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覆膜支架与裸金属支架治疗主髂动脉闭塞性疾病的疗效比较。

Outcomes of covered vs bare metal stents for the treatment of aortoiliac occlusive disease.

机构信息

National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing, China.

National Center for Orthopaedics, Beijing Jishuitan Hospital, Beijing, China.

出版信息

J Vasc Surg. 2024 Feb;79(2):330-338. doi: 10.1016/j.jvs.2023.09.034. Epub 2023 Oct 5.

DOI:10.1016/j.jvs.2023.09.034
PMID:37802401
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.

摘要

目的

回顾性比较自膨式覆膜支架(CS)和裸金属支架(BMS)在 2016 年至 2022 年单中心治疗主髂动脉闭塞性疾病(AIOD)的临床结果。

方法

连续分析了 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,包括根据跨大西洋腔内血管外科学会共识 II(TASC-II)分类的所有病变类别患者。收集相关临床和基线数据,并进行倾向性评分匹配,以比较 CS 和 BMS 在基线特征、手术因素、30 天结局、5 年一期通畅率和肢体存活率方面的差异。通过 Kaplan-Meier 曲线分析随访结果。使用 Cox 比例风险模型识别一期通畅率的预测因素。

结果

共有 209 例 AIOD 患者纳入研究,CS 组 135 例(64.6%),BMS 组 74 例(35.4%)。手术成功率(100%比 100%;P=1.00)、早期(<30 天)死亡率(0%比 0%;P=1.00)、累积手术并发症发生率(12.0%比 8.0%;P=.891)、5 年一期通畅率(83.4%比 86.9%;P=.330)、二期通畅率(96%比 100%;P=.570)和肢体存活率(100%比 100%;P=1.00)两组间差异均无统计学意义。CS 组患者术前踝肱指数较低(0.48±0.26 比 0.52±0.19;P=.032),复杂 AIOD(特别是 TASC D)病例较多(47.4%比 9.5%;P<.001),慢性完全闭塞病变较多(77.0%比 31.1%;P<.001),钙化程度更严重(20.7%比 14.9%;P<.036)。经倾向性评分匹配后,选择 50 例患者(CS 组 25 例,BMS 组 25 例)。结果显示,仅严重钙化(32.0%比 8.0%;P=.034)和踝肱指数升高(0.45±0.15 比 0.41±0.22;P=.038)两组间差异有统计学意义。在手术因素方面,CS 组患者双侧股动脉或联合肱动脉经皮入路的使用率更高(60.0%比 12.0%;P<.001),使用的支架数量更多(2.3±1.2 比 1.3±0.7;P<.001),支架平均长度更长(9.3±3.3 比 5.8±2.6 cm;P<.001),导管内溶栓治疗更多(32.0%比 4.0%;P=.009)。多因素 Cox 生存分析显示,严重钙化(危险比,1.32;95%置信区间,1.04-1.85;P=.048)是一期通畅率的唯一独立预测因素。

结论

所有接受血管内治疗的 AIOD 患者均纳入研究,CS 和 BMS 治疗均取得良好效果。通过倾向性评分匹配,最大限度地减少了两组混杂因素的影响,未匹配和匹配队列的 5 年通畅率总体相似。CS 组患者术后血流动力学改善更明显。对于更复杂的病变,建议首选 CS。特别是对于严重钙化病变,这是一期通畅率的唯一独立预测因素,CS 显示出明显的优势。需要更多样本的研究来探讨支架类型在 AIOD 治疗中的作用。

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