OBJECTIVE

To evaluate the outcomes in patients with atherosclerosis of infrainguinal arteries in 10 years after VEGF165 plasmid therapy.

MATERIAL AND METHODS

There were 45 patients with CLLI Fontaine grade II and III between 2009 and 2011. In addition to basic therapy, a double intramuscular injection of VEGF165 gene plasmid was used. Long-term results of treatment were followed-up throughout 10 years. Baseline data: mean age 63.3±5.8 years, 36 men, 9 women; 27 patients with CLLI grade II and 18 ones with grade III. We analyzed overall mortality and its causes, freedom from amputations, pain-free walking distance in patients with CLLI Fontaine grade II and III.

RESULTS

The results were followed-up in 36 (80%) patients including 23 ones with grade II and 13 patients with grade III. Overall mortality was 44% (n=16). The main causes were acute cardiac failure (n=7), stroke (n=6), cancer (n=2) and gastrointestinal bleeding (n=1). Ten-year freedom from amputations was 81% (n=29), amputation-free survival — 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 gene plasmid therapy for 10 years.

CONCLUSION

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