Abstract
Aim
Comparative analysis of the results of open thrombectomy and conservative therapy in patients with acute thrombosis of the lower limb arteries against the background of the XBB.1.5 (“Kraken”) subvariant of Omicron Severe acute respiratory syndrome-related coronavirus-2 (Sars-cov-2).
Material and methods
The present prospective, open, multicenter comparative study for the period 04/01/2022 to 12/01/2023 included 167 patients with acute thrombosis of the lower limb arteries against the background of the XBB.1.5 (“Kraken”) subvariant of the XBB.1.5 (“Kraken”) subvariant of Omicron Sars-cov-2.
Depending on the treatment strategy, two groups were formed: group 1 — open thrombectomy (n = 136) and drug treatment with an anticoagulant (unfractionated heparin in a therapeutic dosage) and an antiplatelet (acetylsalicylic acid 125 mg once a day); group 2 — only drug therapy (n = 31). This group consisted of patients who refused surgical revascularization and were on a prophylactic dose of unfractionated heparin (5000 U 3 times a day subcutaneously). On the development of acute arterial thrombosis, 80 U/kg (maximum 5000 U) of unfractionated heparin was injected intravenously in a bolus, followed by transfer to intravenous infusion using an infusion pump with an initial rate of 18 U/kg per hour under control of activated partial thromboplastin time. Analgesic and antiplatelet therapy was also prescribed (acetylsalicylic acid 125 mg once a day).
Results
No significant intergroup differences either in mortality rates (group 1: n = 58, 38.2%; group 2: n = 7, 22.6%; p = 0.09) or limb amputation (group 1: n = 63, 46.3%; group 2: n = 9, 29.0%; p = 0.07) were found. However, there was a trend towards a decrease in the incidence of these events in the drug treatment group. After open thrombectomy, rethrombosis developed in 50.7% (n = 69) cases; and thrombosis after rethrombectomy followed by amputation in 46.3% (n = 63). There were no hemorrhagic complications in both groups. Myocardial infarction and ischemic strokes were not recorded.
Conclusion
Anticoagulant therapy demonstrates several advantages over aggressive surgical management. However, probably due to the small size of the studied sample, significant differences were not obtained. Further study of this issue is required with the identification of the optimal reperfusion method in this complex cohort of patients.
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The study was performed in compliance with the ethical principles of conducting scientific medical research involving humans and was approved by the decision of the local ethical committee of the Federal State Budgetary Institution of Higher Education “Amur State Medical Academy” of the Ministry of Health of the Russian Federation (protocol No. 3 dated 2/01/2022).
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The study was performed in accordance with the Good Clinical Practice standards and the principles of the Declaration of Helsinki did not contradict the Federal Law of the Russian Federation of November 21, 2011 No. April 1, 2016 N 200n “On approval of the rules of good clinical practice.”
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Nikolaevich, K.A., Vladimirovich, K.A., Mikhailovich, U.V. et al. Acute thrombosis of the lower limb arteries on the background of the XBB.1.5 (“Kraken”) subvariant of omicron SARS-COV-2 — medical or surgical treatment?. Indian J Thorac Cardiovasc Surg 39, 601–607 (2023). https://doi.org/10.1007/s12055-023-01551-2
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DOI: https://doi.org/10.1007/s12055-023-01551-2