Effect of the REG1 anticoagulation system versus bivalirudin on outcomes after percutaneous coronary intervention (REGULATE-PCI): a randomised clinical trial.
Abstract | BACKGROUND: METHODS: 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.
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Authors | A Michael Lincoff, Roxana Mehran, Thomas J Povsic, Steven L Zelenkofske, Zhen Huang, Paul W Armstrong, P Gabriel Steg, Christoph Bode, Mauricio G Cohen, Christopher Buller, Peep Laanmets, Marco Valgimigli, Toomas Marandi, Viliam Fridrich, Warren J Cantor, Bela Merkely, Jose Lopez-Sendon, Jan H Cornel, Jaroslaw D Kasprzak, Michael Aschermann, Victor Guetta, Joao Morais, Peter R Sinnaeve, Kurt Huber, Rod Stables, Mary Ann Sellers, Marilyn Borgman, Lauren Glenn, Arnold I Levinson, Renato D Lopes, Vic Hasselblad, Richard C Becker, John H Alexander, REGULATE-PCI Investigators |
Journal | Lancet (London, England)
(Lancet)
Vol. 387
Issue 10016
Pg. 349-356
(01 23 2016)
ISSN: 1474-547X [Electronic] England |
PMID | 26547100
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2016 Elsevier Ltd. All rights reserved. |
Chemical References |
- Anticoagulants
- Aptamers, Nucleotide
- Coagulants
- Hirudins
- Oligonucleotides
- Peptide Fragments
- RB 006
- RB 007
- Recombinant Proteins
- Factor IXa
- bivalirudin
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Topics |
- Aged
- Anticoagulants
(therapeutic use)
- Aptamers, Nucleotide
(therapeutic use)
- Coagulants
(administration & dosage)
- Drug Hypersensitivity
(epidemiology)
- Early Termination of Clinical Trials
- Europe
(epidemiology)
- Factor IXa
(antagonists & inhibitors)
- Female
- Hemorrhage
(epidemiology)
- Hirudins
- Humans
- Male
- Middle Aged
- North America
(epidemiology)
- Oligonucleotides
(administration & dosage)
- Peptide Fragments
(therapeutic use)
- Percutaneous Coronary Intervention
- Recombinant Proteins
(therapeutic use)
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