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Randomized Controlled Trial
. 2019 Sep;119(9):1489-1497.
doi: 10.1055/s-0039-1692424. Epub 2019 Jun 23.

Predictors for Residual Pulmonary Vascular Obstruction after Unprovoked Pulmonary Embolism: Implications for Clinical Practice-The PADIS-PE Trial

Leela Raj  1   2 , Philippe Robin  3   4 , Raphael Le Mao  1   4 , Emilie Presles  4   5 , Cécile Tromeur  1   4 , Olivier Sanchez  4   6 , Gilles Pernod  4   7 , Laurent Bertoletti  4   8 , Patrick Jego  4   9 , Florent Leven  10 , Catherine A Lemarié  1   4 , Aurore Martin  11 , Benjamin Planquette  4   6 , Pierre-Yves Le Roux  3   4 , Pierre-Yves Salaun  3   4 , Michel Nonent  12 , Philippe Girard  4   13 , Karine Lacut  1   4 , Solen Melac  1   4 , Patrick Mismetti  4   8 , Silvy Laporte  4   5 , Guy Meyer  4   6 , Christophe Leroyer  1   4 , Francis Couturaud  1   4 ; PADIS-PE Investigators
Affiliations
Randomized Controlled Trial

Predictors for Residual Pulmonary Vascular Obstruction after Unprovoked Pulmonary Embolism: Implications for Clinical Practice-The PADIS-PE Trial

Leela Raj et al. Thromb Haemost. 2019 Sep.

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 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.

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Conflict of interest statement

F.C. reports having received research grant support from Pfizer and fees for board memberships or symposia from Bayer, Bristol-Myers Squibb/Pfizer, and Astra Zeneca, and having received travel support from Bayer, Bristol-Myers Squibb/Pfizer, Daiichi Sankyo, Boehringer Ingelheim, Leo Pharma, Intermune, and Actelion. L.R. declares she has no conflict of interest related to this research. P.R. declares he has no conflict of interest related to this research. R.L.-M. declares he has no conflict of interest related to this research. E.P. declares she has no conflict of interest related to this research. C.T. declares she has no conflict of interest related to this research. O.S. reports having received research grant support from Bayer, Daiichi Sankyo, and Portola Pharmaceuticals, and fees or nonfinancial support for consultancy activities from Actelion, GlaxoSmithKline, Boehringer Ingelheim, and Chiesi. G.P. declares he has no conflict of interest related to this research. L.B. declares he has no conflict of interest related to this research. C.A.L. declares she has no conflict of interest related to this research. P.J. reports having received personal fees or nonfinancial support from Sanofi, GlaxoSmithKline, Bayer, Boehringer Ingelheim, and Leo Pharma. A.M. declares she has no conflict of interest related to this research. F.L. declares he has no conflict of interest related to this research. P.-Y.L.R. declares he has no conflict of interest related to this research. P.-Y.S. declares he has no conflict of interest related to this research. M.N. declares he has no conflict of interest related to this research. B.P. declares he has no conflict of interest related to this research. P.G. reports having received personal fees and nonfinancial support from Bayer and Leo Pharma. K.L. reports having received personal fees from Bayer-Health Care, Bristol-Myers Squibb, and Boehringer Ingelheim. S.M. declares she has no conflict of interest related to this research. P.M. reports having received research grants from Bayer, fees for board memberships from Bayer, Bristol-Myers Squibb/Pfizer, and Daiichi Sankyo, for lectures from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb/Pfizer, Daiichi Sankyo, and Sanofi, and for development of educational presentations from Bayer and Bristol-Myers Squibb/Pfizer. S.L. reports having received research grant support from Bayer and Sanofi, and fees for board memberships or consultancy from Bayer, Boehringer Ingelheim, Leo Pharma, and Sanofi. G.M. reports having received research grant support from Bayer, Boehringer Ingelheim, Leo Pharma, and Sanofi, having been an uncompensated board member and a consultant for Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Leo Pharma, and Pfizer, and having received travel support from Bayer, Boehringer Ingelheim, Daiichi Sankyo, Leo Pharma, and Sanofi. C.L. reports having received research grant support from Pfizer and fees for board memberships or symposia from Bayer and Astra Zeneca and having received travel support from Bayer, Daiichi Sankyo, Leo Pharma, Intermune, and Actelion. No other potential conflict of interest relevant to this article was reported.

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