Kang Won Yu, Campia Umberto, Didier Romain J, Kiramijyan Sarkis, Koifman Edward, Negi Smita I, Lipinski Michael J, Baker Nevin C, Escarcega Ricardo O, Torguson Rebecca, Waksman Ron, Bernardo Nelson L
Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC.
Cardiovasc Revasc Med. 2016 Sep;17(6):399-403. doi: 10.1016/j.carrev.2016.02.004. Epub 2016 Feb 9.
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.
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.
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±9.4years, 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±128.3mm, mean number of stents was 2.02±1.0, and total stent length was 189.0±128.5mm. Mean follow-up was 270.4±190.3days. Primary patency rate at 1year 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).
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.
临床试验数据显示，紫杉醇洗脱支架治疗股腘（FP）闭塞性疾病总体疗效良好。然而，试验结果的外部有效性可能仅限于不太复杂的FP病变，且关于紫杉醇洗脱支架在实际临床应用中的疗效数据有限。
这是一项对2013年2月至2014年10月在本中心接受Zilver® PTX®治疗FP病变的所有患者的数据进行的回顾性分析。主要终点为主要通畅率，定义为通过多普勒超声测得的收缩期峰值流速比<2.0，或血管造影显示直径狭窄<50%，或未进行临床驱动的靶病变血运重建。
在预定时间段内，78例患者接受了Zilver® PTX®治疗FP病变。其中，63例有随访数据并纳入本研究。患者平均年龄为66.3±9.4岁，57.1%为男性。参与者中糖尿病（49.2%）、高血压（93.7%）、高脂血症（93.7%）、既往冠状动脉血运重建（52.4%）或既往外周动脉疾病（77.8%）的患病率较高。25.4%的患者存在严重肢体缺血，76.2%为跨大西洋两岸心血管协会（TASC）C或D级病变，36.5%存在支架内再狭窄（ISR），69.8%为完全闭塞。平均病变长度为218.9±128.3mm，平均支架数量为2.02±1.0，总支架长度为189.0±128.5mm。平均随访时间为270.4±190.3天。根据Kaplan-Meier生存曲线，1年时的主要通畅率为66.7%。与随访时主要通畅的患者相比，预后不良的患者TASC II C或D级病变的患病率更高（100%对68.8%，p = 0.013），更易发生ISR（66.7%对27.1%，p = 0.012），病变更长（291.3±138.7对195.7±117.1，p = 0.011），且病变覆盖不完整（病变完全覆盖：40%对77.1%，p = 0.011）。
与临床试验数据相比，Zilver® PTX®上市后用于治疗FP病变的通畅率较低。这可能与实际临床中TASC II C或D级病变和ISR的高患病率有关。未来的研究应更能代表当代临床实践。
