Remote results of treatment of patients with chronic lower-limb ischaemia by means of indirect revascularization and gene therapy

Chervyakov Yu.V.^1,2, Staroverov I.N.^1,2, Vlasenko O.N.², Nersesyan E.G.^2,3, Isaev A.A.⁴, Deev R.B.⁴

1) Yaroslavl Regional Clinical Hospital, Department of Vascular Surgery,
2) Chair of Surgery, Institute of Postgraduate Education, Yaroslavl State Medical University Yaroslavl,
3) Department of Adult Surgery, Vorkuta Hospital of Emergency Medical Care, Vorkuta,
4) Human Stem Cells Institute, Moscow, Russia

Presented herein are comparative remote results of combined surgical treatment of 121 patients with stage IIB–III lower limb chronic ischaemia (LLCI) by means of indirect revascularization (lumbar sympathectomy – LSE and revascularizing osteotrepanation of the tibial bone – ROT) and gene therapy using the first registered Russian gene therapeutic agent Neovasculgen^®. Depending on the LLCI degree and the method of treatment, during 3 years we assessed such parameters as the limb salvage rate, pain-free walk distance (PFWD), ankle-brachial index (ABI) and linear blood velocity (LBV).

An increase in the PFWD in patients with initial stage IIB LLCI in the group of gene therapy was considerably higher than in other types of treatment (p=0.0001–0.0004). Using indirect methods of revascularization was accompanied and followed by less positive alterations in the PFWD values which by the end of the third year of follow up were observed to decrease. The values of PFWD after ROT at 2 and 3 years were higher than after LSE (p=0.006).

During the first year of follow up the highest increment of the ABI was observed after ROT. At two years, the ABI values after ROT and gene therapy became equal. The worst result during 3 years as compared with other methods of treatment was demonstrated by LSE (p=0.006). Changes in ABI after gene therapy were statistically significant at all terms of follow up (p=0.008–0.02). There were no limb amputations in the remote period of follow up in patients with the initial stage IIB of the disease.

Patients with initial stage III LLCI also showed a considerably better result by the increment of increased PFWD after gene-therapeutic treatment (p=0.001–0.0005). A small increment of the PFWD after LSE maintained during 1 year and after LSE during 2 years. The ABI values in all periods of follow up were higher after gene therapy (p=0.01–0.003). During the 2- and 3-year period the increment of this parameter after ROT was more significant than after LSE (p=0.046–0.05). Changes in the ABI after gene therapy at all terms also turned out to be more substantial (p=0.03–0.008). An increase in the LBV during the first and second years after ROT turned out more significant as compared to LSE (p=0.05).

The limb salvage rate in patients with initial stage III LLCI during the whole period after gene therapy amounted to 78%, after ROT being 54% and after LSE equalling 45%.

KEY WORDS: gene therapy, chronic obliterating diseases of lower-limb arteries, lower limb chronic ischaemia, Neovasculgen, lumbar sympathectomy, revascularizing osteotrepanation.

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