Resumen
No clinical prediction model has been specifically developed or validated to identify patients with unprovoked venous thromboembolism (VTE) who are at high risk of major bleeding during extended anticoagulation. In a prospective multinational cohort study of patients with unprovoked VTE receiving extended anticoagulation after completing $3 months of initial treatment, we derived a new clinical prediction model using a multivariable Cox regression model based on 22 prespecified candidate predictors for the primary outcome of major bleeding. This model was then compared with modified versions of 5 existing clinical scores. A total of 118 major bleeding events occurred in 2516 patients (annual risk, 1.7%; 95% confidence interval [CI], 1.4-2.1). The incidences of major bleeding events per 100 person-years in high-risk and non–high-risk patients, respectively, were 3.9 (95% CI, 3.0-5.1) and 1.1 (0.8-1.4) using the newly derived creatinine, hemoglobin, age, and use of antiplatelet agent (CHAP) model; 3.3 (2.6-4.1) and 1.0 (0.7-1.3) using modified ACCP score, 5.3 (0.6-19.2) and 1.7 (1.4-2.0) using modified RIETE score, 3.1 (2.3-3.9) and 1.1 (0.9-1.5) using modified VTE-BLEED score, 5.2 (3.3-7.8) and 1.5 (1.2-1.8) using modified HAS-BLED score, and 4.8 (1.3-12.4) and 1.7 (1.4-2.0) using modified outpatient bleeding index score. Modified versions of the ACCP, VTE-BLEED, and HAS-BLED scores help identify patients with unprovoked VTE who are at high risk of major bleeding and should be considered for discontinuation of anticoagulation after 3 to 6 months of initial treatment. The CHAP model may further improve estimation of bleeding risk by using continuous predictor variables, but external validation is required before its implementation in clinical practice.
| Idioma original | English |
|---|---|
| Páginas (desde-hasta) | 4605-4616 |
| Número de páginas | 12 |
| Publicación | Blood advances |
| Volumen | 6 |
| N.º | 15 |
| DOI | |
| Estado | Published - ago. 9 2022 |
Nota bibliográfica
Funding Information:Conflict-of-interest disclosure: PW reports receiving honoraria for advisory board meetings from Bayer Healthcare, Sanofi, and Daiichi Sankyo, and Research Funding from BMS/Pfizer. LC has received honoraria from Amag Pharmaceuticals, Bayer Healthcare, BMS-Pfizer Alliance, The Academy, LEO Pharma, Sanofi, Servier, and Valeo. All payments were made to her institution. MC has received research funding from Leo Pharma, BMS, and Pfizer, and honoraria from Bayer, Sanofi, Servier, BMS, Pfizer, and LEO Pharma. All payments were made to his institution. GLG reports support from Portola Pharmaceuticals, Boehringer Ingelheim, Pfizer BMS, LEO Pharma, Daiichi Sankyo, Bayer, Sanofi, and bioMerieux. All payments were made to his institution. S.K. received a grant to develop educational materials from Alexion. S. Schulman has received research grant from Octapharma and honoraria for work in study committees from Daiichi-Sankyo, Boehringer Ingelheim, Bayer, and Sanofi, and for lectures from Servier and Bristol Myers Squibb. The remaining authors declare no competing financial interests.
Funding Information:
P.S.W., T.T., F.K., D.R.A., S.R.K., A.L.-L., M.C., G.L.G., L.A.C., C.K., S. Solymoss, S. Schulman, I.C., M.J.K., and M.A.R. are investigators of the CanVECTOR Network; the Network receives grant funding from the Canadian Institutes of Health Research (Funding Reference: CDT-142654). T.T.’s research was supported by grants from the Swiss National Science Foundation (SNSF P2ZHP3_177999) and the CanVECTOR Network. F.K. was supported by the Frederick Banting and Charles Best doctoral research scholarship from the Canadian Institutes of Health Research. S.R.K. holds a Tier 1 Canada Research Chair in Venous Thromboembolism. P.S.W., M.C., and G.L.G. all hold a Clinical Research Chair from the Department and Faculty of Medicine of the University of Ottawa. G.L.G. also holds a Clinician-scientist Award from the Heart and Stroke Foundation of Canada. L.A.C. is supported by a Tier 2 Research Chair in Thrombosis and Anticoagulation Safety from the Department and Faculty of Medicine of the University of Ottawa and a Heart and Stroke Foundation of Canada National New Investigator Award. M.A.R. is the McGill University Harry Webster Thorp Professor of Medicine.
Funding Information:
This investigator-initiated study was sponsored by the Ottawa Hospital Research Institute and funded by grants from the Canadian Institutes of Health Research (MOP130388) and the Heart and Stroke Foundation of Canada. The funders had no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the manuscript; or in the decision to submit the article for publication.
Publisher Copyright:
© 2022 by The American Society of Hematology.
ASJC Scopus Subject Areas
- Hematology
PubMed: MeSH publication types
- Journal Article
- Research Support, Non-U.S. Gov't