Patient self-management of oral anticoagulation with vitamin K antagonists in everyday practice: clinical outcomes in a single centre cohort after long-term follow-up

Abstract

Background: Patient self-management (PSM) of vitamin K antagonists (VKA) seems a very promising model of care for oral anticoagulation in terms of efficacy and safety. In comparison with other management models of VKA therapy, the number of scientific publications supporting the advantages of PSM is more limited. Currently, most of the scarce information comes from randomized clinical trials. Moreover, a small number of studies have assessed PSM of VKA therapy in real life conditions. Methods: We analyzed clinical outcomes of 927 patients in a single center (6018.6 patient-years of follow-up). Recruitment took place between 2002 and 2017. All patients followed a structured training program, conducted by specialized nurses. Results: Fifty percent of individuals had a mechanical heart valve (MHV), 23% suffered from recurrent venous thromboembolism (VTE) or high-risk thrombophilia, and 13% received VKA therapy because of atrial fibrillation (AF). Median follow-up was 6.5 years (range 0.1-15.97 years), median age was 58.1 years (IQR 48-65.9) and 46.5% were women. The incidence of major complications (either hemorrhagic or thromboembolic) was 1.87% patient-years (pt-ys) with a 95% CI of 1.54-2.27. The incidence of major thromboembolic events was 0.86% pt-ys (95% CI 0.64-1.13) and that of major hemorrhagic events was 1.01% pt-ys (95% CI 0.77-1.31). The incidence of intracranial bleeding was 0.22% pt-ys (95% CI 0.12-0.38). In terms of clinical indication for VKA therapy, the incidence of total major complications was 2.4% pt-ys, 2.0% pt-ys, 0.9% pt-ys and 1.34% pt-ys for MHV, AF, VTE and other (including valvulopathies and myocardiopathies), respectively. Clinical outcomes were worse in patients with multiple comorbidities, previous major complications during conventional VKA therapy, and in older individuals. The percentage of time in therapeutic range (TTR) was available in 861 (93%) patients. Overall, the mean (SD) of TTR was 63.6 ± 13.4%, being higher in men (66.2 ± 13.1%) than women (60.6 ± 13.2%), p < 0.05.

Self-care training and informational support of patients with a mechanical heart valve on the international normalized ratio and bleeding complications

“…This discrepancy may be related to the difference in sample size of the present study with previous studies, because in the present study a smaller sample than the previous studies has been studied. Also, the results of this study are consistent with the results of previous studies showing that, in terms of clinical outcomes, such as the incidence of major complications and mortality by any cause, patients' self-management in a real-life setting seems to be a very good alternative in properly trained patients [27,28]. Complications of bleeding are less frequent in these patients [29]; therefore, to show a statistically significant difference between the two groups in terms of the prevalence of bleeding, it is necessary to perform interventions on a large group of participants.…”

Sex‐influence on the time in therapeutic range (TTR) during oral anticoagulation with coumarin derivatives: Systematic review and meta‐analysis

“…Twenty-two studies met the inclusion criteria of this systematic review and were selected for qualitative synthesis and metaanalysis. 15,16,[25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44] No unpublished study on the topic was found. We performed a manual search and screened the grey literature without identifying any study meeting the eligibility criteria.…”

“…The number of participants ranged from 110 to 104 505, in aggregate (183 612; women: 45%). The lowest measurement of central tendency for age was mean age of 57 years in 15 studies 15,16,[25][26][27][28][29][30][31][32][33]36,39,41,42 and median age of 55 years in four studies, 37,38,40,43 and the three remaining presented only age categories. 34,35,44 The main indication of long-term oral anticoagulation was AF.…”

“…Warfarin use was reported in most studies, and acenocoumarol also appeared in four studies. 32,37,39,42 There was a discrepancy regarding TTR cutoff values to classify the adequacy of oral anticoagulation control in the studies selected for this systematic review (Table 1). For instance, Lobos-Bejarano et al 32 applied two TTR categories encompassing good control (TTR ≥ 65%) and poor anticoagulation control (TTR < 65%).…”

“…There was also a variation in sex-related TTR in the studies. No significant difference in TTR between men and women was observed in 11 studies, 16,25,26,29,31,35,[38][39][40][41][42] and 10 studies 15,27,28,30,[32][33][34]36,37,44 reported female association with lower TTR than males and one study found association between the female sex and higher TTR 43 (Table 1).…”