Prediction of major bleeding in patients receiving DOACs for venous thromboembolism: A prospective cohort study

Vedovati, Maria Cristina; Mancuso, Alessandra; Pierpaoli, Lucia; Paliani, Ugo; Conti, Serenella; Ascani, A.; Galeotti, Giulia; Filippo, Francesco Di; Caponi, Carla; Agnelli, Giancarlo; Becattini, Cecilia

doi:10.1016/j.ijcard.2019.11.105

Cited by 24 publications

(16 citation statements)

References 24 publications

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“…Of the 26 included studies, 12,26–49 14 were RCTs and 12 were prospective cohort studies with a total of 15 603 patients with a first unprovoked or weakly provoked VTE who, after having completed at least 3 months of initial anticoagulant treatment, received extended anticoagulation (Table 1). The duration of initial anticoagulant treatment was exclusively 3 months in 12 studies (Table 1).…”

Section: Resultsmentioning

confidence: 99%

Long‐term risk of recurrent venous thromboembolism among patients receiving extended oral anticoagulant therapy for first unprovoked venous thromboembolism: A systematic review and meta‐analysis

Khan

Tritschler

Kimpton

et al. 2021

Journal of Thrombosis and Haemostasis

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Background The long‐term risk for recurrent venous thromboembolism (VTE) during extended anticoagulation for a first unprovoked VTE is uncertain. Objectives To determine the incidence of recurrent VTE during extended anticoagulation of up to 5 years in patients with a first unprovoked VTE. Methods MEDLINE, EMBASE, and the Cochrane CENTRAL were searched to identify randomized trials and prospective cohort studies reporting recurrent VTE among patients with a first unprovoked VTE who were to receive anticoagulation for a minimum of six additional months after completing ≥3 months of initial treatment. Unpublished data on number of recurrent VTE and person‐years, obtained from authors of included studies, were used to calculate study‐level incidence rate, and random‐effects meta‐analysis was used to pool results. Results Twenty‐six studies and 15 603 patients were included in the analysis. During 11 631 person‐years of follow‐up, the incidence of recurrent VTE and fatal pulmonary embolism per 100 person‐years was 1.41 (95% CI, 1.03–1.84) and 0.09 (0.04–0.16), with 5‐year cumulative incidences of 7.1% (3.0%–13.2%) and 1.2% (0.4%–4.6%), respectively. The incidence of recurrent VTE was 1.08 (95% CI, 0.77–1.44) with direct oral anticoagulants and 1.55 (1.01–2.20) with vitamin K antagonists. The case‐fatality rate of recurrent VTE was 4.9% (95% CI, 2.2%–8.7%). Conclusions In patients with a first unprovoked VTE, the long‐term risk of recurrent VTE during extended anticoagulation is low but not negligible. Thus, clinicians and patients should be aware of this risk and take appropriate and timely action in case of suspicion of recurrent VTE. Estimates from this study can be used to advise patients on what to expect while receiving extended anticoagulation, and estimate the net clinical benefit of extended treatment to guide long‐term management of unprovoked VTE.

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Section: Resultsmentioning

confidence: 99%

Long‐term risk of recurrent venous thromboembolism among patients receiving extended oral anticoagulant therapy for first unprovoked venous thromboembolism: A systematic review and meta‐analysis

Khan

Tritschler

Kimpton

et al. 2021

Journal of Thrombosis and Haemostasis

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“…Existing predictive models and scores, such as the HAS-BLED score, have consistently shown mediocre performance when assessed by measures like the c-statistic. 16 The model developed in this analysis performed slightly better than the HAS-BLED score, but not well enough to warrant extensive application. The limited ability of this newly developed algorithm and previous scores to predict major bleeding can be due, in part, to heterogeneity in the outcome, with different bleeding types having specific risk factors.…”

Section: Discussionmentioning

confidence: 80%

A claims-based score for the prediction of bleeding in a contemporary cohort of patients receiving oral anticoagulation for venous thromboembolism

Alonso

Norby

MacLehose

et al. 2021

Preprint

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Background: Current scores for bleeding risk assessment in patients with venous thromboembolism (VTE) undergoing oral anticoagulation (OAC) have limited predictive capacity. We developed and internally validated a bleeding prediction model using healthcare claims data. Methods and Results: We selected patients with incident VTE in the 2011-2017 MarketScan databases initiating OAC. Hospitalized bleeding events were identified using validated algorithms in the 180 days after VTE diagnosis. We evaluated demographic factors, comorbidities, and medication use prior to OAC initiation as potential predictors of bleeding using stepwise selection of variables in Cox models ran on 1000 bootstrap samples of the patient population. Variables included in >60% of all models were selected for the final analysis. We internally validated the model using bootstrapping and correcting for optimism. We included 165,434 VTE patients initiating OAC, of which 2,294 had a bleeding event. After undergoing the variable selection process, the final model included 20 terms (15 main effects and 5 interactions). The c-statistic for the final model was 0.68 (95% confidence interval [CI] 0.67-0.69). The internally validated c-statistic corrected for optimism was 0.68 (95%CI 0.67-0.69). For comparison, the c-statistic of the HAS-BLED score in this population was 0.62 (95%CI 0.61-0.63). Conclusion: We have developed a novel model for bleeding prediction in VTE using large healthcare claims databases. Performance of the model was moderately good, highlighting the urgent need to identify better predictors of bleeding to inform treatment decisions.

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“…The higher number of patients and events in the current study is a strength to take into account regarding other previous studies that have compared bleeding scores in VTE patients, in which the c-statistic of the RIETE score was more modest. 6,22 In another recent prospective study, the AUC of the RIETE and VTE-BLEED scores for the detection of in-hospital bleeding in patients with acute PE were also high: 0.77 and 0.75, respectively. The addition of D-dimer values could help to improve their performance.…”

Section: Discussionmentioning

confidence: 96%

“…In the latest years, different attempts to develop and validate a prognostic score to identify VTE patients at increased risk for bleeding have been performed, but their predictive values and accuracy are modest. [4][5][6] Recently, a new score to predict major bleeding in stable anticoagulated (i.e., after the first 30 days) patients with VTE, named VTE-BLEED score (►Table 1), was validated after a post-hoc analysis of data from two randomized clinical trials and a prospective cohort study comparing DOACs versus VKAs for the long-term treatment of VTE. [7][8][9] The longterm predictive ability of the score has also been confirmed in a retrospective study including consecutive patients with VTE, despite marked differences in the proportion of high-risk patients, 26 to 37% in the former studies versus 68% in the latter retrospective real-world registry.…”

Section: Introductionmentioning

confidence: 99%

Prediction of Major Bleeding in Anticoagulated Patients for Venous Thromboembolism: Comparison of the RIETE and the VTE-BLEED Scores

Jiménez

Ruiz-Artacho

Nieto

et al. 2021

TH Open

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The performance of validated bleeding risk scores in patients with venous thromboembolism (VTE) could be different depending on the time after index event or the site of bleeding. In this study we compared the “classic” Registro Informatizado de Enfermedad TromboEmbólica (RIETE) score and the more recently developed VTE-BLEED score for the prediction of major bleeding in patients under anticoagulant therapy in different time intervals after VTE diagnosis. Out of 82,239 patients with acute VTE, the proportion of high-risk patients according to the RIETE and VTE-BLEED scores was 7.1 and 62.3%, respectively. The performance of both scores across the different study periods (first 30 days after VTE diagnosis, days 31–90, days 91–180, and days 181–360) was similar, with areas under the receiving operating characteristics (ROC) curve (AUC) ranging between 0.69 and 0.72. However, the positive predictive values were low, ranging between 0.6 and 3.9 (better for early major bleeding than for later periods). A sensitivity analysis limited to patients with unprovoked VTE showed comparable results. Both scores showed a trend toward a better prediction of extracranial than intracranial major bleeding, the RIETE score resulting more useful for early extracranial bleeding and the VTE-BLEED for late intracranial hemorrhages. Our study reveals that the usefulness of available bleeding scores may vary depending on the characteristics of the patient population and the time frame evaluated. Dynamic scores could be more useful for this purpose.

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Prediction of major bleeding in patients receiving DOACs for venous thromboembolism: A prospective cohort study

Cited by 24 publications

References 24 publications

Long‐term risk of recurrent venous thromboembolism among patients receiving extended oral anticoagulant therapy for first unprovoked venous thromboembolism: A systematic review and meta‐analysis

Long‐term risk of recurrent venous thromboembolism among patients receiving extended oral anticoagulant therapy for first unprovoked venous thromboembolism: A systematic review and meta‐analysis

A claims-based score for the prediction of bleeding in a contemporary cohort of patients receiving oral anticoagulation for venous thromboembolism

Prediction of Major Bleeding in Anticoagulated Patients for Venous Thromboembolism: Comparison of the RIETE and the VTE-BLEED Scores

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