Vascular Center, Klinikum Hochsauerland, Arnsberg, Germany.
Universitätsklinikum Freiburg Herzzentrum, Bad Krozingen, Germany.
Vasa. 2022 Jan;51(1):5-12. doi: 10.1024/0301-1526/a000980. Epub 2021 Dec 8.
The MIMICS-3D study aimed to assess the safety and effectiveness of the BioMimics 3D Vascular Stent System for the treatment of symptomatic femoropopliteal artery disease in a real-world patient population. Consecutive participants who were scheduled for implantation of the BioMimics 3D stent were enrolled in the prospective, observational, multicenter study. The primary effectiveness outcome was freedom from clinically driven target lesion revascularization at 12 months and the primary safety outcome was a composite of major adverse events comprising death, major target limb amputation, or clinically driven target lesion revascularization at 30 days. Outcomes through 24 months are reported. A total of 507 patients (70±10 years, 65.5% male sex) were enrolled and treated with the study stent. 24.0% had critical limb-threatening ischemia, lesion length was 127±92 mm, and 56.8% of lesions were totally occluded. The Kaplan-Meier (KM) estimate of freedom from clinically driven target lesion revascularization at twelve-months was 90.6% (95% CI: 87.9%-93.3%) and the 30-day primary safety outcome occurred in 1.2% (95% CI: 0.5%-2.7%) of participants. At 24 months, clinical improvement was achieved in 86.6% and the KM estimate of freedom from clinically driven target lesion revascularization was 82.8% (95% CI: 79.4%-86.4%). The KM estimate of freedom from loss of primary patency according to PSVR >2.4 was 78.6% (95% CI: 74.7%-82.4%). Survival distribution functions regarding primary patency were lower with long lesions (>150 mm; log-rank p<0.001) but did not differ significantly between participants with or without critical limb-threatening ischemia (log-rank p=0.07). Endovascular treatment of atherosclerotic femoropopliteal lesions with the BioMimics 3D Vascular Stent System is efficacious and safe in a real-world setting.
MIMICS-3D 研究旨在评估 BioMimics 3D 血管支架系统在真实世界患者人群中治疗症状性股腘动脉疾病的安全性和有效性。连续计划植入 BioMimics 3D 支架的参与者被纳入前瞻性、观察性、多中心研究。主要有效性结果是 12 个月时无临床驱动的靶病变血运重建，主要安全性结果是 30 天内死亡、主要靶肢截肢或临床驱动的靶病变血运重建的复合事件。报告了 24 个月的结果。共纳入 507 例患者（70±10 岁，65.5%为男性），采用研究支架治疗。24.0%患者为严重肢体缺血，病变长度为 127±92mm，56.8%病变完全闭塞。12 个月时无临床驱动的靶病变血运重建的 Kaplan-Meier（KM）估计值为 90.6%（95%CI：87.9%-93.3%），30 天主要安全性结果发生率为 1.2%（95%CI：0.5%-2.7%）。24 个月时，86.6%患者临床改善，KM 估计值无临床驱动的靶病变血运重建为 82.8%（95%CI：79.4%-86.4%）。根据 PSVR＞2.4，KM 估计值无原发性通畅丧失率为 78.6%（95%CI：74.7%-82.4%）。主要通畅性的生存分布函数与长病变（＞150mm；log-rank p＜0.001）较低，但有或无严重肢体缺血的患者之间无显著差异（log-rank p=0.07）。在真实世界环境中，使用 BioMimics 3D 血管支架系统治疗动脉粥样硬化性股腘动脉病变是有效且安全的。
