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Early Post-Registry Experience with Drug Eluting Stents in the SFA
mathew wooster, Kirsten Dansey, BS, Paul Armstrong, DO, Martin Back, MD, Karl Illig, MD, Brad Johnson, MD, Neil Moudgill, MD, Peter Nelson, MD, Brian Park, MD, Murray Shames, MD.
University of South Florida, tampa, FL, USA.
Objective:
Restenosis remains the primary failure mode after stenting of the superficial femoral artery. Drug-eluting stent technology claims to reduce stent failure and improve durability of endovascular management of SFA occlusive disease. We seek to present our early experience with the Cook Zilver PTX stent.
Methods:
We have retrospectively reviewed a prospectively collected database of patients undergoing placement of the Cook Zilver PTX stent for SFA or popliteal disease since its availability to our institution in October 2013. Patients treated with additional stents to extend coverage of the same lesion were excluded. Patient demographics, comorbidities, concomitant procedures, TASC classification, procedural details, and follow up were reviewed.
Results:
Thirty-one limbs in thirty patients were treated with PTX, five were excluded for concomitant use of non-PTX stents, leaving 26 limbs in 26 patients for analysis. Indications for intervention were claudication in 17 (65.4%), rest pain in 1 (3.8%) and tissue loss in 8 (30.8%). A median of 2 PTX stents per limb was used to treat a mean length of 14.2cm +/- 11cm with initial technical success of 100%. Concomitant inflow (N= 4) or atherectomy (N = 2) interventions were performed in 23%. Sixty-nine percent of lesions were TASC C (N = 7) or D (N = 11) and 42% were total occlusions. Over a mean 20 week follow up, 2 occlusions were noted (mean 27 weeks), one was treated with surgical bypass, the other with endovascular salvage. Review of completion angiograms from the index procedures demonstrated severely compromised outflow in the patient later treated with a fem-distal bypass. A residual stenosis just distal to the stent was noted in the second, which was able to be salvaged with a repeat angioplasty and additional stent placement. Limb salvage in the series was 92.3% with the two patients requiring major amputations for infected, non-healing wounds despite patent stents.
Conclusion:
On mean 20-week follow we have seen 92.3% primary patency and 96.2% secondary patency. A larger number of patients and longer follow up will be required to determine the true real-world efficacy of this touted drug eluting device, but early experience is encouraging and warrants continued trial.
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