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Ischemic and Bleeding Outcomes in Patients With Atrial Fibrillation and Contraindications to Oral Anticoagulation.

ABSTRACT: OBJECTIVES:This study sought to describe clinical outcomes among patients with atrial fibrillation (AF) and contraindications to oral anticoagulation (OAC). BACKGROUND:Treatment with OAC prevents stroke and death in patients with AF, but may be contraindicated among patients at high bleeding risk. METHODS:This was an observational, longitudinal analysis of a nationally representative 5% Medicare sample of patients with chronic AF and CHA₂DS₂-VASc (congestive heart failure, hypertension, age ?75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category) score ?2. They were stratified by both the presence of high bleeding risk contraindications to OAC and by OAC use. We assessed 3-year ischemic and bleeding outcomes using multivariable Cox proportional hazards models adjusted for relevant patient characteristics. RESULTS:Among 26,684 AF patients not treated with OAC, 8,283 (31%) had a high bleeding risk contraindication, primarily a blood dyscrasia (75%) or history of gastrointestinal bleeding (40%). Without OAC, patients with contraindications had worse ischemic and bleeding outcomes at 3 years compared with those without contraindications. We also identified 12,454 patients with OAC contraindications who received OAC. Compared with patients not receiving OAC, use of OAC was associated with reduced mortality (adjusted hazard ratio [HR]: 0.79; 95% confidence interval [CI]: 0.76 to 0.83), stroke (adjusted HR: 0.90; 95% CI: 0.83 to 0.99), and all-cause hospitalization (adjusted HR: 0.93; 95% CI: 0.90 to 0.96) but increased risk of intracranial hemorrhage (adjusted HR: 1.42; 95% CI: 1.17 to 1.72). CONCLUSIONS:High bleeding risk contraindications to OAC are common among older patients with AF, and these patients have higher mortality compared with untreated patients without OAC contraindications. The use of OAC in these patients is associated with lower rates of all-cause stroke, hospitalization, and death but higher risk of intracranial hemorrhage.

SUBMITTER: Steinberg BA

PROVIDER: S-EPMC6927541 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Ischemic and Bleeding Outcomes in Patients With Atrial Fibrillation and Contraindications to Oral Anticoagulation.

Steinberg Benjamin A BA Ballew Nicholas G NG Greiner Melissa A MA Lippmann Steven J SJ Curtis Lesley H LH O'Brien Emily C EC Patel Manesh R MR Piccini Jonathan P JP

JACC. Clinical electrophysiology 20191002 12

<h4>Objectives</h4>This study sought to describe clinical outcomes among patients with atrial fibrillation (AF) and contraindications to oral anticoagulation (OAC).<h4>Background</h4>Treatment with OAC prevents stroke and death in patients with AF, but may be contraindicated among patients at high bleeding risk.<h4>Methods</h4>This was an observational, longitudinal analysis of a nationally representative 5% Medicare sample of patients with chronic AF and CHA<sub>2</sub>DS<sub>2</sub>-VASc (cong ...[more]

PMID: 31857036

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Project description:BackgroundNon-vitamin K antagonist oral anticoagulants (NOAC) have superior safety and comparable efficacy profile compared to vitamin-K antagonists (VKAs), with more convenient dosing schemes. However, issues with adherence to the NOACs remain unsolved.AimsWe sought to investigate the adherence to oral anticoagulation (OAC) and baseline factors associated with poor adherence after ischaemic stroke in patients with atrial fibrillation (AF).MethodsWe recruited hospitalised patients (2013-2019) from two prospective stroke registries in Larissa and Helsinki University Hospitals and invited survived patients to participate in a telephone interview. We assessed adherence with the Adherence to Refills and Medications Scale (ARMS) and defined poor adherence as a score of over 17. In addition to demographics, individual comorbidities, and stroke features, we assessed the association of CHA2DS2-VASc and SAMe-TT2R2 scores with poor adherence.ResultsAmong 396 patients (median age 75.0 years, interquartile range [IQR] 70-80; 57% men; median time from ischaemic stroke to interview 21 months [IQR 12-33]; median ARMS score 17 [IQR 17-19]), 56% of warfarin users and 44% of NOAC users reported poor adherence. In the multivariable regression model adjusted for site, sex, and age, poor adherence was independently associated with tertiary education, absence of heart failure, smoking history, use of VKA prior to index stroke, and prior ischaemic stroke. CHA2DS2-VASc and SAMe-TT2R2 scores were not associated with poor adherence.ConclusionsAdherence was poor in half of AF patients who survived an ischaemic stroke. Independent patient-related factors, rather than composite scores, were associated with poor adherence in these patients.KEY MESSAGESAdherence was poor in half of the atrial fibrillation patients who survived an ischaemic stroke.Independent patient-related factors rather than composite scores were associated with poor adherence.The findings support the importance of recognising adherence support as a crucial part of holistic patient care recommended by recent AF guideline.

Project description:BackgroundThe predictive value of bleeding risk scores for atrial fibrillation in older patients is not as well known. The goal of this study was to evaluate the predictive value of HASBLED, ORBIT and ATRIA for major bleeding (MB) and intracranial hemorrhage (ICH) in patients ≥ 75 years with atrial fibrillation and oral anticoagulation (OAC).MethodsA retrospective unicenter study including patients ≥ 75 years with atrial fibrillation (AF) and OAC. A total of 7613 patients ≥ 75 years with AF and OAC included between 2014 and 2018 (registry: NCT04364516). We analyzed the discriminative value of HASBLED, ATRIA and ORBIT scores for bleeding endpoints (major bleeding as primary endpoint and intracerebral hemorrhage as secondary). Cox regression was used to predict major bleeding with each scale and also for searching other variables potentially predictor of major bleeding. Model discrimination was assessed using Harrell's C-statistic. Calibration was assessed with goodness-of-fit test proposed by Gronnesby and Borgan.ResultsDuring a mean follow up of 4.0 years (IQR: 2.4-5.7 years), 729 patients developed MB (2.61 per 100 patients/year) and 243 patients developed ICH (0.85 per 100 patients/year). Three scores showed a low discrimination for major bleeding, being ORBIT the best (HASBLED C statistic = 0.557; ATRIA C statistic = 0.568; ORBIT C statistic = 0.595) and also a low discrimination for ICH (HASBLED C statistic = 0.509; ATRIA C statistic = 0.522; ORBIT C statistic = 0.526). Among the variables that are part of the scores and other baseline characteristics, after multivariable adjustment only sex (male), dementia, prior admission for bleeding, anemia and liver disease were found as a predictors of MB.ConclusionsIn older patients under oral anticoagulation with atrial fibrillation, the risk scores HASBLED, ATRIA and ORBIT showed a weak discrimination for major bleeding and intracranial hemorrhage. Therefore, other better alternatives should be evaluated for this purpose.

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:ObjectiveThe aim was to evaluate, in patients with atrial fibrillation (AF) and acute ischemic stroke, the association of prior anticoagulation with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) with stroke severity, utilization of intravenous thrombolysis (IVT), safety of IVT, and 3-month outcomes.MethodsThis was a cohort study of consecutive patients (2014-2019) on anticoagulation versus those without (controls) with regard to stroke severity, rates of IVT/mechanical thrombectomy, symptomatic intracranial hemorrhage (sICH), and favorable outcome (modified Rankin Scale score 0-2) at 3 months.ResultsOf 8,179 patients (mean [SD] age, 79.8 [9.6] years; 49% women), 1,486 (18%) were on VKA treatment, 1,634 (20%) on DOAC treatment at stroke onset, and 5,059 controls. Stroke severity was lower in patients on DOACs (median National Institutes of Health Stroke Scale 4, [interquartile range 2-11]) compared with VKA (6, [2-14]) and controls (7, [3-15], p < 0.001; quantile regression: β -2.1, 95% confidence interval [CI] -2.6 to -1.7). The IVT rate in potentially eligible patients was significantly lower in patients on VKA (156 of 247 [63%]; adjusted odds ratio [aOR] 0.67; 95% CI 0.50-0.90) and particularly in patients on DOACs (69 of 464 [15%]; aOR 0.06; 95% CI 0.05-0.08) compared with controls (1,544 of 2,504 [74%]). sICH after IVT occurred in 3.6% (2.6-4.7%) of controls, 9 of 195 (4.6%; 1.9-9.2%; aOR 0.93; 95% CI 0.46-1.90) patients on VKA and 2 of 65 (3.1%; 0.4-10.8%, aOR 0.56; 95% CI 0.28-1.12) of those on DOACs. After adjustments for prognostic confounders, DOAC pretreatment was associated with a favorable 3-month outcome (aOR 1.24; 1.01-1.51).InterpretationPrior DOAC therapy in patients with AF was associated with decreased admission stroke severity at onset and a remarkably low rate of IVT. Overall, patients on DOAC might have better functional outcome at 3 months. Further research is needed to overcome potential restrictions for IVT in patients taking DOACs. ANN NEUROL 2021;89:42-53.

Dataset Information

Ischemic and Bleeding Outcomes in Patients With Atrial Fibrillation and Contraindications to Oral Anticoagulation.

Publications

Ischemic and Bleeding Outcomes in Patients With Atrial Fibrillation and Contraindications to Oral Anticoagulation.

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