Department of Vascular Surgery, Aristotle University of Thessaloniki, AHEPA University General Hospital, Thessaloniki, Greece -
Department of Vascular Surgery, National and Kapodistrian University of Athens, Attikon University Hospital, Athens, Greece.
J Cardiovasc Surg (Torino). 2022 Apr;63(2):137-145. doi: 10.23736/S0021-9509.22.12129-4. Epub 2022 Jan 10.
Stenting of infrainguinal lesions can be rather challenging due to the mechanical stress applied on the arteries during motion. We assessed the short-term and mid-term safety and efficacy of Supera interwoven nitinol stent for the treatment of infrainguinal arterial disease.
We conducted a systematic review for articles published from December 2011 up to May 2021 regarding studies assessing the safety and efficacy of Supera interwoven nitinol stents for the treatment of infra-inguinal peripheral arterial disease. Studies that involved synchronous application of the Supera stent and drug delivering devices, or any alternative endoprosthesis were excluded. Pooled Kaplan-Meier survival curves and smoothed hazard estimates were generated. Data were meta-analyzed using a random effects model. Primary endpoints included primary patency and freedom from clinically driven target lesion revascularization (TRL). Secondary endpoints included technical success and major amputation at 1 year post intervention.
Seventeen studies with 2015 patients (65.3% males) and a mean lesion length of 137.2 mm were included. Of the total treated lesions, 44.9% involved femoropopliteal artery and 37.4% the popliteal artery. Chronic total occlusions made up 49% of the treated lesions. There were no stent fractures reported. The pooled technical success rate is 99.84% (95% CI: 99.26-100). Pooled major amputation rate at 1 year is 1.48% (95% CI: 0.47-2.87). Pooled primary patency and freedom from TLR rates at 1 year are 83.5% (95% CI: 80.24-86.54) and 90.32% (95% CI: 88.75-91.79), respectively. Pooling of individual patient data produced primary patency and freedom from TLR rates of 84.48% (95% CI: 82.66-86.11) and 90.81% (95% CI: 88.64-92.58) respectively. According to the smoothed hazard ratio estimate the risk for losing primary patency peaked between 4 and 5 months while the risk for TLR peaked between 7 and 8 months after the intervention.
This review and meta-analysis indicated the safety and efficacy of Supera stents for the treatment of challenging infrainguinal lesions in the short-term and mid-term periods, with acceptable primary patency and freedom from TLR rates. Clinicians should be aware that between 4 and 5 months patients face a higher risk for event occurrence.
由于在运动过程中动脉受到机械应力，治疗下肢动脉病变的支架置入术颇具挑战性。我们评估了 Supera 编织型镍钛诺支架治疗下肢动脉疾病的短期和中期安全性和疗效。
我们系统检索了 2011 年 12 月至 2021 年 5 月期间发表的评估 Supera 编织型镍钛诺支架治疗下肢外周动脉疾病安全性和疗效的研究。排除了同时应用 Supera 支架和药物输送装置或任何其他内假体的研究。生成了累积 Kaplan-Meier 生存曲线和平滑危险估计值。使用随机效应模型对数据进行了荟萃分析。主要终点包括主要通畅率和无临床驱动的靶病变血运重建（TLR）的通畅率。次要终点包括 1 年后的技术成功率和主要截肢率。
纳入了 17 项研究，共 2015 例患者（65.3%为男性），平均病变长度为 137.2mm。在所有治疗的病变中，44.9%累及股腘动脉，37.4%累及腘动脉。慢性完全闭塞占治疗病变的 49%。未报告支架断裂。累积技术成功率为 99.84%（95%CI：99.26-100）。1 年时的主要截肢率为 1.48%（95%CI：0.47-2.87）。1 年时的累积主要通畅率和无 TLR 通畅率分别为 83.5%（95%CI：80.24-86.54）和 90.32%（95%CI：88.75-91.79）。个体患者数据的汇总分析显示，1 年时的主要通畅率和无 TLR 通畅率分别为 84.48%（95%CI：82.66-86.11）和 90.81%（95%CI：88.64-92.58）。根据平滑危险比估计，主要通畅丧失的风险在干预后 4 至 5 个月达到高峰，而 TLR 的风险在 7 至 8 个月达到高峰。
本综述和荟萃分析表明，Supera 支架治疗下肢动脉病变的短期和中期安全性和疗效良好，具有可接受的主要通畅率和无 TLR 通畅率。临床医生应注意，患者在 4 至 5 个月时面临更高的事件发生风险。
