Long-Term Outcomes of the Viabahn Stent in the Treatment of In-Stent Restenosis in the Superficial Femoral Artery

There is no universally accepted method to treat in-stent restenosis (ISR) in the superficial femoral artery (SFA). It is hypothesized that using the Viabahn expandable polytetrafluoroethylene-covered stent to treat ISR may prevent tissue infiltration and intimal hyperplasia that leads to restenosis. Methods. We studied 22 patients (27 limbs) referred for treatment of severe ISR of the SFA. All patients were treated with the Viabahn stent implanted in the restenotic segments. We also analyzed several demographic, procedural, and laboratory parameters that could potentially be predictors of Viabahn restenosis. Results. Among patients treated, 63% had severe claudication and 37% had critical limb ischemia. Mean treated lesion length was 214.8 +/- 87.2 mm, mean run-off score was 3.9 +/- 2.8. Mean followup period was 21.8 +/- 10.3 months. Ten patients (37%) developed Viabahn restenosis. The mean lesion length was 180.0 +/- 107.9 mm in the restenosis group and 219.4 +/- 78.9 mm in the no-restenosis group (P=.27). There was no significant difference between the two groups in the rest of demographic, procedural, and laboratory parameters. In 90%, restenosis occurred within the first 12 months and the remaining 10% occurred within 14 months. The mean time to restenosis was 6.2 +/- 4.3 months. We observed no Viabahn ISR occurring after 14 month of follow-up. Conclusion. The Viabahn stent can be used to treat ISR in the SFA, with favorable results of 63% primary patency at up to 3 years of follow-up. Analysis of multiple factors showed no association with restenosis occurrence. If the Viabahn remained patent for 14 months, the likelihood of restenosis was low.