Novel Oral Anticoagulants In Patients Research Articles

Use of novel oral anticoagulants in patients with atrial fibrillation

Atrial fibrillation (AF) is one of the most common arrhythmias, which results in disability and death in the patients. The mechanisms of systemic and local atrial activation of the coagulation system provoke the risk of stroke in the presence of even short AF episodes. Novel oral anticoagulants (NOACs), particularly rivaroxaban, have shown their efficacy in preventing stroke in patients with AF. The international ROCKET AF, XANTUS, PREFER, and RIVER studies have studied different aspects of anticoagulant therapy, on the basis of which, the use of rivaroroxaban has been approved for the prevention of ischemic stroke and systemic embolisms in patients with non-valvular AF; the efficacy and safety of the drug have been proven.

Methods for Economic Evaluations of Novel Oral Anticoagulants in Patients with Atrial Fibrillation: A Systematic Review.

Atrial fibrillation (AF) is a severe epidemiological and public health concern among the elderly population worldwide, with substantial economic and social burdens. Economic evaluations can play an essential role in optimizing the utilization of scarce resources. In recent years, the number of economic evaluation studies related to AF has increased due to the rising number of AF patients, the continuous updating of clinical data, and the emergence of real-world evidence. However, there are still deficiencies in model settings and parameter sources in relevant studies. This study aims to review the existing economic evaluations of novel oral anticoagulants (NOACs) in patients with AF and summarize the evidence and methods applied. A comprehensive and systematic search was conducted on electronic databases, including PubMed, Embase, Web of Science (WOS), and The Cochrane Library, from the date of database creation to November 2022. The reporting quality of included literature was assessed using the Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement. A total of 102 studies were included in the review, with 200 comparisons between NOACs and vitamin K antagonists (VKAs), as well as 58 comparisons between different NOACs. The healthcare sector and payer perspectives were the most common, and accordingly, the majority of the evaluations considered only direct medical costs. Most studies used Markov cohort models with the number of health states ranging from 4 to 29. Of included studies, 80 (78%) considered event recurrence and complications, and 78 (76%) considered discontinuation and second-line therapy. All of the studies applied uncertainty analysis to explore the robustness of the results. Of all 200 NOACs-VKAs comparisons, 149 (75%) showed that NOACs were more cost-effective; this proportion was 84% (139 out of 165) in high-income countries but decreased to 29% (10 out of 35) in middle- and low-income countries. Most (82%) of the 28 items in the CHEERS 2022 checklist were elucidated in the majority of included studies. A minority (only 39%) of included studies demonstrated high reporting quality. NOACs may be more cost-effective than VKAs in patients with AF, but this conclusion applies to high-income countries, whereas VKAs may be more cost-effective in middle- and low-income countries. The reporting quality of included studies was variable, and certain methodological issues were presented. This study highlights the economic evaluation methodology of NOACs in patients with AF and provides recommendations for modeling methods and future studies.

Efficacy and Safety of Novel Oral Anticoagulants in Atrial Fibrillation: A Systematic Review.

In recent times, novel oral anticoagulants (NOACs)/direct oral anticoagulants (DOACs) have emerged as an alternative to the traditionally used VitaminK oral antagonists (VKA)like warfarin for the treatment of atrial fibrillation (AF). This systematic review and meta-analysis aims toevaluate the efficacy and safety of NOACs in patients with AF and, thus, the related thromboembolic risks and sequelae. Of the 131 published articles we examined, 11 were included in an in-depth systematic review. The articles we reviewed were from the past ten years, from 2013 onward. The analysis derived the efficacy and safety of NOACs in patients with AF and also included different patients' baseline characteristics and subgroups. This systematic review reiterates previous research findings of superior efficacy and safety of the use of NOACs in the AF population and also illuminates certain head-to-head comparisons of individual NOACs with warfarin.It digressed into subgroups of patients with different baseline characteristics to provide evidence and support the existing guidelines for the use of NOACs in the treatment of AF. Overall, there is marked efficacy and safety of NOACs in patients with AF, be they elderly or Asian, with decreased renal function, or with other comorbidities. Adherence to NOACs was also satisfactory. Despite such a review, there needs to be more research on vast subgroups and also on reversal antidotes like andexanet alfa and idarucizumab, as well as more head-to-head analysis between NOACs over a long duration of study, which would provide more answers and pinpoint reasons as to the differences that exist between demographics and subgroups in the usage of NOACs.

Use of NOACS in Extremes of Body Weight

Certain physiological phenomena in our body lead to severe changes in body weight leading to obesity. If needed, currently, there is no specific regimen for using novel oral anticoagulants (NOACs) in obese patients. It has been found that fixed doses of NOACs bring out more drug exposure to lower BMI patients, whereas it brings out lesser blood drug levels in patients with higher BMI.1 When researchers evaluated NOACs in patients with atrial fibrillation (AF) or venous thromboembolism (VTE), most randomized trials did not exclude body weight from the studies. Hence, the subgroup analysis of these trials showed no considerable difference in outcomes in obese patients.2 The International Society on Thrombosis and Haemostasis showed that NOACs are safer in patients with a body weight of ≤ 120 kg (BMI ≤40 kg/m2) at the usual dose as compared to patients with a body weight of >120 kg (BMI >40 kg/m2).2 Several retrospective studies have shown suboptimal plasma concentrations (in 20%-28% of obese patients studied) with dabigatran and rivaroxaban compared to apixaban.3 Dose reduction is recommended for apixaban if body weight is ≤ 60 kg (in addition to age and renal function). Reduction in the dose of edoxaban is recommended due to the pharmacokinetic property of high systemic exposure in low body weight patients.4 For patients with body weight > 120 kg or BMI > 40 kg/m2, it is suggested to use rivaroxaban and apixaban, while dabigatran, edoxaban, and betrixaban should be avoided.5 For patients with a body weight <60 kg, renal function should be assessed before adjusting the dose of NOACs. These patients overestimate renal function due to lower body muscle mass. Old age and frailty should also be considered, as these factors are related to bad outcomes in patients with low body weight.6 It is suggested to use apixaban (after taking a renal impairment and age into consideration) and edoxaban with caution in low-body weight patients.7 Dabigatran serves as a less-than-ideal drug for low-body weight patients due to high systemic exposure. No conclusive data is available for rivaroxaban.8 Due to a lack of clinical interest in this population subset of extreme body weight changes, we need more data, which leads to the need for more extensive work in this domain, revealing clear answers in the future.

Efficacy evaluation of novel oral anticoagulants in patients with cirrhosis accompanied with portal vein thrombosis: a meta-analysis

Objective: To analyze the safety and efficacy of using novel oral anticoagulants (rivaroxaban and others) in patients with cirrhosis accompanied with portal vein thrombosis (PVT). Methods: Clinical research literature published from the establishment of the database to June 20, 2021, was retrieved from PubMed, Web of Science, CNKI, Wanfang, and Weipu databases by combining subject terms and free words. RevMan software was used for the random group meta-analysis model. Results: In terms of PVT recanalization, the novel oral anticoagulants (such as low molecular weight heparin and others) had a higher recanalization rate than traditional anticoagulants (OR = 13.75, 95%CI 3.58-52.9, P = 0.000 1). In terms of bleeding, the novel oral anticoagulants did not increase the risk of bleeding compared with traditional anticoagulants (OR = 2.42, 95%CI 0.62-9.41, P = 0.20). Conclusion: The novel oral anticoagulant drugs are superior to traditional anticoagulants in terms of the occurrence of PVT recanalization; however, there is no statistically significant difference in terms of the occurrence of bleeding between the two groups.

Stroke Risk with Warfarin vs. NOACs in Artificial Heart Valves: a Meta-Analysis (S45.004)

<h3>Objective:</h3> This systematic review and meta-analysis evaluates multiple clinical outcomes between warfarin and NOACs in patients with artificial heart valves. <h3>Background:</h3> Although novel oral anticoagulants (NOAC) have been proven as effective alternatives to warfarin in patients with atrial fibrillation, the effectiveness of NOACs in patients with artificial (bioprosthetic and mechanical) heart valves is not known. <h3>Design/Methods:</h3> PubMed, CINHAL, and Clinicaltrials.gov were searched through May 2022 for studies comparing clinical outcomes of adults with artificial heart valves that received warfarin vs. NOACs. Data was pooled with Der Simonian and Laird’s random effects model. <h3>Results:</h3> Eight studies (n = 183167, 38% female) met the criteria for study inclusion. Four were randomized control trials (RCTs) and four were retrospective cohort studies. Mechanical and bioprosthetic valves were represented in 14.7% and 85.3% of patients respectively. There was no statistically significant difference between NOACs and warfarin for all bleeding, all-cause mortality, TIA, systemic embolism, and all-stroke outcomes. Overall Warfarin led to 22% more major bleeding (OR = 1.22, 95% CI = [1.05, 1.41], p = 0.01) and more ischemic stroke (OR = 1.72, 95% CI = [1.1, 2.68], p = 0.02) compared to NOACs. Also amongst patients with bioprosthetic heart valves, Warfarin led to 33% more major bleeding compared to NOACs (OR = 1.33, 95% CI = [1.06, 1.66]). However, NOACs led to 65% more major bleeding compared to warfarin among those with mechanical heart valves (OR = 0.35, 95% CI = [0.18, 0.67]). <h3>Conclusions:</h3> Compared with warfarin, NOACs reduced the risk of ischemic stroke and major bleeding in patients with artificial heart valves. NOACs reduced the risk of ischemic stroke and major bleeding in patients with bioprosthetic heart valves, but not in patients with mechanical heart valves compared to Warfarin. <b>Disclosure:</b> Mr. Srivastava has nothing to disclose. Ms. Almader-Douglas has nothing to disclose. Dr. Deo has nothing to disclose. Dr. Sharma has nothing to disclose.

Novel Oral Anticoagulants in Patients With Atrial Fibrillation and Moderate to Severe Mitral Stenosis: A Systematic Review.

The use of novel oral anticoagulants (NOAC) in patients with moderate to severe mitral stenosis (MS) and atrial fibrillation (AF) is not recommended.We aimed to evaluate the efficacy and safety of NOAC usage compared to vitamin K antagonist (VKA) in patients with moderate to severe MS and AF.We conducted a systematic review to identify articles that compared warfarin to NOAC in patients with moderate to severe MS and AF. Only four studies (two observational studies and two trials) met our search criteria and reported a total of 7529 patients with MS and AF with MS and AF, 4138 of them treated with NOAC. In both observational studies, the severity of MS was not determined, and there was heterogeneity in MS etiology. Nevertheless, both studies showed a positive signal toward the efficacy and safety of NOAC compared to VKA in this population. A randomized pilot trial (n=40) was done on patients with moderate to severe MS, and it showed further acceptable efficacy and safety for rivaroxaban use. However, a larger randomized controlled trial (n=4531) disclosed that VKA (warfarin) led to a significantly lower rate of a composite of cardiovascular events or mortality than rivaroxaban, without a higher rate of major bleeding but not fatal bleeding. Our systematic review provides exploratory information on NOAC safety and effectiveness in patients with MS; it also discourages using NOACs for patients with moderate to severe MS and supports the current treatment guidelines. However, more dedicated clinical trials evaluating the use of NOACs in moderate to severe MS are underway. They will categorically establish the safety profile and clinical effectiveness of NOAC in this high-risk population.

Gastrointestinal Bleeding Due to NOACs Use: Exploring the Molecular Mechanisms.

Novel oral anticoagulants (NOACs) are drugs approved for the prevention and treatment of many thromboembolic cardiovascular conditions as a safer alternative to warfarin. We reviewed studies published in PubMed®, UpToDate®, Web of Science®, and Cochrane® about NOACs' risks and benefits in patients requiring anticoagulation, with a focus on gastrointestinal bleeding and on molecular and pathophysiological mechanisms underlying the risk of bleeding in patients treated with them. Apixaban resulted in a lower rate of gastrointestinal bleeding compared to dabigatran and rivaroxaban. However, data reported that gastrointestinal bleeding in patients treated with NOACs was less severe compared to warfarin. Studies show promising results on the increased and widespread use of NOACs in patients who require anticoagulation (for example-in case of atrial fibrillation or high risk of venous thromboembolism), reporting an overall lower risk of major bleeding events. The profile of NOACs was more effective and secure compared to warfarin, but a more careful medical prescription is required in patients who are at high risk of gastrointestinal bleeding.

Safety of Non-Vitamin K Antagonist Oral Anticoagulant Treatment in Patients with Chronic Kidney Disease and Kidney Transplant Recipients

The use of novel oral anticoagulants in patients with impaired renal function or undergoing immunosuppressive therapy is limited due to the risk of drug-to-drug interactions and anticoagulation-related adverse events. This article aims to assess the current data on the safety of direct-acting oral anticoagulant-based therapy in the population of kidney transplant recipients and patients with impaired renal function. The most important factors affecting the safety of treatment are the incidence of bleeding events, thromboembolic events, deaths and drug-to-drug interactions. The available data were compared to the findings on warfarin-based anticoagulation. Findings on the use of novel oral anticoagulants in kidney transplant recipients are limited yet promising in terms of safety and efficacy of use. However, current recommendations state that the co-administration of non-vitamin K antagonist oral anticoagulants with several immunosuppressive agents is contraindicated.

Safety and Efficacy of Vitamin K Antagonists vs. Novel Oral Anticoagulants in Patients With Left Ventricular Thrombus: A Meta-Analysis

Aims: A meta-analysis was conducted to evaluate the safety and efficacy of novel oral anticoagulants (NOACs) compared with vitamin K antagonists (VKAs) in patients with left ventricular thrombus (LVT).Methods and Results: We searched PubMed, Web of Science, and Cochrane Library for cohort studies comparing the use of VKAs vs. NOACs for the treatment of LVT from the earliest date available to September 30, 2020. The predetermined efficacy and safety outcomes included thromboembolic events, resolution of LVT, clinically significant bleedings, and all-cause death. Fixed-effects model was used to estimate the pooled effects. Publication bias analyses and sensitivity analyses were conducted to check the robustness of results. A total of 6 studies enrolling 837 patients (mean age 60.2 ± 1.6 years; 77.2% were male) were included. We found no significant differences in thromboembolic events [relative risk (RR) 1.69, 95% confidence interval (CI) 0.94–3.06, P 0.08, I2 12.7%], the rate of resolution of thrombus (RR 1.08, 95% CI 0.96–1.21, P 0.21, I2 4.8%), and clinically significant bleedings (RR 0.70, 95% CI 0.37–1.32, P 0.27, I2 0%) between the VKAs and NOACs group. Additionally, no significant difference in all-cause mortality was found between the two groups (RR 1.24, 95% CI 0.79–1.96, P 0.35, I2 0.0%). Sensitivity analyses, using the “1-study removed” method, detected no significant differences.Conclusion: NOACs and VKAs have similar efficacy and safety in treating LVT, prompting the inference that NOACs are the possible alternatives of VKAs in LVT therapy.

Pharmacoeconomic Evaluation of Novel Oral Anticoagulants in Patients with Cardiovascular Diseases: A Systematic Review

For decades, the oral anticoagulant warfarin remained the gold standard of medical management for many cardiovascular diseases and main pharmacological agents for the prophylaxis of venous thromboembolism [1].

Abstract 12901: Novel Oral Anticoagulants Are Associated With Decreased Recurrence of Venous Thromboembolism in Patients With Cancer: An Updated Meta-Analysis

Introduction: Patients with cancer are at high risk for recurrent thromboembolic phenomenon. Use of novel oral anticoagulants (NOAC) for treatment of venous thromboembolism (VTE) in such patients is controversial. We conducted this updated meta-analysis to evaluate the pooled efficacy and safety of NOAC in patients with cancer. Methods: We did systematic search of PubMed and Cochrane library databases for randomized controlled trials comparing NOAC with low molecular weight heparin (LMWH) for VTE treatment in cancer patients till April 2020. The efficacy outcomes were recurrent VTE and all-cause mortality rates, and the primary safety outcome was incidence of major bleeding rate. Results: Four randomized controlled studies comparing NOAC with LMWH (1446 patients in NOAC group and 1448 patients in LMWH group) were included in our study. Use of NOAC lead to significant reduction in recurrent VTE rate (odds ratio (OR): 0.55 [0.36-0.84], I 2 = 45 %, p value = 0.006) (Figure 1). However, we did not find any significant difference in rate of major bleeding (OR: 1.30 [0.76-2.23], I 2 = 35%, p value = 0.34) (Figure 2) and all-cause mortality (OR: 1 [0.80 - 1.26], I 2 = 33%, p value = 0.98). Conclusions: This updated meta-analysis showed comparatively lower pooled recurrent VTE rate in patient being treated with NOAC, whereas similar rates of major bleeding and all-cause death. NOAC are more efficacious and has similar safety profile compared with LMWH.

Erratum to: Novel oral anticoagulants in patients with chronic kidney disease and atrial fibrillation.

Erratum to: Novel oral anticoagulants in patients with chronic kidney disease and atrial fibrillation.

Meta-analysis of the safety and efficacy of using minimally interrupted novel oral anticoagulants in patients undergoing catheter ablation for atrial fibrillation.

The ideal periprocedural anticoagulation strategy for patients being treated with a novel oral anticoagulant (NOAC) during catheter ablation (CA) for atrial fibrillation (AF) is unclear. We evaluated the safety and efficacy of using a minimally interrupted NOAC strategy versus an uninterrupted NOAC or vitamin K antagonist (VKA) strategy during AF ablation. The Cochrane Library, PubMed, and EMBASE databases were searched for randomized controlled or prospective observational studies that compared a minimally interrupted NOAC strategy with an uninterrupted NOAC or VKA strategy from the time of database establishment up to December 2019. The primary endpoints were major bleeding, minor bleeding, and symptomatic thromboembolism. The secondary endpoint was silent cerebral infarction (SCI) as detected by post-ablation brain magnetic resonance imaging (MRI). A measurement of treatment effect for the endpoint was reported as pooled odds ratio (OR) with 95% confidence interval (CI). A total of 18 studies (6 randomized, 11 observational, and 1 randomized registry) with 6203 patients were included in the final analysis (47% of the patients received minimally interrupted NOAC). There was no significant difference between treatment groups regarding the risk for major bleeding (OR 1.04, 95% CI 0.69-1.57, P = 0.86, I2 = 27%). Different stratification methods did not yield significant difference regarding the risk for major bleeding. There was no difference between groups regarding the risk for minor bleeding (P = 1.00) or symptomatic thromboembolism (P = 0.26). Brain MRI results showed that both uninterrupted NOAC (OR 0.44, 95% CI 0.23-0.83, P = 0.01, I2 = 72%) and uninterrupted VKA (OR 0.48, 95% CI 0.24-0.97, P = 0.04, I2 = 36%) produced a significant reduction in the rate of SCI when compared with minimally interrupted NOAC. A periprocedural anticoagulation strategy of minimally interrupted NOAC is not superior to uninterrupted NOAC or VKA when used during AF ablation. There is evidence favoring the use of uninterrupted NOAC or VKA in terms of the risk for SCI.

Comparative efficacy and safety of warfarin care bundles and novel oral anticoagulants in patients with atrial fibrillation: a systematic review and network meta-analysis

Warfarin care bundles (e.g. genotype-guided warfarin dosing, patient’s self-testing [PST] or patient’s self-management [PSM] and left atrial appendage closure) are based on the concept of combining several interventions to improve anticoagulation care. NOACs are also introduced for stroke prevention in atrial fibrillation (SPAF). However, these interventions have not been compared in head-to-head trials yet. We did a network meta-analysis based on a systematic review of randomized controlled trials comparing anticoagulant interventions for SPAF. Studies comparing these interventions in adults, whether administered alone or as care bundles were included in the analyses. The primary efficacy outcome was stroke and the primary safety outcome was major bleeding. Thirty-seven studies, involving 100,142 patients were assessed. Compared to usual care, PSM significantly reduced the risk of stroke (risk ratio [RR] 0.24, 95% CI 0.08–0.68). For major bleeding, edoxaban 60 mg (0.80, 0.71–0.90), edoxaban 30 mg (0.48, 0.42–0.56), and dabigatran 110 mg (0.81, 0.71–0.94) significantly reduced the risk of major bleeding compared with usual warfarin care. Cluster rank plot incorporating stroke and major bleeding outcomes indicates that some warfarin care bundles perform as well as NOACs. Both interventions are therefore viable options to be considered for SPAF. Additional studies including head-to-head trials and cost-effectiveness evaluation are still warranted.

Novel Oral Anticoagulants in Patients with Continuous Flow Left Ventricular Assist Devices

Purpose The gold standard for anticoagulation in patients with continuous flow left ventricular assist device (CF-LVADs) is warfarin. However, many patients fail warfarin therapy due to thromboembolic and bleeding events. Warfarin requires regular monitoring and dosage adjustments, and is associated with significant patient time outside recommended therapeutic INR range. Novel oral anticoagulation (NOAC) has been shown to be non-inferior compared to warfarin in stroke prevention with less intracranial hemorrhage in patients with atrial fibrillation. In this study, we sought to evaluate the safety and efficacy of NOACs in patients with CF-LVADs after failed warfarin therapy. Methods Patients who underwent CF-LVAD insertion between 2008 and 2018 were identified in a single-center database. 7 patients with either HeartMate II or HeartWare were switched from warfarin to a NOAC, either apixaban or rivaroxaban, were included. Occurrence of stroke, non-CNS embolism, pump thrombosis, and major GI bleeding or intracranial hemorrhage on warfarin and NOAC were evaluated. Results 5 of 7 patients were male, with an average BMI of 30. Common comorbidities were hypertension (100%), diabetes mellitus (57%) and ischemic cardiomyopathy (57%). There were a total of 3968 patient days on warfarin and 1459 patient days on a NOAC. Patients on warfarin therapy spent an average time of 30% within a therapeutic INR range. The rates of complications under warfarin versus NOAC therapy were: strokes 0.019 vs. 0 /patient-year, non-CNS embolism 0.019 vs. 0 /patient-year, pump thrombosis 0.01 vs. 0 /patient-year, major GI bleeding 0.02 vs. 0.07 /patient-year, and intracranial hemorrhage 0.019 vs. 0 /patient-year.(Table 1). Conclusion Increased complication rates and poor time in therapeutic INR range were present in patients receiving warfarin therapy after CF-LVAD insertion. NOAC therapy with apixaban or rivaroxaban may be a viable alternative. However, large prospective studies are necessary to confirm these results.

Follow-up and management of valvular heart disease patients with prosthetic valve: a clinical practice guideline for Indian scenario

PurposeValvular heart disease (VHD) patients after prosthetic valve implantation are at risk of thromboembolic events. Follow-up care of patients with prosthetic valve has a paramount role in reducing the morbidity and mortality. Currently, in India, there is quintessential need to stream line the follow-up care of prosthetic valve patients. This mandates the development of a consensus guideline for the antithrombotic therapy in VHD patients post prosthetic valve implantation.MethodsA national level panel was constituted comprising 13 leading cardio care experts in India who thoroughly reviewed the up to date literature, formulated the recommendations, and developed the consensus document. Later on, extensive discussions were held on this draft and the recommendations in 8 regional meetings involving 79 additional experts from the cardio care in India, to arrive at a consensus. The final consensus document is developed relying on the available evidence and/or majority consensus from all the meetings.ResultsThe panel recommended vitamin K antagonist (VKA) therapy with individualized target international normalized ratio (INR) in VHD patients after prosthetic valve implantation. The panel opined that management of prosthetic valve complications should be personalized on the basis of type of complications. In addition, the panel recommends to distinguish individuals with various co-morbidities and attend them appropriately.ConclusionsAnticoagulant therapy with VKA seems to be an effective option post prosthetic valve implantation in VHD patients. However, the role for non-VKA oral therapy in prosthetic valve patients and the safety and efficacy of novel oral anticoagulants in patients with bioprosthetic valve need to be studied extensively.

PCV38 - Cost-Effectiveness Of Novel Oral Anticoagulants For Stroke Prevention In Patients With Non-Valvular Atrial Fibrillation In China

The novel oral anticoagulants(NOACs) including apixaban, dabigatran and rivaroxaban have been widely applied to anticoagulation treatment for non-valvular atrial fibrillation(NVAF). The objective of this study was to evaluate the cost effectiveness of apixaban, dabigatran and rivaroxaban for stroke prevention in patients with NVAF in China. A previously published Markov model was adapted to estimate the costs and quality-adjusted life-years (QALYs) of the three NOACs for patients with NVAF from the perspective of health care system. The model included the following health states: NVAF, ischemic stroke (mild, moderate, severe), hemorrhagic stroke (mild, moderate, severe), systemic embolism, myocardial infarction, NVAF subsequent aspirin and death. The time horizon was lifetime and the cycle length was 6 weeks. In the absence of head-to-head evidence, transition probabilities were derived from indirect comparison analyses based on the ARISTOTLE，RE-LY and ROCKET-AF clinical trials. Published health state utilities were used. Only direct medical costs were considered, obtained from published research on Chinese population. Both costs and outcomes were discounted at 3%. Deterministic sensitivity analysis and probabilistic sensitivity analysis were conducted. The lifetime costs for dabigatran(110mg BID), rivaroxaban(20mg QD), dabigatran(150mg BID) and apixaban(5mg BID) were ￥63,489, ￥76,697, ￥78,078 ,and ￥293,871, while the quality-adjusted life-years were 7.00 QALYs, 7.18 QALYs, 7.07 QALYs and 7.23 QALYs, respectively. Dabigatran(150mg) was dominated by rivaroxaban because of higher cost and lower QALY. The incremental cost-effectiveness ratio of rivaroxaban and apixaban compared with dabigatran(110mg) were ￥71,755/QALY and ￥1012,003/QALY respectively. At a willingness-to-pay threshold of ￥178,980(3 times of China per capita GDP in 2017) per QALY, rivaroxaban was cost-effective. Sensitivity analyses indicated that results were robust. Based on the results of this research, rivaroxaban can be a cost-effective option compared with other NOACs for stroke prevention in patients with NVAF in China.

P4821Use of novel oral anticoagulants in patients with atrial fibrillation and moderate to severe renal dysfunction: findings from a prospective national registry

P4821Use of novel oral anticoagulants in patients with atrial fibrillation and moderate to severe renal dysfunction: findings from a prospective national registry

Novel oral anticoagulants in chronic kidney disease: ready for prime time?

Patients with chronic kidney disease (CKD) are at increased risk of atrial fibrillation, stroke, and bleeding posing unique clinical challenges. Novel oral anticoagulants (NOACs) including dabigatran, rivaroxaban, and apixaban have become recognized as alternative therapy to Vitamin K Antagonists (VKA) regarding the prevention of venous thromboembolism (VTE) and reduce the risk of stroke in atrial fibrillation. However, the understanding of NOACs in CKD is still underdeveloped. This review summarizes recent literature on the efficacy and safety of NOACs in patients with CKD. Studies focusing on patients with moderate kidney disease were drawn from post hoc analyses from three major NOAC trials, meta-analyses, and postmarketing surveillance studies. Cumulatively, these studies continue to demonstrate NOACs as equivalent if not superior therapies to VKAs in regards to both efficacy and safety. These studies are limited by small sample sizes as well as a lack of direct comparison between NOACs. The role of NOACs in managing VTE and atrial fibrillation is increasing. Current research suggests that NOACs are at least as efficacious and well tolerated as VKAs. More research is required to elucidate which NOAC is preferable in the clinical setting.