Discussion: Rivaroxaban appears to be safe and effective for the long-term treatment of patients with recurrent or unprovoked VTE. In addition, we observed a statistically significant higher incidence of bleeding in patients with a baseline HAS-BLED score of 3 to 4 compared with those with a score of 0 to 2, with most events occurring during the first 3 months of treatment (RR 5.9). Overall, bleeding events occurred in 33 (7.3%) patients, most occurring within the first 2 years of treatment. During the follow-up period, we recorded 13 (2.9%) major bleeding, 12 (2.7%) clinically relevant non-major bleeding, 8 minor bleeding, and no fatal bleeding events. Recurrent VTE occurred in 12 patients on rivaroxaban treatment (IR 1.7 per 100 person-years). We followed up with the patients for a mean of 22 months (Q1 10.7 Q3 37.4 months). Of these, 267 (55%) were unprovoked VTE, and 377 (87%) were symptomatic. Results: We analyzed 450 consecutive patients treated with rivaroxaban and referred them to the MAC Project database for unprovoked or recurrent VTE. The primary efficacy and safety outcomes were symptomatic recurrent VTE and major bleeding. All patients were followed-up prospectively with clinical controls scheduled at 3, 6, and 12 months after the index event, and then annually for up to 5 years. There were no exclusion criteria, except for life expectancy <6 months and refusal to sign the informed consent form or to attend the planned follow-up visit. The project aims to collect real-life clinical information in unselected patients given oral anticoagulants for VTE over a 5-year follow-up period. Methods: The MAC Project is an ongoing prospective-cohort, multi-center, observational study in Italy. The latest guidelines suggest maintaining long-term anticoagulation in patients with cancer-associated thrombosis (CAT) or with unprovoked VTE and a low bleeding risk. After the acute-phase treatment, the optimal duration of anticoagulation is still debatable. Venous thromboembolism (VTE) is a major cause of death in the world.
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March 2023
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