急性前壁心肌梗死应用DiverCE抽吸导管的有效性:TAPAFAMI试验

Diver CE for thrombectomy in anterior myocardial infarction:A trial of thrombus aspiration during primary angioplasty for anterior myocardial infarction (TAPAFAMI)

目的评估急性前壁ST段抬高心肌梗死(STEMI)患者施行冠状动脉介入治疗(PCI)前应用DiverCE血栓抽吸导管的效果。方法单中心前瞻性评估发病<12h、TIMI血流0～1级的急性前壁STEMI患者施行直接PCI前应用DiverCE血栓抽吸导管的有效性。主要终点是PCI后1h内ST段回落程度。结果164例患者入选本研究。DiverCE组与常规PCI组的年龄(55.3±13.0岁比56.1±14.0岁)、男性(88%比87%)、糖尿病(30%比28%)、既往冠心病(24%比23%)、症状发作到直接PCI时间(348±175min比350±181min)和应用血小板膜糖蛋白Ⅱb/Ⅲa抑制剂(10%比9%)等基线资料均匹配。DiverCE组术后1h内ST段回落率(59%比38%)、即刻TIMI3级血流(96%比80%)、心肌呈色3级血流(70%比46%)和慢血流或无复流率(7%比17%)明显优于常规PCI组(P<0.05)。术后1个月临床结果显示,左心室射血分数(0.54±0.11比0.52±0.13)有改善趋势,死亡(4%比4%)、再次心肌梗死(2%比1%)、靶血管重建(1%比1%)和卒中(1%比1%)差异无统计学意义(P>0.05)。结论与常规PCI比较,在前壁STEMI患者施行支架术前应用DiverCE血栓抽吸导管可以降低远端栓塞、促进ST段回落并改善心肌灌注。

Objective To compare the effect of adjunctive thrombectomy using Diver CE device （lnvatec, Italy） before percutaneous coronary intervention （PCI） versus conventional PCI in patients with anterior myocardial infarction for 〈 12 h and Thrombolysis In Myocardial Infarction （TIMI） flow grade 0 to 1. Methods We conducted a prospective, single-center study in patients with anterior myocardial infarction 〈 12 h and initial TIMI flow grade 0 to 1 who were treated with primary PCI. The magnitude of ST-segment resolution 1 h after PCI was the primary end point. Results A total of 164 patients entered into this study. Both groups were comparable by age （55.3 ± 13.0 years vs. 56. 1 ± 14. 0 years）, males （88% vs. 87% ）, diabetes （30% vs. 28% ） , previous coronary artery disease （24%vs. 23% ） , onset-to-angiogram （348±175 min vs. 350 ± 181 min）, and glycoprotein Ⅱb/Ⅲa inhibitor use （ 10% vs. 9% ）. The magnitude of ST- segment resolution was greater in the Diver CE group compared with the conventional PCI group as ST- sagment resolution 〉70% （59% vs. 38%, P 〈0.05） and TIMI flow grade 3 was obtained in 96% vs. 80% respectively （ P 〈 0. 05 ）. Difference in myocardial blush grade 3 （70% vs. 46% , P 〈 0. 05 ） and slow flow/no reBow （7% vs. 17%, P 〈 0.05）were observed between these two groups. One-month clinical outcome was comparable （death, 4% vs. 4%; myocardial infarction, 2% vs. 1%; target vessel vevascularization, 1% vs. 1% ; stroke, 1% vs. 1%, respectively ） although there was a tendency of improved left ventricle injection fraction in the Driver CE group （0.54 ± 0. 11 vs. 0.52 ± 0.13）. Conclusion Removing thrombus burden with Diver CE device before stenting leads to better myocardial reperfusion, as illustrated by a reduced risk of distal embolization and better ST-segment resolution.