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Postoperative low molecular weight heparin bridging treatment for patients at high risk of arterial thromboembolism (PERIOP2): double blind randomised controlled trial
- Source :
- The BMJ
- Publication Year :
- 2021
- Publisher :
- BMJ Publishing Group Ltd., 2021.
-
Abstract
- Objective To determine the efficacy and safety of dalteparin postoperative bridging treatment versus placebo for patients with atrial fibrillation or mechanical heart valves when warfarin is temporarily interrupted for a planned procedure. Design Prospective, double blind, randomised controlled trial. Setting 10 thrombosis research sites in Canada and India between February 2007 and March 2016. Participants 1471 patients aged 18 years or older with atrial fibrillation or mechanical heart valves who required temporary interruption of warfarin for a procedure. Intervention Random assignment to dalteparin (n=821; one patient withdrew consent immediately after randomisation) or placebo (n=650) after the procedure. Main outcome measures Major thromboembolism (stroke, transient ischaemic attack, proximal deep vein thrombosis, pulmonary embolism, myocardial infarction, peripheral embolism, or vascular death) and major bleeding according to the International Society on Thrombosis and Haemostasis criteria within 90 days of the procedure. Results The rate of major thromboembolism within 90 days was 1.2% (eight events in 650 patients) for placebo and 1.0% (eight events in 820 patients) for dalteparin (P=0.64, risk difference −0.3%, 95% confidence interval −1.3 to 0.8). The rate of major bleeding was 2.0% (13 events in 650 patients) for placebo and 1.3% (11 events in 820 patients) for dalteparin (P=0.32, risk difference −0.7, 95% confidence interval −2.0 to 0.7). The results were consistent for the atrial fibrillation and mechanical heart valves groups. Conclusions In patients with atrial fibrillation or mechanical heart valves who had warfarin interrupted for a procedure, no significant benefit was found for postoperative dalteparin bridging to prevent major thromboembolism. Trial registration Clinicaltrials.gov NCT00432796 .
- Subjects :
- Dalteparin
Male
medicine.drug_class
Low molecular weight heparin
030204 cardiovascular system & hematology
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Thromboembolism
Atrial Fibrillation
medicine
Humans
030212 general & internal medicine
Myocardial infarction
Postoperative Period
Prospective Studies
Stroke
Aged
Aged, 80 and over
business.industry
Research
Warfarin
Anticoagulants
Atrial fibrillation
General Medicine
Middle Aged
medicine.disease
Thrombosis
Pulmonary embolism
Embolism
Anesthesia
Heart Valve Prosthesis
Surgical Procedures, Operative
Female
business
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 17561833 and 09598138
- Volume :
- 373
- Database :
- OpenAIRE
- Journal :
- The BMJ
- Accession number :
- edsair.doi.dedup.....bedb437bcac4b60faec69dd5769484dd