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Risk factors for recurrent venous thromboembolism after unprovoked pulmonary embolism: the PADIS-PE randomised trial

Cécile Tromeur, Olivier Sanchez, Emilie Presles, Gilles Pernod, Laurent Bertoletti, Patrick Jego, Elisabeth Duhamel, Karine Provost, Florence Parent, Philippe Robin, Lucile Deloire, Florent Leven, Fanny Mingant, Luc Bressollette, Pierre-Yves Le Roux, Pierre-Yves Salaun, Michel Nonent, Brigitte Pan-Petesch, Benjamin Planquette, Philippe Girard, Karine Lacut, Solen Melac, Patrick Mismetti, Silvy Laporte, Guy Meyer, Dominique Mottier, Christophe Leroyer, Francis Couturaud
European Respiratory Journal 2018 51: 1701202; DOI: 10.1183/13993003.01202-2017
Cécile Tromeur
Dépt de Médecine Interne et Pneumologie, EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, FranceF-CRIN INNOVTE, Saint-Étienne, France
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Olivier Sanchez
F-CRIN INNOVTE, Saint-Étienne, FranceUniversité Paris Descartes, Université Sorbonne Paris Cité, Service de Pneumologie et de Soins Intensifs, Hôpital Européen Georges Pompidou, AP-HP, Université Paris Descartes, Sorbonne Paris Cité, INSERM UMR S 1140, Paris, France
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Emilie Presles
F-CRIN INNOVTE, Saint-Étienne, FranceUnité de Recherche Clinique, Innovation et Pharmacologie, Centre Hospitalo-Universitaire de Saint-Étienne, INSERM U1059 SAINBIOSE, Université Jean Monnet, Saint-Étienne, France
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Gilles Pernod
F-CRIN INNOVTE, Saint-Étienne, FranceDépt de Médecine Vasculaire, Centre Hospitalo-Universitaire de Grenoble, Université de Grenoble 1, Grenoble, France
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Laurent Bertoletti
F-CRIN INNOVTE, Saint-Étienne, FranceService de Médecine Vasculaire et Thérapeutique, Unité de Pharmacologie Clinique, CIC1408, Centre Hospitalo-Universitaire de Saint-Étienne, INSERM U1059 SAINBIOSE, Université Jean Monnet, Saint-Étienne, France
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Patrick Jego
F-CRIN INNOVTE, Saint-Étienne, FranceService de Médecine Interne, Centre Hospitalo-Universitaire de Rennes, Université de Rennes 1, Rennes, France
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Elisabeth Duhamel
F-CRIN INNOVTE, Saint-Étienne, FranceService de Médecine Interne, Centre Hospitalier Général de Saint-Brieuc, Saint-Brieuc, France
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Karine Provost
Service de Cardiologie, Centre Hospitalier Général de Lannion, Lannion, France
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Florence Parent
Service de Pneumologie, INSERM 999, Centre Hospitalo-Universitaire de Kremlin-Bicêtre, Kremlin-Bicêtre, France
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Philippe Robin
F-CRIN INNOVTE, Saint-Étienne, FranceService de Médecine Nucléaire, EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France
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Lucile Deloire
Service de Radiologie, EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France
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Florent Leven
Service de Cardiologie, EA 4324, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France
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Fanny Mingant
F-CRIN INNOVTE, Saint-Étienne, FranceService d'Hématologie Biologique, EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France
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Luc Bressollette
F-CRIN INNOVTE, Saint-Étienne, FranceService d'Echo-doppler Vasculaire, EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France
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Pierre-Yves Le Roux
F-CRIN INNOVTE, Saint-Étienne, FranceService de Médecine Nucléaire, EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France
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Pierre-Yves Salaun
F-CRIN INNOVTE, Saint-Étienne, FranceService de Médecine Nucléaire, EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France
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Michel Nonent
Service de Radiologie, EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France
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Brigitte Pan-Petesch
F-CRIN INNOVTE, Saint-Étienne, FranceService de Médecine Interne, Centre Hospitalier Général de Quimper, Quimper, France
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Benjamin Planquette
F-CRIN INNOVTE, Saint-Étienne, FranceUniversité Paris Descartes, Université Sorbonne Paris Cité, Service de Pneumologie et de Soins Intensifs, Hôpital Européen Georges Pompidou, AP-HP, Université Paris Descartes, Sorbonne Paris Cité, INSERM UMR S 1140, Paris, France
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Philippe Girard
F-CRIN INNOVTE, Saint-Étienne, FranceDépt Thoracique, Institut Mutualiste Montsouris; Paris, France
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Karine Lacut
Dépt de Médecine Interne et Pneumologie, EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, FranceF-CRIN INNOVTE, Saint-Étienne, France
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Solen Melac
Dépt de Médecine Interne et Pneumologie, EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, FranceF-CRIN INNOVTE, Saint-Étienne, France
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Patrick Mismetti
F-CRIN INNOVTE, Saint-Étienne, FranceService de Médecine Vasculaire et Thérapeutique, Unité de Pharmacologie Clinique, CIC1408, Centre Hospitalo-Universitaire de Saint-Étienne, INSERM U1059 SAINBIOSE, Université Jean Monnet, Saint-Étienne, France
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Silvy Laporte
F-CRIN INNOVTE, Saint-Étienne, FranceUnité de Recherche Clinique, Innovation et Pharmacologie, Centre Hospitalo-Universitaire de Saint-Étienne, INSERM U1059 SAINBIOSE, Université Jean Monnet, Saint-Étienne, France
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Guy Meyer
F-CRIN INNOVTE, Saint-Étienne, FranceUniversité Paris Descartes, Université Sorbonne Paris Cité, Service de Pneumologie et de Soins Intensifs, Hôpital Européen Georges Pompidou, AP-HP, Université Paris Descartes, Sorbonne Paris Cité, INSERM UMR S 1140, Paris, France
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Dominique Mottier
Dépt de Médecine Interne et Pneumologie, EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, FranceF-CRIN INNOVTE, Saint-Étienne, France
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Christophe Leroyer
Dépt de Médecine Interne et Pneumologie, EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, FranceF-CRIN INNOVTE, Saint-Étienne, France
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Francis Couturaud
Dépt de Médecine Interne et Pneumologie, EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, FranceF-CRIN INNOVTE, Saint-Étienne, France
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  • For correspondence: francis.couturaud@chu-brest.fr
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Abstract

We aimed to identify risk factors for recurrent venous thromboembolism (VTE) after unprovoked pulmonary embolism.

Analyses were based on the double-blind randomised PADIS-PE trial, which included 371 patients with a first unprovoked pulmonary embolism initially treated during 6 months who were randomised to receive an additional 18 months of warfarin or placebo and followed up for 2 years after study treatment discontinuation. All patients had ventilation/perfusion lung scan at inclusion (i.e. at 6 months of anticoagulation).

During a median follow-up of 41 months, recurrent VTE occurred in 67 out of 371 patients (6.8 events per 100 person-years). In main multivariate analysis, the hazard ratio for recurrence was 3.65 (95% CI 1.33–9.99) for age 50–65 years, 4.70 (95% CI 1.78–12.40) for age >65 years, 2.06 (95% CI 1.14–3.72) for patients with pulmonary vascular obstruction index (PVOI) ≥5% at 6 months and 2.38 (95% CI 1.15–4.89) for patients with antiphospholipid antibodies. When considering that PVOI at 6 months would not be available in practice, PVOI ≥40% at pulmonary embolism diagnosis (present in 40% of patients) was also associated with a 2-fold increased risk of recurrence.

After a first unprovoked pulmonary embolism, age, PVOI at pulmonary embolism diagnosis or after 6 months of anticoagulation and antiphospholipid antibodies were found to be independent predictors for recurrence.

Abstract

Residual pulmonary embolism is an independent predictor for recurrence after unprovoked pulmonary embolism http://ow.ly/jf0X30fQQGf

Footnotes

  • This article has supplementary material available from erj.ersjournals.com

  • Support statement: The study was supported by grants from the “Programme Hospitalier de Recherche Clinique” (French Dept of Health) and the sponsor was the University Hospital of Brest. The funding source was not involved in designing or conducting the study, collecting, managing, analysing or interpreting the data, preparing, reviewing or approving the manuscript, or deciding to submit this for publication. Funding information for this article has been deposited with the Crossref Funder Registry.

  • Conflict of interest: Disclosures can be found alongside this article at erj.ersjournals.com

  • Received June 18, 2017.
  • Accepted October 4, 2017.
  • Copyright ©ERS 2018
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Risk factors for recurrent venous thromboembolism after unprovoked pulmonary embolism: the PADIS-PE randomised trial
Cécile Tromeur, Olivier Sanchez, Emilie Presles, Gilles Pernod, Laurent Bertoletti, Patrick Jego, Elisabeth Duhamel, Karine Provost, Florence Parent, Philippe Robin, Lucile Deloire, Florent Leven, Fanny Mingant, Luc Bressollette, Pierre-Yves Le Roux, Pierre-Yves Salaun, Michel Nonent, Brigitte Pan-Petesch, Benjamin Planquette, Philippe Girard, Karine Lacut, Solen Melac, Patrick Mismetti, Silvy Laporte, Guy Meyer, Dominique Mottier, Christophe Leroyer, Francis Couturaud
European Respiratory Journal Jan 2018, 51 (1) 1701202; DOI: 10.1183/13993003.01202-2017

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Risk factors for recurrent venous thromboembolism after unprovoked pulmonary embolism: the PADIS-PE randomised trial
Cécile Tromeur, Olivier Sanchez, Emilie Presles, Gilles Pernod, Laurent Bertoletti, Patrick Jego, Elisabeth Duhamel, Karine Provost, Florence Parent, Philippe Robin, Lucile Deloire, Florent Leven, Fanny Mingant, Luc Bressollette, Pierre-Yves Le Roux, Pierre-Yves Salaun, Michel Nonent, Brigitte Pan-Petesch, Benjamin Planquette, Philippe Girard, Karine Lacut, Solen Melac, Patrick Mismetti, Silvy Laporte, Guy Meyer, Dominique Mottier, Christophe Leroyer, Francis Couturaud
European Respiratory Journal Jan 2018, 51 (1) 1701202; DOI: 10.1183/13993003.01202-2017
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