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血栓抽吸后直接支架置入术:ST 段抬高型心肌梗死患者行直接经皮冠状动脉介入治疗的一种新策略。波兰-意大利-匈牙利随机血栓切除术试验(PIHRATE 试验)的结果。

Thrombus aspiration followed by direct stenting: a novel strategy of primary percutaneous coronary intervention in ST-segment elevation myocardial infarction. Results of the Polish-Italian-Hungarian RAndomized ThrombEctomy Trial (PIHRATE Trial).

机构信息

Department of Interventional Cardiology Jagiellonian University Medical College, Krakow, Poland.

出版信息

Am Heart J. 2010 Nov;160(5):966-72. doi: 10.1016/j.ahj.2010.07.024.

DOI:10.1016/j.ahj.2010.07.024
PMID:21095287
Abstract

BACKGROUND

Previous studies with thrombectomy showed different results, mainly due to use of thrombectomy as an additional device not instead of balloon predilatation. The aim of the present study was to assess impact of aspiration thrombectomy followed by direct stenting.

METHODS

Patients with ST elevation myocardial infarction (STEMI) <6 hours from pain onset and occluded infarct-related artery in baseline angiography were randomized into aspiration thrombectomy followed by direct stenting (TS, n = 100) or standard balloon predilatation followed by stent implantation (n = 96). The primary end point of the study was the electrocardiographic ST-segment elevation resolution >70% (STR > 70%) 60 minutes after primary angioplasty (percutaneous coronary intervention [PCI]). Secondary end points included angiographic myocardial blush grade (MBG) after PCI, combination of STR > 70% immediately after PCI and MBG grade 3 (optimal myocardial reperfusion), Thrombolysis In Myocardial Infarction flow after PCI, angiographic complications, and in-hospital major adverse cardiac events.

RESULTS

Aspiration thrombectomy success rate was 91% (crossing of the lesion with thrombus reduction and flow restoration). There was no significant difference in STR ≥ 70% after 60 minutes (53.7% vs 35.1%, P = .29). STR > 70% immediately after PCI (41% vs 26%, P < .05), MBG grade 3 (76% vs 58%, P < .03), and optimal myocardial reperfusion (35.1% vs 11.8%, P < .001) were more frequent in TS. There was no difference in between the groups in 6-month mortality (4% vs 3.1%, P = .74) and reinfarction rate (1% vs 3.1%, P = .29).

CONCLUSIONS

Aspiration thrombectomy and direct stenting is safe and effective in STEMI patients with early presentation (<6 hours). The angiographic parameters of microcirculation reperfusion and ECG ST-segment resolution directly after PCI were significantly better in thrombectomy group despite the lack of the difference in ST-segment resolution 60 minutes after PCI.

摘要

背景

之前的血栓切除术研究结果不同,主要是因为将血栓切除术作为一种额外的设备使用,而不是替代球囊预扩张。本研究旨在评估抽吸血栓切除术联合直接支架置入术的效果。

方法

胸痛发作后 6 小时内发生 ST 段抬高型心肌梗死(STEMI)且基线造影显示梗死相关动脉闭塞的患者被随机分为抽吸血栓切除术联合直接支架置入术(TS 组,n = 100)或标准球囊预扩张联合支架植入术(n = 96)。研究的主要终点是首次经皮冠状动脉介入治疗(PCI)后 60 分钟心电图 ST 段抬高幅度≥70%(STR≥70%)。次要终点包括 PCI 后的血管造影心肌染色分级(MBG)、即刻 PCI 后 STR≥70%和 MBG 分级 3(最佳心肌再灌注)、PCI 后的血栓溶解心肌梗死血流、血管造影并发症和住院期间主要不良心脏事件。

结果

抽吸血栓切除术成功率为 91%(病变通过,血栓减少,血流恢复)。60 分钟后 STR≥70%无显著差异(53.7% vs 35.1%,P =.29)。即刻 PCI 后 STR>70%(41% vs 26%,P<0.05)、MBG 分级 3(76% vs 58%,P<0.03)和最佳心肌再灌注(35.1% vs 11.8%,P<0.001)在 TS 组更为常见。两组间 6 个月死亡率(4% vs 3.1%,P =.74)和再梗死率(1% vs 3.1%,P =.29)无差异。

结论

对于早期(<6 小时)出现的 STEMI 患者,抽吸血栓切除术联合直接支架置入术是安全有效的。尽管 PCI 后 60 分钟时 ST 段分辨率无差异,但血栓切除术组的微血管再灌注和 PCI 后心电图 ST 段分辨率的血管造影参数直接改善更为明显。

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