Ten-year results of conservative treatment of patients with infrainguinal occlusive disease using VEGF165 plasmid construct

Chervyakov Yu.V.

Yaroslavl State Medical University

Staroverov I.N.

Yaroslavl State Medical University;
Yaroslavl Regional Clinical Hospital

Moskovskiy I.A.

Yaroslavl Regional Clinical Hospital

Lonchakova O.M.

Regional Clinical Hospital;
Yaroslavl State Medical University

Istomin A.V.

Yaroslavl Regional Clinical Hospital

Ten-year results of conservative treatment of patients with infrainguinal occlusive disease using VEGF165 plasmid construct

Authors:

Chervyakov Yu.V., Staroverov I.N., Moskovskiy I.A., Lonchakova O.M., Istomin A.V.

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Journal: Russian Journal of Cardiology and Cardiovascular Surgery. 2023;16(1): 110‑117

DOI: 10.17116/kardio202316011110

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To cite this article:

Chervyakov YuV, Staroverov IN, Moskovskiy IA, Lonchakova OM, Istomin AV. Ten-year results of conservative treatment of patients with infrainguinal occlusive disease using VEGF165 plasmid construct. Russian Journal of Cardiology and Cardiovascular Surgery. 2023;16(1):110‑117. (In Russ.)
https://doi.org/10.17116/kardio202316011110

Подписка 2025-2 (Russian Journal of Cardiology and Cardiovascular Surgery)

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OBJECTIVE

To evaluate 10-year outcomes in patients with infrainguinal occlusive disease after gene therapy with VEGF165 plasmid construct.

MATERIAL AND METHODS

There were 45 patients with chronic lower limb ischemia (CLLI) Fontaine grade II and III between 2009 and 2011. In addition to basic therapy, a double intramuscular injection of VEGF165 plasmid construct was used.

RESULTS

Long-term results were annually followed-up throughout 10-year period. At baseline, mean age of patients was 63.3±5.8. There were 36 men and 9 women (27 ones with CLLI grade II and 18 ones with grade III). The following parameters were studied: total mortality and its causes, freedom from amputations, amputation-free survival, pain-free walking distance in patients with CLLI grade II and III. Statistical analysis implied mean, standard deviation, median, confidence interval, U-Mann-Whitney and Wilcoxon tests. The results were followed-up in 36 (80%) patients including 23 ones with CLLI grade II and 13 patients with CLLI grade III. Mean age was 71.5±9.2 years. Overall mortality was 44% (n=16). The main causes were acute heart failure (n=7), stroke (n=6), cancer (n=2), gastrointestinal bleeding (n=1). Ten-year freedom from amputations was 81% (n=29). Amputation-free survival rate was 50% (n=18). Mortality in patients with CLLI grade II was 39%, freedom from amputations 96%, amputation-free survival 57%. In patients with CLLI grade III, these values were 46%, 62% and 47%, respectively. At baseline, pain-free walking distance in patients with CLLI grade II was 167±149 m, after 5 years — 539±292 m, after 10 years — 382±292 m. In patients with CLLI grade III, these values were 30±15, 304±144 and 109±52 m, respectively. There were no adverse events associated with VEGF165 plasmid construct throughout 10-year period.

CONCLUSION

A single course of treatment with VEGF165 plasmid construct in patients with CLLI grade II and III demonstrated effectiveness throughout 10-year period without additional surgical revascularization. Freedom from amputations was 96% and 62%, respectively. Widespread use of gene therapy at the stage of intermittent claudication can reduce the need for surgical interventions and improve the quality of life.

Keywords:

atherosclerosis of lower limb arteries

therapy

VEGF165 plasmid construct

10-year long-term results

Authors:

Chervyakov Yu.V.

Yaroslavl State Medical University

Staroverov I.N.

Yaroslavl State Medical University;
Yaroslavl Regional Clinical Hospital

Moskovskiy I.A.

Yaroslavl Regional Clinical Hospital

Lonchakova O.M.

Regional Clinical Hospital;
Yaroslavl State Medical University

Istomin A.V.

Yaroslavl Regional Clinical Hospital

Received:

07.09.2022

Accepted:

07.09.2022

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