scholarly journals Risk of Recurrent Bleeding Events in Nonvalvular Atrial Fibrillation Treated with Vitamin K Antagonists: A Clinical Practice Research Datalink Study

TH Open ◽  
2019 ◽  
Vol 03 (04) ◽  
pp. e316-e324 ◽  
Author(s):  
Raza Alikhan ◽  
Cinira Lefevre ◽  
Ian Menown ◽  
Steven Lister ◽  
Alex Bird ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Recurrent Bleeding ◽  
Bleeding Events ◽  
Nonvalvular Atrial Fibrillation ◽  
The Impact

Abstract Background There is little evidence on how the occurrence of a bleed in individuals on vitamin K antagonists (VKAs) impacts the risk of subsequent bleeds, and thromboembolic and ischemic events. Such information would help to inform treatment decisions following bleeds. Objective To estimate the impact of bleeding events on the risk of subsequent bleeds, venous thromboembolism (VTE), stroke, and myocardial infarction (MI) among patients initiating VKA treatment for new-onset nonvalvular atrial fibrillation (NVAF). Methods We conducted an observational cohort study using a linked Clinical Practice Research Datalink—Hospital Episode Statistics dataset. Among a cohort of individuals with NVAF, the risk of clinically relevant bleeding, VTE, stroke, and MI was compared between the period prior to the first bleed and the periods following each subsequent bleed. The rate and cost of general practitioner (GP) consultations, prescriptions, and hospitalizations were also compared across these periods. Results The risk of clinically relevant bleeding events was observed to be elevated at least twofold in all periods following the first bleeding event. The risk of VTE, stroke, and MI was not found to differ according to the number of clinically relevant bleeding events. The rate and cost of GP consultations, GP prescriptions, and hospitalizations were increased in all periods relative to the period prior to the first bleed. Conclusions The doubling in the risk of bleeding following the first bleed, taken alongside the stable risk of MI, VTE, and stroke, suggests that the risk–benefit balance for VKA treatment should be reconsidered following the first clinically relevant bleed.

scholarly journals Nonindependence of patient data in the clinical practice research datalink: a case study in atrial fibrillation patients

2020 ◽  
Vol 9 (6) ◽  
pp. 395-403
Author(s):  
Cormac J Sammon ◽  
Thomas P Leahy ◽  
Sreeram Ramagopalan
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Clinical Characteristics ◽  
Patient Data ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Nonvalvular Atrial Fibrillation ◽  
Patient Registration ◽  
The Impact

Aim: The impact of different strategies to handle patients with data recorded under multiple Clinical Practice Research Datalink (CPRD) identifiers (IDs) is unknown. Patients and methods: Six approaches to handling patients appearing under multiple CPRD IDs were defined. The impact of the approaches was illustrated using a case study describing the clinical characteristics of a population of nonvalvular atrial fibrillation patients. Results: 5.6% of patients had more than one CPRD ID. Across all six approaches implemented, no material difference in the characteristics of nonvalvular atrial fibrillation patients were observed. Conclusion: While strategies which longitudinally append patient registration periods under different CPRD IDs maintain independence while using all available data, their implementation had little impact on the results of our case study.

Abstract 18371: Higher Treatment Persistence of Non-Vitamin K Antagonist Oral Anticoagulants than Vitamin K Antagonists at 1 Year in Non-Valvular Atrial Fibrillation in Real-World Practice

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Carlos Martinez ◽  
Christopher Wallenhorst ◽  
Anja Katholing ◽  
Ben Freedman
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Vitamin K ◽  
Real World ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Ease Of Use ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
One Year

Introduction: Oral anticoagulants (OAC) are under-utilised in atrial fibrillation (AF). Even patients prescribed an OAC may stop taking the drug soon after treatment initiation, particularly with Vitamin K Antagonists (VKA). The Non-VKA OAC (NOAC) drugs offer greater ease of use, and persistence is likely to be higher. Aim: To determine persistence on treatment in the first year after inception of NOACs and VKA in incident AF in real-world clinical practice. Methods: We studied 24,467 OAC-naïve patients with incident non-valvular AF diagnosed between Jan 2011-Feb 2014, mean age 73.9 ± 12.5, 45.6% female, in a very large UK primary care database (Clinical Practice Research Datalink, CRPD), with full linkage to medication use. Follow up was for a mean of 1.2 ± 0.9 years. The proportion of OAC initiation in the 90 days after first-time AF and of those remaining on OAC one year after initiation were estimated using competing risk survival analyses censoring for use of alternative OAC. Results: NOAC drugs prescribed included Rivaroxaban, Dabigatran and Apixaban. Overall, 12,579 (51.4%) were commenced on an OAC: 11,888 on VKA and 691 on NOAC, within 90 days after incident AF. Amongst all OAC users, the proportion taking NOAC increased from 0.3% in 2011 to 12.3% in 2014. Persistence, defined as the proportion still taking the OAC after one year, declined over the 12 months to 54.3% for VKA and 80.7% for NOAC (Table). Persistence was significantly greater for NOAC than VKA at all time points. Conclusions: There is a progressive fall in VKA use amongst OAC naïve patients with AF in real-world practice to only 54% at 1 year. This contributes to under-utilisation of anticoagulation in AF and would result in an increased rate of stroke. Persistence was significantly improved with NOACs compared to VKA, and this factor alone could lead to reduced stroke burden with increasing uptake of the NOACs.

Abstract 17152: Frequency and Management of Major Bleeding in Atrial Fibrillation Patients Treated With Warfarin and Non-vitamin K Oral Anticoagulants in Community Practice: Results From the ORBIT-AF II Registry

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Benjamin A Steinberg ◽  
DaJuanicia N Simon ◽  
Laine Thomas ◽  
Jack Ansell ◽  
Gregg C Fonarow ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Vitamin K ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Recurrent Bleeding ◽  
Bleeding Events ◽  
Reversal Agents ◽  
Major Bleeding Events

Background: Non-vitamin K oral anticoagulants (NOACs) are effective at preventing stroke in patients with atrial fibrillation (AF). However, little is known about the frequency of major bleeds on NOACs and how these events are managed in clinical practice. Methods: We assessed the rates, management, and outcomes of ISTH major bleeding events among AF patients in the ORBIT-AF II registry (mean follow-up 213 days). Results: Overall, 103 patients experienced 110 major bleeding events during follow-up n=90/4986 (1.8%) on NOAC, and n=20/1320 (1.5%) on warfarin. Patients with bleeding events on NOAC were slightly younger than those on warfarin (median age 76 vs. 80; p=0.2). Among mutually-exclusive bleeding types, intracranial bleeding was more common in warfarin treated patients than NOAC-treated (15% vs 6.7%), whereas GI bleeding was more common on NOACs (56% vs. 40%, overall p=0.1 for bleeding type). Management of bleeding differed by anticoagulation type: blood products and reversal agents were more commonly used in patients on warfarin (Table). No patient received prothrombin complexes, recombinant factor VIIa, aminocaproic acid, tranexamic acid, aprotinin, or desmopressin. Out of 90 major bleeding events in NOAC patients, only 1 was fatal (1%). Within 30 days following bleeding, there were no strokes and 1 TIA (NOAC). Following a major bleed, the recurrent bleeding rate in NOAC patients in the next 30-days was 4% and the death rate was 4%. Conclusions: Rates of major bleeding with NOACs in clinical practice are comparable to those reported in clinical trials. Compared with warfarin, bleeding among NOAC users was less likely intracranial and more likely to be GI. Management of bleeding in the setting of NOAC rarely includes reversal agents.

scholarly journals Commonly used definitions in real-world studies may underestimate the prevalence of renal disease among nonvalvular atrial fibrillation patients

2019 ◽  
Vol 8 (12) ◽  
pp. 961-968
Author(s):  
Anna Schultze ◽  
Sophie Graham ◽  
Beth L Nordstrom ◽  
Faisal Mehmud ◽  
Sreeram V Ramagopalan
Keyword(s):  
Atrial Fibrillation ◽  
Renal Disease ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Nonvalvular Atrial Fibrillation ◽  
Comorbidity Burden ◽  
Prevalence Estimates ◽  
Look Back ◽  
Comorbidity Index ◽  
The Impact

Aim: To describe comorbidities among treated nonvalvular atrial fibrillation (NVAF) patients and assess the impact of using different time (‘look back’ windows) on the prevalence estimates. Patients & methods: We included all adult nonvalvular atrial fibrillation patients newly initiating treatment in the Clinical Practice Research Datalink. Comorbidities included in the Charlson Comorbidity Index were defined using an all available, 3- and 1-year look back window before the start of treatment. Results: The prevalence of comorbidities was high and increased when using longer look back windows; the largest difference was observed for renal disease (+15.6%). Conclusion: Our findings emphasize the importance of using all available data when characterizing chronic conditions and highlights the high comorbidity burden in this population.

scholarly journals Costs of gastrointestinal bleeding events in atrial fibrillation: a UK Clinical Practice Research Datalink study

2019 ◽  
Vol 15 (5) ◽  
pp. 367-375 ◽  
Author(s):  
Sreeram V Ramagopalan ◽  
Mihail Samnaliev ◽  
Sharada Weir ◽  
Cormac J Sammon ◽  
Robert Carroll ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Healthcare Costs ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Bleeding Events ◽  
Nonvalvular Atrial Fibrillation ◽  
The Mean ◽  
The Difference ◽  
Gi Bleed ◽  
Mean Cost

Aim: To estimate the healthcare costs attributable to gastrointestinal (GI) bleeds in nonvalvular atrial fibrillation (NVAF) patients. Material & methods: A difference-in-differences approach was used in which NVAF patients suffering a (GI) bleed were propensity score matched to those not suffering a GI bleed, and the difference in healthcare costs in the year prior to the GI bleed and the subsequent 3 years was compared between the two groups. Results: The mean cost attributable to GI bleeds was £3989 (p < 0.0001) in the year of the bleed and £1816 (p = 0.001) in the subsequent year. Attributable costs arose primarily from inpatient visits. Conclusion: GI bleeds among NVAF patients are associated with significant healthcare costs up to 2 years following the bleed.

The Association between Oral Anticoagulants and Cancer Incidence among Individuals with Nonvalvular Atrial Fibrillation

2020 ◽  
Vol 120 (10) ◽  
pp. 1384-1394
Author(s):  
Devin Abrahami ◽  
Christel Renoux ◽  
Hui Yin ◽  
Jean-Pascal Fournier ◽  
Laurent Azoulay
Keyword(s):  
Atrial Fibrillation ◽  
Pancreatic Cancer ◽  
Proportional Hazards ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Cox Proportional Hazards ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Nonvalvular Atrial Fibrillation

Abstract Objective Existing evidence on the association between vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) and cancer is limited and contradictory. No observational studies have been conducted to simultaneously address the cancer safety of VKAs and DOACs. The objective of this study was to determine whether use of VKAs and DOACs, separately, when compared with nonuse, is associated with cancer overall and prespecified site-specific incidence. Methods Using the United Kingdom Clinical Practice Research Datalink, we identified patients newly diagnosed with nonvalvular atrial fibrillation (NVAF) between 2011 and 2017. Using a time-varying exposure definition, each person-day of follow-up was classified as use of (1) VKAs, (2) DOACs, (3) VKAs and DOACs (drug switchers), and (4) nonuse of anticoagulants (reference). We also conducted a head-to-head comparison of new users of DOACs versus VKAs using propensity score fine stratification weighting. Hazard ratios (HRs) with 95% confidence intervals (CIs) for cancer overall and prespecified subtypes were estimated using Cox proportional hazards models. Results Compared with nonuse, use of VKAs was not associated with cancer overall (HR: 1.05, 95% CI: 0.91–1.22) or cancer subtypes. Similarly, use of DOACs was not associated with cancer overall (HR: 1.13, 95% CI: 0.93–1.37), but an association was observed for colorectal cancer (HR: 1.73, 95% CI: 1.01–2.99), and pancreatic cancer generated an elevated, though nonsignificant HR (HR: 2.15, 95% CI: 0.72–6.44). Results were consistent in the head-to-head comparison. Conclusion Use of oral anticoagulants is not associated with the incidence of cancer overall among patients with NVAF. Possible associations between DOACs and colorectal and pancreatic cancer warrant further study.

scholarly journals Real-world effects of medications for stroke prevention in atrial fibrillation: protocol for a UK population-based non-interventional cohort study with validation against randomised trial results

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e042947
Author(s):  
Emma Maud Powell ◽  
Ian J Douglas ◽  
Usha Gungabissoon ◽  
Liam Smeeth ◽  
Kevin Wing
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Practice ◽  
Treatment Effectiveness ◽  
Vitamin K Antagonists ◽  
Randomised Trial ◽  
Practice Research ◽  
Clinical Practice Research Datalink ◽  
Drug Effectiveness ◽  
Treatment Groups ◽  
Increased Risk

IntroductionPatients with atrial fibrillation experience an irregular heart rate and have an increased risk of stroke; prophylactic treatment with anticoagulation medication reduces this risk. Direct-acting oral anticoagulants (DOACs) have been approved providing an alternative to vitamin K antagonists such as warfarin. There is interest from regulatory bodies on the effectiveness of medications in routine clinical practice; however, uncertainty remains regarding the suitability of non-interventional data for answering questions on drug effectiveness and on the most suitable methods to be used. In this study, we will use data from Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE)—the pivotal trial for the DOAC apixaban—to validate non-interventional methods for assessing treatment effectiveness of anticoagulants. These methods could then be applied to analyse treatment effectiveness in people excluded from or under-represented in ARISTOTLE.Methods and analysisPatient characteristics from ARISTOTLE will be used to select a cohort of patients with similar baseline characteristics from two UK electronic health record (EHR) databases, Clinical Practice Research Datalink Gold and Aurum (between 1 January 2013 and 31 July 2019). Methods such as propensity score matching and coarsened exact matching will be explored in matching between EHR treatment groups to determine the optimal method of obtaining a balanced cohort.Absolute and relative risk of outcomes in the EHR trial-analogous cohort will be calculated and compared with the ARISTOTLE results; if results are deemed compatible the methods used for matching EHR treatment groups can then be used to examine drug effectiveness over a longer duration of exposure and in special patient groups of interest not studied in the trial.Ethics and disseminationThe study has been approved by the Independent Scientific Advisory Committee of the UK Medicines and Healthcare Products Regulatory Agency. Results will be disseminated in scientific publications and at relevant conferences.

New Drugs for Thromboembolic Prevention in Atrial Fibrillation

2010 ◽  
Vol 6 (4) ◽  
pp. 64
Author(s):  
Jose L Merino ◽  
Jose López-Sendón ◽  
◽  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Negative Impact ◽  
Vitamin K Antagonists ◽  
Coagulation Factor ◽  
Developed Countries ◽  
New Drugs ◽  
Risk Scores ◽  
Bleeding Events ◽  
Risk Patients

Atrial fibrillation (AF) is the most frequent sustained arrhythmia and its prevalence is increasing in developed countries. This progressive increase and the negative impact of this arrhythmia on the patient’s prognosis make AF one of the main healthcare problems faced today. This has led to intense research into the main aspects of AF, one of them being thromboembolism prevention. AF patients have a four to five times higher risk of stroke than the general population. Several factors increase thromboembolic risk in patients with AF and the use of risk scores, such as the Congestive Heart Failure, Hypertension, Age Greater than 75, Diabetes, and Prior Stroke or Transient Ischemic Attack (CHADS2), have been used to identify the best candidates for anticoagulation. Antithrombotic drugs are the mainstay of therapy for embolic prevention. The clinical use of these drugs is based on the risk–benefit ratio, where benefit is the reduction of stroke and systemic embolic events and risk is mostly driven by the increase in bleeding events. Generally, antiplatelets are indicated for low-risk patients in light of the fact anticoagulants are the drug of choice for moderate- or high-risk patients. Vitamin K antagonists have been the only option for oral anticoagulation for the last 50 years. However, these drugs have many pharmacodynamic and pharmacokinetic problems. The problems of anticoagulation with vitamin K antagonists have led to the investigation of new drugs that can be administered orally and have a better dose–response relationship, a shorter half-life and, in particular, higher efficacy and safety without the need for frequent anticoagulation controls. The drugs that have been studied most thoroughly in patients with AF are inhibitors of the activated coagulation factor X and inhibitors of coagulation factor II (thrombin), including ximelagatran and dabigatran. In addition, non-pharmacological therapies have been developed to prevent recurrent embolism in certain patient populations.

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