The predictive ability of bleeding risk stratification models in very old patients on vitamin K antagonist treatment for venous thromboembolism: results of the prospective collaborative EPICA study

Abstract

The predictive ability of bleeding risk stratification models in very old patients on vitamin K antagonist treatment for venous thromboembolism: results of the prospective collaborative EPICA study. J Thromb Haemost 2013; 11: 1053-8. Summary. Background:The optimal duration of anticoagulant treatment after venous thromboembolism (VTE) should be evaluated in relation to bleeding risk. This assessment is particularly difficult with elderly patients, because of their increased risk of both recurrences and hemorrhages. Bleeding risk stratification models have been proposed, but their predictive ability in very elderly patients is unknown. We aimed to assess six bleeding stratification models in this setting, by using information available in our dataset. Patients and methods: Patients aged ! 80 years receiving vitamin K antagonists (VKAs) for the secondary prevention of VTE were eligible for this prospective cohort study. All patients were followed at Italian anticoagulation clinics for monitoring of VKA treatment. Risk factors for bleeding were collected, and major bleeding events and mortality were documented during followup. The association of bleeding events with the available risk factors was tested by means of Cox regression analysis; the c-statistic was used to quantify the predictive validity of the classification schemes. Results: A total of 1078 patients (37.2% males; mean age, 84 years) were enrolled in the study, for a total observation period of 1981 patient-years.The rate of major bleeding was 2.4 per 100 patient-years (47 events; one was fatal). The mortality rate was 5.2 per 100 patient-years. None of the considered risk factors were significantly associated with bleeding events. The predictive validity of the risk stratification models was low, and the most accurate model was not specifically developed for VTE patients (HEMORR 2 HAGES, c-statistic 0.60, 95% confidence interval 0.49-0.70). Conclusions: Bleeding risk stratification models appear to have little accuracy in very elderly VTE patients.

Predicting anticoagulant-related bleeding in patients with venous thromboembolism: a clinically oriented review

“…The HAS-BLED score was derived from 3978 patients in the Euro Heart Survey on atrial fibrillation and has repeatedly been shown to be predictive of bleeding in various conditions, even in patients who are not treated with any anticoagulant drugs (table 4) [44,[49][50][51]. The first study evaluating the HAS-BLED score in VTE patients was performed in 663 elderly patients, and reported a poor c-statistic of 0.55 [52]. A second study, performed in 515 patients with various indications for the use of VKAs, reported a c-statistic of 0.57 for the HAS-BLED score for the entire population of VKA-users, without reporting the area under the curve for the VTE population separately [43].…”

The predictive ability of bleeding risk stratification models in very old patients on vitamin K antagonist treatment for venous thromboembolism: results of the prospective collaborative EPICA study: reply

“…It is has been shown that this group of patients benefit from having aspirin in addition to their warfarin treatment, since it reduces the risk of systemic embolism or death [2].…”

“…The predictive ability of bleeding risk stratification models in very old patients on vitamin K antagonist treatment for venous thromboembolism: results of the prospective collaborative EPICA study: reply We were pleased to read the letter from Gaboreau et al [1] related to our recent article [2]. In this article, in a population of elderly patients anticoagulated with warfarin for venous thromboembolism (VTE), we applied available bleeding scores to evaluate their predictive ability for bleeding risk.…”

The optimal duration of anticoagulant therapy after unprovoked venous thromboembolism – still a challenging issue

“…In the EPICA study OBRI index, HEMORR2HAGES, RIETE score, HASBLED, ATRIA, and the ACCP score have been compared in very old patients (aged ≥ 80 years) receiving VKA for secondary prevention of VTE. All of these risk stratifi cation models appeared to have a scant accuracy in the aged population [38].…”