Statins for venous event reduction in patients with venous thromboembolism: A multicenter randomized controlled pilot trial assessing feasibility

Aurélien Delluc, Waleed Ghanima, Michael J. Kovacs, Sudeep Shivakumar, Susan R. Kahn, Per Morten Sandset, Clive Kearon, Ranjeeta Mallick, Marc A. Rodger

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10 Citations (Scopus)

Abstract

Background: Statins may reduce the risk for recurrent venous thromboembolism (VTE); however, no randomized trials have explored this hypothesis. We performed a pilot randomized trial to determine feasibility of recruitment for a larger trial of secondary VTE prevention with rosuvastatin. Methods: Patients with a newly diagnosed symptomatic proximal deep vein thrombosis and/or pulmonary embolism, receiving standard anticoagulation, were randomly allocated to adjuvant rosuvastatin 20 mg once daily for 180 days or no rosuvastatin for 6 months. Results: Between November 2016 and December 2019, 3391 patients were assessed for eligibility in six centers. Of these patients, 1347 (39.7%) were eligible and approached for participation in the trial and 312 (23.1%) were randomized. The mean rate of randomization was 8.2 ± 4.3 patients per month. During follow-up, five recurrent VTE events were observed, three (1.9%) in the rosuvastatin group (two pulmonary embolism, one deep vein thrombosis), and two (1.3%) in the control group (two pulmonary embolism; P = 0.68). One major arterial event occurred in the rosuvastatin arm and none in the control arm (0.6% vs. 0%, P = 0.50). Conclusion: This pilot trial supports the feasibility of a larger scale randomized controlled trial to determine the efficacy of adjuvant rosuvastatin for the secondary prevention of VTE.

Original languageEnglish
Pages (from-to)126-132
Number of pages7
JournalJournal of Thrombosis and Haemostasis
Volume20
Issue number1
DOIs
Publication statusPublished - Jan 2022
Externally publishedYes

Bibliographical note

Funding Information:
Dr. Aurélien Delluc is the recipient of a University of Ottawa Department of Medicine Research Salary Award. Dr. Susan Kahn holds a Tier 1 Canada Research Chair in Venous Thromboembolism. Dr. Marc Rodger is the McGill University Harry Webster Thorp Professor of Medicine. Aurélien Delluc, Michael J. Kovacs, Sudeep Shivakumar, Susan R. Kahn, Clive Kearon, and Marc A. Rodger are investigators of the CanVECTOR network, which received funding from the Canadian Institutes of Health Research (CDT‐142654). The authors would like to thank Megan Inskip and Veronica Bates for their help in managing the trial. We are also grateful to Dr. Francis Couturaud, Dr. Walter Ageno, Dr. Michiel Coppens, Dr. Stefano Barco, Dr. Stavros Konstantinides, Dr. Fionnuala Ni Ainle, and Dr. Sara Ng for their efforts in launching the SAVER Trial (NCT04319627) in their countries.

Funding Information:
This study was funded by the Canadian Institutes of Health Research (CIHR # PJT 148716) and the Southern and Eastern Norway Regional Health Authority (Grant # 2015112).

Funding Information:
This study was funded by the Canadian Institutes of Health Research (CIHR # PJT 148716) and the Southern and Eastern Norway Regional Health Authority (Grant # 2015112). Dr. Aur?lien Delluc is the recipient of a University of Ottawa Department of Medicine Research Salary Award. Dr. Susan Kahn holds a Tier 1 Canada Research Chair in Venous Thromboembolism. Dr. Marc Rodger is the McGill University Harry Webster Thorp Professor of Medicine. Aur?lien Delluc, Michael J. Kovacs, Sudeep Shivakumar, Susan R. Kahn, Clive Kearon, and Marc A. Rodger are investigators of the CanVECTOR network, which received funding from the Canadian Institutes of Health Research (CDT-142654). The authors would like to thank Megan Inskip and Veronica Bates for their help in managing the trial. We are also grateful to Dr. Francis Couturaud, Dr. Walter Ageno, Dr. Michiel Coppens, Dr. Stefano Barco, Dr. Stavros Konstantinides, Dr. Fionnuala Ni Ainle, and Dr. Sara Ng for their efforts in launching the SAVER Trial (NCT04319627) in their countries.

Publisher Copyright:
© 2021 International Society on Thrombosis and Haemostasis.

ASJC Scopus Subject Areas

  • Hematology

PubMed: MeSH publication types

  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

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Delluc, A., Ghanima, W., Kovacs, M. J., Shivakumar, S., Kahn, S. R., Sandset, P. M., Kearon, C., Mallick, R., & Rodger, M. A. (2022). Statins for venous event reduction in patients with venous thromboembolism: A multicenter randomized controlled pilot trial assessing feasibility. Journal of Thrombosis and Haemostasis, 20(1), 126-132. https://doi.org/10.1111/jth.15537