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.

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Aims Direct oral anticoagulants (DOAC) are progressively replacing vitamin K antagonists in the prevention of thromboembolism in patients with atrial fibrillation. However, their real-world clinical outcomes appear to be contradictory, with some studies reporting fewer and others reporting higher complications than the pivotal randomized controlled trials. We present the results of a clinical model for the management of DOACs in real clinical practice and provide a review of the literature. Methods The MACACOD project is an ongoing, observational, prospective, single-center study with unselected patients that focuses on rigorous DOAC selection, an educational visit, laboratory measurements, and strict follow-up. Results A total of 1,259 patients were included. The composite incidence of major complications was 4.93% py in the whole cohort vs 4.49% py in the edoxaban cohort. The rate of all-cause mortality was 6.11% py for all DOACs vs 5.12% py for edoxaban. There weren’t differences across sex or between Edoxaban reduced or standard doses. However, there were differences across ages, with a higher incidence of major bleeding complications in patients >85 years (5.13% py vs 1.69% py in <75 years). Conclusions We observed an incidence of serious complications of 4.93% py, in which severe bleeding predominated (3.65% py). Considering our results, more specialized attention seems necessary to reduce the incidence of severe complications and also a more critical view of the literature. Considering our results, and our indirect comparison with many real-world studies, more specialized attention seems necessary to reduce the incidence of severe complications in AF patients receiving DOACs.

Background:Patients diagnosed with Rheumatoid Arthritis (RA) have an increased risk of comorbidities and secondary mortality, in a large extent due to cardiovascular events.Objectives:To identify the frequency of comorbidity, mortality and variables related to its increase in a cohort of patients with rheumatoid arthritis established (RAE).Methods:Controlled cross-sectional observational study of a cohort of 188 patients with RAE a 10 year follow-up (5 years if not complete this period).Results:62.8% were women, mean age of patients at the time of inclusion was high 73.3 (+/-13.8) years and mean duration of disease was 12,8 (+/-6,99) years. Regarding CV risk factors, 26.6% smoked, 60.6% hypertension and 52.1 % diabetic. Regarding comorbidities, the most frequent were serious infections (45.2%), CVD (35.1%), Osteoporosis (31.9%), Depression (31.9%) and Kidney disease (26.6%). During follow-up, an improvement was observed inflammatory parameters and activity levels (p <0.001) Table 1. Mortality was associated to CVD and severe infection, and depression to lower mortality (p 0.05). Overall mortality was 32.4%. A logistic regression was performed in the group of patients with time greater evolution 10 years of our cohort, to be able to better represent the influence of disease carrying with her for longer, whose results are shown in Table 2. Analysand survival, men, CVD, severe infections, and Positive Rheumatoid Factor were associated with higher mortality, while treatment with Methotrexate was associated with increased survival. Among the causes of death, the most frequent were infections, CVD and solid cancer.Conclusion:-The incidence of comorbidities in our cohort is similar to that described in the literature.-Relationship between mortality and CVD and severe infection is demonstrated.-The mortality rate observed is higher than that described in the literature, which be influenced by the advanced age of the patients in the cohort and high time evolution of RA.References:[1]Lee YK, Ahn GY, Lee J, Shin JM, Lee TH, Park DJ, Song YJ, Kim MK, Bae SC. Excess mortality persists in patients with rheumatoid arthritis. Int J Rheum Dis. 2021 Jan 19. doi: 10.1111/1756-185X.14058. Epub ahead of print. PMID: 33463890.[2]Mikuls, T. R. (2003). Co-morbidity in rheumatoid arthritis. Best Practice & Research Clinical Rheumatology, 17(5), 729-752.[3]Naz, S. M., & Symmons, D. P. M. (2007). Mortality in established rheumatoid arthritis. Best Practice & Research Clinical Rheumatology, 21(5), 871-883.Table 1.Student’s t test for paired data.VariablesBasal10 yearPDAS285,25 (15,08)2,89 (1,06)0,036VAS38,61 (36,45)26,93 (24,97)<0,001HAQ1,04 (0,79)0,88 (0,87)NSTJC4,96 (5,38)1,40 (2,57)<0,001SJC3,55 (3,69)0,72 (2,11)<0,001ESR (mm/h)31,47 (21,19)25,86 (18,47)<0,001CRP (mg/L)15,24 (16,13)9,41 (21,02)0,001Hemoglobin (mg/dL)13,44 (7,92)13,52 (7,64)NSGlucose (mg/dL)102,26(35,97)103,83 (37, 98)NSCholesterol (mg/dL)203,56 (46,11)195,65 (38,12)0,042LDL (mg/dL)123,91 (40,69)119,58 (33,89)NSHDL (mg/dL)56,73 (19,07)54,84 (20,38)NSTriglycerides (mg/dL)110,85 (60,77)113,44 (55,61)NSTable 2.Logistic regression model. Hosmer-Lemeshow Chi square 9.035 Gl 7 p 0.25. Likelihood ratio test Chi square 64.658 Gl 5 p <0.001. NS, Not significant.VariableUnivariate analysisOR (IC 95%)pMultiivariate analysisFINAL MODELOOR (IC 95%)PDyslipidemia1,02 (0,47-2,23)0,965HT4,73 (1,79-12,48)0,002DM1,42 (0,59-3,44)0,438CV disease11,25 (4,45-28,44)< 0,00112,33 (3.89-39,04)< 0,001Hyperuricemia3,27 (1,39-7,65)0,006Thyroid disease0,56 (0,15-2,11)0,393Interstitial lung disease2,48 (0,77-7,99)0,1277,37 (1,48-36,84)0,015Osteoporosis2,38 (1,07-5,29)0,033Renal disease8,25 (3,41-19,97)< 0,0014,14 (1,34-12,80)0,014Depressión0,32 (0,12-0,84)0,0210,20 (0,06-0,74)0,015Solyd CA1,12 (0,44-2,87)0,809Hematologic CA<0,001 (NS)0,999Amyloidosis2,65 (0,16-43,52)0,496Severe infecction6,22 (2,53-15,29)< 0,0015,59 (1,66-18,79)0,005COVID-19 infection1,31 (0,12-14,91)0,828Disclosure of Interests:None declared