The CardioVascular Center, Tufts Medical Center, Boston, MA (N.K.K., R.H.K., C.D.K., J.E.U.).
West Virginia University Heart and Vascular Institute, Morgantown (M.A.A., J.A.M.).
Circulation. 2019 Jan 15;139(3):337-346. doi: 10.1161/CIRCULATIONAHA.118.038269.
In ST-segment-elevation myocardial infarction (STEMI), infarct size correlates directly with heart failure and mortality. Preclinical testing has shown that, in comparison with reperfusion alone, mechanically unloading the left ventricle (LV) before reperfusion reduces infarct size and that 30 minutes of unloading activates a cardioprotective program that limits reperfusion injury. The DTU-STEMI pilot trial (Door-To-Unload in STEMI Pilot Trial) represents the first exploratory study testing whether LV unloading and delayed reperfusion in patients with STEMI without cardiogenic shock is safe and feasible.
In a multicenter, prospective, randomized exploratory safety and feasibility trial, we assigned 50 patients with anterior STEMI to LV unloading by using the Impella CP followed by immediate reperfusion (U-IR) versus delayed reperfusion after 30 minutes of unloading (U-DR). The primary safety outcome was a composite of major adverse cardiovascular and cerebrovascular events at 30 days. Efficacy parameters included the assessment of infarct size by using cardiac magnetic resonance imaging.
All patients completed the U-IR (n=25) or U-DR (n=25) protocols with respective mean door-to-balloon times of 72 versus 97 minutes. Major adverse cardiovascular and cerebrovascular event rates were not statistically different between the U-IR versus U-DR groups (8% versus 12%, respectively, P=0.99). In comparison with the U-IR group, delaying reperfusion in the U-DR group did not affect 30-day mean infarct size measured as a percentage of LV mass (15±12% versus 13±11%, U-IR versus U-DR, P=0.53).
We report that LV unloading using the Impella CP device with a 30-minute delay before reperfusion is feasible within a relatively short time period in anterior STEMI. The DTU-STEMI pilot trial did not identify prohibitive safety signals that would preclude proceeding to a larger pivotal study of LV unloading before reperfusion. An appropriately powered pivotal trial comparing LV unloading before reperfusion to the current standard of care is required.
URL: https://www.clinicaltrials.gov . Unique identifier: NCT03000270.
在 ST 段抬高型心肌梗死（STEMI）中，梗死面积与心力衰竭和死亡率直接相关。临床前试验表明，与单纯再灌注相比，在再灌注前机械卸载左心室（LV）可减少梗死面积，并且 30 分钟的卸载可激活一种限制再灌注损伤的心脏保护程序。DTU-STEMI 试验（STEMI 试验中的门到卸载试验）是第一项探索性研究，旨在测试在没有心源性休克的 STEMI 患者中，LV 卸载和延迟再灌注是否安全可行。
在一项多中心、前瞻性、随机探索性安全性和可行性试验中，我们将 50 例前壁 STEMI 患者随机分为两组，一组采用 Impella CP 进行 LV 卸载，然后立即再灌注（U-IR），另一组在卸载 30 分钟后再进行再灌注（U-DR）。主要安全性结局是 30 天内主要不良心血管和脑血管事件的复合事件。疗效参数包括心脏磁共振成像评估梗死面积。
所有患者均完成了 U-IR（n=25）或 U-DR（n=25）方案，门球时间分别为 72 分钟和 97 分钟。U-IR 组与 U-DR 组的主要不良心血管和脑血管事件发生率无统计学差异（分别为 8%和 12%，P=0.99）。与 U-IR 组相比，U-DR 组延迟再灌注并未影响 30 天平均梗死面积（U-IR 组为 15±12%，U-DR 组为 13±11%，P=0.53）。
我们报告称，在前壁 STEMI 中，使用 Impella CP 装置进行 LV 卸载并在 30 分钟后再进行再灌注是可行的，且在相对较短的时间内完成。DTU-STEMI 试验未发现会阻止进行更大规模的前负荷 LV 卸载与再灌注对照研究的禁忌安全性信号。需要进行一项比较 LV 卸载与再灌注与当前标准治疗的、适当功率的关键性试验。
网址：https://www.clinicaltrials.gov 。独特标识符：NCT03000270。
