Treatment in patients with cat receiving LMWH: Learnings from predicare, a non-interventional prospective cohort study.

Abstract

e24154 Background: Venous thromboembolism (VTE) is a difficult to treat condition in cancer patients with a persisting risk of recurrent VTE (rVTE). We conducted a prospective multicenter observational cohort study in VTE cancer patients treated with tinzaparin for 6 months in order to validate the Ottawa score. The Ottawa score is composed of 5 items, female (+1), lung (+1), breast (-1), cancer stage I (-2) and previous VTE (+1). Methods: Adult cancer patients with recent diagnosis of documented VTE treated with tinzaparin for 6 months were included. The primary endpoint was the rVTE within the first 6 months. Other endpoints were symptomatic rVTE and major bleeding (MB). All events were adjudicated by a Central Adjudication Committee. To validate the Ottawa score, the area under the curve (AUC) and its 95% CI were calculated on receiver operating characteristic curve analysis. Results: 409 patients were included; median age: 68 years; pulmonary embolism: 60.4%; lung cancer: 31.3%; digestive cancer: 18.3%; stage IV cancers: 67.0%. According to Ottawa score, 58% were classified at high clinical probability of recurrence (score ≥ 1). Among all patients, during the 6 months treatment period, 7.3% and 3.7% had rVTE and MB, respectively. 9.1% had rVTE for patients with a score ≥ 1 compared to 5 % for other patients (score < 1). AUC of the Ottawa score was 0.60 (95% CI 0.55-0.65). Conclusions: This prospective cohort of patients with cancer receiving tinzaparin for VTE reported that the Ottawa score did not accurately predict rVTE. Clinical trial information: NCT03099031 .