Cité, Paris, France NHLI Imperial College, ICMS, Royal Brompton Hospital, London, UK FACT (French Alliance for Cardiovascular Trials), an F-CRIN network, INSERM U1148, Paris, France
Storey, Robert F
Autor Storey, Robert F Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, United Kingdom

Clinical cardiology. 2017 ; 40 (6) : 390-398. [pub] 20170609

Clin Cardiol
ISSN 1932-8737
Medvik
Zdroj

BACKGROUND: Guidelines suggest that "upstream" P2Y12 receptor antagonists should be considered in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS). HYPOTHESIS: Early use of ticagrelor in patients managed with an invasive strategy would be more effective than clopidogrel because of its more rapid onset of action and greater potency. METHODS: In the PLATO trial, 6792 NSTE-ACS patients were randomized to ticagrelor or clopidogrel (started prior to angiography) and underwent angiography within 72 hours of randomization. We compared efficacy and safety outcomes of ticagrelor vs clopidogrel as a function of "early" (<3h) vs "late" (≥3h) time to angiography. Adjusted Cox proportional hazards models evaluated interaction between randomized treatment and time from randomization to angiography on subsequent outcomes. RESULTS: Overall, a benefit of ticagrelor vs clopidogrel for cardiovascular death/myocardial infarction/stroke was seen at day 7 (hazard ratio [HR]: 0.67, P = 0.002), day 30 (HR: 0.81, P = 0.042), and 1 year (HR: 0.80, P = 0.0045). There were no significant interactions in the <3h vs ≥3h groups at any timepoint. For major bleeding, overall there was no significant increase (HR: 1.04, 95% confidence interval: 0.85-1.27); but there was a significant interaction with no difference between ticagrelor and clopidogrel in the early group (HR: 0.79), but higher bleeding risk with ticagrelor in the late angiography group, at 7 days (HR: 1.51, Pint = 0.002). Patterns were similar at 30 days and 1 year. CONCLUSIONS: The benefit of ticagrelor over clopidogrel was consistent in those undergoing early and late angiography, supporting upstream use of ticagrelor.

Článek

Effect of the REG1 anticoagulation system versus bivalirudin on outcomes after percutaneous coronary intervention (REGULATE-PCI): a randomised clinical trial

Lancet. 2016 ; 387 (10016) : 349-56. [pub] 20151105

ISSN 1474-547X
Medvik
Zdroj

BACKGROUND: REG1 is a novel anticoagulation system consisting of pegnivacogin, an RNA aptamer inhibitor of coagulation factor IXa, and anivamersen, a complementary sequence reversal oligonucleotide. We tested the hypothesis that near complete inhibition of factor IXa with pegnivacogin during percutaneous coronary intervention, followed by partial reversal with anivamersen, would reduce ischaemic events compared with bivalirudin, without increasing bleeding. METHODS: We did a randomised, open-label, active-controlled, multicentre, superiority trial to compare REG1 with bivalirudin at 225 hospitals in North America and Europe. We planned to randomly allocate 13,200 patients undergoing percutaneous coronary intervention in a 1:1 ratio to either REG1 (pegnivacogin 1 mg/kg bolus [>99% factor IXa inhibition] followed by 80% reversal with anivamersen after percutaneous coronary intervention) or bivalirudin. Exclusion criteria included ST segment elevation myocardial infarction within 48 h. The primary efficacy endpoint was the composite of all-cause death, myocardial infarction, stroke, and unplanned target lesion revascularisation by day 3 after randomisation. The principal safety endpoint was major bleeding. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, identifier NCT01848106. The trial was terminated early after enrolment of 3232 patients due to severe allergic reactions. FINDINGS: 1616 patients were allocated REG1 and 1616 were assigned bivalirudin, of whom 1605 and 1601 patients, respectively, received the assigned treatment. Severe allergic reactions were reported in ten (1%) of 1605 patients receiving REG1 versus one (<1%) of 1601 patients treated with bivalirudin. The composite primary endpoint did not differ between groups, with 108 (7%) of 1616 patients assigned REG1 and 103 (6%) of 1616 allocated bivalirudin reporting a primary endpoint event (odds ratio [OR] 1·05, 95% CI 0·80-1·39; p=0·72). Major bleeding was similar between treatment groups (seven [<1%] of 1605 receiving REG1 vs two [<1%] of 1601 treated with bivalirudin; OR 3·49, 95% CI 0·73-16·82; p=0·10), but major or minor bleeding was increased with REG1 (104 [6%] vs 65 [4%]; 1·64, 1·19-2·25; p=0·002). INTERPRETATION: The reversible factor IXa inhibitor REG1, as currently formulated, is associated with severe allergic reactions. Although statistical power was limited because of early termination, there was no evidence that REG1 reduced ischaemic events or bleeding compared with bivalirudin. FUNDING: Regado Biosciences Inc.