Dataset Information

ReAl-life Multicenter Survey Evaluating Stroke prevention strategies in non-valvular atrial fibrillation (RAMSES study).

ABSTRACT: OBJECTIVE:Data regarding stroke prevention strategies in non-valvular atrial fibrillation (NVAF) are limited to vitamin K antagonists (VKAs). This study aimed to evaluate real-life stroke prevention strategies for NVAF patients in the era of non-VKA oral anticoagulants (NOACs). METHODS:We established a cross-sectional, multicenter, nationwide registry of NVAF patients. All consecutive atrial fibrillation (AF) patients and without mechanical heart valves or rheumatic mitral stenosis (but including those with any degree of mitral regurgitation) were enrolled in the ReAl-life Multicenter Survey Evaluating Stroke Prevention Strategies (RAMSES Study; ClinicalTrials.gov identifier NCT02344901) in Turkey. Baseline demographic data, medical history, and medications prescribed for NVAF treatment were collected. Univariate analyses were performed for continuous variables, and the chi-square test was used for categorical variables. RESULTS:In total, 6273 patients from 29 provinces of Turkey were enrolled in the study between February and May 2015, with the contribution of 83 investigators. The mean age was 69.6±10.7 years; 56% of the patients were females, and one-fifth of the patients had at least one comorbid disease, the most common being hypertension (69%). The mean CHA2DS2-VASc and HAS-BLED scores were 3.3±1.6 and 1.6±1.1, respectively. The rate of oral anticoagulant (OAC) therapy use was 72% (37% NOAC and 35% VKA). CONCLUSION:The RAMSES study showed a higher prevalence of OAC use among NVAF patients than that reported in previous studies. Although NOACs were preferred over VKAs in daily cardiology practice, there is a need for improved OAC therapies for NVAF patients.

SUBMITTER: Basaran O

PROVIDER: S-EPMC5324932 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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ReAl-life Multicenter Survey Evaluating Stroke prevention strategies in non-valvular atrial fibrillation (RAMSES study).

Başaran Özcan Ö Beton Osman O Doğan Volkan V Tekinalp Mehmet M Aykan Ahmet Çağrı AÇ Kalaycıoğlu Ezgi E Bolat İsmail İ Taşar Onur O Şafak Özgen Ö Kalçık Macit M Yaman Mehmet M Altun İbrahim İ Soylu Mustafa Özcan MÖ Kırma Cevat C Biteker Murat M

Anatolian journal of cardiology 20161001 10

<h4>Objective</h4>Data regarding stroke prevention strategies in non-valvular atrial fibrillation (NVAF) are limited to vitamin K antagonists (VKAs). This study aimed to evaluate real-life stroke prevention strategies for NVAF patients in the era of non-VKA oral anticoagulants (NOACs).<h4>Methods</h4>We established a cross-sectional, multicenter, nationwide registry of NVAF patients. All consecutive atrial fibrillation (AF) patients and without mechanical heart valves or rheumatic mitral stenosi ...[more]

PMID: 27723665

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Project description:OBJECTIVES:To examine the characteristics and persistence in patients newly initiated with oral anticoagulants (OACs) for stroke prevention in non-valvular atrial fibrillation (NVAF). DESIGN:Cohort study in Clinical Practice Research Datalink. SETTING:UK primary care. PARTICIPANTS:15?242 patients with NVAF newly prescribed apixaban, rivaroxaban, dabigatran or vitamin K antagonists (VKAs) between 1 December 2012 and 31 October 2014. 13?089 patients were OAC naïve. OUTCOME MEASURES:Patient characteristics and risk of non-persistence compared to apixaban using Cox regression models over the entire follow-up and using a time-partitioned approach to handle non-proportional hazards. RESULTS:Among the OAC naïve patients, VKAs were most common (78.1%, n=10?218), followed by rivaroxaban (12.1%, n=1589), dabigatran (5.7%, n=741) and apixaban (4.1%, n=541). High baseline stroke risk (CHA2DS2VASc ?2) ranged from 80.2% (dabigatran) to 88.4% (apixaban and rivaroxaban). History of stroke and bleeding was the highest among apixaban (23.7% and 31.6%) and lowest among VKA patients (15.9% and 27.5%). Across the entire follow-up period, adjusting for differences in characteristics, there was no evidence of a difference in non-persistence between VKA and apixaban (HR 0.92 (95% CI 0.68 to 1.23)). Non-persistence was higher with dabigatran (HR 1.67 (1.20 to 2.32)) and rivaroxaban (HR 1.41 (1.02 to 1.93)) than apixaban. Using the partitioned approach, non-persistence was lower with VKA (HR 0.33 (0.22 to 0.48)), and higher with dabigatran (HR 1.65 (1.08 to 2.52)) compared to apixaban in the first 2?months of follow-up. After 2?months, non-persistence was higher with VKA (HR 1.70 (1.08 to 2.66)) and dabigatran (HR 2.10 (1.30 to 3.41)). Pooling OAC naïve and experienced patients, non-persistence was also higher with rivaroxaban compared to apixaban after 2?months of follow-up (HR 1.69 (1.19 to 2.39)). CONCLUSIONS:Observed differential prescribing of OACs can result in channelling bias in comparative effectiveness research. Persistence patterns changed over follow-up time, but there are indications of improved persistence rates with apixaban over other OACs in the UK. A larger study with longer follow-up is needed to corroborate findings. This study is registered on ClinicalTrials.gov (NCT02488421).

Project description:IntroductionEconomic evaluations are becoming increasingly important due to limitations in economic resources, the expense of many new treatments, the need to allocate health spending as effectively as possible, and the need to inform decision makers. Based on the data from the apixaban studies (ARISTOTLE and AVERROES), several economic evaluations have been performed in various countries to demonstrate the efficacy of apixaban versus warfarin and aspirin or other new oral anticoagulants (NOACs) for preventing stroke in patients with non-valvular atrial fibrillation (NVAF).The aim of this study was to perform a systematic literature review of published economic evaluations with apixaban in the indication of stroke prevention in patients with NVAF.MethodsA search in PubMed, Cochrane Library, Google Scholar, and Index Medicus Español was conducted in June 2015. Inclusion and exclusion criteria were established. The main characteristics were recorded for all relevant articles after being reviewed. In addition, a weighted version of the Drummond's checklist was used to further assess the quality of the selected studies.ResultsAfter review, 26 cost-effectiveness analyses through Markov models were included; the identified economic evaluations represent different willingness-to-pay (WTP) thresholds, discount rates, medical costs, and healthcare systems. Apixaban was compared with warfarin/acenocoumarol in 7 of them (27%), with warfarin/NOACs in 14 (54%), with aspirin in 2 (8%), and with warfarin/aspirin in 3 (11%). Models were conducted from Europe (69%), USA (23%), Australia (4%), and Latin America (4%). All models reported cost/quality-adjusted life years (QALYs) gained, 92% reported using a payer perspective, and 8% using a societal perspective; the median quality score of the selected studies was 89 (out of 119), with a range of 55-103. In models performed in Europe, incremental cost-effectiveness ratios (ICERs) of apixaban versus warfarin ranged from €5607/QALY to €57,245/QALY, while ICERs versus aspirin ranged from being dominant to €7334/QALY. In models carried out in the USA, ICERs of apixaban versus warfarin ranged from being dominant to $93,063/QALY.ConclusionDifferent cost-effectiveness analyses suggest that apixaban is a cost-effective therapeutic option according to the WTP thresholds used in countries where cost-effectiveness analyses, were performed.FundingBMS and Pfizer.

Dataset Information

ReAl-life Multicenter Survey Evaluating Stroke prevention strategies in non-valvular atrial fibrillation (RAMSES study).

Publications

ReAl-life Multicenter Survey Evaluating Stroke prevention strategies in non-valvular atrial fibrillation (RAMSES study).

Similar Datasets

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