Safety of Direct Oral Anticoagulants and Vitamin K Antagonists in Oldest Old Patients: A Prospective Study.

OBJECTIVE: The safety of direct oral anticoagulants (DOACs) in oldest old patients with nonvalvular atrial fibrillation (NVAF) in daily clinical practice has not been systematically assessed. This study examined the safety of DOACs and dicumarol (a vitamin K antagonist) in NVAF geriatric patients. DESIGN: Prospective study from January 2010 through June 2015, with follow-up through January 2016. SETTING: Geriatric medicine department at a tertiary hospital. PARTICIPANTS: A total of 554 outpatients, 75 years or older, diagnosed of NVAF and starting oral anticoagulation. MEASUREMENTS: The main outcome was bleeding, which was classified into major (including those life-threatening) and nonmajor episodes. Statistical analyses were performed with Cox regression. RESULTS: A total of 351 patients received DOACs and 193 dicumarol. Patients on DOACs were older, with more frequent comorbidities, mobility limitation and disability in activities of daily living, as well as higher mortality, than those treated with dicumarol. The incidence of any bleeding was 19.2/100 person-years among patients on DOACs and 13.7/100 person-years on dicumarol; corresponding figures for major bleeding were 5.2 for those on DOACs, and 3.3 for those on dicumarol. In crude analyses, hazard ratios (95% confidence intervals) for any bleeding, and for mayor bleeding in patients on DOACs vs dicumarol were 1.60 (1.04-2.44) and 2.22 (0.88-5.59), respectively. Excess risk of bleeding associated with DOACs vs dicumarol disappeared after adjustment for clinical characteristics, so that corresponding figures were 1.19 (0.68-2.08) and 1.01 (0.35-2.93). Results did not vary across subgroups of high-risk patients. CONCLUSION: In very old patients with NVAF, the higher risk of bleeding associated with DOACs vs dicumarol could be mostly explained by the worse clinical profile of patients receiving DOACs. Risk of bleeding was rather high, and warrants close clinical monitoring.

The frailty syndrome is associated with adverse health outcomes in very old patients with stable heart failure: A prospective study in six Spanish hospitals.

BACKGROUND: Most studies on the association between the frailty syndrome and adverse health outcomes in patients with heart failure (HF) have used non-standard definitions of frailty. This study examined the association of frailty, diagnosed by well-accepted criteria, with mortality, readmission and functional decline in very old ambulatory patients with HF. METHODS: Prospective study with 497 patients in six Spanish hospitals and followed up during one year. Mean (SD) age was 85.2 (7.3) years, and 79.3% had LVEF >45%. Frailty was diagnosed as having ≥3 of the 5 Fried criteria. Readmission was defined as a new episode of hospitalisation lasting >24h, and functional decline as an incident limitation in any activity of daily living at the 1-year visit. Statistical analyses were performed with Cox and logistic regression, as appropriate, and adjusted for the main prognostic factors at baseline. RESULTS: At baseline, 57.5% of patients were frail. The adjusted hazard ratio (95% confidence interval) for mortality among frail versus non-frail patients was 1.93 (1.20-3.27). Mortality was higher among patients with low physical activity [1.64 (1.10-2.45)] or exhaustion [1.83 (1.21-2.77)]. Frailty was linked to increased risk of readmission [1.66 (1.17-2.36)] and functional decline [odds ratio 1.67 (1.01-2.79)]. Slow gait speed was related to functional decline [odds ratio 3.59 (1.75-7.34)]. A higher number of frailty criteria was associated with a higher risk of the three study outcomes (P trend<0.01 in each outcome). CONCLUSIONS: Frailty was associated with increased risk of 1-year mortality, hospital readmission and functional decline among older ambulatory patients with HF.

The frailty syndrome and mortality among very old patients with symptomatic severe aortic stenosis under different treatments.

BACKGROUND: The role of frailty as a prognostic factor in non-selected patients with symptomatic severe aortic stenosis (SAS) is still uncertain. This study aims to examine the association between the frailty syndrome and mortality among very old patients with symptomatic SAS, and to assess whether the association varies with the type of SAS treatment. METHODS AND RESULTS: Prospective study of 606 patients aged ≥75years with symptomatic SAS, recruited from February 2010 to January 2015, who were followed up through June 2015. At baseline, frailty was defined as having at least three of the following five criteria: muscle weakness, slow gait speed, low physical activity, exhaustion, and unintentional weight loss. Statistical analyses were performed with multivariate Cox regression. At baseline, 49.3% patients were frail. During a mean follow-up of 98weeks, 35.3% of patients died. The hazard ratio (95% confidence interval) of mortality among frail versus non-frail patients was 1.83 (1.33-2.51). The corresponding results were 1.58 (1.09-2.28) among patients under medical treatment, 3.06 (1.25-7.50) in those with transcatheter aortic valve replacement, and 1.97 (0.83-4.67) in those with surgical aortic valve replacement, p for interaction=0.21. When the frailty criteria were considered separately, mortality was also higher among patients with slow gait speed [1.52 (1.05-2.19)] or low physical activity [1.35 (1.00-1.85)]. CONCLUSIONS: Frailty is associated with increased mortality among patients with symptomatic SAS, and this association does not vary with the type of SAS treatment. Future studies evaluating the benefits of different treatments in SAS patients should account for baseline frailty.