Mid-term clinical outcome and predictors of vessel patency after femoropopliteal stenting with self-expandable nitinol stent.

BACKGROUND

Long-term clinical outcomes after femoropopliteal (FP) stenting with nitinol stents have not yet been clear. We investigated the mid-term efficacy of FP stenting with nitinol stents.

METHODS

This study was a multicenter retrospective study. From April 2004 to December 2008, 511 consecutive patients (639 limbs; mean age 71 +/- 7 years; 71% male) who underwent successful FP stenting with nitinol stents for de novo lesions were retrospectively selected and analyzed in this multicenter study. All patients had a minimum follow-up of 6 months. Restenosis was defined as >2.4 of peak systolic velocity ratio by duplex or >50% stenosis by angiogram. Primary patency was defined as treated vessels without restenosis and repeat revascularization. Secondary patency was defined as target vessels that become totally occluded and are reopened by repeat revascularization.

RESULTS

Sixty-one percent of the patients had diabetes, 76% were claudicant, and 20% were on hemodialysis. Mean lesion length was 151 +/- 75 mm. Mean follow-up period was 22 +/- 11 months. Primary patency was 79.8%, 66.7%, and 63.1%, and secondary patency was 90.4%, 87.3%, and 86.2% at 1, 3, and 5 years, respectively. During the follow-up period, 53 patients (10%) died. Of them, cardiovascular death was 38% and stent fracture had occurred in 14%. On multivariate analysis by Cox proportional hazard ratio, cilostazol administration (hazard ratio [HR], 0.52;P < .0001), stent fracture (HR, 1.6; P = .03), hemodialysis (HR, 1.7; P = .01), and Trans Atlantic Inter-Society Consensus (TASC) II class C/D (HR, 2.4; P < .0001) were the independent predictors of primary patency after successful FP stenting.

CONCLUSION

Clinical efficacy of nitinol stent implantation for FP disease was favorable for up to 5 years.