Predictors for Residual Pulmonary Vascular Obstruction after Unprovoked Pulmonary Embolism: Implications for Clinical Practice—The PADIS-PE TrialFunding This study was supported by grants from the “Programme Hospitalier de Recherche Clinique” (French Department 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, analyzing, or interpreting the data, preparing, reviewing, or approving the manuscript, or deciding to submit this for publication.
10 February 2019
17 April 2019
23 June 2019 (eFirst)
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.
Keywordsunprovoked pulmonary embolism - residual pulmonary vascular obstruction - recurrent venous thromboembolism - risk factors
F.C. had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. He obtained funding for the manuscript and supervised the study. F.C., L.R., O.S., L.B., C.T., P.M., and C.L. contributed to study concept and design. F. C., L.R., O.S., C.T., G.M., L.B., S.L., P.G., E.P., and C.L. contributed to drafting of the manuscript. S.M. contributed to acquisition of data. S.L., E.P., and F.C. contributed to statistical analysis. F.C., K.L., P.Y.S, L.B., M.N., and C.L. provided administrative, technical, or material support. All the authors contributed to analysis and interpretation of data and critical revision of the manuscript for important intellectual content. All the authors approved the final manuscript.
* Members of the Prolongation d'un traitement par Antivitamine K pendant Dix-huit mois versus placebo au décours d'un premier épisode d'embolie pulmonaire Idiopathique traité Six mois (PADIS-PE) Study Group are listed in [Supplementary Appendix] (available in the online version).
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