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

Publication date: Available online 5 November 2015 Source:The Lancet Author(s): 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 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% ...
Source: The Lancet - Category: Journals (General) Source Type: research