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Cost Effectiveness and Resource... Oct 2023The increasing global prevalence of atrial fibrillation (AF) has led to a growing demand for stroke prevention strategies, resulting in higher healthcare costs....
BACKGROUND
The increasing global prevalence of atrial fibrillation (AF) has led to a growing demand for stroke prevention strategies, resulting in higher healthcare costs. High-quality economic evaluations of stroke prevention strategies can play a crucial role in maximising efficient allocation of resources. In this systematic review, we assessed the methodological quality of such economic evaluations.
METHODS
We searched electronic databases of PubMed, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, and Econ Lit to identify model-based economic evaluations comparing the left atrial appendage closure procedure (LAAC) and oral anticoagulants published in English since 2000. Data on study characteristics, model-based details, and analyses were collected. The methodological quality was evaluated using the modified Economic Evaluations Bias (ECOBIAS) checklist. For each of the 22 biases listed in this checklist, studies were categorised into one of four groups: low risk, partial risk, high risk due to inadequate reporting, or high risk. To gauge the overall quality of each study, we computed a composite score by assigning + 2, 0, - 1 and - 2 to each risk category, respectively.
RESULTS
In our analysis of 12 studies, majority adopted a healthcare provider or payer perspective and employed Markov Models with the number of health states varying from 6 to 16. Cost-effectiveness results varied across studies. LAAC displayed a probability exceeding 50% of being the cost-effective option in six out of nine evaluations compared to warfarin, six out of eight evaluations when compared to dabigatran, in three out of five evaluations against apixaban, and in two out of three studies compared to rivaroxaban. The methodological quality scores for individual studies ranged from 10 to - 12 out of a possible 24. Most high-risk ratings were due to inadequate reporting, which was prevalent across various biases, including those related to data identification, baseline data, treatment effects, and data incorporation. Cost measurement omission bias and inefficient comparator bias were also common.
CONCLUSIONS
While most studies concluded LAAC to be the cost-effective strategy for stroke prevention in AF, shortcomings in methodological quality raise concerns about reliability and validity of results. Future evaluations, free of these shortcomings, can yield stronger policy evidence.
PubMed: 37872572
DOI: 10.1186/s12962-023-00486-0 -
Frontiers in Endocrinology 2023Evidence on the association between the risk of new-onset osteoporosis and oral anticoagulants remains controversial. We aimed to compare the risk of osteoporosis... (Meta-Analysis)
Meta-Analysis
AIMS
Evidence on the association between the risk of new-onset osteoporosis and oral anticoagulants remains controversial. We aimed to compare the risk of osteoporosis associated with the use of direct oral anticoagulants (DOACs) with that associated with warfarin use.
METHODS
Studies published up to 15 March 2023 that investigated the association between the use of DOACs and warfarin and the incidence of osteoporosis were identified by online searches in PubMed, Embase, the Cochrane Library, and Web of Science conducted by two independent investigators. Random-effects or fixed-effect models were employed to synthesize hazard ratios (HRs)/relative ratios (RRs) with 95% confidence intervals (CIs) for estimating the risk of osteoporosis correlated with DOAC and warfarin prescriptions (PROSPERO No. CRD42023401199).
RESULTS
Our meta-analysis ultimately included four studies involving 74,338 patients. The results suggested that DOAC use was associated with a significantly lower incidence of new-onset osteoporosis than warfarin use (pooled HR: 0.71, 95% CI: 0.57 to 0.88, < 0.001, : 85.1%). Subanalyses revealed that rivaroxaban was associated with a lower risk of osteoporosis than both warfarin and dabigatran. In addition, DOACs were associated with a lower risk of developing osteoporosis than warfarin in both male and female patients, in patients with atrial fibrillation (AF), and in patients who underwent therapy for > 365 days.
CONCLUSION
DOAC users experienced a lower incidence of osteoporosis than warfarin users. This study may give us insight into safe anticoagulation strategies for patients who are at high risk of developing osteoporosis.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/PROSPERO, identifier CRD42023401199.
Topics: Humans; Male; Female; Warfarin; Stroke; Hemorrhage; Anticoagulants; Atrial Fibrillation; Osteoporosis
PubMed: 37842293
DOI: 10.3389/fendo.2023.1212570 -
Europace : European Pacing,... Oct 2023Limited real-world data show that rivaroxaban following dosage criteria from either ROCKET AF [20 mg/day or 15 mg/day if creatinine clearance (CrCl) < 50 mL/min]... (Meta-Analysis)
Meta-Analysis
Comparisons of effectiveness and safety between on-label dosing, off-label underdosing, and off-label overdosing in Asian and non-Asian atrial fibrillation patients treated with rivaroxaban: a systematic review and meta-analysis of observational studies.
AIMS
Limited real-world data show that rivaroxaban following dosage criteria from either ROCKET AF [20 mg/day or 15 mg/day if creatinine clearance (CrCl) < 50 mL/min] or J-ROCKET AF (15 mg/day or 10 mg/day if CrCl < 50 mL/min) is associated with comparable risks of thromboembolism and bleeding with each other in patients with non-valvular atrial fibrillation (NVAF). We are aimed to study whether these observations differ between Asian and non-Asian subjects.
METHODS AND RESULTS
A systematic review and meta-analysis with random effects was conducted to estimate the aggregate hazard ratio (HR) and 95% confidence interval (CI) using PubMed and MEDLINE databases from 8 September 2011 to 31 December 2022 searched for adjusted observational studies that reported relevant clinical outcomes of NVAF patients receiving rivaroxaban 10 mg/day if CrCl > 50 mL/min, on-label dose rivaroxaban eligible for ROCKET AF or J-ROCKET AF, and rivaroxaban 20 mg/day if CrCl < 50 mL/min. Effectiveness and safety endpoints were compared between ROCKET AF and J-ROCKET AF dosing regimen in Asian and non-Asian subjects, separately. Also, risks of events of rivaroxaban 10 mg/day despite of CrCl > 50 mL/min and rivaroxaban 20 mg/day despite of CrCl < 50 mL/min were compared to that of 'ROCKET AF/J-ROCKET AF dosing'. Sensitivity analyses were performed by sequential elimination of each study from the pool. The meta-regression analysis was performed to explore the influence of potential factors on the effectiveness and safety outcomes. Eighteen studies involving 67 571 Asian and 54 882 non-Asian patients were included. Rivaroxaban following J-ROCKET AF criteria was associated with comparable risks of thromboembolism in the Asian subgroup, whereas rivaroxaban following J-ROCKET AF criteria was associated with higher risks of all-cause mortality (HR:1.30; 95% CI:1.05-1.60) compared with that of ROCKET AF criteria in the non-Asian population. There were no differences in risks of major bleeding between rivaroxaban following J-ROCKET AF vs. ROCKET AF criteria either in the Asian or non-Asian population. The use of rivaroxaban 10 mg despite of CrCl > 50 mL/min was associated with a higher risk of thromboembolism (HR:1.64; 95% CI:1.28-2.11) but lower risk of major bleeding (HR:0.72; 95% CI:0.57-0.90) compared with eligible dosage criteria. The use of rivaroxaban 20 mg despite of CrCl < 50 mL/min was associated with worse clinical outcomes in the risks of thromboembolism (HR:1.32; 95% CI:1.09-1.59), mortality (HR:1.33; 95% CI:1.10-1.59), and major bleeding (HR:1.26; 95% CI:1.03-1.53) compared with eligible dosage criteria. The pooled results were generally in line with the primary effectiveness and safety outcomes by removing a single study at one time. Meta-regression analyses failed to detect the bias in most potential patient characteristics associated with the clinical outcomes.
CONCLUSION
Rivaroxaban dosing regimen following J-ROCKET criteria may serve as an alternative to ROCKET AF criteria for the Asian population with NVAF, whereas the dosing regimen following ROCKET AF criteria was more favourable for the non-Asian population. The use of rivaroxaban 10 mg despite of CrCl > 50 mL/min was associated with a higher risk of thromboembolism but a lower risk of major bleeding, while use of rivaroxaban 20 mg despite of CrCl < 50 mL/min was associated with worse outcome in most clinical events.
Topics: Humans; Anticoagulants; Atrial Fibrillation; Factor Xa Inhibitors; Hemorrhage; Off-Label Use; Rivaroxaban; Stroke; Thromboembolism; Treatment Outcome; Warfarin; Observational Studies as Topic
PubMed: 37738425
DOI: 10.1093/europace/euad288 -
Cardiovascular Therapeutics 2023Optimal antithrombotic therapy during the chronic maintenance period in patients with coronary artery disease (CAD) is unknown. We compared five kinds of mainstream... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Optimal antithrombotic therapy during the chronic maintenance period in patients with coronary artery disease (CAD) is unknown. We compared five kinds of mainstream chronic maintenance antithrombotic strategies at least one year after the acute phase: aspirin alone, clopidogrel alone, ticagrelor alone, continued dual antiplatelet therapy (DAPT) for a period of time, and maintenance with aspirin combined with a low-dose anticoagulant such as rivaroxaban.
METHODS
Ten randomized, controlled trials were selected using PubMed, Ovid MEDLINE, Embase, and Cochrane library through February 2023. The primary outcome was main adverse cardiac events (MACEs), and secondary outcomes include net adverse clinical events (NACEs), cardiac death, all-cause death, ischemic stroke, stent thrombosis, total bleeding, and major bleeding. A network meta-analysis was conducted with a random-effects model. Data extraction was performed by three independent reviewers.
RESULTS
Our search identified ten eligible randomized controlled trials enrolling a total of 82,084 patients comparing different chronic maintenance antithrombotic strategies. As for the primary endpoint, there was no statistical difference in MACE outcomes between any two of the five methods. As for the secondary endpoint, there was no statistical difference in NACE, major bleeding, all-cause death, cardiac death, and stent thrombosis between any two methods. The aspirin plus low-dose rivaroxaban group had a lower incidence of ischemic stroke compared to the aspirin group (OR = 0.49, 95% CrI 0.26-0.91). And the prolonged DAPT group had a higher total bleeding rate compared to aspirin group (OR = 2.4, 95% CrI 1.1-5.9).
CONCLUSIONS
In terms of MACE, NACE, all-cause death, cardiac death, stent thrombosis, and major bleeding, there were no significant differences between using aspirin alone, clopidogrel alone, and ticagrelor alone; extending DAPT duration; and using aspirin combined with low-dose rivaroxaban for chronic maintenance antithrombotic regimens. However, choosing aspirin combined with low-dose rivaroxaban can reduce the incidence of ischemic stroke, and prolonged DAPT may have a higher rate of total bleeding. However, it is important to note that this study is based on indirect comparisons, and there is currently a lack of direct evidence comparing various maintenance antiplatelet therapy regimens. Further high-quality studies are needed to address this gap and provide more conclusive evidence on the comparative effectiveness of different maintenance antiplatelet strategies.
Topics: Humans; Coronary Artery Disease; Network Meta-Analysis; Rivaroxaban; Clopidogrel; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Ticagrelor; Ischemic Stroke; Aspirin
PubMed: 37636560
DOI: 10.1155/2023/5446271 -
Journal of Clinical Medicine Jul 2023Valvular heart disease is a common disease often necessitating valve replacement. Mechanical heart valves (MHVs) are often used in younger patients because of their... (Review)
Review
UNLABELLED
Valvular heart disease is a common disease often necessitating valve replacement. Mechanical heart valves (MHVs) are often used in younger patients because of their longer durability. Their main disadvantage is the need for lifelong anticoagulation. Warfarin is considered a standard treatment, but it is far from perfect. Direct oral anticoagulants (DOACs) are a new and more patient-friendly alternative to warfarin when anticoagulation is required, but have not yet been approved for the indication of mechanical valves.
EVIDENCE ACQUISITION
A literature search of Pubmed, Embase, Web of Science (Core Collection), and Cochrane Library (from inception to May 2023) was performed using a search string that was well defined and not modified during the study. An extensive overview of the search terms used in each database can be found in the Appendix. Only prospective clinical trials were included in this review. A total of 10 publications were included in this review.
RELEVANCE TO CLINICAL PRACTICE
This systematic review summarizes the different types of DOACs and their possible use in the anticoagulation of mechanical valves. We aim to propose future directions in anticoagulation research for mechanical valves.
CONCLUSIONS
DOAC use in MHVs has been halted due to the failure of both dabigatran and apixaban in two major clinical trials. However, rivaroxaban was successful in two small clinical trials. Ample research is still needed to explore new valve designs as well as new anticoagulation targets.
PubMed: 37568386
DOI: 10.3390/jcm12154984 -
GeroScience Feb 2024Balancing stroke prevention and risk of bleeding in patients with atrial fibrillation (AF) is challenging. Direct oral anticoagulants (DOACs) are by now considered... (Meta-Analysis)
Meta-Analysis
Safety outcomes of direct oral anticoagulants in older adults with atrial fibrillation: a systematic review and meta-analysis of (subgroup analyses from) randomized controlled trials.
Balancing stroke prevention and risk of bleeding in patients with atrial fibrillation (AF) is challenging. Direct oral anticoagulants (DOACs) are by now considered standard of care for treating patients with AF in international guidelines. Our objective was to assess the safety of long-term intake of DOACs in older adults with AF. We included RCTs in elderly (≥ 65 years) patients with AF. A systematic search in MEDLINE and EMBASE was performed on 19 April 2022. For determination of risk of bias, the RoB 2 tool was applied. We pooled outcomes using random-effects meta-analyses. The quality of evidence was assessed using GRADE. Eleven RCTs with a total of 63,374 patients were identified. Two RCTs compared apixaban with either warfarin or aspirin, four edoxaban with either placebo, aspirin, or vitamin K antagonists (VKAs), two dabigatran with warfarin and three rivaroxaban with warfarin. DOACs probably reduce mortality in elderly patients with AF (HR 0.89 95%CI 0.77 to 1.02). Low-dose DOACs likely reduce bleeding compared to VKAs (HR ranged from 0.47 to 1.01). For high-dose DOACS the risk of bleeding varied widely (HR ranged from 0.80 to 1.40). We found that low-dose DOACs probably decrease mortality in AF patients. Moreover, apixaban and probably edoxaban are associated with fewer major or clinically relevant bleeding (MCRB) events compared to VKAs. For dabigatran and rivaroxaban, the risk of MCRB varies depending on dose. Moreover, subgroup analyses indicate that in the very old (≥ 85) the risk for MCRB events might be increased when using DOACs.Registration: PROSPERO: CRD42020187876.
Topics: Humans; Aged; Atrial Fibrillation; Warfarin; Rivaroxaban; Dabigatran; Randomized Controlled Trials as Topic; Anticoagulants; Hemorrhage; Aspirin; Pyridines; Thiazoles
PubMed: 37261677
DOI: 10.1007/s11357-023-00825-2 -
European Cardiology 2024Low-dose aspirin lowers cardiovascular event risk; dual-pathway inhibition (DPI) using low-dose aspirin with low-dose rivaroxaban may reduce this risk further. A... (Review)
Review
Dual-pathway Inhibition with Low-dose Aspirin and Rivaroxaban versus Aspirin Monotherapy in Patients with Coronary Artery Disease and Peripheral Artery Disease: Systematic Literature Review and Meta-analysis.
BACKGROUND
Low-dose aspirin lowers cardiovascular event risk; dual-pathway inhibition (DPI) using low-dose aspirin with low-dose rivaroxaban may reduce this risk further. A systematic literature review and meta-analysis compared the efficacy, safety and net clinical benefit (NCB) of DPI with aspirin.
METHODS
PubMed and Embase were searched for randomised controlled trials reporting clinical efficacy, safety and NCB of DPI compared with aspirin alone in patients with coronary artery disease (CAD) and/or peripheral artery disease. Six articles representing four trials were included.
RESULTS
DPI versus aspirin alone significantly reduced major adverse cardiovascular events (HR 0.77; 95% CI [0.69-0.87]; p<0.01), increased International Society on Thrombosis and Haemostasis major bleeding events (HR 1.67; 95% CI [1.37-2.02]; p<0.01) and resulted in a significant NCB (HR 0.79; 95% CI [0.70-0.90]; p<0.01).
CONCLUSION
These results underscore the potential benefit of DPI in patients with CAD, including those in the immediate post-acute coronary syndrome stage and with established CAD, as well as patients with peripheral artery disease.
PubMed: 38708371
DOI: 10.15420/ecr.2023.40 -
Cardiovascular Drugs and Therapy Feb 2024Atrial fibrillation (AF) is an irregular heart rhythm which is becoming more and more common in this new era. Obesity is a risk factor for cardiovascular events, and... (Meta-Analysis)
Meta-Analysis
Comparing the Clinical Outcomes Observed with Rivaroxaban Versus Warfarin for the Management of Obese Patients with Non-valvular Atrial Fibrillation: a Systematic Review and Meta-analysis.
BACKGROUND
Atrial fibrillation (AF) is an irregular heart rhythm which is becoming more and more common in this new era. Obesity is a risk factor for cardiovascular events, and obese patients are more at risk for stroke. The Framingham Heart Study demonstrated an increase in the developmental risk of AF by 4% for every unit (kg/m) increase in body mass index (BMI). An anticoagulant is often required for the management of such patients. In this analysis, we aimed to systematically compare the clinical outcomes which were associated with rivaroxaban versus warfarin for the treatment of obese patients with non-valvular AF.
METHODS
PubMed, EMBASE, Web of Science, http://www.
CLINICALTRIALS
gov , Google Scholar, and Cochrane Central were the searched databases. Clinical outcomes including stroke, systemic embolism, and major bleeding were the endpoints. In this study, dichotomous data were analyzed by the RevMan software version 5.4. Risk ratio (RR) with 95% confidence interval (CI) was used for result interpretation.
RESULTS
Ten studies consisting of a total number of 168,081 obese participants were included whereby 81,332 participants were treated with rivaroxaban and 86,749 participants were treated with warfarin. The risks of ischemic (RR: 0.79, 95% CI: 0.74-0.84; P = 0.00001) and hemorrhagic stroke (RR: 0.61, 95% CI: 0.48-0.76; P = 0.0001) as well as systemic embolism (RR: 0.73, 95% CI: 0.62-0.87; P = 0.0004) were significantly lower with rivaroxaban compared to warfarin for the management of these obese patients with non-valvular AF. Rivaroxaban was also associated with a significantly lower risk of major bleeding (RR: 0.75, 95% CI: 0.65-0.87; P = 0.0001).
CONCLUSION
Based on this analysis, rivaroxaban seemed to be a better option in comparison to warfarin, due to its association with significantly lower risks of stroke and bleeding outcomes in obese patients with non-valvular AF. However, this hypothesis should further be confirmed in larger clinical trials.
Topics: Humans; Warfarin; Rivaroxaban; Atrial Fibrillation; Factor Xa Inhibitors; Anticoagulants; Stroke; Hemorrhage; Obesity; Embolism; Treatment Outcome
PubMed: 35763193
DOI: 10.1007/s10557-022-07361-9