Division of Vascular Surgery, University of Vermont Medical Center, Burlington, VT (D.J.B.).
Department of Health Care Policy and Research, Cornell Weill College of Medicine, New York, NY (A.S., T.S.).
Circ Cardiovasc Interv. 2020 Feb;13(2):e008528. doi: 10.1161/CIRCINTERVENTIONS.119.008528. Epub 2020 Feb 7.
To compare mortality after treatment of superficial femoral-popliteal artery disease with paclitaxel and nonpaclitaxel devices using a multicenter vascular registry.
Patients (N=8376) undergoing endovascular treatment of superficial femoral-popliteal artery disease in the Society for Vascular Surgery Vascular Quality Initiative were studied from October 2016 to December 2017. One-year mortality was compared between 3 groups; plain balloon angioplasty (N=2104) versus paclitaxel-coated balloon angioplasty (N=3543), bare-metal stenting (N= 2045) versus paclitaxel-eluting stents (N=684), and combined paclitaxel versus nonpaclitaxel devices. Mortality rates with hazard ratios (HR) and 95% CI were compared in unadjusted and propensity-matched cohorts and illustrated by Kaplan-Meier analysis with subgroup analysis for intermittent claudication, chronic limb-threatening ischemia, and secondary interventions.
In propensity-matched analyses, mortality was similar after plain balloon angioplasty (12.6%) and paclitaxel-coated balloon angioplasty (9.6%; HR=0.84 [95% CI, 0.66-1.06], =0.14). In propensity-matched groups, mortality was similar after bare-metal stenting (9.8%) and paclitaxel-eluting stenting (8.8%; HR=0.93 [95% CI, 0.62-1.41], =0.75). In the combined, matched analysis mortality was significantly lower in the paclitaxel device group (8.5%) compared with the nonpaclitaxel device group (11.5%; HR=0.82 [95% CI, 0.68-0.98], =0.03). Secondary interventions were similar after nonpaclitaxel (N=1113/4149, 26.8%) and paclitaxel device use (N=1113/4227, 26.3%). For intermittent claudication, mortality was lower after paclitaxel device use (1.6%) compared with nonpaclitaxel devices (4.4%; adjusted HR=0.59 [95% CI, 0.39-0.89], =0.01). For chronic limb-threatening ischemia, the mortality difference was not significant; paclitaxel (12.8%) versus nonpaclitaxel devices (15.5%; adjusted HR=0.85 [95% CI, 0.72-1.00], =0.05).
At 1 year, mortality was similar if not lower after treatment of femoral-popliteal occlusive disease with paclitaxel versus nonpaclitaxel devices. This work highlights the potential use of the Society for Vascular Surgery Vascular Quality Initiative for surveillance of the safety of new peripheral arterial devices.
使用多中心血管登记处比较使用紫杉醇和非紫杉醇装置治疗股浅动脉疾病的死亡率。
2016 年 10 月至 2017 年 12 月，对 Society for Vascular Surgery Vascular Quality Initiative 中接受股浅动脉疾病血管内治疗的患者（N=8376）进行了研究。比较了 3 组患者的 1 年死亡率：单纯球囊血管成形术（N=2104）与紫杉醇涂层球囊血管成形术（N=3543）、裸金属支架（N=2045）与紫杉醇洗脱支架（N=684）以及紫杉醇与非紫杉醇装置联合治疗。未调整和倾向匹配队列的死亡率比较采用风险比（HR）和 95%置信区间（CI），并通过 Kaplan-Meier 分析进行说明，亚组分析间歇性跛行、慢性肢体威胁性缺血和二次干预。
在倾向匹配分析中，单纯球囊血管成形术（12.6%）与紫杉醇涂层球囊血管成形术（9.6%）的死亡率相似（HR=0.84[95%CI，0.66-1.06]，=0.14）。在倾向匹配组中，裸金属支架（9.8%）与紫杉醇洗脱支架（8.8%）的死亡率相似（HR=0.93[95%CI，0.62-1.41]，=0.75）。在联合匹配分析中，紫杉醇装置组的死亡率明显低于非紫杉醇装置组（8.5%比 11.5%）（HR=0.82[95%CI，0.68-0.98]，=0.03）。非紫杉醇装置（N=1113/4149，26.8%）和紫杉醇装置使用（N=1113/4227，26.3%）后的二次干预相似。对于间歇性跛行，紫杉醇装置（1.6%）的死亡率低于非紫杉醇装置（4.4%）（调整后的 HR=0.59[95%CI，0.39-0.89]，=0.01）。对于慢性肢体威胁性缺血，死亡率差异无统计学意义；紫杉醇（12.8%）与非紫杉醇装置（15.5%）（调整后的 HR=0.85[95%CI，0.72-1.00]，=0.05）。
在治疗股浅动脉闭塞性疾病时，使用紫杉醇与非紫杉醇装置 1 年后的死亡率相似，甚至更低。这项工作突出了 Society for Vascular Surgery Vascular Quality Initiative 用于监测新的外周动脉装置安全性的潜力。
