Abstract：
OBJECTIVE: We retrospectively compared the clinical outcomes of self-expanding covered stents (CSs) and bare metal stents (BMSs) in the treatment of aortoiliac occlusive disease (AIOD) at a single center between 2016 and 2022.
METHODS: All patients with AIOD receiving endovascular therapy at a single center from January 2016 to October 2022 were continuously analyzed, including patients with lesions of all classes according to the Trans-Atlantic Inter-Society Consensus II (TASC-II). Relevant clinical and baseline data were collected, and propensity score matching was performed to compare CSs and BMSs in terms of baseline characteristics, surgical factors, 30-day outcomes, 5-year primary patency, and limb salvage. The follow-up results were analyzed by Kaplan-Meier curves. Cox proportional hazard models were used to identify predictors of primary patency.
RESULTS: A total of 209 patients with AIOD were enrolled in the study, including 135 patients (64.6%) in the CS group and 74 patients (35.4%) in the BMS group. Surgical success rates (100% vs 100%; P = 1.00), early (<30-day) mortality rates (0% vs 0%; P = 1.00), cumulative surgical complication rate (12.0% vs 8.0%; P = .891), 5-year primary patency rate (83.4% vs 86.9%; P = .330), secondary patency rate (96% vs 100%; P = .570), and limb salvage rate (100% vs 100%; P = 1.00) did not exhibit significant differences between the two groups. Patients in the CS group had a lower preoperative ankle-brachial index (0.48 ± 0.26 vs 0.52 ± 0.19; P = .032), more cases of complex AIOD (especially TASC D) (47.4% vs 9.5%; P < .001), more chronic total occlusive lesions (77.0% vs 31.1%; P < .001), and more severe calcification (20.7% vs 14.9%; P < .036). After propensity score matching, 50 patients (25 with CS and 25 with BMS) were selected. The results showed that only severe calcification (32.0% vs 8.0%; P = .034) and ankle-brachial index increase (0.45 ± 0.15 vs 0.41 ± 0.22; P = .038) were significantly different between the groups. In terms of surgical factors, patients in the CS group had more use of bilateral femoral or combined brachial artery percutaneous access (60.0% vs 12.0%; P < .001), more number of stents used (2.3 ± 1.2 vs 1.3 ± 0.7; P < .001), longer mean stent length (9.3 ± 3.3 vs 5.8 ± 2.6 cm; P < .001), and more catheter-directed thrombolysis treatment (32.0% vs 4.0%; P = .009). Multivariate Cox survival analysis showed that severe calcification (hazard ratio, 1.32; 95% confidence interval, 1.04-1.85; P = .048) was the only independent predictor of the primary patency rate.
CONCLUSIONS: All patients with AIOD who underwent endovascular therapy were included and achieved good outcomes with both CSs and BMSs. The influence of confounding factors in the two groups was minimized by propensity score matching, and the 5-year patency rates were generally similar in the unmatched and matched cohorts. Postoperative hemodynamic improvement was more obvious in patients in the CS group. For more complex lesions, CS is recommended to be preferred. Especially for severe calcification lesions, which is the only independent predictor of primary patency, CS showed obvious advantages. Further studies with more samples are needed to investigate the role of stent types in AIOD treatment.
METHODS: All patients with AIOD receiving endovascular therapy at a single center from January 2016 to October 2022 were continuously analyzed, including patients with lesions of all classes according to the Trans-Atlantic Inter-Society Consensus II (TASC-II). Relevant clinical and baseline data were collected, and propensity score matching was performed to compare CSs and BMSs in terms of baseline characteristics, surgical factors, 30-day outcomes, 5-year primary patency, and limb salvage. The follow-up results were analyzed by Kaplan-Meier curves. Cox proportional hazard models were used to identify predictors of primary patency.
RESULTS: A total of 209 patients with AIOD were enrolled in the study, including 135 patients (64.6%) in the CS group and 74 patients (35.4%) in the BMS group. Surgical success rates (100% vs 100%; P = 1.00), early (<30-day) mortality rates (0% vs 0%; P = 1.00), cumulative surgical complication rate (12.0% vs 8.0%; P = .891), 5-year primary patency rate (83.4% vs 86.9%; P = .330), secondary patency rate (96% vs 100%; P = .570), and limb salvage rate (100% vs 100%; P = 1.00) did not exhibit significant differences between the two groups. Patients in the CS group had a lower preoperative ankle-brachial index (0.48 ± 0.26 vs 0.52 ± 0.19; P = .032), more cases of complex AIOD (especially TASC D) (47.4% vs 9.5%; P < .001), more chronic total occlusive lesions (77.0% vs 31.1%; P < .001), and more severe calcification (20.7% vs 14.9%; P < .036). After propensity score matching, 50 patients (25 with CS and 25 with BMS) were selected. The results showed that only severe calcification (32.0% vs 8.0%; P = .034) and ankle-brachial index increase (0.45 ± 0.15 vs 0.41 ± 0.22; P = .038) were significantly different between the groups. In terms of surgical factors, patients in the CS group had more use of bilateral femoral or combined brachial artery percutaneous access (60.0% vs 12.0%; P < .001), more number of stents used (2.3 ± 1.2 vs 1.3 ± 0.7; P < .001), longer mean stent length (9.3 ± 3.3 vs 5.8 ± 2.6 cm; P < .001), and more catheter-directed thrombolysis treatment (32.0% vs 4.0%; P = .009). Multivariate Cox survival analysis showed that severe calcification (hazard ratio, 1.32; 95% confidence interval, 1.04-1.85; P = .048) was the only independent predictor of the primary patency rate.
CONCLUSIONS: All patients with AIOD who underwent endovascular therapy were included and achieved good outcomes with both CSs and BMSs. The influence of confounding factors in the two groups was minimized by propensity score matching, and the 5-year patency rates were generally similar in the unmatched and matched cohorts. Postoperative hemodynamic improvement was more obvious in patients in the CS group. For more complex lesions, CS is recommended to be preferred. Especially for severe calcification lesions, which is the only independent predictor of primary patency, CS showed obvious advantages. Further studies with more samples are needed to investigate the role of stent types in AIOD treatment.
摘要：
目的：我们回顾性比较了自膨胀覆膜支架（SECSs）和裸金属支架（BMSs）在2016年至2022年间在单中心治疗主动脉闭塞性疾病（AIOD）的临床结果。
方法：对2016年1月至2022年10月在单中心接受血管内治疗的所有AIOD患者进行连续分析，包括根据跨大西洋社会间共识II（TASC-II）患有所有类别病变的患者。收集相关临床和基线数据，并进行倾向评分匹配，以比较CSs和BMS的基线特征，手术因素，30天的结果，5年主要通畅和保肢。采用Kaplan-Meier曲线对随访结果进行分析。Cox比例风险模型用于确定原发性通畅的预测因子。
结果：共有209名AIOD患者被纳入研究，其中CS组135例(64.6%),BMS组74例(35.4%).手术成功率(100%vs.100%,p=1.00),早期(<30天)死亡率(0%vs.0%,p=1.00),累积手术并发症发生率(12.0%vs.8.0%,p=0.891),5年原发性通畅率（83.4%vs.86.9%,p=0.330),二级通畅率(96%vs.100%,p=0.570)和保肢率(100%vs.100%,p=1.00）两组之间没有显着差异。CS组患者术前踝臂指数（ABI）较低（0.48±0.26vs.0.52±0.19；p=0.032），更多复杂AIOD病例（尤其是TASCD）（47.4%vs.9.5%；p<0.001)，更多慢性总闭塞性（CTO）病变（77.0%vs.31.1％；p<0.001）和更严重的钙化（20.7％vs.14.9%；p<0.036）。在倾向得分匹配后，选择50例患者(25例CSs和25例BMS)。结果显示，只有严重钙化(32.0%vs.8.0%,p=0.034）和ABI增加（0.45±0.15vs.0.41±0.22，p=0.038）组间差异显着。就手术因素而言，CS组患者更多使用双侧股动脉或联合肱动脉经皮入路(60.0%vs.12.0%,p<0.001)，使用的支架数量更多(2.3±1.2vs.1.3±0.7，p<0.001)，较长的平均支架长度(9.3±3.3vs.5.8±2.6，p<0.001）和更多的导管溶栓（CDT）治疗（32.0％vs.4.0%，p=0.009)。多因素Cox生存分析显示严重钙化(HR,1.32；95％CI，1.04-1.85；P=0.048）是主要通畅率的唯一独立预测因子。
结论：所有接受血管内治疗的AIOD患者均被纳入其中，CSs和BMS均取得了良好的结果。通过倾向得分匹配，将两组混杂因素的影响降至最低。无匹配和匹配队列的5年通畅率大致相似.CS组患者术后血流动力学改善更为明显。对于更复杂的病变，建议首选CS。特别是对于严重的钙化病变，这是原发性通畅的唯一独立预测因子，CS表现出明显的优势。需要更多样本的进一步研究来研究支架类型在AIOD治疗中的作用。
方法：对2016年1月至2022年10月在单中心接受血管内治疗的所有AIOD患者进行连续分析，包括根据跨大西洋社会间共识II（TASC-II）患有所有类别病变的患者。收集相关临床和基线数据，并进行倾向评分匹配，以比较CSs和BMS的基线特征，手术因素，30天的结果，5年主要通畅和保肢。采用Kaplan-Meier曲线对随访结果进行分析。Cox比例风险模型用于确定原发性通畅的预测因子。
结果：共有209名AIOD患者被纳入研究，其中CS组135例(64.6%),BMS组74例(35.4%).手术成功率(100%vs.100%,p=1.00),早期(<30天)死亡率(0%vs.0%,p=1.00),累积手术并发症发生率(12.0%vs.8.0%,p=0.891),5年原发性通畅率（83.4%vs.86.9%,p=0.330),二级通畅率(96%vs.100%,p=0.570)和保肢率(100%vs.100%,p=1.00）两组之间没有显着差异。CS组患者术前踝臂指数（ABI）较低（0.48±0.26vs.0.52±0.19；p=0.032），更多复杂AIOD病例（尤其是TASCD）（47.4%vs.9.5%；p<0.001)，更多慢性总闭塞性（CTO）病变（77.0%vs.31.1％；p<0.001）和更严重的钙化（20.7％vs.14.9%；p<0.036）。在倾向得分匹配后，选择50例患者(25例CSs和25例BMS)。结果显示，只有严重钙化(32.0%vs.8.0%,p=0.034）和ABI增加（0.45±0.15vs.0.41±0.22，p=0.038）组间差异显着。就手术因素而言，CS组患者更多使用双侧股动脉或联合肱动脉经皮入路(60.0%vs.12.0%,p<0.001)，使用的支架数量更多(2.3±1.2vs.1.3±0.7，p<0.001)，较长的平均支架长度(9.3±3.3vs.5.8±2.6，p<0.001）和更多的导管溶栓（CDT）治疗（32.0％vs.4.0%，p=0.009)。多因素Cox生存分析显示严重钙化(HR,1.32；95％CI，1.04-1.85；P=0.048）是主要通畅率的唯一独立预测因子。
结论：所有接受血管内治疗的AIOD患者均被纳入其中，CSs和BMS均取得了良好的结果。通过倾向得分匹配，将两组混杂因素的影响降至最低。无匹配和匹配队列的5年通畅率大致相似.CS组患者术后血流动力学改善更为明显。对于更复杂的病变，建议首选CS。特别是对于严重的钙化病变，这是原发性通畅的唯一独立预测因子，CS表现出明显的优势。需要更多样本的进一步研究来研究支架类型在AIOD治疗中的作用。
