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[Results of comprehensive conservative treatment of patients with no-option chronic limb-threatening ischaemia].

AIM
The study was aimed at comparing efficacy of conventional conservative therapy and comprehensive treatment including a plasmid VEGF-165-gene therapy drug in 'no-option' chronic limb-threatening ischaemia with different prevalence of trophic ulcers and infection during a 1-year follow-up period.


PATIENTS AND METHODS
A total of 101 patients (54% being men and 46% women, mean age 69 years) with 'no-option' chronic limb-threatening ischaemia underwent comprehensive conservative treatment. They were subdivided into 4 groups according to the WIFI classification: WIFI 130 (n=38), 131 (n=23), 230 (n=16), 231 (n=24). The control group patients (n=58) received standard treatment using a PGE1 analogue (Vasaprostan) and the study group patients (n=43) underwent standard conservative treatment (SCT) in combination with gene therapy. The end points of the study were as follows: major amputation rate, amputation-free survival, total mortality, and ulcer healing rate during a 1-year of follow up.


RESULTS
Major amputation rate in the control and study groups amounted to 35 and 28% (p=0.48), respectively, with amputation-free survival of 53 and 63% (p=0.35), total mortality of 21 and 12% (p=0.23), ulcer healing rate of 31 and 51% (p=0.04), respectively. The WIfI classification made it possible to single out a subgroup of patients (WIfI combination 130) yielding other statistically significant results: major amputation rate 27% and 0% (p=0.03), amputation-free survival 59 and 94% (p=0.025), ulcer healing rate 50 and 88% (p=0.016), respectively.


CONCLUSION
Using plasmid-based VEGF-165 gene therapy in the subgroup with the WIfI combination 130 decreases the major amputation rate (p=0.03), increases amputation-free survival (p=0.025) and promotes ulcer healing (p=0.016) compared with the standard therapy during 1-year follow up. No significant differences in the compared groups were revealed by all endpoints of the study for other combinations analysed. The total mortality rate in patients with limb-threatening ischaemia does not depend on either the initial severity of ulcer or the selcted methods of conservative treatment.