The CoVID-TE risk assessment model for venous thromboembolism in hospitalized patients with cancer and COVID-19

the CCC19 consortium

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Hospitalized patients with COVID-19 have increased risks of venous (VTE) and arterial thromboembolism (ATE). Active cancer diagnosis and treatment are well-known risk factors; however, a risk assessment model (RAM) for VTE in patients with both cancer and COVID-19 is lacking. Objectives: To assess the incidence of and risk factors for thrombosis in hospitalized patients with cancer and COVID-19. Methods: Among patients with cancer in the COVID-19 and Cancer Consortium registry (CCC19) cohort study, we assessed the incidence of VTE and ATE within 90 days of COVID-19–associated hospitalization. A multivariable logistic regression model specifically for VTE was built using a priori determined clinical risk factors. A simplified RAM was derived and internally validated using bootstrap. Results: From March 17, 2020 to November 30, 2020, 2804 hospitalized patients were analyzed. The incidence of VTE and ATE was 7.6% and 3.9%, respectively. The incidence of VTE, but not ATE, was higher in patients receiving recent anti-cancer therapy. A simplified RAM for VTE was derived and named CoVID-TE (Cancer subtype high to very-high risk by original Khorana score +1, VTE history +2, ICU admission +2, D-dimer elevation +1, recent systemic anti-cancer Therapy +1, and non-Hispanic Ethnicity +1). The RAM stratified patients into two cohorts (low-risk, 0–2 points, n = 1423 vs. high-risk, 3+ points, n = 1034) where VTE occurred in 4.1% low-risk and 11.3% high-risk patients (c statistic 0.67, 95% confidence interval 0.63–0.71). The RAM performed similarly well in subgroups of patients not on anticoagulant prior to admission and moderately ill patients not requiring direct ICU admission. Conclusions: Hospitalized patients with cancer and COVID-19 have elevated thrombotic risks. The CoVID-TE RAM for VTE prediction may help real-time data-driven decisions in this vulnerable population.

Original languageEnglish (US)
Pages (from-to)2522-2532
Number of pages11
JournalJournal of Thrombosis and Haemostasis
Volume19
Issue number10
DOIs
StatePublished - Oct 2021

Bibliographical note

Funding Information:
This work was supported by Texas Cancer Prevention and Research Institute of Texas (RR190104), Hemostasis and Thrombosis Research Society (Mentored Research Award) supported by an independent educational grant from Shire, and National Hemophilia Foundation Shire Clinical Fellowship Award (AL). National Cancer Institute grant P30 CA068485 (SM, BIR, JLW, CYH, YS).

Funding Information:
ARK (or an immediate family member) have currently or during the past 2 years owned stock or held an ownership interest in Merck, Sanofi, and BMS. ALS reports travel support from Pfizer and Astellas, outside the scope of the submitted work. BIR reports grants, personal fees, and non‐financial support from Merck; grants and personal fees from BMS; grants and personal fees from Pfizer, grants and personal fees from Aveo, grants from Astra Zeneca, grants and personal fees from Genentech; personal fees from Synthorx; personal fees from 3D Medicines; personal fees from Arravive; personal fees from Surface Oncology; other from PTC Therapeutics; personal fees from Arrowhead Therapeutics, outside the scope of the submitted work. BH reports research funding to the institution from Amgen, Abbvie, BI, Mirati, Merck, Eli‐Lilly, Astra‐Zeneca, BMS, Novartis, GSK, Pfizer, Advaxis, and GuardantHealth; consulting/advisory role with Merck, BMS, Genentech, Astra‐Zeneca, Amgen, Novartis, TPT, VI, GuardantHealth; and honoraria from PER and OncLive, all outside the scope of the submitted work. GLL reports research grant from Amgen (to institution); consulting for BeyondSpring, G1 Therapeutics, Samsung, TEVA, all outside the scope of the submitted work. GdLL reports honoraria from Boehringer Ingelheim; consulting or advisory role for Pfizer and AstraZeneca; research funding from AstraZeneca; funding to his institution from Merck Sharp & Dohme, EMD Serono, AstraZeneca, Blueprint Medicines, Tesaro, Bavarian Nordic, NOVARTIS, G1 Therapeutics, adaptimmune, BMS, GSK, Abbvie, Rgenix, Pfizer, Roche, Genentech, Lilly, Janssen; travel, accommodations, and expenses from Boehringer Ingelheim, Pfizer, E.R. Squibb Sons, LLC, Janssen, all outside the scope of the submitted work. NMK reports personal fees from G1 Therapeutics, Invitae, Beyond Spring, Spectrum, BMS, Janssen, Total Health, all outside the scope of the submitted work. JW reports research grant support from the National Cancer Institute in support of this work; the funder had no role in the design of conduct of the study, or the decision to publish. Equity in HemOnc.org LLC, Consultant: Westat, IBM Watson Health; outside the scope of the submitted work. VK reports honoraria from Diagnostica Stago, all outside the scope of the submitted work. SG reports research grant support to her institution from Astrazeneca and Isoray, all outside the scope of submitted work. RPR reports research grant support to her institution from BMS and Janssen; Consultant/Advisory Board: BMS, Janssen, and Dova, all outside scope of submitted work. JMP reports honoraria from Radius, outside the scope of the submitted work. BH reports research grant support for his work from the NCI (NCORP 2UG1CA189859‐06), research grant support to his institution from Merck, Boehringer‐Ingelheim, Astra‐Zeneca, BMS, Mirati, AbbVie, Advaxis, Pfizer, Novartis, BeiGene, Elevation Oncology, Blueprint and received fees for consulting from Merck, BMS, Novartis, Janssen, Genentech, Astra‐Zeneca, Boehringer‐Ingelheim, Pfizer, TPT, Apollomics, all outside the scope of the submitted work. CAP (or an immediate family member) have currently or during the past 2 years owned stock or held an ownership interest in Pfizer, Epizyme, Inovio, OPKO Health Inc, Roche., all outside the scope of the submitted work. CH reports funding from the Henry Ford Cancer Institute supporting the current work; research funding paid to her institution from Merck, Exelixis, Bayer, AstraZeneca, Genentech, Dendreon, and Bausch; personal fees from Sanofi/Genzyme, Dendreon, Exelixis, Bristol Myers Squibb, Astellas, Medivation, Bayer, and Janssen Scientific; and stock ownership by an immediate family member in Johnson and Johnson, outside of the scope of the submitted work. RRM received research funding from Bayer, Pfizer, Tempus; serves on Advisory Board for AstraZeneca, Bayer, Bristol Myers Squibb, Calithera, Exelixis, Janssen, Merck, Novartis, Pfizer, Sanofi, Tempus; is a consultant for Dendreon, Vividion; serves on the molecular tumor board at Caris, all unrelated to the current scope of work. SG reports research funding to the institution from Astra‐Zeneca and consulting/advisory role with Puma Biotechnology. MAT reports travel support from Syapse; royalties from UpToDate, Connect MDS/AML Registry in Celgene (now owned by BMS), Myeloma Registry in Takeda; stock ownership in Doximity; personal fees from VIA Oncology (now owned by Elsevier ClinicalPath), Adaptive Advisory Board, and GSK. Dr. Thompson is the Local PI for Clinical Trials in AbbVie, BMS, CRAB CTC, Denovo, Research Network, Eli Lilly, LynxBio, Strata Oncology, TG Therapeutics, all outside the submitted work. ZB reports research support from Bristol‐Myers Squibb and Genentech/imCORE; honoraria from UpToDate, all outside the scope of the submitted work. NAP reports honoraria for consulting/advisory boards: Merck, AstraZeneca, BMS, Eli Lilly, Genentech, Pfizer, Amgen, G1 Therapeutics, Xencor, Viosera, Inivata, all outside of the scope of submitted work. SP reports personal fees from Abbvie, Amgen, AstraZeneca, Bayer, Biocartis, Boehringer‐Ingelheim, Bistrol‐Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, F. Hoffmann‐La Roche, Foundation Medicine, Illumina, Janssen, MerckSharp and Dohme, Merck Serono, Merrimack, Novartis, Pharma Mar, Pfizer, Regeneron, Sanofi, Seattle Genetics and Takeda, AstraZeneca, Boehringer‐Ingelheim, Bristol‐Myers Squibb, Eli Lilly, F. Hoffmann‐La Roche, Merck Sharp and Dohme, Novartis, Pfizer, Takeda, Bioinvent; non‐financial support from Sponsored by Amgen, AstraZeneca, Boehringer‐Ingelheim, Bristol‐Meyers Squibb, Clovis, F. Hoffmann‐La Roche, Illumina, Merck Sharp and Dohme, Merck Serono, Novartis, Pfizer, Sanofi, (all fees to institution), outside the submitted work; PG (all unrelated to this study, in the last 3 years) has provided consulting or advisory services for AstraZeneca, Bayer, Bristol Myers Squibb, Clovis Oncology, Dyania Health, Driver, EMD Serono, Exelixis, Foundation Medicine, Genentech/Roche, Genzyme, GlaxoSmithKline, Heron Therapeutics, Immunomedics, Infinity Pharmaceuticals, Janssen, Merck & Co., Mirati Therapeutics, Pfizer, QED Therapeutics, Seattle Genetics, and 4D Pharma PLC; and has received research funding from Bavarian Nordic, Bristol Myers Squibb, Clovis Oncology, Debiopharm, GlaxoSmithKline, Immunomedics, Kure It Cancer Research, Merck & Co., Mirati Therapeutics, Pfizer, and QED Therapeutics. YS reports honoraria from Boehringer Ingelheim, AstraZeneca, Novartis, and Eisai; consulting or advisory role for Pfizer, AstraZeneca, Novartis, Roche, Genentech, and Janssen, all outside the scope of the submitted work. AD, AL, AS, C‐YH, DGB, DPS, DKC, DRR, DGS, IJA, JG, JF, ML, SM have nothing to disclose.

Funding Information:
This work was supported by Texas Cancer Prevention and Research Institute of Texas (RR190104), Hemostasis and Thrombosis Research Society (Mentored Research Award) supported by an independent educational grant from Shire, and National Hemophilia Foundation Shire Clinical Fellowship Award (AL). National Cancer Institute grant P30 CA068485 (SM, BIR, JLW, CYH, YS).

Publisher Copyright:
© 2021 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis

Keywords

  • COVID-19
  • SARS-CoV-2
  • clinical decision rules
  • thrombosis
  • venous thromboembolism

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