Department of Clinical Medicine, Cardiovascular Sciences and Immunology, Federico II University, Naples, Italy.
Catheter Cardiovasc Interv. 2012 Jun 1;79(7):1118-26. doi: 10.1002/ccd.23405. Epub 2012 Mar 14.
Distal embolization may decrease coronary and myocardial reperfusion after percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI). In this setting, manual thrombectomy (MT) resulted in better perfusion and clinical outcomes when compared with "conventional" PCI (direct stenting or stenting after predilation). MGuard net protective stent (MGS, Inspire-MD, Tel-Aviv, Israel) is a new bare-metal stent (BMS) with a polyethylene theraphthalate mesh coverage anchored to the external surface of the struts aiming to minimize distal embolization during PCI.
We intend to determine whether MGS implantation is comparable with a strategy of MT pretreatment followed by BMS deployment.
The MGUard versus bAre-metal stents plus manual thRombectomy in ST-elevation myocarDial Infarction pAtieNts (GUARDIAN) is a multicentre, prospective, randomized, noninferiority, open-label trial with a planned inclusion of 556 STEMI patients. Patients are assigned to treatment with MGS or MT pretreatment followed by BMS implantation in the infarct-related artery. All patients are treated medically according to current international guidelines. Randomization is performed before coronary angiography. The primary endpoint is complete (≥ 70%) ST-segment resolution at 60 min after PCI. Secondary endpoints are thrombolysis in myocardial infarction (TIMI) coronary flow grade ≥ 2, corrected TIMI frame count <23, myocardial blush grade of the infarct related area ≥ 2, and major adverse cardiac events rate at 30-day, 6-month, and 1-year follow-up. A cardiac magnetic resonance imaging substudy is planned to investigate microvascular obstruction and infarct size area reduction, at prespecified time-points, among 80 consecutive patients enrolled.
If MGS implantation is noninferior to a strategy of MT pretreatment followed by BMS deployment, it will lend support to the use of this treatment as another possible option for STEMI patients undergoing PCI.
经皮冠状动脉介入治疗（PCI）治疗 ST 段抬高型心肌梗死（STEMI）时，远端栓塞可能会降低冠状动脉和心肌再灌注。在此背景下，与“常规”PCI（直接支架置入或预扩张后置入支架）相比，手动血栓切除术（MT）可改善灌注和临床结局。MGuard 网保护支架（MGS，Inspire-MD，Tel-Aviv，以色列）是一种新型的无聚合物支架（BMS），其聚对苯二甲酸乙二醇酯（PET）网覆盖在支架的外表面，旨在减少 PCI 期间的远端栓塞。
我们旨在确定 MGS 植入是否与 MT 预处理后再行 BMS 置入的策略相当。
MGuard 网与 MT 预处理后 bare-metal stents 在 STEMI 患者中的疗效比较（GUARDIAN）是一项多中心、前瞻性、随机、非劣效性、开放标签试验，计划纳入 556 例 STEMI 患者。患者被分配接受 MGS 或 MT 预处理后再行梗死相关动脉内 BMS 置入治疗。所有患者均根据当前国际指南进行药物治疗。在冠状动脉造影前进行随机分组。主要终点是 PCI 后 60 分钟时完全（≥70%）ST 段回落。次要终点是心肌梗死溶栓治疗（TIMI）血流分级≥2、校正 TIMI 帧数＜23、梗死相关区域心肌染色分级≥2、以及 30 天、6 个月和 1 年随访时的主要不良心脏事件发生率。计划进行心脏磁共振成像亚组研究，在 80 例连续纳入的患者中，在预定时间点评估微血管阻塞和梗死面积减少。
如果 MGS 植入术与 MT 预处理后再行 BMS 置入术的策略相当，将为 STEMI 患者行 PCI 时使用该治疗方法作为另一种可能的选择提供支持。
