What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Cancer-associated venous thromboembolism (n=2245). Intervention: Clinical prediction model. Primary outcome: Adjudicated on-treatment recurrent cancer-associated thrombosis (c-statistic 0.63, 95% CI 0.54-0.72).

September 19, 2024Open Access

Risk of Recurrent Venous Thromboembolism in Patients with Cancer: An Individual Patient Data Meta-analysis and Development of a Prediction Model

Key Result

A clinical prediction model for recurrent cancer-associated thrombosis incorporating age, breast cancer, metastatic disease, DOAC treatment, and DVT only demonstrated modest discrimination with a c-statistic of 0.63.

Study Design

Type

Meta-Analysis (n=2,245)

Blinding

Open-label

Multicenter

Yes

Structured PICO

Can a clinical prediction model accurately identify patients with cancer-associated venous thromboembolism at high risk for recurrence during anticoagulant treatment?

Population

2,245 patients with cancer and acute cancer-associated venous thromboembolism (CAT) pooled from four randomized controlled trials (Hokusai VTE Cancer, SELECT-D, CLOT, and CATCH), excluding patients using vitamin K antagonists.

Intervention

Development and validation of a clinical prediction model for on-treatment recurrent CAT.

Outcome

Adjudicated on-treatment recurrent CAT during a 6-month follow-up.hard clinical

A clinical prediction model for recurrent cancer-associated thrombosis demonstrated only modest discrimination (c-statistic 0.63), highlighting that predicting recurrence at the initiation of anticoagulation remains challenging.

Main Result

Effect estimate: c-statistic 0.63 (95% CI 0.54-0.72)

Limitations

Unable to assess other potential predictors such as cancer stage, kidney function, hemoglobin levels, leukocyte count, history of VTE, and cancer treatment due to missing data.
Could not directly compare performance to other risk assessment tools like the Ottawa score.
Lack of access to data from more recent trials such as CANVAS or Caravaggio.
Use of only RCT data may limit generalizability due to strict eligibility criteria.
Differences in cancer treatment, follow-up, and diagnostic procedures between older and newer trials.
Variation in the definition of recurrent VTE across the included trials.

Abstract

About 7% of patients with cancer-associated venous thromboembolism (CAT) develop a recurrence during anticoagulant treatment. Identification of high-risk patients may help guide treatment decisions.To identify clinical predictors and develop a prediction model for on-treatment recurrent CAT.For this individual patient data meta-analysis, we used data from four randomized controlled trials evaluating low-molecular-weight heparin or direct oral anticoagulants (DOACs) for CAT (Hokusai VTE Cancer, SELECT-D, CLOT, and CATCH). The primary outcome was adjudicated on-treatment recurrent CAT during a 6-month follow-up. A clinical prediction model was developed using multivariable logistic regression analysis with backward selection. This model was validated using internal-external cross-validation. Performance was assessed by the c-statistic and a calibration plot.After excluding patients using vitamin K antagonists, the combined dataset comprised 2,245 patients with cancer and acute CAT who were treated with edoxaban (23%), rivaroxaban (9%), dalteparin (47%), or tinzaparin (20%). Recurrent on-treatment CAT during the 6-month follow-up occurred in 150 (6.7%) patients. Predictors included in the final model were age (restricted cubic spline), breast cancer (odds ratio OR: 0.42; 95% confidence interval CI: 0.20-0.87), metastatic disease (OR: 1.44; 95% CI: 1.01-2.05), treatment with DOAC (OR: 0.66; 95% CI: 0.44-0.98), and deep vein thrombosis only as an index event (OR: 1.72; 95% CI: 1.31-2.27). The c-statistic of the model was 0.63 (95% CI: 0.54-0.72) after internal-external cross-validation. Calibration varied across studies.The prediction model for recurrent CAT included five clinical predictors and has only modest discrimination. Prediction of recurrent CAT at the initiation of anticoagulation remains challenging.

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