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Thromboembolic and bleeding complications during oral anticoagulation therapy in cancer patients with atrial fibrillation: a Danish nationwide population-based cohort study.

ABSTRACT: Coexisting cancer in patients with atrial fibrillation (AF) has been associated with thromboembolism and bleeding. We used Danish population-based medical databases to conduct a population-based cohort study that included all AF patients who redeemed a prescription for vitamin K antagonists (VKA) or non-VKA oral anticoagulant (NOAC) between July 2004 and December 2013. We characterized these patients according to the presence (N = 11,855) or absence (N = 56,264) of a cancer diagnosis before redemption of their oral anticoagulant prescription, and then examined their 1-year risk of thromboembolic or bleeding complications or death. We next used Cox regression to compare the hazard ratios for complications among VKA- or NOAC-treated AF patients with versus without a cancer diagnosis, after adjusting for sex, age, and CHA₂ DS₂ VASc score. One-year risks of thromboembolic complications in AF patients who redeemed a VKA prescription were similar in those with (6.5%) and without (5.8%) cancer [hazard ratio (HR) 1.0 (95% confidence interval (CI): 0.93, 1.1)]. This also was found for bleeding complications (5.4% vs. 4.3%, HR 1.1 [95% CI: 1.0, 1.2]). For AF patients with cancer who redeemed a NOAC prescription, risks were also similar for thromboembolic complications (4.9% of cancer patients vs. 5.1% of noncancer patients, HR 0.80 [95% CI: 0.61, 1.1]), and for bleeding complications (4.4% vs. 3.1%, HR 1.2 [95% CI: 0.92, 1.7]). The absolute risks of thromboembolic or bleeding complications were nearly the same in patients with and without cancer who redeemed prescription for VKAs or NOACs.

SUBMITTER: Ording AG

PROVIDER: S-EPMC5463075 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Thromboembolic and bleeding complications during oral anticoagulation therapy in cancer patients with atrial fibrillation: a Danish nationwide population-based cohort study.

Ording Anne G AG Horváth-Puhó Erzsébet E Adelborg Kasper K Pedersen Lars L Prandoni Paolo P Sørensen Henrik T HT

Cancer medicine 20170519 6

Coexisting cancer in patients with atrial fibrillation (AF) has been associated with thromboembolism and bleeding. We used Danish population-based medical databases to conduct a population-based cohort study that included all AF patients who redeemed a prescription for vitamin K antagonists (VKA) or non-VKA oral anticoagulant (NOAC) between July 2004 and December 2013. We characterized these patients according to the presence (N = 11,855) or absence (N = 56,264) of a cancer diagnosis before rede ...[more]

PMID: 28544489

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Project description:OBJECTIVES:We compared long-term outcomes in patients with atrial fibrillation (AF) with and without a secondary precipitant. DESIGN AND SETTING:Retrospective cohort study based on Danish nationwide registries. PARTICIPANTS:Patients with AF with and without secondary precipitants (1996-2015) were matched 1:1 according to age, sex, calendar year, CHA2DS2-VASc score and oral anticoagulation therapy (OAC), resulting in a cohort of 39 723 patients with AF with a secondary precipitant and the same number of patients with AF without a secondary precipitant. Secondary precipitants included alcohol intoxication, thyrotoxicosis, myocardial infarction, surgery and infection in conjunction with AF. PRIMARY AND SECONDARY OUTCOMES:The primary outcome in this study was thromboembolic events. Secondary outcomes included AF rehospitalisation and death. Long-term risks of outcomes were examined by multivariable Cox regression analysis. RESULTS:The most common precipitants were infection (55.0%), surgery (13.2%) and myocardial infarction (12.0%). The 5-year absolute risk of thromboembolic events (taking death into account as a competing risk) in patients with AF grouped according to secondary precipitants were 8.3% (alcohol intoxication), 8.5% (thyrotoxicosis), 12.1% (myocardial infarction), 11.6% (surgery), 12.2% (infection), 10.1% (>1 precipitant) and 12.3% (no secondary precipitant). In the multivariable analyses, AF with a secondary precipitant was associated with the same or an even higher thromboembolic risk than AF without a secondary precipitant. One exception was patients with AF and thyrotoxicosis: those not initiated on OAC therapy carried a lower thromboembolic risk the first year of follow-up than matched patients with AF without a secondary precipitant and no OAC therapy. CONCLUSIONS:In general, AF with a secondary precipitant was associated with the same thromboembolic risk as AF without a secondary precipitant. Consequently, this study highlights the need for more research regarding the long-term management of patients with AF associated with a secondary precipitant.

Project description:ObjectivesThis study sought to describe clinical outcomes among patients with atrial fibrillation (AF) and contraindications to oral anticoagulation (OAC).BackgroundTreatment with OAC prevents stroke and death in patients with AF, but may be contraindicated among patients at high bleeding risk.MethodsThis 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.ResultsAmong 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).ConclusionsHigh 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.

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:ObjectivesOutcomes of atrial fibrillation (AF) in patients with severe mental disorders are largely unknown. We compared rates of stroke, fatal thromboembolic events and bleeding in patients with AF with and without mental disorders.DesignNationwide registry-based cohort study.SettingDenmark (population 5.6 million), 2000-2015.ParticipantsPatients with AF with schizophrenia (n=534), severe depression (n=400) or bipolar disease (n=569) matched 1:5 on age, sex and calendar time to patients with AF without mental disorders.ExposureInpatient or hospital-based outpatient diagnosis of schizophrenia, severe depression or bipolar disease.Primary and secondary outcome measuresHRs for stroke, fatal thromboembolic events and major bleeding comparing patients with and without mental disorders estimated by Cox regression with sequential adjustment for risk factors for stroke and bleeding, comorbidity and initiation of oral anticoagulant therapy (OAT).ResultsCompared with matched comparisons, crude 5-year HRs of ischaemic stroke were 1.37 (95% CI 0.88 to 2.14) for schizophrenia, 1.36 (95% CI 0.89 to 2.08) for depression and 1.04 (95% CI 0.69 to 1.56) for bipolar disease. After adjusting for risk factors, comorbidity and OAT, these HRs declined towards the null. Crude HRs of fatal thromboembolic events were 3.16 (95% CI 1.78 to 5.61) for schizophrenia, 1.31 (95% CI 0.67 to 2.56) for depression and 1.53 (95% CI 0.93 to 2.53) for bipolar disease. Rates of major bleeding were increased in patients with schizophrenia (crude HR 1.37, 95% CI 0.99 to 1.90) and severe depression (HR 1.25, 95% CI 0.87 to 1.78) but not bipolar disease (HR 0.82, 95% CI 0.58 to 1.15).ConclusionPatients with AF with schizophrenia or severe depression experienced increased rates of stroke and major bleeding compared with matched comparisons. This increase was largely explained by differences in the prevalence of risk factors for stroke and bleeding, comorbidity and initiation of OAT during follow-up. Patients with AF with schizophrenia further experienced higher mortality following thromboembolic events than matched comparisons without mental disorders.

Dataset Information

Thromboembolic and bleeding complications during oral anticoagulation therapy in cancer patients with atrial fibrillation: a Danish nationwide population-based cohort study.

Publications

Thromboembolic and bleeding complications during oral anticoagulation therapy in cancer patients with atrial fibrillation: a Danish nationwide population-based cohort study.

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