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Paclitaxel-eluting Stents Versus Surgical Bypass For Long-segment Femoral-popliteal Occlusive Disease
Lauren Farley, MD, Christopher Latz, MD, Akeem Bartley, MD,
Charles James Bailey, MD.
University of South Florida, Tampa, FL, USA.
OBJECTIVES: The optimal treatment for advanced peripheral arterial disease (PAD) remains without consensus. Paclitaxel-coated devices (PCD) have proven beneficial, as compared to non-coated devices, though remain underrepresented in randomized trials investigating revascularization strategies. This study reports our institutional experience comparing outcomes of paclitaxel-eluting stents versus open surgical bypass for long-segment femoral-popliteal occlusive disease.
METHODS: A retrospective review of our institutional database was performed from 2013 to 2020 to identify all patients who underwent either paclitaxel-eluting stent placement (Zilver PTX, Cook Medical, Bloomington, IN) or open surgical bypass for Trans-Atlantic Inter-Society Consensus (TASC) level C and D femoral-popliteal lesions. Patient demographic, clinical, and procedural-related metrics were analyzed. Kaplan-Meier and Cox regression methods were used to estimate amputation-free survival (AFS) and freedom from stent or bypass occlusion.
RESULTS: Over the study period, 138 Zilver PTX paclitaxel-eluting stents and 126 open surgical bypass met criteria. Cohorts were similar with respect to demographics, comorbidities, ankle-brachial index (ABI), and TASC classification (TASC D- Zilver PTX, 60.9% vs Open bypass, 62.7%; p=0.80). A larger percentage of patients were treated for critical limb threatening ischemia (CLTI, Rutherford 4-6) versus intermittent claudication (IC, Rutherford 1-3) (CLTI, 58.3% vs IC, 41.7%; p<0.001). Patients with CLTI more frequently received open surgical bypass (Zilver PTX, 47.8% vs Open bypass, 69.8; p<0.001). Kaplan-Meier estimates an overall greater amputation free survival (AFS) in the Zilver PTX cohort versus open surgical bypass (Figure 1, p=0.01). Zilver PTX demonstrated an overall greater freedom from occlusion than open bypass (p=0.01), with event rates similar to vein bypass and both outperforming prosthetic graft (Figure 2, p=0.002). Multivariable analysis identified an increased risk of occlusion with use of a prosthetic graft (aHR: 2.87; 95% CI: 1.35-6.08; p=0.006), and CLTI as a predictor of decreased AFS (aHR: 2.5; 95% CI: 1.45-4.45; p=0.001).
CONCLUSIONS: Our real-world experience demonstrates the safety and efficacy of paclitaxel-eluting stents in the management of long-segment femoral-popliteal occlusive disease, with amputation free survival and freedom from occlusion similar to autologous vein bypass.
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