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🫀 Пероральные антикоагулянты у очень пожилых пациентов с ФП и высоким риском кровотечений: реальные данные
🧪 Что изучали — национальная когортная база данных Южной Кореи (2014–2017), пациенты с ФП ≥80 лет и ≥1 критерием ELDERCARE-AF (n=23 858); сравнивали группы: без ОАК, априори варфарин, ДОАК (69% на низких и 9% на очень низких дозах). Анализ — propensity score weighting.
📈 Ключевые результаты — ДОАК ассоциированы со снижением риска ишемического инсульта (HR 0,81; 95% ДИ 0,68–0,96) и общей смертности (HR 0,91; 95% ДИ 0,86–0,96) по сравнению с отсутствием ОАК, несмотря на рост крупных кровотечений (HR 1,44; 95% ДИ 1,21–1,70). Композитная чистая клиническая польза ДОАК была выше (HR 0,93; 95% ДИ 0,88–0,98).
📍 Что это меняет на практике — даже у пациентов 80+ с высоким риском кровотечений ДОАК, применяемые в обычной практике (включая низкие дозы), обеспечивают лучшую чистую клиническую пользу, чем отказ от ОАК. Не следует необоснованно отказывать в антикоагуляции только из-за возраста и риска кровотечений.
🔗 Источник — PubMed | DOI:10.1093/europace/euaf230
❓ Следует ли назначать апиксабан или ривароксабан при онкологически ассоциированной ВТЭ?
✅ Ответ исследования — сравнительное когортное исследование (n=10 589; обе базы США) показало похожий риск рецидива ВТЭ (HR 0,66; 95% ДИ 0,40–1,11) и крупных кровотечений (HR 0,95; 95% ДИ 0,73–1,23) между апиксабаном и ривароксабаном, но на апиксабане достоверно меньше клинически значимых некрупных кровотечений (HR 0,84; 95% ДИ 0,74–0,96; p=0,009).
📍 Как применить — для пациентов с канцер-ассоциированной ВТЭ, у которых минимизация кровотечений является приоритетом, апиксабан может рассматриваться как более безопасный выбор по сравнению с ривароксабаном. Постоянный мониторинг и учет сопутствующего онкологического лечения необходимы.
🔗 Источник — PubMed | DOI:10.1371/journal.pmed.1004754
🧾 КОГОРТА: пациенты с ВТЭ, получающие ОАК с/без сопутствующей антиагрегантной терапии
✅ Делать
- Оценивать назначение двойной терапии критически, особенно при отсутствии показаний к антиагрегантам
- Снижать длительность комбинации до минимума, исходя из клинической необходимости
⚠️ С осторожностью
- Контролировать пациентов на двойной терапии на предмет клинически значимых некрупных кровотечений (CRNMB): риск выше (17,7% против 10% за 3 года, p=0,047)
🚫 Избегать
- Рутинного назначения антиагрегантов вместе с ОАК при ВТЭ без чётких показаний
🔗 Источник — PubMed | DOI:10.1253/circj.CJ-25-0464
1. Direct oral anticoagulants in very elderly and high bleeding risk patients with atrial fibrillation often excluded from oral anticoagulation therapy: a nationwide population-based cohort study.
title
Direct oral anticoagulants in very elderly and high bleeding risk patients with atrial fibrillation often excluded from oral anticoagulation therapy: a nationwide population-based cohort study
journal
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
publication_date
2025-03-16
impact_factor
3.51
quartile
Q1
doi
10.1093/europace/euaf230
pmid
41020486
objective
To investigate the optimal oral anticoagulant (OAC) strategy for net clinical benefit in very elderly, high bleeding risk patients with atrial fibrillation (AF) who meet ELDERCARE-AF-like criteria.
methods
{'design': 'Nationwide population-based cohort study', 'data_source': 'Korean nationwide claims database', 'population': {'criteria': 'AF patients aged ≥ 80 years with at least 1 ELDERCARE-AF trial inclusion criteria', 'period': '2014-2017', 'total_patients': 23858, 'groups': {'no_OAC': 16575, 'warfarin': 2390, 'DOAC': 4893}}, 'analysis': 'Propensity score weighting', 'outcomes': ['ischemic stroke', 'major bleeding', 'all-cause death', 'net clinical outcome']}
results
{'DOAC_types': {'low_dose': '69%', 'very_low_dose': '9%'}, 'DOAC_vs_no_OAC': {'ischemic_stroke_HR': 0.81, 'ischemic_stroke_CI': '0.68-0.96', 'all_cause_death_HR': 0.91, 'all_cause_death_CI': '0.86-0.96', 'major_bleeding_HR': 1.44, 'major_bleeding_CI': '1.21-1.70', 'net_clinical_outcome_HR': 0.93, 'net_clinical_outcome_CI': '0.88-0.98'}}
conclusion
In very elderly, high-bleeding risk AF patients, direct oral anticoagulants prescribed in routine practice provided better effectiveness and net clinical benefit compared to no OAC treatment, despite a higher risk of major bleeding.
Journal: Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
Impact Factor: 3.51
Date: 2025/3/16
PMID: 41020486
DOI: 10.1093/europace/euaf230
2. Concomitant Antiplatelet Therapy in Patients With Venous Thromboembolism Treated With Anticoagulants - Insights From the COMMAND VTE Registry-2.
Intervention
['Direct oral anticoagulants (DOACs) with or without concomitant antiplatelet therapy']
title
Concomitant Antiplatelet Therapy in Patients With Venous Thromboembolism Treated With Anticoagulants - Insights From the COMMAND VTE Registry-2
journal
Circulation Journal
journal_details
{'official_journal': 'Japanese Circulation Society', 'impact_factor': 1.96, 'quartile': 'Q1'}
date
2025-09-29
doi
10.1253/circj.CJ-25-0464
pmid
41016753
objective
To investigate the effect of concomitant antiplatelet therapy (CAT) on clinical outcomes in venous thromboembolism (VTE) patients treated with anticoagulants.
design
Multicenter registry study (COMMAND VTE Registry-2)
setting
31 centers in Japan
period
January 2015 - August 2020
participants
{'initial_enrolled': 5197, 'excluded_non_oral_anticoagulants': 407, 'final_analyzed': 4790, 'propensity_matched': 676, 'groups': [{'CAT_group': 338}, {'AC_only_group': 338}]}
outcomes
{'recurrent_VTE_3yr': {'CAT': '4.9%', 'AC_only': '7.3%', 'p_value': 0.5}, 'major_bleeding_3yr': {'CAT': '9.4%', 'AC_only': '12.4%', 'p_value': 0.36}, 'stroke_3yr': {'CAT': '6.7%', 'AC_only': '4.1%', 'p_value': 0.24}, 'CRNMB_3yr': {'CAT': '17.7%', 'AC_only': '10.0%', 'p_value': 0.047, 'significant_increase_in_CAT': True}}
main_finding
Concomitant antiplatelet therapy in VTE patients treated with anticoagulants did not significantly impact risks of recurrent VTE, major bleeding, or stroke, but was associated with a significantly increased risk of clinically relevant non-major bleeding (CRNMB) over 3 years in matched analysis.
keywords
['venous thromboembolism', 'direct oral anticoagulants', 'antiplatelet therapy', 'major bleeding', 'non-major bleeding', 'stroke', 'registry']
Journal: Circulation journal : official journal of the Japanese Circulation Society
Impact Factor: 1.96
Date: 2025/9/29
PMID: 41016753
DOI: 10.1253/circj.CJ-25-0464
3. Comparative safety and effectiveness of apixaban and rivaroxaban for treatment of cancer-associated venous thromboembolism: A retrospective cohort study.
title
Comparative safety and effectiveness of apixaban and rivaroxaban for treatment of cancer-associated venous thromboembolism: A retrospective cohort study.
journal
PLoS Medicine
publication_date
2025-05-21
impact_factor
10.42
quartile
Q1
doi
10.1371/journal.pmed.1004754
pmid
41004533
study_type
Retrospective cohort study
data_sources
['Medicare fee-for-service (2016-2020)', 'MarketScan (2016-2022)']
population
{'criteria': 'Individuals with active cancer (diagnosis within 6 months before index VTE), new users of apixaban or rivaroxaban within 30 days of index VTE; Medicare: ≥65 years, MarketScan: 18-64 years.', 'n_apixaban': 6329, 'n_rivaroxaban': 4260}
main_outcomes
['Hospitalization for recurrent VTE', 'Hospitalization for major bleeding', 'Hospitalization or outpatient visit for clinically relevant non-major bleeding']
follow_up
['6 months', 'Entire available follow-up']
methods
{'adjustment': ['Inverse probability of treatment weighting for baseline covariates', 'Inverse probability of censoring weighting'], 'statistical_analysis': ['Adjusted Cox proportional hazards models', 'Pooling with inverse variance-weighted fixed-effects model']}
key_results
{'recurrent_vte': {'hazard_ratio': 0.66, 'ci_95': [0.4, 1.11], 'p_value': 0.11, 'interpretation': 'No statistically significant difference'}, 'major_bleeding': {'hazard_ratio': 0.95, 'ci_95': [0.73, 1.23], 'p_value': 0.7, 'interpretation': 'No statistically significant difference'}, 'non_major_bleeding': {'hazard_ratio': 0.84, 'ci_95': [0.74, 0.96], 'p_value': 0.009, 'interpretation': 'Statistically significant lower risk with apixaban'}, 'long_term_pattern': 'Same patterns persisted during extended follow-up'}
conclusion
In cancer-associated VTE, apixaban was associated with similar risks of recurrent VTE and major bleeding, and a lower risk of clinically relevant non-major bleeding compared with rivaroxaban.
clinical_implication
Apixaban may be a favorable option for cancer-associated VTE when minimizing bleeding risk is a priority.
limitations
['Observational design may leave residual confounding despite adjustments']
Journal: PLoS medicine
Impact Factor: 10.42
Date: 2025/5/21
PMID: 41004533
DOI: 10.1371/journal.pmed.1004754
4. Comparative safety and effectiveness of direct oral anticoagulants and warfarin in patients with venous thromboembolism in Finland, Norway and Sweden.
title
Comparative safety and effectiveness of direct oral anticoagulants and warfarin in patients with venous thromboembolism in Finland, Norway and Sweden
journal
Journal of comparative effectiveness research
publication_date
2025-09-25
impact_factor
1.86
quartile
Q2
doi
10.57264/cer-2024-0207
pmid
40995802
aim
To compare the effectiveness and safety of direct oral anticoagulants (DOACs: apixaban, rivaroxaban) versus warfarin in the treatment of venous thromboembolism (VTE) using Nordic population-based registries.
design
Observational cohort study
data_source
['Swedish', 'Norwegian', 'Finnish national administrative data (2012-2018)']
population
{'inclusion_criteria': ['Treatment-naive adult patients', 'Noncancer-related VTE', 'Treated with either a DOAC (apixaban or rivaroxaban) or warfarin'], 'sample_sizes': {'warfarin': 22450, 'apixaban': 14542, 'rivaroxaban': 23002}}
methods
{'statistical_analysis': ['Inverse probability of treatment weighting (IPTW)', 'Cox proportional hazards models', 'Meta-analysis of country-specific estimates'], 'outcomes': ['Risk of bleeding (overall and by site: gastrointestinal [GI], intracranial hemorrhage [ICH], other)', 'Risk of recurrent VTE', 'Follow-up: 6 months after treatment initiation']}
results
{'apixaban_vs_warfarin': {'bleeding_overall': {'hazard_ratio': 0.51, 'CI_95': [0.43, 0.61]}, 'bleeding_gi': {'hazard_ratio': 0.65, 'CI_95': [0.45, 0.93]}, 'bleeding_ich': {'hazard_ratio': 0.58, 'CI_95': [0.34, 0.97]}, 'bleeding_other': {'hazard_ratio': 0.45, 'CI_95': [0.34, 0.58]}, 'recurrent_vte': {'hazard_ratio': 0.85, 'CI_95': [0.71, 1.02]}}, 'rivaroxaban_vs_warfarin': {'bleeding_overall': {'hazard_ratio': 0.86, 'CI_95': [0.75, 0.99]}, 'bleeding_gi': {'hazard_ratio': 1.06, 'CI_95': [0.84, 1.34]}, 'bleeding_ich': {'hazard_ratio': 0.68, 'CI_95': [0.47, 1.0]}, 'bleeding_other': {'hazard_ratio': 0.81, 'CI_95': [0.69, 0.95]}, 'recurrent_vte': {'hazard_ratio': 0.74, 'CI_95': [0.63, 0.87]}}}
conclusion
Direct oral anticoagulants (apixaban, rivaroxaban) showed improved safety and at least similar effectiveness compared with warfarin for treatment of VTE in a large Nordic real-world cohort, consistent with clinical trial data.
Journal: Journal of comparative effectiveness research
Impact Factor: 1.86
Date: 2025/9/25
PMID: 40995802
DOI: 10.57264/cer-2024-0207
5. Validation of a machine learning model for predicting gastrointestinal bleeding in patients with direct oral anticoagulants.
title
Validation of a machine learning model for predicting gastrointestinal bleeding in patients with direct oral anticoagulants
journal
Scandinavian journal of gastroenterology
publication_date
2025-09-25
impact_factor
1.83
quartile
Q2
doi
10.1080/00365521.2025.2565321
pmid
40992402
objective
To develop and validate machine learning (ML) models to predict gastrointestinal bleeding (GIB) in patients using direct oral anticoagulants (DOACs) and to compare their performance with conventional risk scores.
methods
{'study_design': 'Retrospective analysis', 'population': {'total_patients': 4494, 'age': '>=18 years', 'inclusion_period': 'December 2014 to October 2020'}, 'cohorts': {'training': 3147, 'internal_validation': 677, 'external_validation': 670}, 'algorithms': ['Gradient Boosting Machine (GBM)', 'XGBoost', 'Generalized Linear Model (GLM)'], 'prediction_timepoints_months': [12, 24], 'comparators': ['HAS-BLED', 'ATRIA', 'VTE-BLEED', 'ORBIT'], 'metrics': ['Area under the receiver operating characteristic curve (AUC)', 'Specificity at 100% sensitivity']}
results
{'auc': {'24_months': {'xgboost': {'training': 0.862, 'internal_validation': 0.819, 'external_validation': 0.905}, 'orbit': {'24_month': 0.78}}, '12_months': {'xgboost': {'training': 0.917, 'internal_validation': 0.839, 'external_validation': 0.948}, 'orbit': {'12_month': 0.728}}}, 'specificity_at_100_sensitivity': {'12_months': {'xgboost': 0.798, 'gbm': 0.798, 'glm': 0.678, 'orbit': 0.398}, '24_months': {'glm': 0.438, 'orbit': 0.4}}}
conclusions
['ML models, particularly XGBoost, outperformed traditional bleeding risk scores in predicting GIB in DOAC users.', 'Despite superior performance, the overall effectiveness of the ML models was deemed unsatisfactory.', 'Further research is needed to improve model performance.']
Journal: Scandinavian journal of gastroenterology
Impact Factor: 1.83
Date: 2025/9/25
PMID: 40992402
DOI: 10.1080/00365521.2025.2565321