Bradenton Cardiology Center, Manatee Memorial Hospital, FL (S.J.M.).
Columbia University Irving Medical Center, New York, NY (S.A.P.).
Circ Cardiovasc Interv. 2023 Feb;16(2):e012433. doi: 10.1161/CIRCINTERVENTIONS.122.012433. Epub 2023 Feb 21.
Poor myocardial reperfusion due to distal embolization and microvascular obstruction after percutaneous coronary intervention is associated with increased risk of morbidity and mortality. Prior trials have not shown a clear benefit of routine manual aspiration thrombectomy. Sustained mechanical aspiration may mitigate this risk and improve outcomes. The objective of this study is to evaluate sustained mechanical aspiration thrombectomy before percutaneous coronary intervention in high thrombus burden acute coronary syndrome patients.
This prospective study evaluated the Indigo CAT RX Aspiration System (Penumbra Inc, Alameda CA) for sustained mechanical aspiration thrombectomy before percutaneous coronary intervention at 25 hospitals across the USA. Adults presenting within 12 hours of symptom onset with high thrombus burden and target lesion(s) located in a native coronary artery were eligible. The primary end point was a composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening New York Heart Association class IV heart failure within 30 days. Secondary end points included Thrombolysis in Myocardial Infarction thrombus grade, Thrombolysis in Myocardial Infarction flow, myocardial blush grade, stroke, and device-related serious adverse events.
From August 2019 through December 2020, a total of 400 patients were enrolled (mean age 60.4 years, 76.25% male). The primary composite end point rate was 3.60% (14/389 [95% CI, 2.0-6.0%]). Rate of stroke within 30 days was 0.77%. Final rates of Thrombolysis in Myocardial Infarction thrombus grade 0, Thrombolysis in Myocardial Infarction flow 3, and myocardial blush grade 3 were 99.50%, 97.50%, and 99.75%, respectively. No device-related serious adverse events occurred.
Sustained mechanical aspiration before percutaneous coronary intervention in high thrombus burden acute coronary syndrome patients was safe and was associated with high rates of thrombus removal, flow restoration, and normal myocardial perfusion on final angiography.
经皮冠状动脉介入治疗后由于远端栓塞和微血管阻塞导致的心肌再灌注不良与发病率和死亡率增加相关。先前的试验并未显示常规手动抽吸血栓切除术的明确益处。持续机械抽吸可能会降低这种风险并改善结果。本研究的目的是评估在高血栓负荷急性冠状动脉综合征患者中行经皮冠状动脉介入治疗前持续机械抽吸血栓切除术的效果。
本前瞻性研究在美国 25 家医院评估了 Indigo CAT RX 抽吸系统（Penumbra Inc，加利福尼亚州阿拉米达）在经皮冠状动脉介入治疗前进行持续机械抽吸血栓切除术的效果。符合条件的患者为发病 12 小时内、血栓负荷高且靶病变位于原生冠状动脉内的成年患者。主要终点为 30 天内心血管死亡、再发心肌梗死、心源性休克或新发或恶化的纽约心脏协会（NYHA）心功能分级Ⅳ级心力衰竭的复合终点。次要终点包括血栓溶解心肌梗死（TIMI）血栓分级、TIMI 血流分级、心肌灌注分级、卒中和器械相关严重不良事件。
2019 年 8 月至 2020 年 12 月，共纳入 400 例患者（平均年龄 60.4 岁，76.25%为男性）。主要复合终点发生率为 3.60%（14/389 [95%CI，2.0-6.0%]）。30 天内卒中发生率为 0.77%。最终 TIMI 血栓分级 0 级、TIMI 血流分级 3 级和心肌灌注分级 3 级的发生率分别为 99.50%、97.50%和 99.75%。未发生器械相关严重不良事件。
在高血栓负荷急性冠状动脉综合征患者中行经皮冠状动脉介入治疗前持续机械抽吸血栓切除术是安全的，与血栓清除率高、血流恢复和最终血管造影正常心肌灌注相关。
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