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
Dipartimento di Angiologia, Ospedale SS. Filippo e Nicola, Avezzano, Italy
Alberto Tosetto
Divisione di Ematologia, Ospedale San Bortolo, Vicenza, Italy
Walter Ageno
Dipartimento di Emergenza e Accettazione, Centro Trombosi ed Emostasi, Ospedale di Circolo, Università dell’Insubria, Varese, Italy
Rossella Marcucci
From the *Department of Medical and Surgical Critical Care, Thrombosis Centre and Centre for the Study at Molecular and Clinical Level of Chronic, Degenerative and Neoplastic Diseases to Develop Novel Therapies, University of Florence, Italy; †Fondazione Don Carlo Gnocchi, ONLUS, S.Maria degli Ulivi- IRCCS, Firenze.
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
12Atherosclerosis and Thrombosis Unit, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy
Domizio Serra
Daniele Pastori
Department of Internal Medicine and Medical Specialties, I Clinica Medica, Atherothrombosis Center, Sapienza University of Rome, Rome, Italy
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<0.0001). All-cause mortality was higher in VKA-treated (5.9%) than in DOAC-treated patients (2.6%, p<0.001).Conclusion Italian centres treat most patients with VTE with DOACs and prefer VKA for those with more serious clinical conditions. Recurrences were significantly more frequent in DOAC-treated patients due to increased incidence after 180 days of treatment, probably due to reduced adherence to treatment. These results underline the importance of structured surveillance of DOAC-treated patients with VTE to strengthen treatment adherence during extended therapy.
