Abstract
Background
Clinical trial data show overall favorable outcomes of paclitaxel-eluting stents for treatment of femoro-popliteal (FP) occlusive disease. However, external validity of trial results may be restricted to less complex FP lesions, and limited data on outcomes of paclitaxel-eluting stents in real world practice have been published.
Methods
This is a retrospective analysis of data of all patients who received Zilver® PTX® for FP lesion from February 2013 to October 2014 at our center. The primary endpoint was primary patency, defined as peak systolic velocity ratio < 2.0 by Doppler ultrasound, or angiographic diameter stenosis < 50%, or freedom from clinically driven target lesion revascularization.
Results
Seventy-eight patients received Zilver® PTX® for FP lesions in the pre-specified time period. Of them, 63 had follow-up data and were included in this study. Mean patient age was 66.3 ± 9.4 years, and 57.1% of the patients were men. Participants had a high prevalence of diabetes (49.2%), hypertension (93.7%), hyperlipidemia (93.7%), previous coronary revascularization (52.4%), or previous peripheral arterial disease (77.8%). Critical limb ischemia was present in 25.4% of the patients, Trans-Atlantic Inter-Society Consensus (TASC) class C or D in 76.2%, in-stent restenosis (ISR) in 36.5%, and total occlusion in 69.8%. Mean lesion length was 218.9 ± 128.3 mm, mean number of stents was 2.02 ± 1.0, and total stent length was 189.0 ± 128.5 mm. Mean follow-up was 270.4 ± 190.3 days. Primary patency rate at 1 year was 66.7% by Kaplan–Meier survival curve. When compared with patients with primary patency at follow up, those with an adverse outcome had higher prevalence of TASC II class C or D lesions (100% vs. 68.8%, p = 0.013), and were more likely to have ISR (66.7% vs. 27.1%, p = 0.012), longer lesion (291.3 ± 138.7 vs. 195.7 ± 117.1, p = 0.011), and incomplete coverage of the lesion (full coverage of lesions: 40% vs. 77.1%, p = 0.011).
Conclusion
Post marketing use of Zilver® PTX® for the treatment of FP lesions is associated with lower patency rates compared with clinical trial data. This may be related to the high prevalence of TASC II class C or D lesions and ISR in real world practice. Future studies should be more representative of contemporary clinical practice.
1
Introduction
Thanks to remarkable advances of technologies and techniques in the field of peripheral endovascular intervention (PEI), complex femoropopliteal (FP) lesions once considered not amenable to endovascular treatment can now be successfully approached with PEI. Some of these advances led to the 2007 update , of the Trans-Atlantic Inter-Society Consensus (TASC) guidelines , with new recommendations for PEI instead of surgery. However, while the TASC guidelines have not been updated since 2007, techniques and technologies have continued to evolve and in the real world endovascular treatment is now frequently used in place of guideline-recommended surgical intervention. Among the novel treatment modalities introduced for the endovascular approach of FP lesions (e.g. plain balloon angioplasty, cryotherapy, brachytherapy, atherectomy, bare-metal stents, graft stents, angioplasty with drug-coated balloons [DCBs], and drug-eluting stent [DES]), DCBs and DES have come into the spotlight for their promising results, particularly when paclitaxel is used as the antiproliferative agent. Paclitaxel is a taxane derivative that inhibits microtubule breakdown, thereby impairing the normal cell cycle . Because of its highly lipophilic properties , this drug is rapidly absorbed by tissues, reaching therapeutic concentration in the arterial wall even after exposure to the drug for a short duration. Several studies have demonstrated that the use of paclitaxel-coated balloons and DES such as the Zilver® PTX® (Cook Medical, Bloomington, IN) for FP lesions is effective to prevent in-stent restenosis (ISR) . However, the external validity of the trial results may be limited to less complex FP lesions. A number of reports on the clinical outcomes in real world experience using Zilver® PTX® in the treatment of FP lesions have been published. We report here our initial experience with Zilver® PTX® in our high-volume center.
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
