Background Cancer patients with acute venous thromboembolism (VTE) receiving anticoagulant treatment have an increased bleeding risk. Objectives We performed a prespecified secondary analysis of the randomized, open-label, Phase III CATCH trial (NCT01130025) to assess the rate and sites of and the risk factors for clinically relevant bleeding (CRB). Patients/Methods Patients with active cancer and acute, symptomatic VTE received either tinzaparin 175 IU kg once daily or warfarin (target International Normalized Ratio [INR] of 2.0-3.0) for 6 months. Fisher's exact test was used to screen prespecified clinical risk factors; those identified as being significantly associated with an increased risk of CRB then underwent competing risk regression analysis of time to first CRB. Results Among 900 randomized patients, 138 (15.3%) had 180 CRB events. CRB occurred in 60 patients (81 events) in the tinzaparin group and in 78 patients (99 events) in the warfarin group (hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.45-0.89). Common bleeding sites were gastrointestinal (36.7%; n = 66), genitourinary (22.8%; n = 41), and nasal (10.0%; n = 18). In multivariate analysis, the risk of CRB increased with age > 75 years (HR 1.83, 95% CI 1.14-2.94) and intracranial malignancy (HR 1.97, 95% CI 1.07-3.62). In the warfarin group, 40.4% of CRB events occurred in patients with with an INR of < 3.0. A lower time in therapeutic range was associated with a higher risk of CRB. Conclusions CRB is a frequent complication in cancer patients with VTE during anticoagulant treatment, and is associated with age > 75 years and intracranial malignancy.

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Background: medical correction of the hemostatic system is one of the most important directions for complex treatment of obliterating diseases of lower limbs arteries (ODLLA), including cases of chronic limb-threatening ischaemia (CLTI).Aim: to evaluate the efficacy and safety of the sulodexide use in patients with ODLLA when conducting a comprehensive treatment of CLTI.Patients and Methods: 520 patients underwent two-center prospective study, 318 of whom (211 — with signs of ODLLA, 107 — without signs of CLTI) underwent revascularization interventions, whereas, 202 patients with CLTI received multicomponent complex conservative treatment. In addition to standard treatment, 30 patients who underwent surgery interventions and the group of 50 patients receiving conservative treatment received sulodexide orally in 2 capsules bis in day (1000 LE/day). The severity of the pain syndrome, the distance of pain-free walking, some laboratory indicators of hemostatic system, as well as the presence of adverse events and complications were evaluated before and after treatment. Results: in operated patients with both CLTI and without it, regardless of the sulodexide use, there was a significant decrease in the severity of pain syndrome and an increase in the distance of pain-free walking. Sulodexide use was accompanied by reduced fibrinogen, D-dimer, soluble fibrin monomer complexes (SFMC) and plasminogen activator inhibitor (PAI-1) in the subgroup of patients with CLTI, and indicators of fibrinogen and PAI-1 in the subgroup of patients without CLTI (p<0.05). In non-operated patients with CLTI, sulodexide use was accompanied by a decrease in pain syndrome and indicators of fibrinogen, D-dimer, SFMC, and PAI-1 (p<0.05). However, it was less significant after performed revascularization. There were no adverse events or complications associated with the sulodexide use.Conclusions: improvement of clinical and laboratory parameters was mainly determined by the efficacy of performed limb revascularization. In the complex treatment of patients with ODLLA, the sulodexide use was safe and effective, which was manifested by a decrease in the pain severity, an increase in the distance of pain-free walking and normalization of some coagulogram indicators.KEYWORDS: chronic limb-threatening ischaemia, critical limb ischemia, obliterating diseases of lower limb arteries, complex treatment, sulodexide.FOR CITATION: Katelnitsky I.I., Darvin V.V., Zorkin A.A. Comprehensive treatment of patients with chronic limb-threatening ischaemia: are we using all the possibilities of anticoagulant therapy? Russian Medical Inquiry. 2020;4(7):445–451. DOI: 10.32364/2587-6821-2020-4-7-445-451.

Цель: улучшить результаты лечения больных облитерирующим атеросклерозом с критической ишемией нижних конечностей путем индивидуального подбора антикоагулянтной терапии для профилактики возникновения тромбозов после реконструктивных операций на артериях нижних конечностей. Материалы и методы: 82 пациента разделенны на две группы: I группа (48 пациентов)-реконструктивные операции на артериях нижних конечностей и антикоагулянтная терапия под контролем коагулограммы. II группа (34 пациента)-реконструктивные операции с подбором антикоагулянтной терапии с помощью показателей гемостазиограммы и теста Тромбодинамики Т-2. Результаты: из 48 пациентов I исследуемой группы хороший эффект у 36 больных (75,00 %), у 9 (18,75 %)удовлетворительный, а в 3-х наблюдениях (6,25 %)-неудовлетворительный. Во II группе хорошие результаты у 33-х (97,06 %) больных, а у 1-го (2,94 %) пациента удовлетворительный результат. Неудовлетворительных результатов не было. Проанализировано количество повторных операций в течение 1 года, выполненных в I группе, которых статистически достоверно было в 2 раза больше, чем во II. Все повторные операции связаны с развившимися тромботическими осложнениями. При сочетании большинства показателей гемостазиограммы и теста «Тромбодинамика Т-2» проводилась коррекция дозы гепаринотерапии, увеличивая на 2500 ЕД, т.е. пациент получал по 7500ЕД 4 р\сут. Если при проведении «Тромбодинамики Т-2» и коагулограммы на 6 сутки после оперативного лечения определялась гиперкоагуляция, то доза гепарина увеличивалась повторно на 2500 ЕД. Выводы: Сравнительный анализ показателей гемостазиограммы в первые часы после выполненного оперативного лечения малопоказателен для прогнозирования частоты тромботических осложнений, в то время как через 6 суток после оперативного лечения указывает на наличие статистически значимых отличий между исследуемыми группами. Это свидетельствует о более адекватном подборе дозы гепарина во II группе.