[Prolongation of anti vitamin K treatment for 18 months versus placebo after 6 months treatment of a first episode of ideopathic pulmonary embolism: a mutlicentre, randomised double blind trail. The PADIS-EP Trial]

F. Couturaud; G. Pernod; C. Pison; P. Mismetti; O. Sanchez; G. Meyer; F. Parent; P. Girard; G. Simonneau; L. Drouet; P. Gueret; P. Jego; P. Delaval; E. Duhamel; Y. Gruel; B. Delahousse; S. Regina; P. Pottier; J. Connaud; F. Lecomte; K. Provost; N. Vilmans; X. Gosset; A. Bura-Rivière; G. Meach; K. Lacut; J.-L. Bosson; K. Guillot; D. Mottier; C. Leroyer

[Prolongation of anti vitamin K treatment for 18 months versus placebo after 6 months treatment of a first episode of ideopathic pulmonary embolism: a mutlicentre, randomised double blind trail. The PADIS-EP Trial]

F. Couturaud ¹ G. Pernod ² C. Pison ³ P. Mismetti ⁴ O. Sanchez ⁵ G. Meyer ⁶ F. Parent ⁷ P. Girard G. Simonneau ⁸ L. Drouet ⁹ P. Gueret ¹⁰ P. Jego ¹¹ P. Delaval E. Duhamel Y. Gruel ¹² B. Delahousse S. Regina ¹² P. Pottier ¹³ J. Connaud F. Lecomte K. Provost N. Vilmans X. Gosset A. Bura-Rivière G. Meach K. Lacut J.-L. Bosson ¹⁴ K. Guillot ¹⁵ D. Mottier C. Leroyer ¹⁶

1 GETBO - Groupe d'Etude de la Thrombose de Bretagne Occidentale

2 Laboratoire d'Hématologie

3 Département de médecine aiguë spécialisée

4 GRT (EA 3065) - Groupe de recherche sur la thrombose

5 Departamento de Matemática Aplicada

6 Ecole Vétérinaire de Toulouse

7 Service de pneumologie [Béclère]

8 Cytokines, chimiokines et immunopathologie

9 Service de Biochimie

10 Fédération de cardiologie

11 Service de médecine interne

12 Pathologies Respiratoires : Protéolyse et Aérosolthérapie

13 LETG - Nantes - Littoral, Environnement, Télédétection, Géomatique

14 Service d'angiologie

15 Centre d'Investigation Clinique - Epidemiologie Clinique/essais Cliniques Saint Etienne

16 DMIP - Brest - Département de Médecine Interne et Pneumologie [Brest]

Abstract : BACKGROUND: After stopping a 3 to 6 months course of oral anticoagulation for a first episode of idiopathic venous thromboembolism (VTE), the risk of recurrent VTE is high (10% per year). In this setting, international guidelines recommend at least 6 months treatment. However, this recommendation is not satisfactory for the following reasons: (1) no randomized trial has compared 6 months to extended duration (2 years) anticoagulation; and (2), even though the frequency of recurrent VTE is similar after pulmonary embolism (PE) and deep vein thrombosis (DVT), the fatality rate of recurrent VTE after PE is higher than that after DVT. METHODS: A French multicentre double blind randomized trial. The main objective is to demonstrate, after a first episode of symptomatic idiopathic PE treated for 6 months using a vitamin K antagonist, that extended anticoagulation for 18 months (INR between 2 and 3) is associated with an increased benefit / risk ratio (recurrent VTE and severe anticoagulant-related bleeding) compared to placebo. The double blind evaluation is ensured using by active warfarin and placebo, and blinded INR. The protocol was approved by the ethics board of the Brest Hospital on the 7th of March 2006. For an alpha risk of 5% and a beta risk of 20%, the estimated sample size is 374 patients. EXPECTED RESULTS: This study has the potential to: (1) demonstrate that the benefit / risk ratio of extended anticoagulation for 18 months is higher than that observed with placebo in patients with a first episode of idiopathic PE initially treated for 6 months, during and after the treatment period; and (2) to validate or invalidate the contribution of isotope lung scans, lower limb Doppler ultrasound and D-Dimer at 6 months of treatment as predictors of recurrent VTE (medico-economic analysis included).

Document type :

Journal articles

Domain :

Life Sciences [q-bio] / Pharmaceutical sciences / Pharmacology

Complete list of metadatas

https://hal-ujm.archives-ouvertes.fr/ujm-00439737
Contributor : Patrick Mismetti <>
Submitted on : Tuesday, December 8, 2009 - 2:49:25 PM
Last modification on : Wednesday, September 4, 2019 - 1:52:11 PM

[Prolongation of anti vitamin K treatment for 18 months versus placebo after 6 months treatment of a first episode of ideopathic pulmonary embolism: a mutlicentre, randomised double blind trail. The PADIS-EP Trial]

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[Prolongation of anti vitamin K treatment for 18 months versus placebo after 6 months treatment of a first episode of ideopathic pulmonary embolism: a mutlicentre, randomised double blind trail. The PADIS-EP Trial]

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