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A pilot randomized trial of atorvastatin as adjunct therapy in patients with acute venous thromboembolism

Tzu-Fei Wang1, Amanda P Waller2, Ella Lin3

  • 1Division of Hematology, Department of Internal Medicine, The Ohio State University Wexner Medical Center.

Blood Coagulation & Fibrinolysis : an International Journal in Haemostasis and Thrombosis
|November 16, 2020
PubMed

Insights

This pilot study investigated statins for venous thromboembolism (VTE). Adjunct atorvastatin did not reduce thrombin generation in VTE patients but did lower LDL cholesterol. Future studies face enrollment challenges.

Area of Science:

  • Cardiovascular Medicine
  • Hematology
  • Pharmacology

Background:

  • Venous thromboembolism (VTE) is a significant cardiovascular disease requiring optimized treatment.
  • Statins are widely used for cardiovascular risk reduction, but their role in acute VTE management is unclear.

Purpose of the Study:

  • To investigate the effect of adding atorvastatin to anticoagulation on thrombin generation in patients with acute VTE.
  • To assess secondary endpoints including recurrent thrombosis, bleeding, and post-thrombotic syndrome.

Main Methods:

  • A single-center pilot randomized study comparing anticoagulation alone versus anticoagulation plus atorvastatin (40mg daily) in acute VTE patients.
  • Primary endpoint: reduction in endogenous thrombin potential or peak thrombin concentration.
  • Follow-up duration: 9 months.

Main Results:

  • The study was terminated early due to low recruitment (21 patients over 3.5 years).
  • Adjunct atorvastatin did not significantly reduce thrombin generation.
  • Atorvastatin significantly reduced LDL cholesterol at 3 months but did not affect d-dimer or hs-CRP.
  • High rates of ineligibility and lost follow-up were observed.

Conclusions:

  • This pilot study did not demonstrate a reduction in thrombin generation with atorvastatin in VTE patients.
  • Low patient recruitment and high dropout rates present significant barriers for future VTE-statin research.
  • Findings highlight challenges in designing and conducting clinical trials for VTE management.

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