Efficacy and safety of direct oral anticoagulants with and without Aspirin: A systematic review and Meta-analysis

Almas, Talal; Musheer, Adeena; Ejaz, Arooba; Shaikh, Faizan; Paracha, Anousheh Awais; Raza, Fizza; Khan, Maryam; Masood, Fahad; Siddiqui, Farhan Ahmed; Raza, Saamia; Wasim, Muhammad Fahad; Mankani, Muhammad Hasnain; Fatima, Kaneez; Minhas, Abdul Mannan Khan

doi:10.1016/j.ijcha.2022.101016

Cited by 5 publications

(8 citation statements)

References 23 publications

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“…27,28 More than 20% of patients were prescribed with acetylsalicylic acid or a P2Y12 inhibitor along with the oral anticoagulant, a combination that increases their risk of suffering major bleeding. 17 This situation was previously described in observational studies with real-life data, where patients with NVAF treated with DOACs with polypharmacy had a lower risk of stroke and embolism than those with warfarin. 5 More than 30% of the subjects included in this study were 80 or older, a determining factor of the prescriber's approach to treating the patient with NVAF.…”

Section: Discussionmentioning

confidence: 76%

“…The clinical characteristics of the patients included were consistent with the data previously described in Colombia for patients with AF using oral anticoagulants, with a similar proportion of women (52%) and an average age close to 70 years, 8,12 and were also consistent with studies carried out in the United States, Italy, Japan, Pakistan, and Turkey. [13][14][15][16][17] The average CHA 2 DS 2 -VASc score of 3.6 points for this population was similar to that reported by Medina-Morales et al in Colombia, 12 Brown et al in the United States, 14 and Gedikly in Turkey, 16 but higher than that reported in Pakistan (1.6 points), 17 which can be explained by the inclusion criteria used in the different studies, the heterogeneity of the populations, or even the use of pharmacological therapies at different times of the evolution of the disease.…”

Section: Discussionmentioning

confidence: 99%

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Clinical Characteristics, Patterns of Use, and incidence of Adverse Events in Patients With Nonvalvular Atrial Fibrillation Treated With Oral Anticoagulants in Colombia

Machado‐Duque¹,

Gaviria‐Mendoza²,

Reyes³

et al. 2023

VHRM

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The aim was to analyze the characteristics, treatment patterns, and clinical outcomes of Colombian patients with nonvalvular atrial fibrillation (NVAF) under treatment with oral anticoagulants (OAs). Patients and Methods: Retrospective cohort in patients with NVAF identified from a drug dispensing database, aged ≥18 years, with first prescription of an OA (index) between January/2013 and June/2018, and a follow-up until June/2019. Data from the clinical history, pharmacological variables, and outcomes were searched. International Classification of Diseases-10 codes were used to identify the patient sample and outcomes. Patients were followed until a general composite outcome of effectiveness (thrombotic events), bleeding/safety or persistence (switch/discontinuation of anticoagulant) events. Descriptive and multivariate analyzes (Cox regressions comparing warfarin and direct oral anticoagulants-DOACs) were carried out. Results: A total of 2076 patients with NVAF were included. The 57.0% of patients were women and the mean age was 73.3±10.4 years. Patients were followed for a mean of 2.3±1.6 years. 8.7% received warfarin before the index date. The most frequent OA was rivaroxaban (n=950; 45.8%), followed by warfarin (n=459; 22.1%) and apixaban (n=405; 19.5%). Hypertension was present in 87.5% and diabetes mellitus in 22.6%. The mean CHA 2 DS 2 -VASc Score was 3.6±1.5. The 71.0% (n=326/459) of the warfarin patients presented the general composite outcome, and 24.6% of those with DOACs (n=397/1617). The main effectiveness and safety outcomes were stroke (3.1%) and gastrointestinal bleeding (2.0%) respectively. There were no significant differences between patients with warfarin and DOACs regarding thrombotic events (HR: 1.28; 95% CI: 0.68-2.42), but warfarin was associated with higher bleeding/safety events (HR: 4.29; 95% CI: 2.82-6.52) and persistence events (HR: 4.51; 95% CI: 3.81 −5.33). Conclusion:The patients with NVAF in this study were mainly older adults with multiple comorbidities. Compared to warfarin, DOACs were found to be equally effective, but safer and had a lower probability of discontinuation or switch.

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Section: Discussionmentioning

confidence: 76%

Section: Discussionmentioning

confidence: 99%

Clinical Characteristics, Patterns of Use, and incidence of Adverse Events in Patients With Nonvalvular Atrial Fibrillation Treated With Oral Anticoagulants in Colombia

Machado‐Duque¹,

Gaviria‐Mendoza²,

Reyes³

et al. 2023

VHRM

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“…In ARISTOTLE 31% of participants were using aspirin and 11% using amiodarone at baseline whereas, in our cohort only 6% were recorded as using aspirin and 4% amiodarone. Amiodarone potentiates the effects of warfarin and concomitant use of amiodarone with DOACs is associated with increased risk of major bleeding [36], whilst concomitant use of aspirin increases the risk of bleeding for both warfarin[37] and DOACs [38]. The difference in concomitant medication usage between our cohort and the trial population may explain some of the observed differences in treatment effects.…”

Section: Discussionmentioning

confidence: 99%

“…There are known racial differences in the treatment effects of OACs with Asian patients experiencing a higher risk of haemorrhagic stroke and intracranial haemorrhage compared with White patients; in ARISTOTLE Asian participants experienced double the risk of stroke or systemic embolism when on warfarin therapy when compared with White participants [37]. The reasons for the increased risk of bleeding associated with warfarin therapy in Asian patients is hypothesised to be associated with differences in drug metabolism and prevelance of cerebral microbleeds [38]. The difference in proportion of Asian patients between our cohort and ARISTOTLE is therefore likely to explain some of the differences in treatment effects seen and limits the generalisability of our study, with the results of our study of most relevanance to White patients.…”

Section: Discussionmentioning

confidence: 99%

Comparison of oral anticoagulants for stroke prevention in atrial fibrillation using the UK Clinical Practice Research Datalink Aurum: A reference trial (ARISTOTLE) emulation study

Powell,

Gungabissoon,

Tazare

et al. 2024

Preprint

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Background Stroke prevention treatment guidance for patients with atrial fibrillation (AF) uses evidence generated from randomised controlled trials (RCTs). However, applicability to patient groups excluded from trials remains unknown. Real-world patient data provides an opportunity to evaluate outcomes in a trial analogous population of direct oral anticoagulants (DOACs) users and in patients otherwise excluded from RCTs, however there remains uncertainty on the validity of the methods and suitability of the data. Successful reference trial emulation can support the generation of evidence around treatment effects in groups excluded or underrepresented in the original trials. We used linked UK primary care data to investigate whether we could emulate the pivotal ARISTOTLE trial (apixaban vs warfarin) and extend the analysis to investigate the impact of warfarin time in therapeutic range (TTR) on results. Methods and findings Patients with AF in a UK primary care database Clinical Practice Research Datalink (CPRD Aurum) prescribed apixaban or warfarin from 1 Jan 2013 to 31 Jul 2019 were selected. ARISTOTLE eligibility criteria were applied to this population and matched to the RCT apixaban arm on baseline characteristics creating a trial-analogous apixaban cohort; this was propensity-score matched to warfarin users in the CPRD Aurum. ARISTOTLE outcomes were assessed using Cox proportional hazards regression stratified by prior warfarin exposure status during 2.5 years of patient follow-up and results benchmarked against the trial results before treatment effectiveness was further evaluated based on (warfarin) time in therapeutic range (TTR). The analysis sample comprised 8734 apixaban users and propensity-score matched 8734 warfarin users in CPRD. Results [Hazard Ratio (95% Confidence Interval)] confirmed apixaban non-inferiority for stroke or systemic embolism (SE) [CPRD 0.98 (0.82,1.19) vs trial 0.79 (0.66,0.95)] and death from any cause [CPRD 1.03 (0.93,1.14) vs trial 0.89 (0.80,0.998)] but did not indicate apixaban superiority. Absolute event rates for Stroke/SE were similar for apixaban in CPRD Aurum and ARISTOTLE (1.27%/year) whereas a lower event rate was observed for warfarin (CPRD Aurum 1.29%/year, ARISTOTLE 1.60%/year) Analysis by TTR suggested non-inferiority of apixaban in those with TTR < 0.75 [Stroke/SE 0.94 (0.75,1.19), all-cause death 0.99 (0.87,1.12)]. However, apixaban was associated with increased hazards compared with well-controlled warfarin treatment (TTR >= 0.75) [Stroke/SE 1.49 (1.13,1.97), all-cause death 1.75 (1.49,2.06)]. The main limitation of the study’s methodology are the risk of residual confounding, channelling bias and attrition bias in the warfarin arm. Conclusions Analysis of non-interventional data generated results demonstrating non-inferiority of apixaban vs warfarin consistent with the pre-specified benchmarking criteria. Unlike in ARISTOTLE superiority of apixaban vs warfarin was not seen which may be linked to the lower proportion of Asian patients and higher proportion of patients with well-controlled warfarin compared to ARISTOTLE. The methodological template developed can be used to investigate treatment effects of oral anticoagulants in patient groups excluded from or under-represented in trials and also provides a framework which can be adapted to investigate treatment effects for other conditions.

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“…In their systematic review and meta-analysis, Almas et al assessed the safety and efficacy of DOACs with and without acetylsalicylic acid (ASA). The risk of major bleeding was significantly lower in the DOAC-alone group compared with the DOAC-plus-ASA group [ 55 ]. In the current literature, apixaban appears to have the best safety profile for bleeding among the four available DOACs, with similar efficacy to warfarin for stroke/SE [ 56 , 57 , 58 , 59 ].…”

Section: Discussionmentioning

confidence: 99%

Direct Oral Anticoagulants as the First Choice of Anticoagulation for Patients with Peripheral Artery Disease to Prevent Adverse Vascular Events: A Systematic Review and Meta-Analysis

Pomozi

Nagy

Fehérvári

et al. 2023

JCDD

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The best method of anticoagulation for patients with peripheral artery disease (PAD) is still a topic of interest for physicians. We conducted a meta-analysis to compare the effects of direct oral anticoagulants (DOACs) with those of vitamin-K-antagonist (VKA) anticoagulants in patients with peripheral artery disease. Five databases (Medline (via PubMed), EMBASE, Scopus, Web of Science, and CENTRAL) were searched systematically for studies comparing the effects of the two types of anticoagulants in patients with PAD, with an emphasis on lower-limb outcomes, cardiovascular events, and mortality. In PAD patients with concomitant non-valvular atrial fibrillation (NVAF), the use of DOACs significantly reduced the risk of major adverse limb events (HR = 0.58, 95% CI, 0.39–0.86, p < 0.01), stroke/systemic embolism (HR 0.76; 95% CI 0.61–0.95; p < 0.01), and all-cause mortality (HR 0.78; 95% CI 0.66–0.92; p < 0.01) compared with warfarin, but showed similar risks of MI (HR = 0.81, 95% CI, 0.59–1.11, p = 0.2) and cardiovascular mortality (HR = 0.77, 95% CI, 0.58–1.02, p = 0.07). Rivaroxaban at higher doses significantly increased the risk of major bleeding (HR = 1.16, 95% CI, 1.07–1.25, p < 0.01). We found no significant difference in terms of revascularization (OR = 1.49, 95% CI, 0.79–2.79, p = 0.14) in PAD patients in whom a poor distal runoff was the reason for the anticoagulation. DOACs have lower rates of major limb events, stroke, and mortality than VKAs in PAD patients with atrial fibrillation. Rivaroxaban at higher doses increased the risk of major bleeding compared with other DOAC drugs. More high-quality studies are needed to determine the most appropriate anticoagulation regimen for patients with lower-limb atherosclerosis.

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Efficacy and safety of direct oral anticoagulants with and without Aspirin: A systematic review and Meta-analysis

Cited by 5 publications

References 23 publications

Clinical Characteristics, Patterns of Use, and incidence of Adverse Events in Patients With Nonvalvular Atrial Fibrillation Treated With Oral Anticoagulants in Colombia

Clinical Characteristics, Patterns of Use, and incidence of Adverse Events in Patients With Nonvalvular Atrial Fibrillation Treated With Oral Anticoagulants in Colombia

Comparison of oral anticoagulants for stroke prevention in atrial fibrillation using the UK Clinical Practice Research Datalink Aurum: A reference trial (ARISTOTLE) emulation study

Direct Oral Anticoagulants as the First Choice of Anticoagulation for Patients with Peripheral Artery Disease to Prevent Adverse Vascular Events: A Systematic Review and Meta-Analysis

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