Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
EuroIntervention. 2011 Aug;7(4):428-36. doi: 10.4244/EIJV7I4A71.
In the setting of ST-elevation myocardial infarction (STEMI), epicardial vasoconstriction and thrombus load may lead to stent undersizing and malapposition after primary percutaneous coronary intervention (PPCI), which can both be responsible for stent thrombosis or restenosis. Aggressive stent deployment can, on the other hand, cause distal embolisation and the no-reflow phenomenon. The purpose of our study was to evaluate the safety and feasibility of a novel self-expanding stent by assessing the clinical, angiographic and intravascular outcomes after stent deployment at three days and at six months follow-up.
This prospective, multicentre, non-randomised study enrolled 25 STEMI patients undergoing PPCI; a nitinol, self-expanding, coronary stent (STENTYS® stent; STENTYS, Paris, France) was used in all patients. Angiography and intravascular ultrasound (IVUS) or optical coherence tomography (OCT) were performed immediately after stent deployment, after three days and at six months. Primary safety endpoints were mortality, reinfarction, stent thrombosis and stroke at discharge and at six months. The primary feasibility endpoints were technical, device and procedural success, and stent apposition at three days and six months. Secondary endpoints included distal embolisation, binary restenosis, ischaemia-driven target lesion revascularisation (TLR) and late lumen loss (LLL). There were no adverse events at discharge or at six months. Technical, device and procedural success were 100%, 96% and 96%, respectively. IVUS showed a significant vasodilatation distal to the culprit lesion at three-day follow-up (+19%), with a concordant expansion of the implanted stent (+18%), p≤0.001 for both values. One case of distal embolisation was reported. There were no cases of late stent malapposition at six months. In-stent and in-segment LLL were 0.71±0.71 mm and 0.58±0.61 mm. Binary restenosis was 25%, ischaemia-driven TLR was 12%.
This study shows that the use of the STENTYS® self-expanding stent is safe and feasible in STEMI patients. Three days after the procedure, the stent expanded to the same extent as the epicardial vasodilatation and appeared completely apposed to the vessel wall. This could be of benefit in preventing stent thrombosis in the setting of STEMI.
在 ST 段抬高型心肌梗死（STEMI）的情况下，心外膜血管收缩和血栓负荷可能导致直接经皮冠状动脉介入治疗（PPCI）后的支架过小和贴壁不良，这两者都可能导致支架血栓形成或再狭窄。另一方面，积极的支架扩张可能导致远端栓塞和无复流现象。我们的研究目的是评估一种新型自膨式支架的安全性和可行性，通过评估支架置入后 3 天和 6 个月随访时的临床、血管造影和血管内结果来评估。
这项前瞻性、多中心、非随机研究纳入了 25 例接受 PPCI 的 STEMI 患者；所有患者均使用镍钛诺自膨式冠状动脉支架（STENTYS®支架；STENTYS，巴黎，法国）。支架置入后即刻、3 天和 6 个月行血管造影和血管内超声（IVUS）或光学相干断层扫描（OCT）检查。主要安全性终点为出院时和 6 个月时的死亡率、再梗死、支架血栓形成和卒。主要可行性终点为 3 天和 6 个月时的技术、器械和程序成功以及支架贴壁。次要终点包括远端栓塞、二元再狭窄、缺血驱动的靶病变血运重建（TLR）和晚期管腔丢失（LLL）。出院时和 6 个月时均无不良事件。技术、器械和程序成功率分别为 100%、96%和 96%。IVUS 显示在 3 天的随访中，在罪犯病变的远端有明显的血管扩张（+19%），同时植入的支架也有相应的扩张（+18%），p≤0.001。报告了 1 例远端栓塞病例。6 个月时无晚期支架贴壁不良。支架内和节段内的 LLL 分别为 0.71±0.71mm 和 0.58±0.61mm。二元再狭窄率为 25%，缺血驱动的 TLR 率为 12%。
这项研究表明，在 STEMI 患者中使用 STENTYS®自膨式支架是安全可行的。在手术后 3 天，支架扩张到与心外膜血管扩张相同的程度，并且完全与血管壁贴合。这可能有助于预防 STEMI 中的支架血栓形成。
