Different safety profiles of oral anticoagulants in very elderly non-valvular atrial fibrillation patients. A retrospective propensity score matched cohort study

Zoppellaro, Giacomo; Zanella, Luca; Denas, Gentian; Gennaro, Nicola; Ferroni, Eliana; Fedeli, Ugo; Jose, Seena Padayattil; Costa, Giorgio; Corti, Maria Chiara; Andretta, Margherita; Pengo, Vittorio

doi:10.1016/j.ijcard.2018.04.117

Cited by 20 publications

(15 citation statements)

References 24 publications

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“…Surprisingly, we could not detect a benefit for DOACs in terms of occurrence of intracranial hemorrhage. This finding is in contrast with data widely reported in previous studies [2, 4] and may be, at least in part, due to the older age of our cohort. Conversely, the higher rate of gastrointestinal bleeding in DOACs patients is in keeping with previous published data [2, 4, 21].…”

Section: Discussioncontrasting

confidence: 99%

“…However, the proportion of patients aged 80 years or older was low and, therefore, the applicability of the results of these trials to very elderly patients is still a matter of debate. Additional data on the safety of the DOACs in very elderly patients comes from retrospective observational studies only [4, 5]. More information is available from studies on elderly patients treated with VKAs [6–9], which showed an acceptably low bleeding risk even in advanced classes of age, with a favorable net clinical benefit of the treatment [5, 10].…”

Section: Introductionmentioning

confidence: 99%

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Oral anticoagulation in very elderly patients with atrial fibrillation: Results from the prospective multicenter START2-REGISTER study

Poli

Antonucci²,

Ageno

et al. 2019

PLoS ONE

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Direct oral anticoagulants (DOACs) have shown similar efficacy and safety with respect to warfarin in patients with atrial fibrillation (AF). However, the proportion of patients aged ≥85 years enrolled in clinical trials was low and the applicability of their results to very elderly patients is still uncertain. We have carried out a prospective cohort study on AF patients aged ≥85 years enrolled in the Survey on anticoagulaTed pAtients RegisTer (START2-Register) and treated with either VKAs or DOACs, with the aim to evaluate mortality, bleeding and thrombotic rates during a long-term follow-up. We enrolled 1124 patients who started anticoagulation at ≥85 years with VKA (58.7%) or DOACs (41.3%), Clinical characteristics of patients were similar, except for a higher prevalence of coronary artery disease and renal failure in VKAs patients and of a history of previous bleeding and previous stroke/TIA in patients on DOACs. Median CHA 2 DS 2 VASc and HAS-BLED scores were similar between the two groups. During follow-up, 47 major bleedings (rate 2.3 x100 pt-yrs) and 19 stroke/TIA (0.9 x100 pt-yrs) were recorded. The incidence of bleeding was similar between patients on VKAs and DOACs. Patients on DOACs showed a higher rate of thrombotic events during treatment (rate 1.84 and 0.50,respectively). Mortality rate was higher in patients on VKAs than in patients on DOACs (HR 0.64 (95% CI 0.46–0.91). In conclusion, we confirm the overall safety and effectiveness of anticoagulant treatment in very elderly AF patients, with lower mortality rates in DOACs patients, similar bleeding risk, and a higher risk for cerebral thrombotic events in DOACs patients.

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Section: Discussioncontrasting

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Oral anticoagulation in very elderly patients with atrial fibrillation: Results from the prospective multicenter START2-REGISTER study

Poli

Antonucci²,

Ageno

et al. 2019

PLoS ONE

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“…A population-based analysis on linked claims data among patients aged 80 years or older in northeastern Italy found numerically lower risks of ischemic stroke and MB among NOACs (dabigatran, rivaroxaban, or apixaban) compared with warfarin users. 26 Similarly, a study among patients aged 90 years or older using the National Health Insurance Research Database in Taiwan found that NOACs were associated with a lower risk of ICH with no difference in ischemic stroke. 27 A retrospective claims study using US MarketScan data comparing rivaroxaban and warfarin found that, among NVAF patients aged 80 years or older, rivaroxaban was associated with a lower risk of stroke/SE and a similar risk of MB compared with warfarin.…”

Section: Discussionmentioning

confidence: 98%

Comparisons between Oral Anticoagulants among Older Nonvalvular Atrial Fibrillation Patients

Deitelzweig

Keshishian

et al. 2019

J American Geriatrics Society

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OBJECTIVES Older adult patients are underrepresented in clinical trials comparing non–vitamin K antagonist oral anticoagulants (NOACs) and warfarin. This subgroup analysis of the ARISTOPHANES study used multiple data sources to compare the risk of stroke/systemic embolism (SE) and major bleeding (MB) among very old patients with nonvalvular atrial fibrillation (NVAF) prescribed NOACs or warfarin. DESIGN Retrospective observational study. SETTING The Centers for Medicare & Medicaid Services and three US commercial claims databases. PARTICIPANTS A total of 88 582 very old (aged ≥80 y) NVAF patients newly initiating apixaban, dabigatran, rivaroxaban, or warfarin from January 1, 2013, to September 30, 2015. MEASUREMENTS In each database, six 1:1 propensity score matched (PSM) cohorts were created for each drug comparison. Patient cohorts were pooled from all four databases after PSM. Cox proportional hazards models were used to estimate hazard ratios (HRs) of stroke/SE and MB. RESULTS The patients in the six matched cohorts had a mean follow‐up time of 7 to 9 months. Compared with warfarin, apixaban (HR = .58; 95% confidence interval [CI] = .49‐.69), dabigatran (HR = .77; 95% CI = .60‐.99), and rivaroxaban (HR = .74; 95% CI = .65‐.85) were associated with lower risks of stroke/SE. For MB, apixaban (HR = .60; 95% CI = .54‐.67) was associated with a lower risk; dabigatran (HR = .92; 95% CI = .78‐1.07) was associated with a similar risk, and rivaroxaban (HR = 1.16; 95% CI = 1.07‐1.24) was associated with a higher risk compared with warfarin. Apixaban was associated with a lower risk of stroke/SE and MB compared with dabigatran (stroke/SE: HR = .65; 95% CI = .47‐.89; MB: HR = .60; 95% CI = .49‐.73) and rivaroxaban (stroke/SE: HR = .72; 95% CI = .59‐.86; MB: HR = .50; 95% CI = .45‐.55). Dabigatran was associated with a lower risk of MB (HR = .77; 95% CI = .67‐.90) compared with rivaroxaban. CONCLUSION Among very old NVAF patients, NOACs were associated with lower rates of stroke/SE and varying rates of MB compared with warfarin. J Am Geriatr Soc 67:1662–1671, 2019

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“…Для профилактики тромбоэмболических осложнений уже 10 лет применяются прямые оральные антикоагулянты (ПОАК), зарекомендовавшие себя как безопасная альтернатива варфарину. Об этом свидетельствуют результаты самых крупных исследований [4][5][6] и данные реальной клинической практики [7,8]. Единственным исследованием, в котором проведено прямое сравнение ПОАК между собой, стал недавно опубликованный регистр REGINA: сравнивались пациенты с ФП в возрасте ≥67 лет, принимающие дабигатран, апиксабан и ривароксабан в соответствующих дозировках [9].…”

Section: Comparison Of Noacs In Patients Over 75 Years Oldunclassified

Safety of Non-Vitamin K Oral Anticoagulants in Elderly Patients with Atrial Fibrillation

Габитова

Крупенин

Соколова

et al. 2020

Racionalʹnaâ farmakoterapiâ v kardiologii

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Цель. Изучить безопасность применения прямых оральных антикоагулянтов (ПОАК) у пациентов с фибрилляцией предсердий (ФП) старше 75 лет. Материал и методы. В наблюдательное исследование включались пациенты ≥75 лет с подтвержденной ФП, получающие дабигатран в сниженной дозе, апиксабан или ривароксабан в полной или сниженной дозах. Учитывался предшествующий опыт приема ПОАК с момента начала терапии (у пациентов старше 75 лет) или с момента достижения пациентом 75 лет; фиксировались эпизоды геморрагических событий, ассоциированных с приемом антикоагулянта. Группы пациентов были сопоставимы между собой по показателям шкал риска CHA 2 DS 2-VASc и HAS-BLED. Результаты. В исследование включено 102 пациента (39 мужчин и 63 женщины), средний возраст 79,4±4,1 лет. В группу приема дабигатрана (110 мг 2 р/сут) включены 32 пациента, 36 пациентов-в группу ривароксабана (20/15 мг 1 р/сут) и 34 пациента-в группу апиксабана (5/2,5 мг 2 р/сут). Зафиксировано 19 малых кровотечений, 10 (53%) из которых-в группе дабигатрана и 9 (47%)-в группе ривароксабана. Среди пациентов, принимавших апиксабан, геморрагических событий отмечено не было. По структуре кровотечений чаще всего наблюдались гематурия (31,6%), обширные подкожные гематомы (26,3%) и интенсивные носовые кровотечения (26,3%). За все время наблюдения у пациентов ни в одной из групп не было зафиксировано ни одного ишемического события. Заключение. У пациентов старческого возраста все ПОАК (дабигатран, ривароксабан и апиксабан) на фоне 1,5-годичного наблюдения продемонстрировали хороший профиль безопасности, не приведя к развитию больших кровотечений.

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Different safety profiles of oral anticoagulants in very elderly non-valvular atrial fibrillation patients. A retrospective propensity score matched cohort study

Cited by 20 publications

References 24 publications

Oral anticoagulation in very elderly patients with atrial fibrillation: Results from the prospective multicenter START2-REGISTER study

Oral anticoagulation in very elderly patients with atrial fibrillation: Results from the prospective multicenter START2-REGISTER study

Comparisons between Oral Anticoagulants among Older Nonvalvular Atrial Fibrillation Patients

Safety of Non-Vitamin K Oral Anticoagulants in Elderly Patients with Atrial Fibrillation

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