Prediction models for recurrence and bleeding in patients with venous thromboembolism: A systematic review and critical appraisal

Winter, Maria A. de; Es, Nick van; Büller, Harry R.; Visseren, Frank L J; Nijkeuter, Mathilde

doi:10.1016/j.thromres.2020.12.031

Cited by 31 publications

(26 citation statements)

References 63 publications

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“…28 39 40 41 42 43 44 This may be explained by methodological limitations, as all model derivation studies were considered to be at high risk of bias according to the PROBAST tool. 27 36…”

Section: Discussionmentioning

confidence: 99%

“…Published bleeding risk scores were selected from the most recent systematic review. 27 For the present study, all models developed in patients with VTE were selected for evaluation, 6 14 15 16 17 18 as well as the most frequently used prediction model derived in a broader population of patients with anticoagulation. 28 29 We updated the search of the systematic review to identify potentially relevant new bleeding risk scores published up to November 10, 2020.…”

Section: Methodsmentioning

confidence: 99%

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Estimating Bleeding Risk in Patients with Cancer-Associated Thrombosis: Evaluation of Existing Risk Scores and Development of a New Risk Score

et al. 2021

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Background Bleeding risk is highly relevant for treatment decisions in cancer-associated thrombosis (CAT). Several risk scores exist, but have never been validated in patients with CAT and are not recommended for practice. Objectives To compare methods of estimating clinically relevant (major and clinically relevant nonmajor) bleeding risk in patients with CAT: (1) existing risk scores for bleeding in venous thromboembolism, (2) pragmatic classification based on cancer type, and (3) new prediction model. Methods In a posthoc analysis of the Hokusai VTE Cancer study, a randomized trial comparing edoxaban with dalteparin for treatment of CAT, seven bleeding risk scores were externally validated (ACCP-VTE, HAS-BLED, Hokusai, Kuijer, Martinez, RIETE, and VTE-BLEED). The predictive performance of these scores was compared with a pragmatic classification based on cancer type (gastrointestinal; genitourinary; other) and a newly derived competing risk-adjusted prediction model based on clinical predictors for clinically relevant bleeding within 6 months after CAT diagnosis with nonbleeding-related mortality as the competing event (“CAT-BLEED”). Results Data of 1,046 patients (149 events) were analyzed. Predictive performance of existing risk scores was poor to moderate (C-statistics: 0.50–0.57; poor calibration). Internal validation of the pragmatic classification and “CAT-BLEED” showed moderate performance (respective C-statistics: 0.61; 95% confidence interval [CI]: 0.56–0.66, and 0.63; 95% CI 0.58–0.68; good calibration). Conclusion Existing risk scores for bleeding perform poorly after CAT. Pragmatic classification based on cancer type provides marginally better estimates of clinically relevant bleeding risk. Further improvement may be achieved with “CAT-BLEED,” but this requires external validation in practice-based settings and with other DOACs and its clinical usefulness is yet to be demonstrated.

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“…28 39 40 41 42 43 44 This may be explained by methodological limitations, as all model derivation studies were considered to be at high risk of bias according to the PROBAST tool. 27 36…”

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Estimating Bleeding Risk in Patients with Cancer-Associated Thrombosis: Evaluation of Existing Risk Scores and Development of a New Risk Score

et al. 2021

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“…Additional clinical data were retrospectively collected by the participating centers for the 4‐week period prior to the gastrointestinal bleeding event (cases) or the 4‐week period before the day at which patients were matched (controls). The variables included were chosen based on their known association with bleeding in cancer patients as well as in the non‐cancer population or based on their potential protective properties in gastrointestinal bleeding 16‐22 . The following data were collected: resected or non‐resected tumors (patients with resected tumors at the moment of inclusion of the Hokusai VTE Cancer study, which had a recurrence at the time of this case‐control study, were classified as non‐resected); local or advanced disease (advanced cancer is defined as locally advanced or metastatic cancer); cancer therapy (different types of chemotherapy or surgery); interventions (e.g., endoscopy); concomitant medications including proton‐pump inhibitors, corticosteroids, non‐steroidal anti‐inflammatory drugs (NSAIDs) and antiplatelet agents; edoxaban dose; weight; and laboratory results (kidney function, hemoglobin and platelets).…”

Section: Methodsmentioning

confidence: 99%

“…The variables included were chosen based on their known association with bleeding in cancer patients as well as in the non-cancer population or based on their potential protective properties in gastrointestinal bleeding. [16][17][18][19][20][21][22] The following data…”

Section: Data Collectionmentioning

confidence: 99%

“…A hemoglobin level below 10 g/dl in the month prior to bleeding also appeared to be associated with gastrointestinal bleeding, which is in line with findings from modeling studies that identified anemia as a consistent predictor. 16 Whether a low hemoglobin is a true predictor or simply a reflection of occult blood loss is unknown.…”

Section: Ta B L E 1 Baseline Characteristics Of Cases and Matched Con...mentioning

confidence: 99%

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Risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer using edoxaban

Bosch¹,

Mulder²,

Huisman³

et al. 2021

Journal of Thrombosis and Haemostasis

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Background In the Hokusai VTE Cancer study, the risk of major bleeding was 2.9% higher in the edoxaban group compared with the dalteparin group, mainly due to more gastrointestinal bleedings in patients with gastrointestinal cancer. The identification of risk factors for gastrointestinal bleeding may help to guide the use of DOACs in these patients. Objectives To evaluate risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban. Patients/Methods In this nested case‐control study in patients with gastrointestinal cancer randomized to edoxaban in the Hokusai VTE Cancer study, cases (patients with clinically relevant gastrointestinal bleeding during treatment) were randomly matched to three controls (patients who had no gastrointestinal bleeding). Data for the 4‐week period prior to bleeding were retrospectively collected. Odds ratios (ORs) were calculated in a crude conditional logistic regression model and a multivariable model adjusted for age, sex, and cancer type. Results Twenty‐four cases and 64 matched controls were included. In the multivariable analysis, advanced cancer, defined as regionally advanced or metastatic cancer (OR 3.6, 95% CI 1.01–12.6) and low hemoglobin levels (OR 4.8, 95% CI 1.5–16.0) were significantly associated with bleeding. There was no significant difference in patients with resected tumors (OR 0.4, 95% CI 0.1–1.4), or in patients on chemotherapy (OR 1.3, 95% CI 0.5–3.5). Conclusion Advanced cancer and low hemoglobin levels were associated with an increased risk of gastrointestinal bleeding in patients with gastrointestinal cancer receiving edoxaban. We were unable to identify other risk factors, mainly due to limited statistical power.

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Risikofaktoren für Rezidive venöser Thromboembolien (VTE)

Bauersachs

2023

Klinische Angiologie

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Prediction models for recurrence and bleeding in patients with venous thromboembolism: A systematic review and critical appraisal

Cited by 31 publications

References 63 publications

Estimating Bleeding Risk in Patients with Cancer-Associated Thrombosis: Evaluation of Existing Risk Scores and Development of a New Risk Score

Estimating Bleeding Risk in Patients with Cancer-Associated Thrombosis: Evaluation of Existing Risk Scores and Development of a New Risk Score

Risk factors for gastrointestinal bleeding in patients with gastrointestinal cancer using edoxaban

Risikofaktoren für Rezidive venöser Thromboembolien (VTE)

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