远端血栓保护装置PercuSurge用于急性冠状动脉综合征经皮冠状动脉介入治疗

Prevention of distal embolization during percutaneous coronary intervention in patients with acute coronary syndrome

目的 评价在高危急性冠状动脉综合征 (ACS)患者的经皮冠状动脉介入治疗 (PCI)过程中联合应用远端血栓保护装置PercuSurge预防远端血栓栓塞的安全性及有效性。方法 15 4例ACS患者接受了PCI。其中 ,74例ACS患者 (男 6 5例 ,女 9例 ,平均年龄 5 7± 10岁 ,ST段抬高心肌梗死 5 3例 ,不稳定型心绞痛及非ST段抬高心肌梗死 2 1例 )在PercuSurge装置的保护下进行PCI(PercuSurge组 ) ;80例ACS患者 (男 6 8例 ,女 12例 ,平均年龄 (5 6± 10岁 ,ST段抬高心肌梗死 5 8例 ,不稳定型心绞痛及非ST段抬高心肌梗死 2 2例 )进行无保护的常规PCI(对照组 )。首要研究终点是院内和 30d的MACE。次级研究终点是PCI术后的TIMI血流和PercuSurge的临床疗效及并发症。结果 两组全部病例均成功地置入血管支架 ,PercuSurge组全部成功放置PercuSurgeGuardWire保护装置 ,平均阻滞球囊直径 4 8± 0 6mm ,平均阻滞时间 9± 7min。PercuSurge组术后TIMI 3级血流率显著高于对照组(94 5 9%与 81 2 5 % ,P <0 0 5 )。并发症包括 1例血管夹层 (1 35 % )、1例远端小血管血栓栓塞(1 35 % )、1例PercuSurge导丝所致血管穿孔 (1 35 % )。PercuSurge组院内及 30d主要不良心脏事件(MACE)显著低于对照组 (分别为 4 0 5 %与 16 2 5 %、2

Objective To evaluate the safety and efficacy of the PercuSurge GuardWire Occlusion and Aspiration System during high risk PCI in the patients with acute coronary syndrome (ACS) to prevent distal embolization Methods 154 patients with ACS were underwent PCI with the PercuSurge Guardwire distal protection device (PercuSurge group) or a conventional guidewire (control group) PercuSurge GuardWire device was employed in 74 patients (mean age, 57±10 years; 65 males] presenting with ST elevation MI ( n =53) and unstable angina/non ST elevation MI ( n =21) 80 cases (mean age, 56±10 years; 68 males) presenting with ST elevation MI ( n =58) and unstable angina/non ST elevation MI ( n =22) who underwent regular PCI without PercuSurge GuardWire device were in control group The primary study endpoints were major adverse cardiac events (MACE) in hospital and at the 30 day following up, the secondary endpoints were Thrombolysis in Myocardial Infarction (TIMI) trial flow post PCI, clinical efficacy and complication of the device Results In the PercuSurge group, Protection device assisted angioplasty with stent implantation was successful and retrieved in all patients The mean distal occlusive balloon inflated size was 4 8±0 6 mm and the mean occlusive time was 9±7 min The post PCI TIMI flow was improved significantly compared with the control group (94 59% TIMI 3 flow vs 81 25% TIMI 3 flow, P <0 05) with the protection device Device complications included coronary perforation in 1 (1 35%), 1 distal thrombembolism (1 35%) and 1 coronary dissection (1 35%) The MACEs in hospital and at 30 day follow up of the PrecuSurge group were significantly fewer than those of the control group (4 05% vs 16 25% and 2 70% vs 10% respectively, P <0 05) Conclusion This preliminary study demonstrates the feasibility and safety of using the PercuSurge GuardWire system during high risk PCI in ACS patients to prevent distal embolization