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)

Catheter Cardiovasc Interv. 2017 Nov 1;90(5):790-797. doi: 10.1002/ccd.27192. Epub 2017 Jul 19.

Abstract

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.

Keywords: balloon angioplasty; endovascular therapy; femoropopliteal disease; small vessel diameter; stent implantation.

Publication types

  • Comparative Study
  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Alloys*
  • Angioplasty, Balloon / adverse effects
  • Angioplasty, Balloon / instrumentation*
  • Disease-Free Survival
  • Female
  • Femoral Artery* / diagnostic imaging
  • Femoral Artery* / physiopathology
  • Humans
  • Japan
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Peripheral Arterial Disease / diagnostic imaging
  • Peripheral Arterial Disease / physiopathology
  • Peripheral Arterial Disease / therapy*
  • Popliteal Artery* / diagnostic imaging
  • Popliteal Artery* / physiopathology
  • Proportional Hazards Models
  • Prosthesis Design
  • Retrospective Studies
  • Risk Factors
  • Stents*
  • Time Factors
  • Treatment Outcome
  • Vascular Patency

Substances

  • Alloys
  • nitinol