REAL-FP Compares Balloon Angioplasty Versus Stenting of Small Femoropopliteal Vessels


August 9, 2017—Findings from a study assessing whether balloon angioplasty alone for small femoropopliteal disease improved outcomes as compared with stent implantation were published online ahead of print by Norihiko Kamioka, MD, et al in Catheterization and Cardiovascular Interventions.

After evaluating clinical outcomes of balloon angioplasty alone versus nitinol stent implantation in patients with small femoropopliteal artery disease in the REAL-FP (Retrospective Multicenter Analysis for Femoropopliteal Stenting) study, the investigators concluded that lesions in small (< 4.0-mm diameter) femoropopliteal vessels had better primary patency at 3 years after treatment with balloon angioplasty alone compared to routine or bailout stenting. The difference was especially pronounced for lesions 75- to 150-mm long.

As summarized in Catheterization and Cardiovascular Interventions, the investigators performed a multicenter retrospective analysis of 337 consecutive patients (371 limbs) with femoropopliteal arteries that were ≤ 4.0 mm in diameter and ≤ 150 mm in length.

The cumulative 3-year primary patency was significantly higher in the balloon angioplasty group than the stent group (53.8% vs 34.2%; P = .002). Assisted primary patency and freedom from any major adverse limb events were also significantly higher in the balloon angioplasty group than in the stent group (70.9% vs 44.2%; P < .001 and 60.6% vs 36.4%; P = .001, respectively). Secondary patency was not significantly different between the two groups (86.9% vs 86.9%; P = .67).

Predictors of restenosis were diabetes mellitus (hazard ratio [HR], 1.61; 95% confidence interval [CI], 1.14–2.31; P = .01); no administration of cilostazol (HR, 1.5; 95% CI, 1.07–2.13; P = .02); stent implantation (HR, 1.68; 95% CI, 1.15–2.41; P = .01); and lesion length > 75 mm (HR, 2.09; 95% CI, 1.5–2.92; P < .001), reported the investigators in Catheterization and Cardiovascular Interventions.


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