Page 215 - 2019_07 resto del Mondo-web

Coagulation & its Disorders
Six months versus two years of oral anticoagulation after a first episode
of unprovoked deep-vein thrombosis. The PADIS-DVT randomized clinical trial
Ferrata Storti Foundation
Haematologica 2019 Volume 104(7):1493-1501
These results were presented on July 9, 2017, in the abstract session of the 56th International Society of Thrombosis and Haemostasis Annual Meeting, Berlin, CA, July 6-9, 2017.
Francis Couturaud,1 Gilles Pernod,2 Emilie Presles,3 Elisabeth Duhamel,4 Patrick Jego,5 Karine Provost,6 Brigitte Pan-Petesch,7 Claire Bal dit Sollier,8 Cécile Tromeur,1 Clément Hoffmann,9 Luc Bressollette,9 Philippe Lorillon,10 Philippe Girard,11 Emmanuelle Le Moigne,1 Aurélia Le Hir,1 Marie Guégan,1 Silvy Laporte,3 Patrick Mismetti,12 Karine Lacut,1 Jean-Luc Bosson,13 Laurent Bertoletti,12 Oliver Sanchez,14 Guy Meyer,14 Christophe Leroyer1 and Dominique Mottier1 for the “PADIS-DVT” investigators.*
1Département de Médecine Interne et Pneumologie, CHU de Brest, Université de Bretagne Occidentale, EA 3878, CIC INSERM 1412, F-CRIN INNOVTE, Brest; 2Département de Médecine Vasculaire, CHU de Grenoble, Université de Grenoble 1, F- CRIN INNOVTE, Grenoble; 3Unité de Recherche Clinique, Innovation et Pharmacologie, CHU de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, F-CRIN INNOVTE, Saint-Etienne; 4Service de Médecine Interne, Centre Hospitalier Général de Saint-Brieuc, F-CRIN INNOVTE, Saint-Brieuc; 5Service de Médecine Interne, CHU de Rennes, Université de Rennes 1, Rennes; 6Service de Cardiologie, Centre Hospitalier Général de Lannion, Lannion; 7Service d’Hématologie, Centre Hospitalier Général de Quimper, Quimper; 8Clinique des Anticoagulants d’Ile de France (C.R.E.A.T.I.F.), CHU de Lariboisière, Paris; 9Service d’Echo-Doppler Vasculaire, and EA 3878, CIC INSERM 1412, CHU de Brest, Université de Bretagne Occidentale, F-CRIN INNOVTE, Brest; 10Pharmacie Centrale, CHU de Brest, Université de Bretagne Occidentale, Brest; 11Département Thoracique, Institut Mutualiste Montsouris, F-CRIN INNOVTE, Paris; 12Service de Médecine Vasculaire et Thérapeutique, Unité de Pharmacologie Clinique, CIC1408, CHU de Saint- Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, F-CRIN INNOVTE, Saint- Etienne and 13CIC and UMR CNRS 5525, CHU de Grenoble, Université de Grenoble 1, Grenoble, France.
*Members of the Prolongation d’un traitement par antivitamine K pendant dix-huit mois versus placebo au décours d’un premier épisode de thrombose veineuse profonde Idiopathique traité six mois (PADIS-DVT) Study Group are listed in the Online Appendix.
ABSTRACT
The optimal duration of anticoagulation after a first episode of unpro- voked deep-vein thrombosis is uncertain. We aimed to assess the benefits and risks of an additional 18 months of treatment with war- farin versus placebo, after an initial 6 months of anticoagulation for a first unprovoked proximal deep-vein thrombosis. We conducted a multicenter, randomized, double-blind, controlled trial comparing an additional 18 months of warfarin with placebo in patients with a unprovoked proximal deep-vein thrombosis initially treated for 6 months (treatment period: 18 months; follow up after treatment period: 24 months). The primary out- come was the composite of recurrent venous thromboembolism or major bleeding at 18 months. Secondary outcomes were the composite at 42 months, as well as each component of the composite, and death unrelated to pulmonary embolism or major bleeding, at 18 and 42 months. All out- comes were centrally adjudicated. A total of 104 patients, enrolled between July 2007 and October 2013 were analyzed on an intention-to-treat basis; no patient was lost to follow-up. During the 18-month treatment period, the primary outcome occurred in none of the 50 patients in the warfarin group and in 16 out of 54 patients (cumulative risk, 29.6%) in the placebo group (hazard ratio, 0.03; 95% confidence interval: 0.01 to 0.09; P<0.001). During the entire 42-month study period, the composite outcome occurred
Correspondence:
FRANCIS COUTURAUD
francis.couturaud@chu-brest.fr
Received: November 5, 2018. Accepted: January 2, 2019. Pre-published: January 3, 2019.
doi:10.3324/haematol.2018.210971
Check the online version for the most updated information on this article, online supplements, and information on authorship & disclosures: www.haematologica.org/content/104/7/1493
©2019 Ferrata Storti Foundation
Material published in Haematologica is covered by copyright. All rights are reserved to the Ferrata Storti Foundation. Use of published material is allowed under the following terms and conditions: https://creativecommons.org/licenses/by-nc/4.0/legalcode. Copies of published material are allowed for personal or inter- nal use. Sharing published material for non-commercial pur- poses is subject to the following conditions: https://creativecommons.org/licenses/by-nc/4.0/legalcode, sect. 3. Reproducing and sharing published material for com- mercial purposes is not allowed without permission in writing from the publisher.
haematologica | 2019; 104(7)
1493
ARTICLE