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

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

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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Age Factors*
  • Double-Blind Method
  • Factor VIII / metabolism
  • Female
  • France / epidemiology
  • Humans
  • Male
  • Middle Aged
  • Practice Guidelines as Topic
  • Predictive Value of Tests
  • Prognosis
  • Pulmonary Embolism / diagnosis*
  • Pulmonary Embolism / epidemiology
  • Risk
  • Sensitivity and Specificity
  • Stenosis, Pulmonary Vein / diagnosis*
  • Stenosis, Pulmonary Vein / epidemiology

Substances

  • Factor VIII

Associated data

  • ClinicalTrials.gov/NCT00740883