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Suboptimal use of non-vitamin K antagonist oral anticoagulants: Results from the RAMSES study.

ABSTRACT: This study aimed to investigate the potential misuse of novel oral anticoagulants (NOACs) and the physicians' adherence to current European guideline recommendations in real-world using a large dataset from Real-life Multicenter Survey Evaluating Stroke Prevention Strategies in Turkey (RAMSES Study).RAMSES study is a prospective, multicenter, nationwide registry (ClinicalTrials.gov identifier NCT02344901). In this subgroup analysis of RAMSES study, patients who were on NOACs were classified as appropriately treated (AT), undertreated (UT), and overtreated (OT) according to the European Society of Cardiology (ESC) guidelines. The independent predictors of UT and OT were determined by multivariate logistic regression.Of the 2086 eligible patients, 1247 (59.8%) received adequate treatment. However, off-label use was detected in 839 (40.2%) patients; 634 (30.4%) patients received UT and 205 (9.8%) received OT. Independent predictors of UT included >65 years of age, creatinine clearance ?50?mL/min, urban living, existing dabigatran treatment, and HAS-BLED score of <3, whereas that of OT were creatinine clearance <50?mL/min, ongoing rivaroxaban treatment, and HAS-BLED score of ?3.The suboptimal use of NOACs is common because of physicians' poor compliance to the guideline recommendations in patients with nonvalvular atrial fibrillation (NVAF). Older patients who were on dabigatran treatment with good renal functions and low risk of bleeding were at risk of UT, whereas patients who were on rivaroxaban treatment with renal impairment and high risk of bleeding were at risk of OT. Therefore, a greater emphasis should be given to prescribe the recommended dose for the specified patients.

SUBMITTER: Basaran O

PROVIDER: S-EPMC5008576 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Suboptimal use of non-vitamin K antagonist oral anticoagulants: Results from the RAMSES study.

Başaran Özcan Ö Dogan Volkan V Beton Osman O Tekinalp Mehmet M Aykan Ahmet Cağri AC Kalaycioğlu Ezgi E Bolat Ismail I Taşar Onur O Şafak Özgen Ö Kalcik Macit M Yaman Mehmet M İnci Sinan S Altintaş Bernas B Kalkan Sedat S Kirma Cevat C Biteker Murat M

Medicine 20160801 35

This study aimed to investigate the potential misuse of novel oral anticoagulants (NOACs) and the physicians' adherence to current European guideline recommendations in real-world using a large dataset from Real-life Multicenter Survey Evaluating Stroke Prevention Strategies in Turkey (RAMSES Study).RAMSES study is a prospective, multicenter, nationwide registry (ClinicalTrials.gov identifier NCT02344901). In this subgroup analysis of RAMSES study, patients who were on NOACs were classified as a ...[more]

PMID: 27583892

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Project description:BackgroundUse of the non-vitamin K antagonist oral anticoagulants (NOACs) is endorsed by current guidelines for stroke prevention in patients with atrial fibrillation (AF). However efficacy and safety of NOACs in patients undergoing catheter ablation (RFCA) of AF has not been well established yet.ObjectivesTo perform a meta-analysis of all studies comparing NOACs and vitamin K antagonist oral anticoagulants (VKAs) in patients undergoing RFCA.Data sourcesStudies were searched for in PubMed and Google Scholar databases.Study eligibility criteriaStudies were considered eligible if: they evaluated the clinical impact of NOACs versus VKAs; they specifically analyzed the use of anticoagulants during periprocedural phase of RFCA; they reported clinical outcome data.Study appraisal and synthesis methods25 studies were selected, including 9881 cases. The summary measure used was the risk ratio (RR) with 95% confidence interval (CI). The random-effects or the fixed effect model were used to synthesize results from the selected studies.ResultsThere was no significant difference in thromboembolic complications (RR 1.39; p=0.13). Bleeding complications were significantly lower in the NOACs-treated arm as compared to VKAs (RR=0.67, p<0.001). Interestingly, a larger number of thromboembolic events was found in the VKAs-treated arm in those studies where VKAs had been interrupted during the periprocedural phase (RR=0.68; p=ns). In this same subgroup a significantly higher incidence of both minor (RR=0.54; p=0.002) and major bleeding (RR=0.41; p=0.01) events was recorded. Conversely, the incidence of thromboembolic events in the VKAs-treated arm was significantly lower in those studies with uninterrupted periprocedural anticoagulation treatment (RR=1.89; p=0.02).LimitationsAs with every meta-analysis, no patients-level data were available.Conclusions and implicationsThe use of NOACs in patients undergoing RFCA is safe, given the lower incidence of bleedings observed with NOACs. On the other side, periprocedural interruption of VKAs and bridging with heparin is associated with a higher bleeding rate with no significant benefit on onset of thromboembolic events.

Project description:BackgroundWarfarin is a well-established agent for use in the prevention of stroke or systemic embolic event (SEE) in patients with nonvalvular atrial fibrillation (NVAF) and for the treatment of venous thromboembolism (VTE). However, management of patients requiring oral anticoagulation with warfarin can be complicated by the need for frequent monitoring, drug-drug and drug-food interactions, and a variable response based on genetic polymorphisms. The non-vitamin K antagonist oral anticoagulants (NOACs) were developed as alternatives to warfarin; they do not require routine monitoring and have predictable pharmacokinetics, fewer drug-drug interactions, and limited drug-food interactions. Four NOACs-dabigatran, rivaroxaban, apixaban, and edoxaban-have received approval from the US Food and Drug Administration for the prevention of stroke or SEE in NVAF and for the treatment of VTE. Selecting the most appropriate agent for each patient should be done in consideration of patient preferences and characteristics, including renal function, bleeding risk, and the need for other medications.MethodsA search was performed on the terms atrial fibrillation and venous thromboembolism with individual terms dabigatran, apixaban, edoxaban, or rivaroxaban to identify relevant manuscripts; large randomized clinical trials, metaanalyses, and treatment guideline recommendations were given preference. Searches to identify registries, treatment guidelines, and metaanalyses relevant to specific subgroups were also used.ResultsNOACs are effective in reducing the risk of stroke or SEE in patients with NVAF and are associated with fewer incidents of intracranial bleeding vs warfarin.ConclusionNOACs provide a convenient and safe alternative to warfarin and may result in improved therapeutic outcomes for patients with NVAF or VTE. The use of NOACs in other indications and patient populations is under investigation, and clinical trials investigating their use in acute coronary syndrome, medically ill patients, percutaneous coronary intervention, cardioversion, catheter ablation, coronary arterial disease, and heart failure have been announced.

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Suboptimal use of non-vitamin K antagonist oral anticoagulants: Results from the RAMSES study.

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Suboptimal use of non-vitamin K antagonist oral anticoagulants: Results from the RAMSES study.

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