Abstract
Summary 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 13200 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 (
| Original language | English (US) |
|---|---|
| Pages (from-to) | 349-356 |
| Number of pages | 8 |
| Journal | The Lancet |
| Volume | 387 |
| Issue number | 10016 |
| DOIs | |
| State | Published - Jan 23 2016 |
Fingerprint
ASJC Scopus subject areas
- Medicine(all)
Cite this
Effect of the REG1 anticoagulation system versus bivalirudin on outcomes after percutaneous coronary intervention (REGULATE-PCI) : A randomised clinical trial. / REGULATE-PCI Investigators.
In: The Lancet, Vol. 387, No. 10016, 23.01.2016, p. 349-356.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Effect of the REG1 anticoagulation system versus bivalirudin on outcomes after percutaneous coronary intervention (REGULATE-PCI)
T2 - A randomised clinical trial
AU - REGULATE-PCI Investigators
AU - Lincoff, A. Michael
AU - Mehran, Roxana
AU - Povsic, Thomas J.
AU - Zelenkofske, Steven L.
AU - Huang, Zhen
AU - Armstrong, Paul W.
AU - Steg, P. Gabriel
AU - Bode, Christoph
AU - Cohen, Mauricio G
AU - Buller, Christopher
AU - Laanmets, Peep
AU - Valgimigli, Marco
AU - Marandi, Toomas
AU - Fridrich, Viliam
AU - Cantor, Warren J.
AU - Merkely, Bela
AU - Lopez-Sendon, Jose
AU - Cornel, Jan H.
AU - Kasprzak, Jaroslaw D.
AU - Aschermann, Michael
AU - Guetta, Victor
AU - Morais, Joao
AU - Sinnaeve, Peter R.
AU - Huber, Kurt
AU - Stables, Rod
AU - Sellers, Mary Ann
AU - Borgman, Marilyn
AU - Glenn, Lauren
AU - Levinson, Arnold I.
AU - Lopes, Renato D.
AU - Hasselblad, Vic
AU - Becker, Richard C.
AU - Alexander, John H.
PY - 2016/1/23
Y1 - 2016/1/23
N2 - Summary 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 13200 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 (
AB - Summary 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 13200 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 (
UR - http://www.scopus.com/inward/record.url?scp=84959556076&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84959556076&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(15)00515-2
DO - 10.1016/S0140-6736(15)00515-2
M3 - Article
C2 - 26547100
AN - SCOPUS:84959556076
VL - 387
SP - 349
EP - 356
JO - The Lancet
JF - The Lancet
SN - 0140-6736
IS - 10016
ER -