Periendoscopic management of direct oral anticoagulants: a prospective cohort study.


Journal

Gut
ISSN: 1468-3288
Titre abrégé: Gut
Pays: England
ID NLM: 2985108R

Informations de publication

Date de publication:
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

969-976

Commentaires 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.

Auteurs

Franco Radaelli (F)

Gastroenterology Unit, Valduce Hospital, Como, Italy.

Lorenzo Fuccio (L)

Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

Silvia Paggi (S)

Gastroenterology Unit, Valduce Hospital, Como, Italy.

Cesare Hassan (C)

Gastroenterology Unit, Nuovo Regina Margherita Hospital, Rome, Italy.

Alessandro Repici (A)

Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research and University Hospital, Rozzano, Milan, Italy.

Emanuele Rondonotti (E)

Gastroenterology Unit, Valduce Hospital, Como, Italy.

Rossella Semeraro (R)

Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research and University Hospital, Rozzano, Milan, Italy.

Milena Di Leo (M)

Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research and University Hospital, Rozzano, Milan, Italy.

Andrea Anderloni (A)

Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Research and University Hospital, Rozzano, Milan, Italy.

Arnaldo Amato (A)

Gastroenterology Unit, Valduce Hospital, Como, Italy.

Cristina Trovato (C)

Digestive Endoscopy Unit, European Institute of Oncology, Milan, Italy.

Ivana Bravi (I)

Digestive Endoscopy Unit, European Institute of Oncology, Milan, Italy.

Andrea Buda (A)

Gastroenterology Unit, Santa Maria del Prato Hospital, Feltre, Italy.

Mario de Bellis (M)

Gastroenterology and Endoscopy Unit, Department of Abdominal Oncology, Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale, Naples, Italy.

Valentina D'Angelo (V)

Gastroenterology and Endoscopy Unit, Department of Abdominal Oncology, Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale, Naples, Italy.

Sergio Segato (S)

Gastroenterology and GI Endoscopy Unit, Ospedale di Circolo e Fondazione Macchi, Varese, Italy.

Ottaviano Tarantino (O)

Gastroenterology Unit, S. Giuseppe Hospital, Empoli, Italy.

Alessandro Musso (A)

Gastroenterology Unit, Città della Salute e della Scienza, Turin, Italy.

Renato Fasoli (R)

Digestive Endoscopy Unit, ASL 1 Liguria, Imperia Hospital, Imperia, Italy.

Leonardo Frazzoni (L)

Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

Elisa Liverani (E)

Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

Carlo Fabbri (C)

Gastroenterology and Digestive Endoscopy Unit, AUSL Bologna Bellaria-Maggiore Hospital, Bologna, Italy.

Emilio Di Giulio (E)

Department of Medical-Surgical Sciences and Translational Medicine, Sant'Andrea Hospital, Sapienza University, Rome, Italy.

Gianluca Esposito (G)

Department of Medical-Surgical Sciences and Translational Medicine, Sant'Andrea Hospital, Sapienza University, Rome, Italy.

Flavia Pigò (F)

Gastroenterology and Digestive Endoscopy Unit, S. Agostino-Estense Hospital, Modena, Italy.

Andrea Iannone (A)

Gastroenterology Unit, University of Bari, Bari, Italy.

Francesco Dentali (F)

Department of Clinical Medicine, University of Insubria, Varese, Italy.

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