Periendoscopic management of direct oral anticoagulants: a prospective cohort study.
Administration, Oral
Aged
Anticoagulants
/ administration & dosage
Cohort Studies
Elective Surgical Procedures
Endoscopy, Gastrointestinal
/ adverse effects
Female
Follow-Up Studies
Gastrointestinal Hemorrhage
/ etiology
Humans
Italy
Male
Middle Aged
Patient Safety
Perioperative Care
/ methods
Prospective Studies
Risk Assessment
Stroke
/ prevention & control
Thromboembolism
/ prevention & control
Time Factors
Treatment Outcome
Withholding Treatment
bleeding
therapeutic endoscopy
Journal
Gut
ISSN: 1468-3288
Titre abrégé: Gut
Pays: England
ID NLM: 2985108R
Informations de publication
Date de publication:
06 2019
06 2019
Historique:
received:
06
03
2018
revised:
10
07
2018
accepted:
14
07
2018
pubmed:
2
8
2018
medline:
27
6
2019
entrez:
2
8
2018
Statut:
ppublish
Résumé
To assess the frequency of adverse events associated with periendoscopic management of direct oral anticoagulants (DOACs) in patients undergoing elective GI endoscopy and the efficacy and safety of the British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) recommendations (NCT02734316). Consecutive patients on DOACs scheduled for elective GI endoscopy were prospectively included. The timing of DOAC interruption and resumption before and after the procedures were recorded, along with clinical and procedural data. Procedures were stratified into low-risk and high-risk for GI-related bleeding, and patients into low-risk and high-risk for thromboembolic events. Patients were followed-up for 30 days for major and clinically relevant non-major bleeding events (CRNMB), arterial and venous thromboembolism and death. Of 529 patients, 38% and 62% underwent high-risk and low-risk procedures, respectively. There were 45 (8.5%; 95% CI 6.3% to 11.2%) major or CRNMB events and 2 (0.4%; 95% CI 0% to 1.4%) thromboembolic events (transient ischaemic attacks). Overall, the incidence of bleeding events was 1.8% (95% CI 0.7% to 4%) and 19.3% (95% CI 14.1% to 25.4%) in low-risk and high-risk procedures, respectively. For high-risk procedures, the incidence of intraprocedural bleeding was similar in patients who interrupted anticoagulation according to BSG/ESGE guidelines or earlier (10.3%vs10.8%, p=0.99), with a trend for a lower risk as compared with those who stopped anticoagulation later (10.3%vs25%, p=0.07). The incidence of delayed bleeding appeared similar in patients who resumed anticoagulation according to BSG/ESGE guidelines or later (6.6%vs7.7%, p=0.76), but it tended to increase when DOAC was resumed earlier (14.4%vs6.6%, p=0.27). The risk of delayed major bleeding was significantly higher in patients receiving heparin bridging than in non-bridged ones (26.6%vs5.9%, p=0.017). High-risk procedures in patients on DOACs are associated with a substantial risk of bleeding, further increased by heparin bridging. Adoption of the BSG/ESGE guidelines in periendoscopic management of DOACs seems to result in a favourable benefit/risk ratio. NCT02734316; Pre-results.
Identifiants
pubmed: 30064986
pii: gutjnl-2018-316385
doi: 10.1136/gutjnl-2018-316385
doi:
Substances chimiques
Anticoagulants
0
Banques de données
ClinicalTrials.gov
['NCT02734316']
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
969-976Commentaires et corrections
Type : ErratumIn
Informations de copyright
© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: FR received grants outside the submitted work from BMS/Pfizer and Boehringer Ingelheim. FD received grants outside the submitted work from BMS/Pfizer, Boehringer Ingelheim, Daiichi Sankyo, Roche and Sanofi.