Journal of Blood & Lymph

Baseline Analysis on the Outcome of Patients with Deep Vein Thrombosis (DVT) Before the Global Impact of New Oral Anticoagulants in Italy: Data from RIETE Registry

Abstract

Pierpaolo Di Micco, Adriana Visonà, Gianluca Di Micco, Anna Guida, David Jimenez, Paolo Prandoni, Iolanda Enea, Alferio Niglio, Laurent Bertoletti and Manuel Monreal

Background: In patients with venous thromboembolism (VTE), assessment of the risk of recurrent VTE and major bleeding may help to guide intensity and duration of anticoagulant therapy. Methods: We used the Registro Informatizado de Enfermedad Tromboemb?lica (RIETE) to identify predictors of poor adherence to guidelines in patients with- and without cancer, and to assess the rate and severity of VTE recurrences and major bleeding during the course of anticoagulation in Italian patients with deep vein thrombosis (DVT). Results: A total of 3541 patients with objectively diagnosed VTE were enrolled in Italy, of whom 1832 (52%) initially presented DVT. Of these, 409 (22%) patients had already known cancer at baseline. In all, 32% of patients with cancer and 74% of those without cancer received long-term therapy with vitamin K antagonists, 55% and 19% respectively received long-term therapy with low-molecular-weight heparin, and 11% and 5.3% respectively received long-term therapy with Fondaparinux. During the 3-month study period, DVT patients with cancer experienced an increased rate of DVT recurrences (odds ratio: 3.1; 95% CI: 1.2-8.2), major bleeding episodes (odds ratio: 4.3; 95% CI: 2.2-8.4), all-cause death (odds ratio: 11; 95% CI: 6.7-19), and fatal bleeding (odds ratio: 11; 95% CI: 1.1-101), compared with those without cancer. Interestingly, the rate of major bleeding events outweighed the rate of VTE recurrences, both in patients with cancer (19 major bleeds vs. 4 PE recurrences and 8 DVT recurrences) and in those without cancer (16 major bleeds vs. 5 PE recurrences and 9 DVT recurrences). Conclusions: In real life, adherence of VTE therapy to guidelines is poor. During the course of anticoagulation, the rate of major bleeding events exceeded the rate of VTE recurrences.