Sydney Medical School Nepean, Faculty of Medicine and Health, Charles Perkins Centre Nepean, The University of Sydney, New South Wales, Australia; Department of Cardiology, Nepean Hospital, Sydney, New South Wales, Australia.
Sydney Medical School Nepean, Faculty of Medicine and Health, Charles Perkins Centre Nepean, The University of Sydney, New South Wales, Australia; Department of Cardiology, Nepean Hospital, Sydney, New South Wales, Australia; Department of Medical Imaging, Nepean Hospital, Sydney, New South Wales, Australia.
J Am Soc Echocardiogr. 2024 Oct;37(10):996-1007. doi: 10.1016/j.echo.2024.06.019. Epub 2024 Jul 8.
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.
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.
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.
Pre-pPCI sonothrombolysis may be key to improving MSI in STEMI. Multicenter trials and health economic analyses are required before clinical translation.
超声溶栓是一种利用超声对比剂治疗 ST 段抬高型心肌梗死（STEMI）的治疗应用。最近的试验表明，在直接经皮冠状动脉介入治疗（pPCI）前后进行超声溶栓可以增加梗死血管的通畅性，改善微血管血流，减少梗死面积，并提高射血分数。然而，目前尚不清楚 pPCI 前的超声溶栓是否对治疗有益。我们设计了一项平行的 3 臂假对照随机对照试验来解决这个问题。
符合纳入标准的首次 STEMI 患者，发病 6 小时内接受 pPCI，按 1:1:1 随机分为 3 组：pPCI 前/后超声溶栓组（第 1 组）、pPCI 前假超声溶栓后组（第 2 组）和 pPCI 前/后假治疗组（第 3 组）。我们的主要终点是通过心脏磁共振成像在第 4 天±2 天评估的梗死面积（左心室质量的百分比）。次要终点包括第 4 天±2 天和 6 个月的心肌挽救指数（MSI）和超声心动图参数。
由于 COVID 大流行，我们的试验提前停止。在 2020 年 9 月至 2021 年 6 月期间筛选的 122 名患者中，有 51 名（年龄 60 岁，男性 82%）在随机分组后入组。中位超声溶栓时间为 pPCI 前 5 分钟，pPCI 后 15 分钟，无明显门球时间延迟。第 1 组（8%[四分位距 4,11]）、第 2 组（11%[7,19]）或第 3 组（15%[9,22]）的中位梗死面积有减少的趋势。同样，与第 2 组（51%[45,70]）和第 3 组（48%[37,73]）相比，第 1 组（79%[64,85]）的 MSI 有改善的趋势。住院期间无重大不良心脏事件发生。
pPCI 前的超声溶栓可能是改善 STEMI 患者 MSI 的关键。在临床转化之前，需要进行多中心试验和健康经济学分析。
