Effect of the REG1 anticoagulation system versus bivalirudin on outcomes after percutaneous coronary intervention (REGULATE-PCI): a randomised clinical trial
Lancet
; 387(10016): 349-356, 2016.
Article
in English
| Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP
| ID: biblio-1064588
Responsible library:
BR79.1
Localization: BR79.1
ABSTRACT
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 11 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...
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Collection:
National databases
/
Brazil
Database:
Sec. Est. Saúde SP
/
SESSP-IDPCPROD
Main subject:
Percutaneous Coronary Intervention
/
Anticoagulants
Type of study:
Controlled clinical trial
/
Prognostic study
Language:
English
Journal:
Lancet
Year:
2016
Document type:
Article
Institution/Affiliation country:
Canadian VIGOUR Centre, University of Alberta/CA
/
Cleveland Clinic Coordinating Center for Clinical Research/US
/
Duke Clinical Research Institute, Duke Medicine/US
/
Hospital Universitario La Paz, IdiPaz/ES
/
Instituto Dante Pazzanese de Cardiologia/BR
/
Medical Center Alkmaar/NL
/
Medical University of Lodz, Bieganski Hospital/PL
/
Mount Sinai School of Medicine/US
/
National Institute of Cardiovascular Diseases/SK
/
North Estonia Medical Centre/EE