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🫀 DOAC и варфарин при ФП или ВТЭ у пациентов с ХБП: свежий мета-анализ
🔥 Главное в 3 пунктах:
- У пациентов с фибрилляцией предсердий (ФП) и ХБП ДОАК значимо снижают риск геморрагического инсульта (RR=0,455; 95% ДИ 0,275–0,752) и больших (особенно внутричерепных) кровотечений (RR=0,604 и RR=0,424 соответственно) по сравнению с варфарином.
- Не выявлено различий по ишемическим инсультам между ДОАК и варфарином у больных с ФП и ХБП.
- У пациентов с ВТЭ на фоне ХБП эффективность и безопасность ДОАК сопоставимы с варфарином; разницы по рецидивам/летальности и крупным кровотечениям нет.
🧪 Контекст: 15 РКИ (16 361 пациент) – системный обзор и мета-анализ прямых сравнения warfarin vs. ДОАК (апиксабан, ривароксабан, др.) у пациентов с ХБП и ФП или ВТЭ.
📍 Практическое значение:
— Для больных с ФП и ХБП ДОАК — предпочтительная стратегия для профилактики инсульта и минимизации риска серьезных кровотечений, включая внутричерепные.
— Для пациентов с ВТЭ на фоне ХБП можно использовать оба подхода в зависимости от клинической ситуации и индивидуальных факторов риска.
❓ Вопрос практики: Какой дозы ДОАК придерживаться при продлённой терапии ВТЭ, особенно у пациентов с сопутствующим раком?
✅ Ответ исследования:
Метанализ 5 РКИ (n=8 781): уменьшенная доза ДОАК (апиксабан/ривароксабан) столь же эффективна, как и стандартная, в профилактике рецидива ВТЭ (ОШ 0,94 [0,68–1,29]; p=0,70), но реже вызывает крупные/клинически значимые кровотечения (ОШ 0,71 [0,61–0,82]; p<0,0001). Анализ подтвердил эквивалентность по эффективности у больных с и без онкозаболеваний.
📍 Как применить:
— У пациентов с высоким геморрагическим риском при необходимости длительной антикоагулянтной терапии (в т.ч. при онкологии) можно безопасно снижать дозу ДОАК после первых месяцев приема.
— При выборе периода дозовой коррекции учитывать уровень риска рецидива и кровотечений.
🫀 Интракраниальные кровоизлияния при антикоагулянтной терапии у пациентов с опухолями мозга: что выбрать?
🧪 Что изучали: Метаанализ 10 ретроспективных когортных исследований (n=1 572) — пациенты с первичными или метастатическими опухолями мозга, получавшие ДОАК (апиксабан и др.) или НМГ.
📈 Ключевые результаты:
— Риск любого внутричерепного кровоизлияния при ДОАК был в 2 раза ниже, чем при НМГ (ОР=0,50 [0,29–0,87]; p=0,01).
— Наибольшее снижение риска отмечено у пациентов с первичными опухолями мозга (ОР=0,20 [0,08–0,54]).
📍 Что это меняет на практике:
— ДОАК становятся разумным, безопасным выбором у пациенток с опухолями мозга и нуждающихся в антикоагуляции, особенно при первичных ЦНС-новообразованиях.
— Тем не менее, данные ограничены ретроспективными исследованиями и требуют подтверждения в РКИ.
1. A Sole Case of Concurrent Arterial and Venous Thromboses with Massive Pulmonary Embolism and Carriage of Four Genetic Polymorphisms: Factor V Leiden, PAI-1 4G/5G, MTHFR C677T, and ACE I/D-A Case Report.
title
A Sole Case of Concurrent Arterial and Venous Thromboses with Massive Pulmonary Embolism and Carriage of Four Genetic Polymorphisms: Factor V Leiden, PAI-1 4G/5G, MTHFR C677T, and ACE I/D-A Case Report
journal
Reports (MDPI)
publication_date
2025-09-22
doi
10.3390/reports8030167
pmid
40981125
abstract
{'background_and_clinical_significance': 'Arterial and venous thromboses are typically distinct clinical entities, each governed by unique pathophysiological mechanisms. The concurrent manifestation of both, particularly in the setting of massive pulmonary embolism (PE), is exceptionally rare and poses significant diagnostic and therapeutic challenges.', 'case_presentation': 'A 61-year-old male with well-controlled hypertension and type 2 diabetes developed extensive thromboses involving deep vein thrombosis (DVT) of the right popliteal vein, arterial thrombosis of the left iliac artery, and massive PE. Initial conservative management followed ESC 2019 Guidelines for Acute PE due to absence of hemodynamic instability, utilizing unfractionated heparin (UFH), low-molecular-weight heparin, a direct oral anticoagulant (DOAC), and adjunctive therapy. Failed percutaneous revascularization and persistent arterial occlusion necessitated surgical thromboendarterectomy (TEA). Post hoc genetic testing was initiated due to the atypical and severe presentation with absence of classical provoking factors. Four thrombophilia-associated polymorphisms were identified: heterozygous Factor V Leiden (FVL; R506Q genotype), PAI-1 (4G/5G genotype), MTHFR (c.677C>T genotype), and homozygous ACE I/D (DD genotype).', 'conclusions': 'While each variant has been individually associated with thrombotic risk, their co-occurrence in a single patient with simultaneous arterial and venous thromboses has not, to our knowledge, been previously documented. This case highlights the potential for gene-gene interactions to amplify thrombotic risk, even when variants are considered to confer only modest or moderate risk individually. The report underscores the need for a multidisciplinary approach and draws attention to questions of pharmacogenetics, anticoagulation, and future research into cumulative genetic risk in complex thrombotic phenotypes.'}
patient_characteristics
{'age': 61, 'sex': 'male', 'medical_history': ['well-controlled hypertension', 'type 2 diabetes']}
clinical_findings
{'thromboses': ['deep vein thrombosis (right popliteal vein)', 'arterial thrombosis (left iliac artery)', 'massive pulmonary embolism']}
management
{'initial_therapy': ['unfractionated heparin (UFH)', 'low-molecular-weight heparin', 'direct oral anticoagulant (DOAC)', 'adjunctive therapy'], 'reason_for_conservative_management': 'absence of hemodynamic instability', 'subsequent_intervention': ['surgical thromboendarterectomy (TEA) due to failed percutaneous revascularization and persistent arterial occlusion']}
genetic_findings
[{'polymorphism': 'Factor V Leiden', 'genotype': 'heterozygous (R506Q)'}, {'polymorphism': 'PAI-1', 'genotype': '4G/5G'}, {'polymorphism': 'MTHFR', 'genotype': 'c.677C>T'}, {'polymorphism': 'ACE I/D', 'genotype': 'homozygous DD'}]
provoking_factors
None (no trauma, surgery, malignancy, or antiphospholipid syndrome)
implications
['Potential amplification of thrombotic risk via gene-gene interactions', 'Importance of multidisciplinary approach', 'Highlights questions of pharmacogenetics and anticoagulation', 'Suggests need for future research into cumulative genetic risk in complex thrombotic phenotypes']
Journal: Reports (MDPI)
Impact Factor: —
Date: 2025/9/22
PMID: 40981125
DOI: 10.3390/reports8030167
2. Accelerated Apixaban Removal by Using the ADVanced Organ Support (ADVOS) Albumin Hemodialysis System-A Case Report.
title
Accelerated Apixaban Removal by Using the ADVanced Organ Support (ADVOS) Albumin Hemodialysis System-A Case Report
journal
The Thoracic and Cardiovascular Surgeon Reports
publication_date
2024-07-01
doi
10.1055/a-2682-8640
pmid
40959463
abstract
In patients on direct oral anticoagulants (DOAC), emergency surgery is characterized by the occurrence of a massively increased tendency to bleed. Currently, there is no approved antidote for postoperative patients, making specific therapy challenging in these situations. Emergency surgery was required for a 72-year-old male patient who was in cardiogenic shock due to severe aortic regurgitation resulting from acute prosthetic valve endocarditis. Due to atrial fibrillation, the patient was on apixaban, a factor Xa (FXa) inhibitor anticoagulant, until surgery. We used the ADVanced Organ Support (ADVOS) albumin hemodialysis system postoperatively to treat persisting shock with multi-organ failure, acidosis, and DOAC removal. Serial drug-level measurements revealed strongly accelerated apixaban clearance. In line with this, we observed only moderate drainage losses. ADVOS accelerates the removal of apixaban and is a promising therapy for preventing bleeding complications in patients receiving DOAC therapy after emergency surgery.
authors
[]
keywords
[]
study_type
case report
patient_demographics
{'age': 72, 'sex': 'male'}
clinical_conditions
['prosthetic valve endocarditis', 'cardiogenic shock', 'severe aortic regurgitation', 'atrial fibrillation', 'multi-organ failure', 'acidosis']
interventions
['apixaban (prior to surgery)', 'ADVOS albumin hemodialysis system (postoperative)']
outcomes
['strongly accelerated apixaban clearance', 'only moderate drainage losses observed', 'suggested reduction in bleeding risk']
conclusions
['ADVOS system accelerates apixaban removal in emergency postoperative patients', 'ADVOS is a promising therapy to prevent bleeding complications in DOAC-treated patients requiring emergency surgery']
Journal: The Thoracic and cardiovascular surgeon reports
Impact Factor: —
Date: 2024/7/1
PMID: 40959463
DOI: 10.1055/a-2682-8640
3. Efficacy and safety of reduced-dose versus full-dose direct oral anticoagulants for extended treatment of venous thromboembolism: A meta-analysis with trial sequential analysis and reconstructed time-to-event data.
title
Efficacy and safety of reduced-dose versus full-dose direct oral anticoagulants for extended treatment of venous thromboembolism: A meta-analysis with trial sequential analysis and reconstructed time-to-event data.
journal
Thrombosis Research
publication_date
2025-06-25
impact_factor
5.05
quartile
Q1
doi
10.1016/j.thromres.2025.109476
pmid
40957133
registration_number
CRD420251048675
objective
To evaluate the efficacy and safety of reduced-dose versus full-dose direct oral anticoagulants (DOACs) for extended venous thromboembolism (VTE) treatment.
methods
{'study_design': 'Meta-analysis of randomized controlled trials with trial sequential analysis and reconstructed time-to-event data', 'data_sources': 'Major electronic databases through April 2025', 'study_selection': 'RCTs comparing reduced-dose versus full-dose DOACs for VTE treatment', 'statistical_methods': ['Pooled risk ratios (RR) with 95% confidence intervals (CI) using random-effects models', 'Time-to-event data reconstructed from Kaplan-Meier curves', 'Trial Sequential Analysis (TSA)'], 'number_of_trials': 5, 'total_participants': 8781}
results
{'efficacy': {'recurrent_vte': {'risk_ratio': 0.94, 'ci': '0.68-1.29', 'p_value': 0.7}, 'hr_time_to_event': 0.89, 'ci_time_to_event': '0.78-1.02', 'p_value_time_to_event': 0.1}, 'safety': {'major_or_clinically_relevant_non_major_bleeding': {'risk_ratio': 0.71, 'ci': '0.61-0.82', 'p_value': '<0.0001'}, 'hr_time_to_event': 0.61, 'ci_time_to_event': '0.57-0.66', 'p_value_time_to_event': '<0.001'}, 'all_cause_mortality': 'No differences observed', 'subgroups': ['Consistent results in patients with and without active cancer', 'Consistent results across DOAC types (apixaban and rivaroxaban)'], 'tsa': 'Sufficient evidence for both efficacy and safety outcomes'}
conclusion
Reduced-dose DOACs are as effective as full-dose regimens in preventing recurrent VTE, with a better safety profile, suggesting they may be preferred for patients requiring extended anticoagulation, particularly those at high risk of recurrence.
Journal: Thrombosis research
Impact Factor: 5.05
Date: 2025/6/25
PMID: 40957133
DOI: 10.1016/j.thromres.2025.109476
4. Intracranial Hemorrhage With Direct Oral Anticoagulants vs Low-Molecular-Weight Heparin in Brain Tumors: A Review and Meta-Analysis.
title
Intracranial Hemorrhage With Direct Oral Anticoagulants vs Low-Molecular-Weight Heparin in Brain Tumors: A Review and Meta-Analysis
journal
Neurology
publication_date
2025-09-16
impact_factor
4.57
quartile
Q1
doi
10.1212/WNL.0000000000214140
pmid
40953341
objective
Evaluate the safety of direct oral anticoagulants (DOACs) versus low-molecular-weight heparin (LMWH) on the development of intracranial hemorrhage (ICH) in patients with brain tumors.
methods
{'databases': ['MEDLINE', 'Embase', 'Web of Science', 'Cochrane Central Register of Controlled Trials'], 'search_period': '2010-01 to 2025-06', 'study_types': ['randomized-controlled trials', 'cohort studies'], 'population': 'Adults (≥18 years) with primary or metastatic brain tumors receiving therapeutic DOACs (apixaban, rivaroxaban, edoxaban, betrixaban, dabigatran) vs LMWH (enoxaparin, dalteparin, nadroparin, tinzaparin)', 'exclusions': ['studies with prophylactic dosing', 'non-brain tumor patients'], 'outcome': 'Development of ICH', 'analysis': 'Pooled risk ratios (RRs) using restricted random-effects model, heterogeneity and bias analysis, prespecified subgroups and sensitivity analyses', 'registration': 'PROSPERO (CRD42025635334)'}
results
{'studies_included': 10, 'design': 'Retrospective cohort studies', 'total_patients': 1572, 'doac_patients': 645, 'lmwh_patients': 895, 'age_range_doac': '60.4-67', 'age_range_lmwh': '53-64', 'follow_up_duration_months': '3-12', 'main_outcome': {'ich_any': {'doac_vs_lmwh': {'RR': 0.5, 'CI_95': '0.29-0.87', 'p': 0.01, 'I2': 49.5}}}, 'subgroup_3months': {'studies': 3, 'RR': 0.23, 'CI_95': '0.09-0.57', 'p': '<0.01', 'I2': '<0.01'}, 'stratified': {'primary_brain_tumors': {'studies': 5, 'RR': 0.2, 'CI_95': '0.08-0.54', 'p': '<0.01', 'I2': '<0.01'}, 'metastatic_brain_tumors': {'studies': 5, 'RR': 0.86, 'CI_95': '0.44-1.68', 'p': 0.66, 'I2': 36.04}}, 'sensitivity_analyses': {'leave_one_out': 'robustness confirmed', 'cumulative_meta_analysis': 'stable estimates with narrowing CIs'}, 'publication_bias': {'egger_p': 0.19, 'begg_p': 0.59, 'evidence': 'none'}}
conclusion
DOACs were associated with significantly lower ICH risk than LMWH in anticoagulated brain tumor patients, particularly with primary brain tumors. Findings support DOACs as a safe anticoagulant for arterial and venous thromboembolism but warrant cautious interpretation due to study design limitations.
Journal: Neurology
Impact Factor: 4.57
Date: 2025/9/16
PMID: 40953341
DOI: 10.1212/WNL.0000000000214140
5. Efficacy and safety of oral anticoagulants in the treatment of chronic kidney disease with atrial fibrillation or venous thromboembolism: a systematic review and meta-analysis.
title
Efficacy and safety of oral anticoagulants in the treatment of chronic kidney disease with atrial fibrillation or venous thromboembolism: a systematic review and meta-analysis
journal
Frontiers in Pharmacology
publication_date
2025-04-21
impact_factor
5.35
quartile
Q1
doi
10.3389/fphar.2025.1615284
pmid
40949128
objective
To compare the efficacy and safety of warfarin versus direct oral anticoagulants (DOACs) in treating chronic kidney disease (CKD) patients with atrial fibrillation (AF) or venous thromboembolism (VTE).
methods
{'data_sources': ['PubMed', 'Embase', 'Web of Science', 'Cochrane Library', 'ClinicalTrials.gov'], 'search_date': 'up to 2024-06-30', 'inclusion_criteria': 'RCTs assessing efficacy and safety of warfarin and DOACs in CKD with AF or VTE', 'outcomes': {'CKD+VTE': ['thrombosis recurrence or VTE-related deaths', 'major bleeding'], 'CKD+AF': ['stroke or systemic embolism', 'major bleeding']}, 'bias_assessment_tool': "Cochrane Collaboration's tool", 'studies_screened': 540, 'studies_included': 15, 'total_participants': 16361}
results
{'CKD_AF': {'DOACs_vs_warfarin_hemorrhagic_stroke': {'RR': 0.455, 'CI_95': '0.275-0.752', 'p_value': 0.002, 'effect': 'DOACs reduced risk'}, 'DOACs_vs_warfarin_ischemic_stroke': {'difference': 'not significant'}, 'DOACs_vs_warfarin_major_bleeding': {'RR': 0.604, 'CI_95': '0.442-0.825', 'p_value': 0.002, 'effect': 'DOACs reduced risk'}, 'DOACs_vs_warfarin_intracranial_bleeding': {'RR': 0.424, 'CI_95': '0.287-0.626', 'p_value': '<0.001', 'effect': 'DOACs reduced risk'}}, 'CKD_VTE': {'DOACs_vs_warfarin_recurrent_VTE_or_death': {'RR': 0.663, 'CI_95': '0.409-1.073', 'p_value': 0.094, 'effect': 'no significant difference'}, 'DOACs_vs_warfarin_major_bleeding': {'RR': 0.543, 'CI_95': '0.209-1.407', 'p_value': 0.208, 'effect': 'no significant difference'}}}
conclusion
DOACs demonstrate superior efficacy and safety compared to warfarin in patients with AF and CKD, while in VTE with CKD, DOACs show similar efficacy and safety to warfarin.
clinical_trials_registration
{'url': 'http://www.clinicaltrials.gov', 'identifier': 'CRD42024510727'}
Journal: Frontiers in pharmacology
Impact Factor: 5.35
Date: 2025/4/21
PMID: 40949128
DOI: 10.3389/fphar.2025.1615284