Immediate results of conservative treatment of patients with unreconstructable critical limb ischaemia and trophic changes

Cherviakov, I V; Ха, Х Н; Климов, А Е; Гавриленко, А. В.

doi:10.33529/angio2019201

Cited by 4 publications

(2 citation statements)

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“…Но логично предположить, что результативность генной терапии у больных может различаться -применение препаратов группы простагландина Е1 при КИНК IV ст. в краткосрочном периоде это демонстрируют [9].…”

Section: Discussionunclassified

“…Такие больные определяются понятием нереконструктабельный пациент с угрожающей хронической ишемией нижних конечностей (ХИНК), и их лечение остается крайне сложным и нерешенным вопросом. Однако базисная терапия, рекомендованная в национальных рекомендациях по лечению больных заболеваниями артерий нижних конечностей, даже в сочетании с препаратами группы простагландина Е1 у пациентов с угрожающей ХИНК не демонстрирует высокой эффективности [7][8][9]. В последние годы больные угрожающей ХИНК являются предметом многочисленных исследований, в которых используют клеточную и генную терапию с целью стимуляции собственного ангиогенеза пациента.…”

Section: Introductionunclassified

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The first experience of gene therapy for the complex treatment of no-option chronic limb-threatening ischemia

Валентинович¹,

Ха²

2020

PKiK

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Aim. To evaluate the effects of complex treatments with no-option chronic limb-threatening ischemia patients with ulcers, using plasmid-based vascular endothelial growth factor-165 (VEGF-165) gene therapy in a one year follow-up period.Methods. In total, 43 patients with no-option chronic limb-threatening ischemia were enrolled in a one year follow-up study. All patients received standard conservative treatment in combination with gene therapy. The mean patient age was 68.0 ± 9.8 years; 65 % men and 35 % women. Patients were divided into four subgroups according to WIfI (Wound, Ischemia, and foot Infection) combinations: 130 — 37 % (n = 16); 131 — 21 % (n = 9); 230 — 21 % (n = 9), and 231 — 21 % (n = 9). Effectiveness criteria were set at major amputation rates, amputation-free survival rates, total mortality, and rates of ulcer healing in the one year follow-up period.Results. Major amputation rates, amputation-free survival rates, total mortality, and rates of ulcer healing during the one year follow-up were; 28, 63, 12 and 51 %, respectively. Separately, a subgroup of WIfI 130 combination patients experienced significant improvements (p = 0.01): amputation-free survival — 94 %, limb salvage rates — 100 %, and rate of ulcer healing — 88 %.Conclusion. Using a plasmid-based VEGF-165 gene therapy approach in the subgroup with the WIfI 130 combination was beneficial. Gene therapy was not effective in patients with large ulcer areas and depth, and local infections (subgroups; 230 and 231). The higher WIfI combinations led to an increase in major amputation rates, reduced amputation-free survival and ulcer healing rates. Total mortality was independently not associated with ulcer area and depth, and severity of local infection. Total mortality between subgroups 130, 131, 230, 231 for WIfI combinations during 1 year of follow-up was not statistically differences (log-rank test, p = 0.67)Received 2 June 2020. Revised 16 October 2020. Accepted 28 October 2020.Conflict of interest: Authors declare no conflicts of interest.Funding: The study did not have sponsorship.

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Section: Discussionunclassified

Section: Introductionunclassified