Division of Cardiology, University of Colorado, Denver, CO, USA.
Rocky Mountain Regional VA Medical Center, Denver, CO, USA.
J Endovasc Ther. 2020 Feb;27(1):60-65. doi: 10.1177/1526602819885652. Epub 2019 Nov 5.
To report a propensity score analysis comparing outcomes of the Supera interwoven nitinol stent to bare nitinol stents (BNS) in the femoropopliteal segment. A retrospective study was conducted utilizing data extracted from the Excellence in Peripheral Artery Disease (XLPAD) registry ( identifier NCT01904851) on 871 patients (mean age 65.1 years; 713 men) who underwent femoropopliteal balloon angioplasty with either Supera stent implantation in 118 limbs or other contemporary BNS in 753 limbs between January 2006 and December 2016. All patients in both groups were matched for baseline demographic and clinical characteristics in a 1:1 propensity score matching using the nearest neighbor method to create the 118-patient matched BNS cohort. One-year outcomes included all-cause mortality, target vessel revascularization (TVR), and target limb revascularization (TLR). An additional core laboratory analysis was conducted to measure the deployed length of Supera stents. In unmatched data, the Supera stent group had a numerically lower rate of TVR (7.6% vs 13.4%, p=0.08) and a significantly lower 1-year TLR rate (7.6% vs 16.2%, p=0.02) compared to the BNS group. Both groups had similar 1-year mortality (2.5% vs 2.7%, p=0.9). Kaplan-Meier analysis demonstrated that the Supera group had a significantly lower risk of TVR (p=0.02) and TLR (p=0.002) than the BNS group. After propensity matching, the 1-year TVR estimate was lower for Supera stents (7.6% vs 12.7%, p=0.08) and significantly lower for TLR (7.6% vs 13.6%, p=0.04) than the BNS group. There was no statistically significant association between Supera stent elongation (>10% of the labeled stent length) and 1-year risk of TLR (p=0.6). Supera stent usage in femoropopliteal intervention was associated with reduced risk of 1-year repeat target limb revascularization compared with BNS treatment in both unmatched and matched cohorts.
报告一项倾向评分分析,比较 Supera 编织型镍钛诺支架与裸镍钛诺支架(BNS)在股腘段的治疗效果。本回顾性研究利用 Excellence in Peripheral Artery Disease(XLPAD)登记研究(标识符 NCT01904851)的数据进行,纳入 2006 年 1 月至 2016 年 12 月间接受股腘段球囊血管成形术的 871 例患者(平均年龄 65.1 岁;713 例男性),其中 118 例采用 Supera 支架植入,753 例采用其他当代 BNS。在两组中,均通过最近邻匹配法进行 1:1 倾向评分匹配,以匹配基线人口统计学和临床特征,从而创建 118 例匹配的 BNS 队列。在未匹配数据中,Supera 支架组的 TVR 发生率(7.6% vs 13.4%,p=0.08)和 TLR 发生率(7.6% vs 16.2%,p=0.02)均低于 BNS 组,尽管这两组间存在数值差异。两组间的 1 年死亡率相似(2.5% vs 2.7%,p=0.9)。Kaplan-Meier 分析显示,Supera 组的 TVR 风险(p=0.02)和 TLR 风险(p=0.002)显著低于 BNS 组。经过倾向评分匹配后,Supera 支架的 1 年 TVR 估计值更低(7.6% vs 12.7%,p=0.08),TLR 更低(7.6% vs 13.6%,p=0.04)。Supera 支架的伸长率(>10%的标记支架长度)与 1 年 TLR 风险之间无统计学显著相关性(p=0.6)。在未匹配和匹配队列中,与 BNS 治疗相比,Supera 支架在股腘介入治疗中的应用与 1 年重复靶肢体血运重建风险降低相关。