First-in-man experience of self-expanding nitinol stents combined with drug-coated balloon in the treatment of femoropopliteal occlusive disease.

Purpose The present study aimed to determine the safety and efficacy of a drug-coated balloon inflated within a thin-strut self-expanding bare-metal stent in patients with severe and complex femoropopliteal occlusive disease. Methods This prospective study used the Pulsar-self-expanding stent and Passeo-18 Lux drug-coated balloon in patients with severe and complex femoropopliteal occlusive disease. The primary endpoint was the 12-month primary patency, and the secondary endpoints included 24-month primary patency, assisted primary patency, secondary patency, and clinically associated target lesion revascularisation. Results The study included 44 patients (51 limbs). The mean age of the patients was 67.6 ± 10.2 years, with 73% men. Chronic limb severity was classified as Rutherford Category III in 41% of the patients, stage IV in 31%, and stage V in 27%. Lesions were predominantly Trans-Atlantic Inter-Society Consensus (TASC 2007) D (51%) and C (45%), with 32 (63%) chronic total occlusions. Procedural success was obtained in all cases. The mean lesion length was 200 ± 74.55 mm (95% CI = 167.09-208.01) with a mean number of stents per limb used of 1.57 ± 0.70 (95% CI = 1.37-1.76). Distal embolisation occurred in two patients. The primary patency rates at the 12- and 24-month follow-up were 94% (95% CI = 82.9-98.1) and 88% (95% CI = 75.7-94.5), respectively. The assisted primary was 94% (95% CI = 82.9-98.1) and secondary patency was 96% (95% CI = 85.2-99.0) at 24-month follow-up. The cumulative stent fracture rate at the 24-month follow-up was 10%. Freedom from clinically driven target lesion revascularisation was 94% (95% CI = 83-98%) at 12-month follow-up and 88% (95% CI = 76-94%) at 24-month follow-up, with two patients requiring a bypass graft. Conclusion Our novel approach involving the combination of a thin-strut bare-metal stent and a drug-coated balloon may be safe and effective, with sustainable and promising clinical outcomes up to 24 months after treatment.