Dataset Information

Oral Anticoagulant Adequacy in Non-Valvular Atrial Fibrillation in Primary Care: A Cross-Sectional Study Using Real-World Data (Fantas-TIC Study).

ABSTRACT: Background: Oral anticoagulants (OAs) are the treatment to prevent stroke in atrial fibrillation (AF). Anticoagulant treatment choice in non-valvular atrial fibrillation (NVAF) must be individualized, taking current guidelines into account. Adequacy of anticoagulant therapy under the current criteria for NVAF in real-world primary care is presented. Methods: Cross-sectional study, with real-world data from patients treated in primary care (PC). Data were obtained from the System for the Improvement of Research in Primary Care (SIDIAP) database, covering 60,978 NVAF-anticoagulated patients from 287 PC centers in 2018. Results: In total, 41,430 (68%) were treated with vitamin K antagonists (VKAs) and 19,548 (32%) NVAF with direct-acting oral anticoagulants (DOACs). Inadequate prescription was estimated to be 36.0% and 67.6%, respectively. Most DOAC inadequacy (77.3%) was due to it being prescribed as a first-line anticoagulant when there was no history of thromboembolic events or intracranial hemorrhage (ICH). A total of 22.1% had missing estimated glomerular filtration rate (eGFR) values. Common causes of inadequate VKA prescription were poor control of time in therapeutic range (TTR) (98.8%) and ICH (2.2%). Conclusions: Poor adequacy to current criteria was observed, being inadequacy higher in DOACs than in VKAs. TTR and GFR should be routinely calculated in electronic health records (EHR) to facilitate decision-making and patient safety.

SUBMITTER: Dalmau Llorca MR

PROVIDER: S-EPMC7956646 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Oral Anticoagulant Adequacy in Non-Valvular Atrial Fibrillation in Primary Care: A Cross-Sectional Study Using Real-World Data (Fantas-TIC Study).

Dalmau Llorca M Rosa MR Aguilar Martín Carina C Carrasco-Querol Noèlia N Hernández Rojas Zojaina Z Forcadell Drago Emma E Rodríguez Cumplido Dolores D Pepió Vilaubí Josep M JM Castro Blanco Elisabet E Gonçalves Alessandra Q AQ Fernández-Sáez José J

International journal of environmental research and public health 20210224 5

<b>Background</b>: Oral anticoagulants (OAs) are the treatment to prevent stroke in atrial fibrillation (AF). Anticoagulant treatment choice in non-valvular atrial fibrillation (NVAF) must be individualized, taking current guidelines into account. Adequacy of anticoagulant therapy under the current criteria for NVAF in real-world primary care is presented. <b>Methods</b>: Cross-sectional study, with real-world data from patients treated in primary care (PC). Data were obtained from the System fo ...[more]

PMID: 33668315

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Project description:Background: The use of direct oral anticoagulant (DOAC) off-label doses in atrial fibrillation (AF) patients may result in poor clinical outcomes. However, the true prevalence remains scarce. This study aims at estimating the prevalence of DOAC off-label doses in AF patients. Methods: Databases of MEDLINE, EMBASE, and COCHRANE were searched from inception through February 2020 for real-world studies that reported the off-label definition and prevalence data of AF patients using DOACs. The primacy outcomes were the overall prevalence of DOAC off-label doses and the corresponding underdose and overdose. The random-effects model was used for data synthesis. Variations on individual DOAC and different regions were examined by subgroup analyses. Results: A total of 23 studies involving 162,474 AF patients were finally included. The overall prevalence of DOAC off-label doses was 24% (95% CI, 19-28%), with 18% for dabigatran, 27% for rivaroxaban, 24% for apixaban, and 26% for edoxaban. The prevalence of underdosed DOACs was 20% (95% CI, 16-24%) with significant difference among individual anticoagulants (13% for dabigatran, 22% for rivaroxaban, 22% for apixaban, and 18% for edoxaban; P interaction =0.02). The prevalence of overdosed DOACs was 5% (95% CI, 3-7%), with the lowest prevalence observed in apixaban (2%). Subgroup analyses by regions demonstrated that the prevalence of DOAC off-label doses was higher in Asia (32%) than in North America (14%) and in Europe (22%), with underdose being predominant. Regardless of different regions, the prevalence of overdose was relatively low (4-6%). Conclusion: This study provides an estimation of DOAC off-label doses in the real-world setting. The prevalence rate of DOAC off-label doses in AF patients was relatively high, with underdose being predominant. Clinicians in Asia preferred to prescribe underdose of DOACs to AF patients. More evidence about the appropriateness of DOAC off-label doses in AF patients is urgently needed. Education programs concerning the appropriate prescription of DOACs within the drug labels and accepted guidelines are necessary to DOAC prescribers to ensure the safety and effectiveness of anticoagulation therapy for patients with AF.

Project description:Patients enrolled into pivotal randomized controlled trials (RCTs) may differ substantially from those treated in a real-world (RW) setting, which may result in a different benefit-risk profile. The aim of the study was to assess the external validity of pivotal RCT findings concerning direct oral anticoagulants (DOACs) for the treatment of nonvalvular atrial fibrillation (NVAF) by comparing patients recruited in RCTs to those treated with DOACs registered in a southern Italian local health unit (LHU) in the years 2013-2017. The Palermo LHU claims database was used to describe the baseline characteristics of incident DOAC users (washout > 1 year) with NVAF compared with those of enrolled patients in DOAC pivotal RCTs. In the RW, DOAC treatment discontinuation was calculated during the follow-up and compared with DOAC treatment discontinuation of enrolled patients in DOAC pivotal RCTs. Rates of effectiveness and safety outcomes during the follow-up were calculated in an unmatched and in a simulated RCT population, by matching individual incidental RW and RCT DOAC users (excluding edoxaban users) on age, sex, and CHADS2 score. Overall, 42,336 and 7092 incident DOAC users with NVAF were identified from pivotal RCTs and from the RW setting, respectively. In RCTs, DOAC use was more common among males (62.6%) compared with an almost equal sex distribution in the RW. RCT patients were younger (mean age ± standard deviation: 70.7 ± 9.2 years) than RW patients (76.0 ± 8.6 years). Compared with RCTs, a higher proportion of RW dabigatran users (30.4% vs. 19.6%) and a lower proportion of RW apixaban (15.9% vs. 25.3%) and rivaroxaban (20.4% vs. 23.7%) users discontinued the treatment during the follow-up (p-value < 0.001). The rate of ischemic stroke was lower in RW high-dose dabigatran users (unmatched/-matched population: 0.40-0.11% per year) than in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) population (0.93% per year). Major bleeding rates were lower in RW users than in RCT users. In conclusion, except for dabigatran, a lower proportion of DOAC discontinuers was observed in the real-world than in pivotal RCT settings. This study provides reassurance to practicing physicians that DOAC use appears to be effective in stroke prevention and is likely safer in RW patients than in RCT enrolled patients. These results may be related to a lower burden of comorbidities despite more advanced age in the RW population compared to the pivotal RCT population.

Project description:This study examined characteristics and treatment persistence among patients prescribed oral anticoagulants (OACs) for stroke prevention in non-valvular atrial fibrillation (NVAF). We identified 15,244 patients (51.8% male, 72.7% aged ?70) with NVAF and no prior OAC therapy who were prescribed apixaban (n = 1,303), rivaroxaban (n = 5,742), dabigatran (n = 1,622) or vitamin-K antagonists (VKAs, n = 6,577) between 1-Dec-2012 and 31-Oct-2014 in German primary care (IMS® Disease Analyzer). We compared OAC persistence using Cox regression over patients' entire follow-up and using a data-driven time-partitioned approach (before/after 100 days) to handle non-proportional hazards. History of stroke risk factors (stroke/transient ischaemic attack [TIA] 15.2%; thromboembolism 14.1%; hypertension 84.3%) and high bleeding risk (HAS-BLED score?3 68.4%) was common. Apixaban-prescribed patients had more frequent history of stroke/TIA (19.7%) and high bleeding risk (72.6%) than other OACs. 12-month persistence rates were: VKA 57.5% (95% confidence interval (CI) 56.0-59.0%), rivaroxaban 56.6% (54.9-58.2%), dabigatran 50.1% (47.2-53.1%), apixaban 62.9% (58.8-67.0%). Over entire follow-up, compared to VKA, non-persistence was similar with apixaban (adjusted hazard ratio 1.08, 95% CI 0.95-1.24) but higher with rivaroxaban (1.21, 1.14-1.29) and dabigatran (1.53, 1.40-1.68). Using post-hoc time-partitioned approach: in first 100 days, non-persistence was higher with apixaban (1.37, 1.17-1.59), rivaroxaban (1.41, 1.30-1.53) and dabigatran (1.91, 1.70-2.14) compared to VKA. Compared to apixaban, rivaroxaban non-persistence was similar (1.03, 0.89-1.20), dabigatran was higher (1.39, 1.17-1.66). After 100 days, apixaban non-persistence was lower than VKA (0.66, 0.52-0.85); rivaroxaban (0.97, 0.87-1.07) and dabigatran (1.10, 0.95-1.28) were similar to VKA. Furthermore, rivaroxaban (1.46, 1.13-1.88) and dabigatran (1.67, 1.26-2.19) non-persistence was higher than apixaban. This study describes real-world observations on OAC use, particularly early apixaban use following approval for NVAF, in Germany. We identified potential differential OAC prescribing and higher persistence with apixaban than other OACs after 100 days' treatment. Larger studies are needed with longer follow-up to establish long-term patterns.

Dataset Information

Oral Anticoagulant Adequacy in Non-Valvular Atrial Fibrillation in Primary Care: A Cross-Sectional Study Using Real-World Data (Fantas-TIC Study).

Publications

Oral Anticoagulant Adequacy in Non-Valvular Atrial Fibrillation in Primary Care: A Cross-Sectional Study Using Real-World Data (Fantas-TIC Study).

Similar Datasets

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