Prediction of major bleeding in patients receiving DOACs for venous thromboembolism: A prospective cohort study.
In the direct oral anticoagulants (DOACs) era, extended anticoagulation is an attractive strategy after venous thromboembolism (VTE). The role of currently available bleeding risk scores for VTE patients treated with DOACs in clinical practice is undefined.
Consecutive patients with VTE were included in a prospective multicenter cohort at the initiation of treatment with DOACs. The role of ATRIA, HAS-BLED, Kuijer, ORBIT, RIETE and VTE-BLEED scores in predicting major bleeding (ISTH definition) while on DOAC treatment was assessed.
Overall, 1034 patients were included and followed for one year or until the end of treatment or the occurrence of major bleeding. During study period, 26 major bleedings occurred in 25 patients (2.8% patient-year). Anemia, bleeding history and creatinine clearance <60 ml/min were significant predictors of major bleedings. The predictive value of bleeding risk scores was modest. In the 12-month study period, ORBIT (HR intermediate-high vs. low risk patients 3.62, 95% CI 1.65-7.94 and c-statistics 0.645, 95% CI 0.523-0.767) and VTE-BLEED (HR high vs. low 16.11, 95% CI 2.18-119.09 and c-statistics 0.674, 95% CI 0.593-0.755) score significantly predicted major bleeding. The lowest incidence of major bleeding (0.3%) was observed in the low-risk category of VTE-BLEED, while the highest (7.1%) in the high-risk category of ORBIT.
In a real-life cohort of patients with VTE treated with DOACs, the predictive value of currently available bleeding risk scores was modest and not statistically different. Whether these scores can be used for decision making on anticoagulation should be assessed in management studies.
Vedovati MC
，Mancuso A
，Pierpaoli L
，Paliani U
，Conti S
，Ascani A
，Galeotti G
，Di Filippo F
，Caponi C
，Agnelli G
，Becattini C
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Comparative Effectiveness and Safety of Direct-acting Oral Anticoagulants and Warfarin in Patients with Venous Thromboembolism and Active Cancer: An Observational Analysis.
There is limited evidence to support the use of direct-acting oral anticoagulants (DOACs) in patients with venous thromboembolism (VTE) and active cancer. This study aimed to assess the effectiveness of DOACs versus warfarin for the prevention of recurrent VTE and major bleeding events in patients with VTE and active cancer.
We identified patients with incident VTE and active cancer who newly initiated treatment with DOACs or warfarin from Truven Health MarketScan Commercial Claims and Medicare supplemental databases. Patients were followed up from treatment initiation (index date) until the occurrence of >7-day gap in treatment, the start of the study comparator, an outcome of interest (recurrent VTE or major bleeding), inpatient death, disenrollment, or end of the study period, whichever occurred first. We controlled for confounders via propensity score matching and estimated the hazard ratios (HRs) using Cox proportional hazards regression models.
A total of 9952 patients were included in the matched cohort (4976 DOACs users and 4976 warfarin users). Patient characteristics were well balanced after matching. We observed a lower incidence of recurrent VTE (3 vs 5 per 100 person-years) and major bleeding events (2 vs 3 per 100 person-years) in the DOAC group compared to warfarin group, respectively. In Cox regression models, use of DOACs (vs warfarin) was associated with a lower risk of recurrent VTE (hazard ratio (HR), 0.59; 95% CI, 0.42-0.82) and major bleeding events (HR, 0.64; 95% CI, 0.44-0.94).
On the basis of our findings, among patients with VTE and active cancer, DOACs offer superior effectiveness with a lower risk of bleeding when compared with warfarin for the secondary prevention of VTE.
Dawwas GK
，Dietrich E
，Smith SM
，Davis K
，Park H
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Comparison of Four Bleeding Risk Scores to Identify Rivaroxaban-treated Patients With Venous Thromboembolism at Low Risk for Major Bleeding.
Outpatient treatment of acute venous thromboembolism (VTE) requires the selection of patients with a low risk of bleeding during the first few weeks of anticoagulation. The accuracy of four systems, originally derived for predicting bleeding in VTE treated with vitamin K antagonists (VKAs), was assessed in VTE patients treated with rivaroxaban.
All patients treated with rivaroxaban in the multinational EINSTEIN deep vein thrombosis (DVT) and pulmonary embolism (PE) trials were included. Major bleeding was defined as ≥2 g/dL drop in hemoglobin or ≥2-unit blood transfusion, bleeding in critical area, or bleeding contributing to death. The authors examined the incidence of major bleeding in patients with low-risk assignment by the systems of Ruiz-Gimenez et al. (score = 0 to 1), Beyth et al. (score = 0), Kuijer et al. (score = 0), and Landefeld and Goldman. (score = 0). For clinical relevance, the definition of low risk for all scores except Kuijer includes all patients < 65 years with no prior bleeding history and no comorbid conditions (current cancer, renal insufficiency, diabetes mellitus, anemia, prior stroke, or myocardial infarction).
A total of 4,130 patients (1,731 with DVT only, 2,399 with PE with or without DVT) were treated with rivaroxaban for a mean (±SD) duration of 207.6 (±95.9) days. Major bleeding occurred in 1.0% (40 of 4,130; 95% confidence interval [CI] = 0.7% to 1.3%) overall. Rates of major bleeding for low-risk patients during the entire treatment period were similar: Ruiz-Gimenez et al., 12 of 2,622 (0.5%; 95% CI = 0.2% to 0.8%); Beyth et al., nine of 2,249 (0.4%; 95% CI = 0.2% to 0.8%); Kuijer et al., four of 1,186 (0.3%; 95% CI = 0.1% to 0.9%); and Landefeld and Goldman, 11 of 2,407 (0.5%; 95% CI = 0.2% to 0.8%). At 30 days, major bleed rates for low-risk patients were as follows: Ruiz-Gimenez et al., five of 2,622 (0.2%; 95% CI = 0.1% to 0.4%); Beyth et al., five of 2,249 (0.2%; 95% CI = 0.1% to 0.5%); Kuijer et al., three of 1,186 (0.3%; 95% CI = 0.1% to 0.7%); and Landefeld and Goldman, seven of 2,407 (0.3%; 95% CI = 0.1% to 0.6%). No low-risk patient had a fatal bleed.
Four scoring systems that use criteria obtained in routine clinical practice, derived to predict low bleeding risk with VKA treatment for VTE, identified patients with less than a 1% risk of major bleeding during full-course treatment with rivaroxaban.
Kline JA
，Jimenez D
，Courtney DM
，Ianus J
，Cao L
，Lensing AW
，Prins MH
，Wells PS
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