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

Eur Respir J. 2018 Jan 4;51(1):1701202. doi: 10.1183/13993003.01202-2017. Print 2018 Jan.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antibodies, Antiphospholipid / blood
  • Anticoagulants / therapeutic use
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Lung / physiopathology
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Perfusion
  • Proportional Hazards Models
  • Pulmonary Embolism / complications
  • Pulmonary Embolism / diagnosis*
  • Recurrence
  • Risk Factors
  • Venous Thromboembolism / complications
  • Venous Thromboembolism / diagnosis*
  • Warfarin / therapeutic use

Substances

  • Antibodies, Antiphospholipid
  • Anticoagulants
  • Warfarin