Bleeding and thrombotic complications during treatment with direct oral anticoagulants or vitamin K antagonists in venous thromboembolic patients included in the prospective, observational START2-register

Autor: Daniela Poli, Emilia Antonucci, Vittorio Pengo, Niccolò Maggini, Sophie Testa, Antonio Insana, Carmelo Paparo, Pasquale Pignatelli, Gualtiero Palareti, Paolo Prandoni, Elvira Grandone, Cristina Legnani, Daniela Mastroiacovo, Alberto Tosetto, Walter Ageno, Rossella Marcucci, Oriana Paoletti, Giovanna Colombo, Benilde Cosmi, Giuliana Guazzaloca, Ludovica Migliaccio, Anna Falanga, Teresa Lerede, Luca Barcella, Gentian Denas, Elisa Bison, Lucia Ruocco, Paolo Chiarugi, Giuliana Martini, Simona Pedrini, Federica Bertola, Lucilla Masciocco, Pasquale Saracino, Angelo Benvenuto, Claudio Vasselli, Marco Marzolo, Antonietta Piana, Francesco Cibecchini, Andrea Toma, Pietro Barbera, Donatella Colaizzo, Domizio Serra, Daniele Pastori, Serena Rupoli, Giuseppe Malcangi, Giovanni Nante, Rosella Sangiorgio
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: BMJ Open, Vol 10, Iss 11 (2020)
Druh dokumentu: article
ISSN: 2020-0404
2044-6055
DOI: 10.1136/bmjopen-2020-040449
Popis: Objective The proportion and characteristics of Italian patients affected by venous thromboembolism (VTE) treated with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs), and complications occurring during follow-up.Design A prospective cohort of 2728 VTE patients included in the Survey on anticoagulaTed pAtients RegisTer (START2-Register) from January 2014 to June 2018 was investigated. Characteristics of patients, type of treatment and complications occurring during 2962 years of follow-up were analysed.Setting About 60 Italian anticoagulation and thrombosis centres participated in the observational START2-RegisterParticipants 2728 adult patients with VTE of a lower limb and/or pulmonary embolism (PE), with a follow-up after the initial phase treatment.Interventions Patients could receive DOACs or VKAs; both prescribed by the National and Regional Health Systems for patients with VTE.Outcomes measures Efficacy: rate of VTE recurrence (all thrombotic complications were also recorded). Safety: the rate of major and clinically relevant non-major bleeding events.Results Almost 80% of patients were treated with DOACs. The prevalence of symptomatic PE and impaired renal function was higher in patients receiving VKAs. Duration of anticoagulation was >180 days in approximately 70% of patients. Bleeding events were similar in both treatment groups. The overall eventuality of recurrence was significantly higher in DOAC cohorts versus VKA cohorts (HR 2.15 (1.14–4.06), p=0.018); the difference was almost completely due to recurrences occurring during extended treatment (2.73% DOAC vs 0.49% VKA, p
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