Why the study?
Octogenarians are at high risk of ischaemic and bleeding events, and low body weight increases major bleeding risk in anticoagulated AF patients, but the comparative safety and effectiveness of NOACs versus well-controlled VKAs in this real-life setting remained to be evaluated.
Do NOACs reduce mortality compared to well-controlled VKAs in patients aged ≥ 80 years with AF and low body weight (≤ 60 kg)?
Do NOACs reduce mortality compared to well-controlled VKAs in patients aged ≥ 80 years with AF and low body weight (≤ 60 kg)?
In octogenarians with AF and low body weight, NOACs are associated with a significant reduction in all-cause mortality compared to well-controlled VKAs, without an increase in major bleeding.
May support NOAC preference over VKA in octogenarians with low body weight; leaves open need for randomized confirmation of mortality benefit.
BACKGROUND: Octogenarian patients are at high risk of both ischaemic and bleeding events, and the low body weight is considered a risk factor for major bleeding in atrial fibrillation (AF) patients on anticoagulation therapy. The aim of our study was to compare the safety and effectiveness of NOACs versus well-controlled VKA therapy among patients aged > 80 year with AF and low body weight in real-life setting. METHODS: Data for this study were sourced from the multicenter prospectively maintained Atrial Fibrillation Research Database (NCT03760874). From this, we selected AF patients aged ≥ 80 years and weighted ≤ 60 kg who received NOACs or VKAs treatment (only those with a time in therapeutic range > 70%). 279 patients (136 in NOAC group and 143 in VKA group) were selected. RESULTS: A total of 71 patients (17 in NOAC vs 54 in VKA group) died during the follow-up. The incidence rate of all-cause mortality was 27.70 per 100 person-years (14.91 in NOAC vs 37.94 in VKA group, adjusted hazard ratio 0.43; 95% CI 0.25 to 0.975; P = .003). 22 patients (9 in NOAC vs 13 in VKA group, P = .6) had major bleeding events. Diabetes mellitus, COPD and age resulted positively associated with death, whereas NOACs, parossistic AF and weight negatively associated with mortality. CONCLUSIONS: Our real-world data might suggest the safe and efficacy use of NOACs in this setting of population, justified by a reduction in overall mortality over VKAs. Further studies are needed to confirm these data.
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Russo et al. (2020) studied this question.
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