背景:超声溶栓是超声与超声造影对ST段抬高型心肌梗死(STEMI)患者的治疗应用。最近的试验表明,超声溶栓,直接经皮冠状动脉介入治疗(pPCI)前后分娩,增加梗死血管通畅,改善微血管流量,减少梗死面积,提高射血分数。然而,目前尚不清楚pPCI术前超声溶栓是否对治疗获益至关重要.我们设计了一项平行的三臂假对照随机对照试验来解决这个问题。
方法:在症状发作后6小时内首次接受pPCI的STEMI患者按1:1:1随机分为三组:pPCI前/后超声溶栓(第1组),pPCI术后假超声溶栓术前(第2组),和假pPCI前/后(组3)。我们的主要终点是第4±2天通过心脏MRI评估的梗死面积(%LV质量)。次要终点包括第4±2天和第6个月时的心肌抢救指数(MSI)和超声心动图参数。
结果:由于COVID大流行,我们的试验提前停止。在2020年9月至2021年6月期间筛查的122名患者中,51名患者(年龄60岁,男性82%)被纳入随机分组后。中位超声溶栓在pPCI前5分钟和后15分钟,没有明显的门到气球延迟。第1组(8%[IQR4,11])之间的中位梗死面积有减少的趋势,第2组(11%[7,19])或第3组(15%[9,22])。类似地,与第2组(51%[45,70])和第3组(48%[37,73])相比,第1组(79%[64,85])中存在改善MSI的趋势,在住院期间没有发生重大不良心脏事件。
结论:pPCI前超声溶栓可能是改善STEMI患者MSI的关键。在临床翻译之前,需要进行多中心试验和卫生经济分析。
BACKGROUND: Sonothrombolysis is a therapeutic application of ultrasound with ultrasound contrast for patients with ST elevation myocardial infarction (STEMI). Recent trials demonstrated that
sonothrombolysis, delivered before and after primary percutaneous coronary intervention (pPCI), increases infarct vessel patency, improves microvascular flow, reduces infarct size, and improves ejection fraction. However, it is unclear whether pre-pPCI
sonothrombolysis is essential for therapeutic benefit. We designed a parallel 3-arm sham-controlled randomized controlled trial to address this.
METHODS: Patients presenting with first STEMI undergoing pPCI within 6 hours of symptom onset were randomized 1:1:1 into 3 arms: sonothrombolysis pre-/post-pPCI (group 1), sham pre-
sonothrombolysis post-pPCI (group 2), and sham pre-/post-pPCI (group 3). Our primary end point was infarct size (percentage of left ventricular mass) assessed by cardiac magnetic resonance imaging at day 4 ± 2. Secondary end points included myocardial salvage index (MSI) and echocardiographic parameters at day 4 ± 2 and 6 months.
RESULTS: Our trial was ceased early due to the COVID pandemic. From 122 patients screened between September 2020 and June 2021, 51 patients (age 60, male 82%) were included postrandomization. Median sonothrombolysis took 5 minutes pre-pPCI and 15 minutes post-, without significant door-to-balloon delay. There was a trend toward reduction in median infarct size between group 1 (8% [interquartile range, 4,11]), group 2 (11% [7, 19]), or group 3 (15% [9, 22]). Similarly there was a trend toward improved MSI in group 1 (79% [64, 85]) compared to groups 2 (51% [45, 70]) and 3 (48% [37, 73]) No major adverse cardiac events occurred during hospitalization.
CONCLUSIONS: Pre-pPCI
sonothrombolysis may be key to improving MSI in STEMI. Multicenter trials and health economic analyses are required before clinical translation.