Unit of Vascular Surgery, Department of Medicine and Surgery, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy -
Unit of Vascular Surgery, Department of General and Specialist Surgery, Arcispedale S. Maria Nuova, Reggio Emilia, Italy.
Int Angiol. 2023 Feb;42(1):9-18. doi: 10.23736/S0392-9590.22.04959-8. Epub 2022 Dec 19.
The purpose is to evaluate the follow-up outcomes after femoro-popliteal stenting with Cook Zilver PTX in a multicenter experience.
Collected data from four Units were retrospectively joined and analyzed considering Zilver PTX deployed from August 2009 according to the instruction for use. Patient demographics, preoperative comorbidities, Rutherford classification, arterial characteristics and stent data were considered. Target lesion revascularization (TLR) was defined as reintervention performed for ≥50% diameter stenosis after recurrent clinical symptoms. Primary outcome was the freedom from TLR (ffTLR) and its risk factors. Secondary outcomes were primary patency (PP) of the stent, amputation-free survival (AFS) and their risk factors.
Considering 203 patients (mean age: 73.5 years ±10.6; male: 66.5%) and 263 stents (median 2 stents/patient, range 1-5stent/patient), chronic limb-threatening ischemia (CLTI) affected 154 patients (75.9%). The length of the treated lesion was <120 mm in 99 (48.8%), ≥120 mm and <200 mm in 65 (32%) and ≥200 mm in 39 (19.2%) cases, respectively; the reference vessel mean diameter was 5.5±0.7 mm; chronic total occlusion was treated in 153 (75.4%) patients, the popliteal artery was involved in 56 (27.6%) cases and prior endovascular intervention was performed in 27 (13.3%) cases. Two or more crural run-off vessels were patent in 124 (61.1%). Mean follow-up was 23.2 months ±21.3. At 1, 2 and 3 years, the ffTLR was 90.6±4.2%, 86.4±6.1% and 80.4±8.3%, respectively, and the PP was 85.6±5.0%, 74.2±7.6% and 72.7±8.2%, respectively. Negative prognostic factor for ffTLR and PP was the reference vessel diameter (P=0.001 and P<0.001, respectively). At 1, 2 and 3 years, the AFS was 81.8±6.0%, 75.5±7.1% and 74.2±7.5% respectively; coronary artery disease (P=0.041) and CLTI (P=0.011) resulted negative prognostic factors.
In the real-world practice, around 3/4 of patients were treated for CLTI. The rate of ffTLR is high, and PP is substantially lower. A small vessel diameter (<5 mm) is a negative factor for both ffTLR and PP. The rate of AFS is about 75% at 2 years and CLTI and coronary artery disease are negative prognostic factors.
目的是评估在多中心经验中使用 Cook Zilver PTX 进行股腘动脉支架置入后的随访结果。
回顾性收集四个单位的数据，根据使用说明，考虑自 2009 年 8 月起部署 Zilver PTX。考虑患者人口统计学、术前合并症、Rutherford 分类、动脉特征和支架数据。靶病变血运重建（TLR）定义为复发性临床症状后进行≥50%直径狭窄的再介入。主要结果是无 TLR （ffTLR）及其危险因素。次要结果是支架的原发性通畅率（PP）、无截肢生存率（AFS）及其危险因素。
考虑 203 例患者（平均年龄：73.5 岁±10.6；男性：66.5%）和 263 个支架（中位数 2 个支架/患者，范围 1-5 个支架/患者），慢性肢体威胁性缺血（CLTI）影响 154 例患者（75.9%）。治疗病变的长度<120mm 的患者有 99 例（48.8%），≥120mm 和<200mm 的患者有 65 例（32%），≥200mm 的患者有 39 例（19.2%）；参考血管平均直径为 5.5±0.7mm；153 例（75.4%）患者治疗慢性完全闭塞，56 例（27.6%）患者累及腘动脉，27 例（13.3%）患者行腔内治疗前。124 例（61.1%）患者有两条或两条以上的小腿流出血管通畅。平均随访时间为 23.2 个月±21.3。在 1、2 和 3 年时，ffTLR 分别为 90.6±4.2%、86.4±6.1%和 80.4±8.3%，PP 分别为 85.6±5.0%、74.2±7.6%和 72.7±8.2%。ffTLR 和 PP 的负预后因素是参考血管直径（P=0.001 和 P<0.001）。在 1、2 和 3 年时，AFS 分别为 81.8±6.0%、75.5±7.1%和 74.2±7.5%；冠心病（P=0.041）和 CLTI（P=0.011）是负预后因素。
在真实世界的实践中，约 3/4 的患者接受 CLTI 治疗。ffTLR 的发生率较高，而 PP 则明显降低。小血管直径（<5mm）是 ffTLR 和 PP 的负危险因素。AFS 的 2 年发生率约为 75%，CLTI 和冠心病是负预后因素。
