Clinical outcomes of balloon angioplasty alone versus nitinol stent implantation in patients with small femoropopliteal artery disease: Observations from the Retrospective Multicenter Analysis for Femoropopliteal Stenting (REAL-FP).

Objectives: We sought to assess whether balloon angioplasty (BA) alone for small femoropopliteal disease improved the outcome following endovascular therapy as compared with stent implantation.

Background: The optimal strategy of endovascular therapy for small vessel arteries in femoropopliteal disease remains unclear.

Methods: We performed a multicenter retrospective analysis of 337 consecutive patients (371 limbs) with femoropopliteal arteries 4.0 mm or less in diameter and 150 mm or less in length.

Results: Cumulative 3-year incidence of primary patency was significantly higher in the BA group than in the stent group (53.8% vs. 34.2%, P = 0.002). While assisted-primary patency and freedom from any major adverse limb events were also significantly higher in the BA group than in the stent group (70.9% vs. 44.2%, P < 0.001 and 60.6% vs. 36.4%, P = 0.001, respectively), secondary patency did not significantly differ between the two groups (86.9% vs. 86.9%, P = 0.67). Predictors of restenosis were diabetes mellitus (hazard ratio [HR], 1.61; 95% confidence interval [CI], 1.14-2.31; P = 0.01), no administration of cilostazol (HR, 1.50; 95% CI, 1.07-2.13; P = 0.02), stent implantation (HR, 1.68; 95% CI, 1.15-2.41; P = 0.01), and lesion length >75.0 mm(HR, 2.09; 95% CI, 1.50-2.92; P < 0.001).

Conclusions: Lesions in small (<4.0 mm diameter) FP vessels demonstrated better primary patency at 3 years when successfully treated with balloon angioplasty alone as opposed to routine or bailout stenting. This difference was especially pronounced for lesions 75 to 150 mm in length.