Section of Vascular/Endovascular Surgery, Minneapolis Heart Institute at Abbott Northwestern, Minneapolis, MN, USA.
Department of Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
J Endovasc Ther. 2021 Apr;28(2):236-245. doi: 10.1177/1526602820980419. Epub 2020 Dec 17.
To report the safety and effectiveness outcomes through 2 years of the BioMimics 3D Vascular Stent System in the treatment of symptomatic patients with atherosclerotic femoropopliteal disease.
The tubular, nitinol BioMimics 3D stent, which was designed to impart a helical shape to the arterial segment, was implanted in 271 patients (mean age 68.4±9.5 years; 180 men) with de novo femoropopliteal lesions enrolled at 43 investigational sites [31 US (n=162), 6 German (n=78), and 6 Japanese (n=31)] in the prospective, single-arm MIMICS-2 investigational device exemption trial ( identifier NCT02400905) between June 2015 and October 2016. Mean lesion length was 81.2±38.4 mm, 30.0% of patients had total occlusions, and 45.9% had moderate to severe calcification. Primary safety and effectiveness endpoints were compared at 1 year with prespecified objective performance goals (OPGs) set by the VIVA Physicians organization. Outcomes through 2 years are reported.
The primary effectiveness endpoint of 12-month primary stent patency was met by 182 of 249 patients (73.1%, 95% CI 67.3% to 78.2%), exceeding the OPG of 66%. The primary safety endpoint of 30-day freedom from major adverse events (MAEs) was met in 268 of 269 patients (99.6%, 95% CI 97.7% to 100%), exceeding the OPG of 88%. Kaplan-Meier estimates of freedom from loss of primary patency were 83.1% at 12 months and 70.2% at 24 months, freedom from MAEs estimates were 86.9% at 12 months and 79.2% at 24 months, and freedom from clinically-driven target lesion revascularization estimates were 88.0% at 12 months and 83.0% at 24 months. At 24 months, 88.2% of patients showed improvement of ≥1 Rutherford category; the ankle-brachial index was >0.9 for 64.4% vs 11.3% at baseline. There were no cases of stent fracture.
Through 24 months, the BioMimics 3D Vascular Stent System provided safe and effective treatment for femoropopliteal lesions in patients with symptomatic peripheral artery disease.
报告在 2 年内使用 BioMimics 3D 血管支架系统治疗有症状的粥样硬化性股腘动脉疾病患者的安全性和有效性结果。
在 2015 年 6 月至 2016 年 10 月期间，在 43 个研究地点（31 个美国[n=162]、6 个德国[n=78]和 6 个日本[n=31]）进行了一项前瞻性、单臂的 MIMICS-2 研究器械豁免试验（标识符 NCT02400905），共纳入 271 名患有新发股腘动脉病变的患者（平均年龄 68.4±9.5 岁；180 名男性），植入管状、镍钛诺 BioMimics 3D 支架。该支架旨在赋予动脉节段螺旋形状。平均病变长度为 81.2±38.4mm，30.0%的患者有完全闭塞，45.9%的患者有中重度钙化。主要安全性和有效性终点与 VIVA 医师组织设定的预设客观表现目标（OPG）在 1 年时进行比较。报告了 2 年的结果。
在 249 名患者中有 182 名（73.1%，95%CI 67.3%至 78.2%）达到了 12 个月时主要支架通畅率的主要有效性终点，超过了 OPG 的 66%。在 269 名患者中有 268 名（99.6%，95%CI 97.7%至 100%）达到了 30 天免于主要不良事件（MAE）的主要安全性终点，超过了 OPG 的 88%。12 个月时无原发性通畅丢失的 Kaplan-Meier 估计值为 83.1%，24 个月时为 70.2%；12 个月时免于 MAE 的估计值为 86.9%，24 个月时为 79.2%；12 个月时免于临床驱动的靶病变血运重建的估计值为 88.0%，24 个月时为 83.0%。24 个月时，88.2%的患者至少改善了 1 个 Rutherford 类别；踝肱指数>0.9 的比例从基线时的 11.3%上升至 64.4%。没有支架断裂的病例。
在 24 个月内，BioMimics 3D 血管支架系统为有症状的外周动脉疾病患者的股腘动脉病变提供了安全有效的治疗。
