InnoRa GmbH, Berlin, Germany.
Experimental Radiology, Charité-Universitätsmedizin Berlin, corporate member of FreieUniversität Berlin, Humboldt-Universitätzu Berlin, and Berlin Institute of Health, Berlin, Germany.
J Endovasc Ther. 2021 Dec;28(6):938-949. doi: 10.1177/15266028211028219. Epub 2021 Jul 19.
Drug penetration into the deeper arterial wall of heavily calcified lesions is one of the limitations of drug-coated balloons and drug-eluting stents in vascular interventions. The Temporary Spur Stent (TSS) system is characterized by a self-expanding nitinol stent that is uniformly covered in radialspikes, which, when coated, should allow a deeper penetration and longer retention of the drug into the diseased artery walls by penetrating through the calcified plaques.
Uncoated TSS and paclitaxel (PTX)-coated TSS systems have been deployed in porcine peripheral arteries. Four weeks after the deployment of uncoated TSS systems, no adverse vascular remodeling or neointimal formation in the treated vessel segments were noticed. PTX-coated TSS systems transferred 9%±7% of the drug that was on the device to the targeted vessel area (196±163 ng PTX/mg arterial tissue) and the addition of the fluorescent dye Nile red to the coating showed that the spikes promote the transfer of the coating to the deeper layers of the vessel wall. The PTX-coated TSS systems showed a significant reduction in neointimal proliferation compared to the uncoated TSS systems: quantitative angiography showed a vessel diameter stenosis of 37.2%±11.0% and 16.4%±8.8% 4 weeks after the treatment with uncoated and PTX-coated TSS systems, respectively.
The treatment with the TSS system was well tolerated and the spikesfacilitate the transfer of the coating into deeper layers of the vessel wall. Moreover, the PTX-coated TSS systems effectively inhibit neointimal proliferation.
药物渗透到重度钙化病变的动脉壁深层是药物涂层球囊和药物洗脱支架在血管介入治疗中的局限性之一。临时支架刺突系统（TSS）的特点是自扩张镍钛诺支架均匀覆盖有径向刺突，当涂层时，应该通过穿透钙化斑块使药物更深入地渗透到病变的动脉壁中，并更长时间地保留在其中。
未涂层的 TSS 和紫杉醇（PTX）涂层的 TSS 系统已在猪外周动脉中部署。在部署未涂层的 TSS 系统 4 周后，未观察到治疗血管段出现不良的血管重塑或新生内膜形成。PTX 涂层的 TSS 系统将 9%±7%的药物转移到目标血管区域（196±163ngPTX/mg 动脉组织），并且将荧光染料尼罗红添加到涂层中表明刺突促进了涂层向血管壁深层的转移。与未涂层的 TSS 系统相比，PTX 涂层的 TSS 系统显著减少了新生内膜增殖：定量血管造影显示，未涂层和 PTX 涂层的 TSS 系统治疗后 4 周时血管直径狭窄率分别为 37.2%±11.0%和 16.4%±8.8%。
TSS 系统的治疗耐受良好，刺突促进了涂层向血管壁深层的转移。此外，PTX 涂层的 TSS 系统能有效抑制新生内膜增殖。
