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Net Clinical Benefit of Oral Anticoagulation Among Older Adults With Atrial Fibrillation.

ABSTRACT: BACKGROUND:While guidelines recommend anticoagulation for all atrial fibrillation (AF) patients ?75 years, evidence for the net clinical benefit (NCB) of anticoagulant in older adults is sparse. We sought to determine the association between age and NCB of anticoagulation in older adults with AF. METHODS AND RESULTS:We examined adults ?75 years with incident AF in the Anticoagulation and Risk Factors in Atrial Fibrillation-Cardiovascular Research Network cohort. Using a Markov state transition model, we estimated the lifetime NCB of warfarin and apixaban relative to no treatment in quality-adjusted life years (QALYs). In the decision model, each month patients face a chance of stroke, hemorrhage, or death from a competing cause; the likelihood of each is a function of individual patients' stroke risk, hemorrhage risk, and life expectancy. We defined minimal clinically relevant lifetime benefit as 0.10 QALYs. In a sensitivity analysis, we examined the effect of competing risks of death on NCB using 2 models, one including competing risks and the second without competing risks. We included 14?946 patients, with a median age of 81 years and median CHA2DS2-VASc score of 4. In the main analysis, after age 87, NCB associated with warfarin decreased below 0.10 lifetime QALYs while NCB associated with apixaban did not decrease below 0.10 lifetime QALYs until after age 92. In sensitivity analyses, over a 3-year horizon, removing competing risks of death resulted in higher NCB (at 90 years, median difference using warfarin 0.010 QALYs [95% CI, 0.009-0.013], median difference using apixaban 0.025 QALYs [95% CI, 0.024-0.026]). CONCLUSIONS:The NCB of anticoagulation decreases with advancing age. The competing risk of death diminishes the NCB of anticoagulation for older patients with AF. Physicians should consider competing mortality risks when recommending anticoagulants to older adults with AF.

SUBMITTER: Shah SJ

PROVIDER: S-EPMC7117790 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Net Clinical Benefit of Oral Anticoagulation Among Older Adults With Atrial Fibrillation.

Shah Sachin J SJ Singer Daniel E DE Fang Margaret C MC Reynolds Kristi K Go Alan S AS Eckman Mark H MH

Circulation. Cardiovascular quality and outcomes 20191111 11

<h4>Background</h4>While guidelines recommend anticoagulation for all atrial fibrillation (AF) patients ≥75 years, evidence for the net clinical benefit (NCB) of anticoagulant in older adults is sparse. We sought to determine the association between age and NCB of anticoagulation in older adults with AF.<h4>Methods and results</h4>We examined adults ≥75 years with incident AF in the Anticoagulation and Risk Factors in Atrial Fibrillation-Cardiovascular Research Network cohort. Using a Markov sta ...[more]

PMID: 31707823

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Project description:BackgroundGuidelines recommend warfarin use in patients with atrial fibrillation solely on the basis of risk for ischemic stroke without antithrombotic therapy. These guidelines rely on ischemic stroke rates observed in older trials and do not explicitly account for increased risk for hemorrhage.ObjectiveTo quantify the net clinical benefit of warfarin therapy in a cohort of patients with atrial fibrillation.DesignMixed retrospective and prospective cohort study of patients with atrial fibrillation between 1996 and 2003.SettingAn integrated health care delivery system.Patients13 559 adults with nonvalvular atrial fibrillation.MeasurementsWarfarin exposure, patient characteristics, CHADS(2) score (1 point for each of congestive heart failure, hypertension, age, and diabetes and 2 points for stroke), and outcome events were ascertained from health plan records and databases. Net clinical benefit was defined as the annual rate of ischemic strokes and systemic emboli prevented by warfarin minus intracranial hemorrhages attributable to warfarin, multiplied by an impact weight. The base-case impact weight was 1.5, reflecting the greater clinical impact of intracranial hemorrhage versus thromboembolism.ResultsPatients accumulated more than 66 000 person-years of follow-up. The adjusted net clinical benefit of warfarin for the cohort overall was 0.68% per year (95% CI, 0.34% to 0.87%). Adjusted net clinical benefit was greatest for patients with a history of ischemic stroke (2.48% per year [CI, 0.75% to 4.22%]) and for those 85 years or older (2.34% per year [CI, 1.29% to 3.30%]). The net clinical benefit of warfarin increased from essentially zero in CHADS(2) stroke risk categories 0 and 1 to 2.22% per year (CI, 0.58% to 3.75%) in CHADS(2) categories 4 to 6. The patterns of results were preserved when weighting factors for intracranial hemorrhage of 1.0 and 2.0 were used.LimitationsResidual confounding is a possibility. Some outcome events were probably missed by the screening algorithm or when medical records were unavailable.ConclusionExpected net clinical benefit of warfarin therapy is highest among patients with the highest untreated risk for stroke, which includes the oldest age category. Risk assessment that incorporates both risk for thromboembolism and risk for intracranial hemorrhage provides a more quantitatively informed basis for the decision on antithrombotic therapy in patients with atrial fibrillation.Primary funding sourceNational Institute on Aging; National Heart, Lung, and Blood Institute; and Massachusetts General Hospital.

Project description:BackgroundAtrial fibrillation is a common cause of stroke among older adults and is often first detected during hospitalization, given frequent use of cardiac telemetry.MethodsIn a 20% national sample of Medicare fee-for-service beneficiaries, we identified patients aged 65-or-older newly diagnosed with atrial fibrillation while hospitalized in 2016. Our primary outcome was an oral anticoagulant claim within 7-days of discharge. Multivariable logistic regression analyses assessed relationships between anticoagulation initiation and thromboembolic and bleeding risk scores while controlling for demographics, frailty, comorbidities, and hospitalization characteristics.ResultsAmong 38,379 older adults newly diagnosed with atrial fibrillation while hospitalized (mean age 78.2 [SD 8.4]; 51.8% female; 83.3% white), 36,633 (95.4%) had an indication for anticoagulation and 24.6% (9011) of those initiated an oral anticoagulant following discharge. Higher CHA2 DS2 -VASc score was associated with a small increase in oral anticoagulant initiation (predicted probability 20.5% [95% CI, 18.7%-22.3%] for scores <2 and 24.9% [CI, 24.4%-25.4%] for ≥4). Elevated HAS-BLED score was associated with a small decrease in probability of anticoagulant initiation (25.4% [CI, 24.4%-26.4%] for score <2 and 23.1% [CI, 22.5%-23.8%] for ≥3). Frailty was associated with decreased likelihood of oral anticoagulant initiation (24.7% [CI, 23.2%-26.2%] for non-frail and 18.1% [CI, 16.6%-19.6%] for moderately-severely frail). Anticoagulant initiation varied by primary reason for hospitalization, with predicted probability highest among patients with a primary diagnosis of atrial fibrillation (46.1% [CI, 45.0%-47.3%]) and lowest among those with non-cardiovascular conditions (13.8% [CI, 13.3%-14.3%]) and bleeds (3.6% [CI, 2.4%-4.8%]).ConclusionsOral anticoagulant initiation is uncommon among older adults newly diagnosed with atrial fibrillation during hospitalization, even among patients hospitalized primarily for atrial fibrillation and patients with high thromboembolic risk. Clinicians should discuss risks and benefits of oral anticoagulants with all inpatients found to have atrial fibrillation.

Project description:ImportanceAnticoagulation management services (AMSs; ie, warfarin clinics) have evolved to include patients treated with direct oral anticoagulants (DOACs), but it is unknown whether DOAC therapy management services improve outcomes for patients with atrial fibrillation (AF).ObjectiveTo compare outcomes associated with 3 DOAC care models for preventing adverse anticoagulation-related outcomes among patients with AF.Design, setting, and participantsThis retrospective cohort study included 44 746 adult patients with a diagnosis of AF who initiated oral anticoagulation (DOAC or warfarin) between August 1, 2016, and December 31, 2019, in 3 Kaiser Permanente (KP) regions. Statistical analysis was conducted from August 2021 through May 2023.ExposuresEach KP region used an AMS to manage warfarin but used distinct approaches to DOAC care: (1) usual care (UC) by the prescribing clinician, (2) UC plus an automated population management tool (PMT), or (3) pharmacist-managed AMS care. Propensity scores and inverse probability of treatment weights (IPTWs) were estimated. Direct oral anticoagulant care models were first indirectly compared using warfarin as a common comparator within each region and then directly compared across regions.Main outcomes and measuresPatients were followed up until the first occurrence of an outcome (composite of thromboembolic stroke, intracranial hemorrhage, other major bleeding, or death), discontinuation of KP membership, or December 31, 2020.ResultsOverall, 44 746 patients were included: 6182 in the UC care model (3297 DOAC; 2885 warfarin), 33 625 in the UC plus PMT care model (21 891 DOAC; 11 734 warfarin), and 4939 in the AMS care model (2089 DOAC; 2850 warfarin). Baseline characteristics (mean [SD] age, 73.1 [10.6] years, 56.1% male, 67.2% non-Hispanic White, median CHA2DS2-VASc [congestive heart failure, hypertension, age ≥75 years, diabetes, stroke, vascular disease, age 65-74 years, female sex] score of 3 [IQR, 2-5]) were well balanced after IPTW. Over a median follow-up of 2 years, patients who received the UC plus PMT or AMS care model did not have significantly better outcomes than those who received UC. The incidence rate of the composite outcome was 5.4% per year for DOAC and 9.1% per year for warfarin for those in the UC group, 6.1% per year for DOAC and 10.5% per year for those in the UC plus PMT group, and 5.1% per year for DOAC and 8.0% per year for those in the AMS group. The IPTW-adjusted hazard ratios (HRs) for the composite outcome comparing DOAC vs warfarin were 0.91 (95% CI, 0.79-1.05) in the UC group, 0.85 (95% CI, 0.79-0.90) in the UC plus PMT group, and 0.84 (95% CI, 0.72-0.99) in the AMS group (P = .62 for heterogeneity across care models). When directly comparing patients receiving DOAC, the IPTW-adjusted HR was 1.06 (95% CI, 0.85-1.34) for the UC plus PMT group vs the UC group and 0.85 (95% CI, 0.71-1.02) for the AMS group vs the UC group.Conclusions and relevanceThis cohort study did not find appreciably better outcomes for patients receiving DOAC who were managed by either a UC plus PMT or AMS care model compared with UC.

Project description:Background/objectivesOral anticoagulation (OAC) is challenging in older patients with nonvalvular atrial fibrillation (NVAF) who are often frail and have cognitive impairment. We examined the characteristics of older NVAF patients associated with higher odds of physical and cognitive impairments. We also examined if these high-risk patients have different OAC prescribing patterns and their satisfaction with treatment because it may impact optimal management of their NVAF.MethodsThe patients in the Systematic Assessment of Geriatric Elements in Atrial Fibrillation (SAGE-AF study cohort 2016-2018) had NVAF, were aged 65 and older, and eligible for the receipt of OAC. Measures included frailty (Fried Frailty scale), cognitive impairment (Montreal Cognitive Assessment Battery), OAC prescribing and type (direct oral anticoagulant [DOAC] or vitamin K antagonist [VKA]), depressive symptoms (Patient Health Questionnaire-9), bleeding, stroke risk, and treatment benefit (Anti-Clot Treatment Scale).ResultsPatients (n = 1,244) were 49% female, aged 76 (standard deviation = 7) years. A total of 14% were frail, and 42% had cognitive impairment. Frailty and cognitive impairment co-occurred in 9%. Odds of having both impairments versus none were higher with depression (odds ratio [OR] = 4.62; 95% confidence interval [CI] = 2.59-8.26), older age (OR = 1.56; 95% CI = 1.29-1.88), lower education (OR = 3.81; 95%CI = 2.13-6.81), race/ethnicity other than non-Hispanic White (OR = 7.94; 95% CI = 4.34-14.55), bleeding risk (OR = 1.43; 95% CI = 1.12-1.81), and stroke risk (OR = 1.35; 95% CI = 1.13-1.62). OAC prescribing was not associated with CI and frailty status. Among patients taking OACs (85%), those with both impairments were more likely to take DOAC than VKA (OR = 1.69; 95% CI = 1.01-2.80). Having both impairments (OR = 1.87; 95% CI = 1.08-3.27) or cognitive impairment (OR = 1.56; 95% CI = 1.09-2.24) was associated with higher odds of reporting lower treatment benefit.ConclusionIn a large cohort of older NVAF patients, half were frail or cognitively impaired, and 9% had both impairments. We highlight the characteristics of patients who may benefit from cognitive and physical function screenings to maximize treatment and enhance prognosis. Finally, the co-occurrence of impairment was associated with low perceived benefit of treatment that may impede optimal management.

Project description:Background and Purpose- Patients with intracerebral hemorrhage (ICH) and atrial fibrillation (AF) are at risk for ischemic events. While risk calculators (CHA2DS2-VASc and HAS-BLED) have been validated to assess risk for ischemic stroke and major bleeding in AF patients, decisions about anticoagulation must consider the net clinical benefit of anticoagulation. Furthermore, stroke and bleeding risk are highly correlated, making decisions more difficult. Methods- We examined patients in the GERFHS III study (Genetic and Environmental Risk Factors for Hemorrhagic Stroke)-a population-based retrospective study of spontaneous ICH patients without a structural or traumatic cause in the Greater Cincinnati/Northern Kentucky region between July 2008 and December 2012. CHA2DS2-VASc and HAS-B(L)ED (minus L because labile international normalized ratio was unavailable) scores were calculated for ICH patients with AF. Using a Markov state transition model, we estimated net clinical benefit of anticoagulation relative to no treatment in quality-adjusted life years (QALYs). We defined minimal clinically relevant benefit as 0.1 QALYs. Results- Among 1186 cases of spontaneous ICH, 95 cases had AF and met our survival criteria. Within 1 year, 8 of 95 (8%) would be expected to have a major bleeding event on anticoagulation, and 5 of 95 (5%) of patients would be expected to have an ischemic stroke off anticoagulation. Sixty-eight of 95 (71%) patients would have higher risk for major bleeding than for ischemic stroke. Anticoagulation with directly acting anticoagulants would result in no clinically significant gain or loss in 73%. Roughly 12% would gain >0.1 QALYs, and 15% would lose >0.1 QALYs. Among patients receiving aspirin, most have no significant net clinical benefit or loss. Overall, anticoagulation of the entire cohort would result in an aggregate loss of 0.92 QALYs. Conclusions- Our analysis suggests that universal anticoagulation after ICH would be associated with a net loss of QALY. Additional factors should be considered before anticoagulating patients with AF after ICH. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT00930280.

Project description:BACKGROUND:Cardiological societies recommend, in their guidelines, that patients with atrial fibrillation and an intermediate (or higher) risk of stroke and systemic embolization should be treated with oral anticoagulant drugs. For patients who do not have mitral valve stenosis or a mechanical valve prosthesis, non-vitamin-K dependent oral anticoagulants (NOAC) are preferred over vitamin K antagonists (VKA) for this purpose. It is unclear, however, whether patients with chronic kidney disease and atrial fibrillation benefit from oral anticoagulation to the same extent as those with normal kidney function. It is also unclear which of the two types of anti - coagulant drug is preferable for patients with chronic kidney disease; NOAC are, in part, renally eliminated. METHODS:This review is based on pertinent publications retrieved by a selective literature search, and on international guidelines. RESULTS:Current evidence suggests that patients with atrial fibrillation who have chronic kidney disease with a glomerular filtration rate (GFR) above 15 mL/ min/1.73 m² should be treated with an oral anticoagulant drug if they have an at least intermediate risk of embolization, as assessed with the CHA2DS2-VASc score. For patients with advanced chronic kidney disease (GFR from 15 to 29 mL/ min/1.73 m²), however, this recommendation is based only on registry studies. For dialysis patients with atrial fibrillation, decisions whether to give oral anticoagulant drugs should be taken on an individual basis, in view of the elevated risk of hemorrhage and the unclear efficacy of such drugs in these patients. The subgroup analyses of the NOAC approval studies show that, for patients with atrial fibrillation and chronic kidney disease with a creatinine clearance of >25-30 mL/min, NOAC should be given in preference to VKA, as long as the patient does not have mitral valve stenosis or a mechanical valve prosthesis. For those whose creatinine clearance is less than 25 mL/min, the relative merits of NOAC versus VKA are still debated. CONCLUSION:The cardiological societies' recommendation that patients with atrial fibrillation should be given oral anticoagulant drugs applies to the majority of such patients who also have chronic kidney disease.

Dataset Information

Net Clinical Benefit of Oral Anticoagulation Among Older Adults With Atrial Fibrillation.

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Net Clinical Benefit of Oral Anticoagulation Among Older Adults With Atrial Fibrillation.

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