Leela Raj1,2, Philippe Robin3,4, Raphael Le Mao1,4, Emilie Presles4,5, Cécile Tromeur1,4, Olivier Sanchez4,6, Gilles Pernod4,7, Laurent Bertoletti4,8, Patrick Jego4,9, Florent Leven10, Catherine A Lemarié1,4, Aurore Martin11, Benjamin Planquette4,6, Pierre-Yves Le Roux3,4, Pierre-Yves Salaun3,4, Michel Nonent12, Philippe Girard4,13, Karine Lacut1,4, Solen Melac1,4, Patrick Mismetti4,8, Silvy Laporte4,5, Guy Meyer4,6, Christophe Leroyer1,4, Francis Couturaud1,4. 1. Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, and EA 3878, CIC INSERM 1412, Brest, France. 2. Faculty of Heath Science, McMaster University, Hamilton, Ontario, Canada. 3. Service de Médecine Nucléaire and EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France. 4. F-CRIN INNOVTE, Saint Etienne, France. 5. Unité de recherche clinique, Innovation et pharmacologie, Centre Hospitalo-Universitaire de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, Saint-Etienne, France. 6. Université 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, and INSERM UMR S 1140, Paris, France. 7. Département de Médecine Vasculaire, Centre Hospitalo-Universitaire de Grenoble, Université de Grenoble 1, Grenoble, France. 8. Service de Médecine Vasculaire et Thérapeutique, Unité de Pharmacologie Clinique, CIC1408, Centre Hospitalo-Universitaire de Saint-Etienne, and INSERM U1059 SAINBIOSE, Université Jean Monnet, Saint-Etienne, France. 9. Service de Médecine Interne, Centre Hospitalo-Universitaire de Rennes, Université de Rennes 1, Rennes, France. 10. Service de Cardiologie and EA 3878, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France. 11. Service d'Echo-doppler Vasculaire, and EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France. 12. Service de Radiologie, and EA 3878, CIC INSERM 1412, Centre Hospitalo-Universitaire de Brest, Université de Bretagne Occidentale, Brest, France. 13. Département Thoracique, Institut Mutualiste Montsouris, Paris, France.
Abstract
BACKGROUND: We aimed to identify risk factors for residual pulmonary vascular obstruction after a first unprovoked pulmonary embolism (PE). METHODS: Analyses were based on data from the double-blind randomized "PADIS-PE" trial that included 371 patients with a first unprovoked PE initially treated during 6 uninterrupted months; all patients underwentbaseline ventilation-perfusion lung scanning at inclusion (i.e., after 6 months of anticoagulation). Each patient's pulmonary vascular obstruction indexes (PVOIs) at PE diagnosis and at inclusion were centrally assessed. RESULTS: Among the 371 included patients, residual PVOI was available in 356 patients, and 150 (42.1%) patients had PVOI ≥ 5%. At multivariable analysis, age > 65 years (odds ratio [OR], 2.81, 95% confidence interval [CI], 1.58-5.00), PVOI ≥ 25% at PE diagnosis (OR, 3.53, 95% CI, 1.94-6.41), elevated factor VIII (OR, 3.89, 95% CI, 1.41-10.8), and chronic respiratory disease (OR, 2.18, 95% CI, 1.11-4.26) were independent predictors for residual PVOI ≥ 5%. Patients with ≥ 1 of these factors represented 94.5% (123 patients) of all patients with residual PVOI ≥ 5%. CONCLUSION: Six months after a first unprovoked PE, age > 65 years, PVOI ≥ 25% at PE diagnosis, elevated factor VIII, or chronic respiratory disease were found to be independent predictors for residual pulmonary vascular obstruction. CLINICAL TRIALS REGISTRATION: URL: http://www.controlled-trials.com. Unique identifier: NCT00740883. Georg Thieme Verlag KG Stuttgart · New York.
RCT Entities:
BACKGROUND: We aimed to identify risk factors for residual pulmonary vascular obstruction after a first unprovoked pulmonary embolism (PE). METHODS: Analyses were based on data from the double-blind randomized "PADIS-PE" trial that included 371 patients with a first unprovoked PE initially treated during 6 uninterrupted months; all patients underwent baseline ventilation-perfusion lung scanning at inclusion (i.e., after 6 months of anticoagulation). Each patient's pulmonary vascular obstruction indexes (PVOIs) at PE diagnosis and at inclusion were centrally assessed. RESULTS: Among the 371 included patients, residual PVOI was available in 356 patients, and 150 (42.1%) patients had PVOI ≥ 5%. At multivariable analysis, age > 65 years (odds ratio [OR], 2.81, 95% confidence interval [CI], 1.58-5.00), PVOI ≥ 25% at PE diagnosis (OR, 3.53, 95% CI, 1.94-6.41), elevated factor VIII (OR, 3.89, 95% CI, 1.41-10.8), and chronic respiratory disease (OR, 2.18, 95% CI, 1.11-4.26) were independent predictors for residual PVOI ≥ 5%. Patients with ≥ 1 of these factors represented 94.5% (123 patients) of all patients with residual PVOI ≥ 5%. CONCLUSION: Six months after a first unprovoked PE, age > 65 years, PVOI ≥ 25% at PE diagnosis, elevated factor VIII, or chronic respiratory disease were found to be independent predictors for residual pulmonary vascular obstruction. CLINICAL TRIALS REGISTRATION: URL: http://www.controlled-trials.com. Unique identifier: NCT00740883. Georg Thieme Verlag KG Stuttgart · New York.