Ikari Yuji, Sakurada Masami, Kozuma Ken, Kawano Shigeo, Katsuki Takaaki, Kimura Kazuo, Suzuki Takahiko, Yamashita Takehiro, Takizawa Akinori, Misumi Kazuo, Hashimoto Hideki, Isshiki Takaaki
Department of Cardiology, Tokai University School of Medicine, Isehara, Japan.
JACC Cardiovasc Interv. 2008 Aug;1(4):424-31. doi: 10.1016/j.jcin.2008.06.004.
This study evaluated safety and efficacy of upfront thrombus aspiration during primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI).
Distal embolization during primary PCI results in reduced myocardial perfusion and poor clinical outcomes.
The VAMPIRE (VAcuuM asPIration thrombus REmoval) study was a prospective, randomized, controlled multicenter trial conducted in 23 institutions. Patients (N = 355) presenting within 24 h of STEMI symptoms onset were randomized to primary PCI with (n = 180) or without (n = 175) upfront thrombus aspiration using Nipro's TransVascular Aspiration Catheter (Osaka, Japan).
The TransVascular Aspiration Catheter reached the lesion in 100% of cases. It successfully crossed the target obstruction in 86% without any delay in procedure time or time to reperfusion; whereas macroscopic thrombi were removed in 75% of the cases. Procedure success was similar between groups (98.9% vs. 98.3%). There was a trend toward lower incidence of slow or no reflow (primary end point-defined as a Thrombolysis In Myocardial Infarction flow grade <3) in patients treated with aspiration versus conventional primary PCI (12.4% vs. 19.4%, p = 0.07). Rate of myocardial blush grade 3 was higher in the aspiration group (46.0% vs. 20.5%, p < 0.001). Aspiration was most effective in patients presenting after 6 h of symptoms onset (slow flow rate: 8.1% vs. 37.6%, p = 0.01).
This study suggested the safety of primary PCI with upfront thrombectomy using a novel device in patients with STEMI. The study showed a trend toward improved myocardial perfusion and lower clinical events in patients treated with aspiration. Patients presenting late after STEMI appear to benefit the most from thrombectomy.
本研究评估了直接血栓抽吸术在ST段抬高型心肌梗死(STEMI)患者直接经皮冠状动脉介入治疗(PCI)中的安全性和有效性。
直接PCI期间的远端栓塞会导致心肌灌注减少和临床预后不良。
VAMPIRE(真空抽吸血栓清除)研究是一项在23个机构进行的前瞻性、随机、对照多中心试验。STEMI症状发作后24小时内就诊的患者(N = 355)被随机分为接受使用日本大阪Nipro公司的经血管抽吸导管进行直接血栓抽吸术的直接PCI组(n = 180)和不进行直接血栓抽吸术的直接PCI组(n = 175)。
经血管抽吸导管在100%的病例中到达病变部位。它在86%的病例中成功穿过目标阻塞部位,且未导致手术时间或再灌注时间出现任何延迟;而75%的病例中清除了肉眼可见的血栓。两组的手术成功率相似(98.9%对98.3%)。与传统直接PCI相比,接受抽吸术治疗的患者出现慢血流或无复流(主要终点定义为心肌梗死溶栓血流分级<3)的发生率有降低趋势(12.4%对19.4%,p = 0.07)。抽吸组心肌显影3级的比例更高(46.0%对20.5%,p < 0.001)。抽吸术在症状发作6小时后就诊的患者中效果最为显著(慢血流发生率:8.1%对37.6%,p = 0.01)。
本研究表明在STEMI患者中使用新型装置进行直接PCI联合直接血栓切除术是安全的。该研究显示接受抽吸术治疗的患者心肌灌注有改善趋势且临床事件减少。STEMI发病较晚就诊的患者似乎从血栓切除术中获益最大。