Yan Hong-bing, Wang Jian, Li Nan, Zhu Xiao-ling, Gao Hai, Ai Hui, Li Xiang, Ye Ming, Chi Yun-peng, Zhang Hong
Emergency Center for Heart, Lung and Vessel Diseases, Beijing Anzhen Hospital, Capital University of Medical Sciences, Beijing 100029, China.
Chin Med J (Engl). 2007 Apr 5;120(7):557-61.
Different feasible and safe thrombectomy and distal protection devices have been used in clinical practice. The efficiency and safety of adjunct thrombectomy using Diver CE device (Invatec, Italy) versus Guardwire Plus device (Medtronic, USA) before percutaneous coronary intervention (PCI) were compared in patients with acute inferior ST-segment-elevation myocardial infarction (STEMI) for less than 12 hours, thrombolysis in myocardial infarction (TIMI) flow grade 0 to 1, and total occlusion of the proximal right coronary artery (= 3 mm in diameter) in a prospective randomized single-center study.
The primary end point was the magnitude of ST-segment resolution (STR) (> 70%) measured immediately, 90 minutes and 6 hours after PCI, myocardial blush grade and slow flow or no-reflow. Secondary end points were left ventricular end-diastolic volume (LVEDV), left ventricle ejection fraction (LVEF) and major adverse cardiac events (MACEs) including death, myocardial infarction, target vessel revascularization and stroke at 30 days.
A total of 122 patients were equally divided into Diver CE group and Guardwire Plus group, which were comparable by age ((60 +/- 14) years vs (60 +/- 13) years), male (82% vs 84%), diabetes (31% vs 28%), previous coronary artery disease (25% vs 23%), onset-to-angiogram ((350 +/- 185) min vs (345 +/- 180) min), and use of glycoprotein IIb/IIIa inhibitor (11% vs 13%). The magnitude of ST-segment resolution was similar in the two groups as ST-segment resolution > 70% (57% vs 59%; P > 0.05). Similar slow flow/no-reflow rates were observed in the Diver CE group (8%) and the Guardwire Plus group (7%). TIMI flow grade 3 was obtained in 95% vs 97% patients, respectively (P > 0.05). Myocardial blush grade 3 was similar (70% vs 72%; P > 0.05). Thirty-day clinical outcome was comparable (LVEF, 0.54 +/- 0.12 vs 0.53 +/- 0.11; death, 3% vs 3%; myocardial infarction, 2% vs 0%; and target vessel revascularization, 2% vs 2%; P > 0.05, respectively).
Removal of thrombus burden with the Diver CE catheter before stenting leads to similar improvement of myocardial reperfusion in patients with inferior STEMI and total occlusion of the proximal right coronary artery (= 3 mm in diameter) compared with the Guardwire Plus device, as illustrated by a reduced risk of distal embolization and improved ST-segment resolution.
在临床实践中已使用了不同的可行且安全的血栓切除术及远端保护装置。在一项前瞻性随机单中心研究中，对急性下壁ST段抬高型心肌梗死（STEMI）发病时间小于12小时、心肌梗死溶栓（TIMI）血流分级为0至1级且近端右冠状动脉完全闭塞（直径≥3 mm）的患者，比较了在经皮冠状动脉介入治疗（PCI）前使用Diver CE装置（意大利Invatec公司）与Guardwire Plus装置（美国美敦力公司）进行辅助血栓切除术的效率和安全性。
主要终点为PCI术后即刻、90分钟及6小时测量的ST段回落幅度（STR）（>70%）、心肌显影分级以及慢血流或无复流情况。次要终点为左心室舒张末期容积（LVEDV）、左心室射血分数（LVEF）以及30天时的主要不良心脏事件（MACE），包括死亡、心肌梗死、靶血管血运重建和卒中。
总共122例患者被平均分为Diver CE组和Guardwire Plus组，两组在年龄（（60±14）岁对（60±13）岁）、男性比例（82%对84%）、糖尿病（31%对28%）、既往冠状动脉疾病（25%对23%）、发病至血管造影时间（（350±185）分钟对（345±180）分钟）以及糖蛋白IIb/IIIa抑制剂使用情况（11%对13%）方面具有可比性。两组的ST段回落幅度相似，ST段回落>70%的比例分别为57%和59%（P>0.05）。Diver CE组（8%）和Guardwire Plus组（7%）的慢血流/无复流率相似。TIMI血流3级分别在95%和97%的患者中获得（P>0.05）。心肌显影3级相似（70%对72%；P>0.05）。30天临床结局具有可比性（LVEF，0.54±0.12对0.53±0.11；死亡，3%对3%；心肌梗死，2%对0%；靶血管血运重建，2%对2%；P均>0.05）。
与Guardwire Plus装置相比，在支架置入前使用Diver CE导管清除血栓负荷，在患有下壁STEMI且近端右冠状动脉完全闭塞（直径≥3 mm）的患者中，可使心肌再灌注得到相似改善，表现为远端栓塞风险降低和ST段回落改善。
