The Drug-Eluting Resorbable Scaffold in the Superficial Femoral Artery: 2-year Analysis.

BACKGROUND

In-stent restenosis remains a challenge in superficial femoral artery (SFA) treatment, though a great efficacy has been shown in drug-eluting stents (DESs). The concept of "leave nothing behind" has further driven interest to bioresorbable vascular stents. Some drug-eluting resorbable scaffold (DRS) has shown promise in coronary artery and SFA. We brought a first in-human study of DRS for treatment of peripheral artery disease (PAD) involving the de novo lesions in SFA.

METHODS

This DRS system is a device-drug combination consisting of a paclitaxel-eluting poly (L-lactide-co-ε-caprolactone) scaffold, using proprietary 3D multi-axis precision printing technology. Safety and performance were evaluated in 30 patients with de novo occlusion or stenosis in SFA.

RESULTS

De novo lesions were located in SFA. Mean lesion length was 37.76 ± 17.45 mm. The study device was successfully deployed in 100% of cases. At 12 months, there were two unrelated deaths, and no amputations occurred in the rest cases. The binary restenosis rates were 4.35%. The ankle brachial index improved from preprocedural 0.58 ± 0.17 to 0.83 ± 0.17 at 12 months of follow-up (P < 0.0001). At 2 years, 85.71% of the patients improved in Rutherford-Becker compared to the score preprocedure.

CONCLUSION

The safety of this DRS was demonstrated with no procedure or device-related deaths and amputations within 2 years. The low occurrence of revascularizations was consistent with duplex-ultrasonography showing sustained patency at 12 months. The percent of improvement in Rutherford-Becker clinical category was still high at 2 years.