Department of Interventional Cardiology, Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
EuroIntervention. 2012 Dec 20;8(8):945-54. doi: 10.4244/EIJV8I8A144.
The aim of the pilot SECRITT trial was to evaluate the safety and feasibility of sealing the high risk IVUS and optical coherence tomography-derived thin cap fibroatheroma (TCFA), with a dedicated nitinol self-expanding vShield device.
After screening with angiography, fractional flow reserve (FFR), intravascular ultrasound virtual histology (IVUS-VH) and optical coherence tomography (OCT), 23 patients met enrolment criteria (presence of non-obstructive VH-derived TCFA lesion with thin cap on OCT) and were randomised to vShield (n=13) versus medical therapy (n=10). In the shielded group, baseline percent diameter stenosis was 33.2±13.5%, FFR was 0.93±0.06. At six-month follow-up in shielded patients percent diameter stenosis further decreased to 18.7±16.9% and FFR remained the same 0.93±0.05. Average late loss was 0.24±0.13 mm. Average baseline fibrous cap thickness was 48±12 µm. After shield placement at six-month follow-up neo-cap formation was observed with average cap thickness of 201±168 µm. There were no dissections after shield placement and no plaque ruptures. In addition, mean stent area of 8.76±2.16 mm2 increased to 9.45±2.30 mm2, that is by 9% at six-month follow-up. The number of malapposed struts decreased from 10.7% to 7.6% and the number of uncovered struts at six months was 8.1%. There were no device-related major adverse cardiovascular events (MACE) events at six-month follow-up.
High risk plaque passivation and sealing with a vShield self-expanding nitinol device appears feasible and safe. A long-term larger randomised study with streamlined screening criteria is needed to evaluate the efficacy of this approach over medical therapy.
SECＲITT 试验的初步目的是评估专用的镍钛诺自膨式 vShield 装置对易损性血管内超声和光相干断层扫描衍生的薄帽纤维粥样瘤（TCFA）进行密封的安全性和可行性。
经过血管造影、血流储备分数（FFR）、血管内超声虚拟组织学（IVUS-VH）和光学相干断层扫描（OCT）筛选后，23 名患者符合入选标准（存在非阻塞性 VH 衍生的 TCFA 病变，OCT 上有薄帽），并被随机分为 vShield 组（n=13）和药物治疗组（n=10）。在屏蔽组中，基线时的直径狭窄率为 33.2%±13.5%，FFR 为 0.93±0.06。在屏蔽患者的 6 个月随访中，直径狭窄率进一步降至 18.7%±16.9%，FFR 仍为 0.93±0.05。平均晚期损失为 0.24±0.13mm。平均基线纤维帽厚度为 48±12µm。在 6 个月的随访中，在放置屏蔽物后观察到新的帽形成，平均帽厚度为 201±168µm。放置屏蔽物后无夹层，无斑块破裂。此外，支架面积（8.76±2.16）mm2增加到 9.45±2.30mm2，即 6 个月随访时增加了 9%。支架贴壁不良的支架数量从 10.7%降至 7.6%，6 个月时无覆盖支架的数量为 8.1%。6 个月时无器械相关的主要不良心血管事件（MACE）。
使用 vShield 自膨式镍钛诺装置对高危斑块进行钝化和密封似乎是可行和安全的。需要进行一项长期的、更大规模的随机研究，并采用简化的筛选标准，以评估该方法优于药物治疗的疗效。
