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DES for Femoropopliteal ISR Provided Favorable 2-Year Outcomes
Treatment of femoropopliteal in-stent restenosis with paclitaxel-eluting stents resulted in favorable outcomes out to 2 years, according to findings from a prospective, multi-arm study.
“In this difficult-to-treat patient population, freedom from clinically driven [target lesion revascularization] was 60.8% at 2 years,” the researchers wrote. “Although revascularization was required for some patients, the TLR procedures were predominantly percutaneous interventions (88%, 37 of 42) and no patients underwent amputation.”
In the study, researchers considered 108 patients with 119 in-stent restenosis (ISR) lesions who were enrolled in a single-arm clinical trial of 787 patients treated with paclitaxel-eluting nitinol stents (Zilver PTX, Cook Medical). Patients (mean age, 68.3 ± 9.4 years; 61.1% men) had a mean lesion length of 133 ± 91.7 mm, and 33.6% of lesions were more than 150 mm long and 31.1% were totally occluded.
The procedural success rate was 98.2%, with a mean of 2.1 (± 1.2) stents placed per lesion. Primary patency was 95.7% at 6 months and 78.8% at 1 year, and the rate of freedom from TLR was 96.2% at 6 months, 81% at 1 year and 60.8% at 2 years.
In all, 40 patients experienced major adverse events, which were all TLRs. The 1-year fracture rate of stents used in ISR lesions was 1.2%.
Before treatment, 81.1% of patients had Rutherford scores of at least 3. By 2 years, 60.9% of patients had Rutherford scores of 1 or less. Both ankle brachial index and walking impairment questionnaire scores significantly improved. There were no significant risk factors associated with loss of patency.
Disclosure: Zeller reports receiving research grants and speaker honoraria from Cook Medical.
Perspective
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In this study, Zeller and colleagues provide useful information on an area that has become quite frustrating for physicians who work in the endovascular arena, namely superficial femoral artery (SFA) ISR. Currently, no “silver bullet” therapy exists to assure long-term patency rates in patients who undergo repeat procedures for SFA ISR. Although this study did show high primary patency rates at 6 months (96%), there was a noticeable drop-off at 1 year. Additionally, 40 patients underwent repeat procedures for TLR. Although far from perfect, given the paucity of alternate equally effective modalities to treat SFA ISR, this study does offer some insight on the potential usefulness of drug-coated technology in the peripheral vasculature. Ongoing research, as the authors also comment on, involving drug-coated balloons plus/minus atherectomy will most likely increase our knowledge base on the treatment of this entity. There was also a lack of a control arm in this study, which the authors clearly acknowledge.
Overall, I feel this study adds to the clinician’s armamentarium to treat SFA ISR. Enthusiasm should be tempered, however, as physicians need to consider the financial costs and possible complications of repeat stenting (ie, stent fracture/thrombosis). Future studies involving drug-eluting technology alone or in combination with current therapies will hopefully shed more light on this vexing issue.