Division of Cardiology, Careggi Hospital, Florence, Italy.
Circ Cardiovasc Interv. 2013 Jun;6(3):224-30. doi: 10.1161/CIRCINTERVENTIONS.112.000172. Epub 2013 Jun 4.
Manual thrombus aspiration (MTA) is completely ineffective in 30% of cases, and the high profiles of the catheters prevent their use in tortuous and calcified vessels. The rheolytic thrombectomy (RT) device has the potential for improved thrombus removal in acute myocardial infarction as compared with MTA. No data exist on the comparison between the 2 techniques.
Randomized study, including 80 acute myocardial infarction patients allocated to RT or MTA before infarct artery stenting. Primary end point of this study is residual thrombus burden by optical coherence tomography. Secondary end points are (1) residual thrombolysis in myocardial infarction thrombus grade; (2) postintervention thrombolysis in myocardial infarction flow and myocardial blush; (3) early ST-segment resolution; (4) percentage of malapposed stent struts at 6 months; (5) 6-month restenosis; and (6) 6-month major adverse cardiovascular events. All but 1 patient had residual thrombus after manual aspiration thrombectomy or RT. The number of optical coherence tomography quadrants containing thrombus in MTA arm was higher than in the RT arm, but this difference did not reach significance (median value 65 and 53, respectively; P=0.083). Large residual thrombus was more frequently revealed in the manual aspiration thrombectomy arm (patients with number of quadrants above the median value 60% in the manual aspiration thrombectomy arm and 37% in the RT arm, P=0.039). All markers of reperfusion were better in the RT arm. At 6 months, the percentage of malapposed stent struts in the MTA arm was higher than in the RT arm (2.7±4.5% and 0.8±1.6%, respectively; P=0.019).
MTA or RT allows only incomplete removal of thrombus in patients with acute myocardial infarction. The primary end point of the study was not met. However, RT as compared with MTA seems to be more effective in thrombus removal and myocardial reperfusion.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01281033.
手动血栓抽吸术(MTA)在 30%的病例中完全无效,并且导管的高轮廓阻止其在迂曲和钙化的血管中使用。与 MTA 相比,旋切血栓切除术(RT)装置在急性心肌梗死中具有更好的血栓清除潜力。目前尚无这两种技术比较的数据。
这项研究纳入了 80 例急性心肌梗死患者,随机分为 RT 组或 MTA 组,在梗死动脉支架置入术前进行。本研究的主要终点是光学相干断层扫描(OCT)检测的残余血栓负荷。次要终点包括:(1)残余血栓溶解心肌梗死血栓分级;(2)介入后心肌梗死溶栓血流和心肌灌注;(3)早期 ST 段缓解;(4)6 个月时支架贴壁不良比例;(5)6 个月时再狭窄;(6)6 个月时主要不良心血管事件。除 1 例患者外,所有患者在手动抽吸血栓切除术或 RT 后均存在残余血栓。在 MTA 组中,OCT 检测到的含有血栓的象限数量高于 RT 组,但差异无统计学意义(中位数分别为 65 和 53;P=0.083)。手动抽吸血栓切除术组中更常发现大量残余血栓(中位数象限数大于 60%的患者占手动抽吸血栓切除术组的 60%,而 RT 组为 37%,P=0.039)。RT 组所有再灌注标志物均较好。6 个月时,MTA 组支架贴壁不良比例高于 RT 组(分别为 2.7±4.5%和 0.8±1.6%;P=0.019)。
在急性心肌梗死患者中,MTA 或 RT 仅能部分清除血栓。研究的主要终点未达到。然而,与 MTA 相比,RT 在血栓清除和心肌再灌注方面似乎更有效。