Background: Fasciotomy can increase the mobility of the superficial femoral artery and decrease the incidence of stent fractures. This study aimed to compare the long-term patency of drug-eluting nitinol stents with and without fasciotomy in patients with prolonged superficial femoral artery occlusions.
Methods: A randomized clinical trial was conducted in 60 (1:1) patients with long femoropopliteal steno-occlusive lesions >200 mm. Patients in group 1 (Zilver) underwent recanalization of femoropopliteal artery occlusion with stenting. In group 2 (ZilverFas), the femoropopliteal occlusion was recanalized with stenting and fasciotomy of Gunter's canal. The follow-up assessment of the patency took place after 6-12 months.
Results: Twelve-month primary patency in Zilver and ZilverFas groups was 51% and 80%, respectively (P = 0.02). The freedom from target lesion revascularization in the Zilver and ZilverFas groups was 50% and 76%, respectively (P = 0.04). At 1 year, primary-assisted patency and secondary patency for the ZilverFas and Zilver groups were 83% vs. 62% (P = 0.07) and 86% vs. 65% (P = 0.05), respectively. In the Zilver and ZilverFas groups, the number of stent fractures was 14 and 7, respectively (P = 0.05). The multivariable Cox regression indicated that the stent fracture and diabetes mellitus were independent predictors of restenosis and reocclusion. Fasciotomy reduced the risk of reocclusion and restenosis by 2.94 times.
Conclusions: Our study has shown that decompressing the stented segment with fasciotomy significantly improves the patency of the femoropopliteal segment and significantly reduces the number and severity of stent fractures.
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