Drug Eluting Versus Covered Stent for Femoropopliteal Artery Lesions: Results of the ULTIMATE Study

Drug Eluting Versus Covered Stent for Femoropopliteal Artery Lesions: Results of the ULTIMATE Study
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DOI:
10.1016/j.ejvs.2022.05.046
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发表时间:
2022-10-01
影响因子:
5.7
通讯作者:
Kichikawa, Kimihiko
Kichikawa, Kimihiko
中科院分区:
医学1区
文献类型:
--
作者:
Ichihashi, Shigeo;Takahara, Mitsuyoshi;Kichikawa, Kimihiko

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目的:支架移植物(SG)和药物洗脱支架(DES)的出现是为了对抗内膜增生。目前尚不清楚哪种类型的支架在股腘(FP)动脉病变中能产生更好的效果。本研究比较了血管内治疗两年后 VIABAHN SG 和 Eluvia DES 的临床数据。 方法:在这项回顾性多中心研究中,分析了 504 例病灶长度 > 10 cm 接受 SG 或 DES 治疗的病例。在血管内手术前后以及此后每三个月进行一次踝肱指数(ABI)测量。当 ABI 与基线值相比下降 >= 0.15 时,进行双功能超声检查支架通畅性。结果指标包括支架通畅率、无靶病灶血运重建(TLR)、支架血栓形成以及伴随通畅率损失的急性肢体缺血(ALI)。进行倾向评分匹配 (PSM) 以调整混杂的基线特征。结果:PSM 提取了 SG 组中的 219 个肢体和 DES 组中的 109 个肢体。与 SG 组相比,DES 组两年时无 TLR 的比率(86.0 +/- 4.2% 对比 73.1 +/- 4.8%,p = 0.040)和伴有通畅丧失的 ALI 率(98.9 +/- 1.1% 对比 93.5 +/- 1.8%,p = 0.029)具有统计学显着更高的比率。初次通畅率(75.9 +/- 5.9% vs. 69.5 +/- 5.9%,p = .087)和无支架血栓形成(90.4 +/- 3.3% vs. 81.2% +/- 3.0%,p = .11)没有统计学上的显着差异。对于病变
Objective: Stent grafts (SG) and drug eluting stents (DES) have emerged to combat intimal hyperplasia. It remains unclear which type of stent yields superior outcomes in femoropopliteal (FP) arterial lesions. This study compared the clinical data between the VIABAHN SG and the Eluvia DES two years after endovascular treatment.Methods: In this retrospective multicentre study, 504 cases with a lesion length > 10 cm treated either with SG or DES were analysed. Ankle brachial index (ABI) measurements were conducted before and after the endovascular procedure, and every three months thereafter. When the ABI dropped >= 0.15 compared with the baseline value, a duplex ultrasound was conducted to check stent patency. The outcome measures were stent patency rates, freedom from target lesion revascularisation (TLR), stent thrombosis, and acute limb ischaemia (ALI) accompanying loss of patency rates. Propensity score matching (PSM) was performed to adjust for confounding baseline characteristics.Results: PSM extracted 219 limbs in the SG group and 109 limbs in the DES group. Compared with the SG group, the DES group had statistically significantly higher rates of freedom from TLR (86.0 +/- 4.2% vs. 73.1 +/- 4.8%, p = .040), and ALI accompanying loss of patency (98.9 +/- 1.1% vs. 93.5 +/- 1.8%, p = .029) at two years. Primary patency (75.9 +/- 5.9% vs. 69.5 +/- 5.9%, p = .087) and freedom from stent thrombosis (90.4 +/- 3.3% vs. 81.2% +/- 3.0%, p = .11) were not statistically significantly different. For lesions