急性下壁心肌梗死应用Guardwire Plus与Diver CE两种装置的对比研究

Diver CE versus Guardwire Plus for thrombectomy during primary angioplasty for inferior myocardial infarction

目的单中心前瞻性随机比较急性下壁心肌梗死(AIMI)患者施行 PCI 前应用Guardwire Plus 与 Diver CE 两种血栓去除装置的效果。方法采用单中心前瞻性随机方法比较发病<12 h、TIMI 血流0～1级 AIMI 患者施行直接 PCI 前应用 Guardwire Plus 与 Diver CE 两种血栓去除装置的有效性。主要终点是 PCI 后1 h 内 ST 段回落程度。结果 122例患者人选本研究。Diver CE 组和 Guardwire Plus 组的年龄[(59.6±14)岁比(60.1±13)岁]、男性(82%比84%)、糖尿病(31%比28%)、既往冠心病(25%比23%)、症状发作到直接 PCI 时间[(550±185)rain比(345±180)min]和应用血小板膜糖蛋白Ⅱb/Ⅲa受体拮抗剂(11%比13%)等基线资料均匹配。两组 ST 段回落(70%)率(57%比59%)、慢血流和无再流发生率(8%比7%)、TIMI 血流3级率(95%比97%)和心肌染色血流3级率(70%比72%)差异均无统计学意义(P>0.05)。术后1个月临床结果显示,左心室射血分数[(0.54±0.12)比(0.53±0.11)]、死亡(3%比3%)、再次心肌梗死(2%比0)和靶血管重建(2%比2%)差异也无统计学意义(P>0.05)。结论与 Guardwire Plus 装置比较,在 AIMI 患者施行支架术前应用 Diver CE 装置去除血栓,同样可以降低远端栓塞、促进 ST 段回落并改善心肌灌注。

Objective In this randomized prospective single-center study, we compared the efficacy of adjunctive thrombeetomy using Diver CE device （Invatec, Italy ） versus Guardwire Plus device （Medtranie, USA） before pereutaneous coronary intervention （PCI） in patients with 〈 12 h acute inferior myocardial infarction （AIMI） and Thrombolysis In Myocardial Infarction （TIMI） flow grade 0 to 1. The primary end point was the magnitude of ST-segment resolution after PCI. Methods A total of 122 patients （61 in Diver CE group and 61 in Guardwire Plus group） were studied. The magnitude of ST-segment resolution, myocardial blush grade and slow flow or no re-flow 1 h after PCI were measured in study patients. Results Baseline characteristics were similar between groups： age （59. 6 s 14 years vs. 60. 1 s 13 years）, males （82% vs. 84%）, diabetes （31%vs. 28% ）, previous coronary artery disease （25% vs. 23%）, onset-to-angiogram （350±185 min vs, 345 s 180 min）, and glycoprotein Ⅱ b/Ⅲ a inhibitor use （ 11% vs. 13%, all P 〉 0. 05 ）. The magnitude of ST-segment resolution was also similar in these two groups ： ST- segment resolution 〉70% （57% vs. 59%, P 〉0. 05）. Slow flow / no reflow rate （8% vs. 7% ）, TIMI flow grade 3 （95% vs. 97% ） and myocardial blush grade 3 （70% vs. 72% ） post PCI were not different in the groups （all P 〉0. 05）. Left ventricle ejection fraction （0. 54 ±0. 12 vs. 0. 53 ±0. 11 ）, death （3% vs. 3% ）, re-myocardial infarction （2% vs. 0） and target vessel revascularization （2% vs. 2% ） at one month post PCI were comparable （ all P 〉 0. 05 ）. Conclusion Efficacy of removing thrombus burden with Diver CE device or Guardwire Plus device was similar in patients with 〈 12 h acute inferior myocardial infarction.