biostudies-literaturePalareti GFondazione Arianna Anticoagulazionee040449https://www.ebi.ac.uk/biostudies/studies/S-EPMC7703414biostudies-literatureUnknown10(11)<h4>Objective</h4>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.<h4>Design</h4>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.<h4>Setting</h4>About 60 Italian anticoagulation and thrombosis centres participated in the observational START2-Register PARTICIPANTS: 2728 adult patients with VTE of a lower limb and/or pulmonary embolism (PE), with a follow-up after the initial phase treatment.<h4>Interventions</h4>Patients could receive DOACs or VKAs; both prescribed by the National and Regional Health Systems for patients with VTE.<h4>Outcomes measures</h4>Efficacy: rate of VTE recurrence (all thrombotic complications were also recorded).<h4>Safety</h4>the rate of major and clinically relevant non-major bleeding events.<h4>Results</h4>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).<h4>Conclusion</h4>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.BMJ openBleeding and thrombotic complications during treatment with direct oral anticoagulants or vitamin K antagonists in venous thromboembolic patients included in the prospective, observational START2-register.PMC7703414NAAntonucci EBertola FMarzolo MTesta SInsana AMartini GPoli DSTART2 Register InvestigatorsGrandone EPiana ARupoli SPaoletti OCosmi BMarcucci RVasselli CPengo VSaracino PBison ENante GPrandoni PPaparo CBarbera PSerra DRuocco LGuazzaloca GAgeno WBenvenuto APignatelli PMalcangi GBarcella LCibecchini FFalanga ALerede TChiarugi PLegnani CMastroiacovo DTosetto AColombo GToma AColaizzo DSangiorgio RMigliaccio LPedrini SMasciocco LMaggini NDenas GPastori DPalareti GfalseBleeding and thrombotic complications during treatment with direct oral anticoagulants or vitamin K antagonists in venous thromboembolic patients included in the prospective, observational START2-register.<h4>Objective</h4>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.<h4>Design</h4>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.<h4>Setting</h4>About 60 Italian anticoagulation and thrombosis centres participated in the observational START2-Register PARTICIPANTS: 2728 adult patients with VTE of a lower limb and/or pulmonary embolism (PE), with a follow-up after the initial phase treatment.<h4>Interventions</h4>Patients could receive DOACs or VKAs; both prescribed by the National and Regional Health Systems for patients with VTE.<h4>Outcomes measures</h4>Efficacy: rate of VTE recurrence (all thrombotic complications were also recorded).<h4>Safety</h4>the rate of major and clinically relevant non-major bleeding events.<h4>Results</h4>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).<h4>Conclusion</h4>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.2020-01-01T00:00:00Z2020 Nov2024-11-20T09:20:25.168Z2021-02-20T09:58:56ZS-EPMC77034143324701710.1136/bmjopen-2020-040449