Abstract
Background: Treatment of in-stent restenosis (ISR) of the femoropopliteal (FP) artery remains a challenge to the endovascular specialist. Silverhawk (SA) and excimer laser atherectomy (ELA) use different mechanisms in restenotic tissue reduction. We report data on FP ISR treatment with SA and ELA in an unselected cohort of patients treated at a single center. Methods: Demographic, clinical, angiographic and procedural data was collected on all patients that underwent SA and ELA (laser Elite 83.3%, Booster or Tandem 16.7%) for FP ISR from January 2005 until June 2010. Major adverse events and oneyear target lesion revascularization (TLR) were obtained by review of medical records and phone calls. Univariate analysis was used to compare the 2 groups. Cox Regression analysis for TLR over time was performed to adjust for differences between the 2 cohorts and modeled for the following variables: SA vs. ELA, lesion length, TASC D lesions (versus A-C), diabetes, age, gender and bail out stenting. Results: 81 consecutive patients (41 SA, 40 ELA) were included in the analysis. ELA was utilized more frequently in longer lesions, subacute presentation, TASC D lesions, and in patients with more angiographic thrombus. Percent stenosis post ELA was 56.6% 0.7% vs SA 33.8% 7.5% (p1⁄40.015). Percent stenosis post ELA was 56.6% 0.7% vs SA 33.8% 7.5% (p1⁄40.015). Final angiographic success (< 30% residual narrowing post final treatment) was similar between ELA and SA respectively (92.5% vs. 100%, p1⁄40.12). Embolic filter protection was used equally in both modalities (ELA 57.5% vs. SA 56.1%, p1⁄41.00). DE requiring treatment occurred in 2.5% in ELA vs 7.3% of SA (p1⁄40.2). There were no device related complications. The primary outcome of TLR at 1 year occurred in 48.7% and 31.7% of ELA and SA respectively (p1⁄40.171). ELA had a steeper failure rate than SA in the first 6 months post treatment and to a lesser extent after 6 months, whereas SA showed lesser TLR initially but a higher TLR after 6 months. Cox Regression analysis showed that SA was a predictor of TLR at 1 year. Conclusions: Both SA and ELA continued to have high TLR rates in treating ISR of the FP arteries. SA appears to be a predictor of TLR at 1 year.
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