Key result
Sonothrombolysis more than doubles pre-PCI angiographic recanalization to 48% vs PCI alone in STEMI.
Why the study?
Does sonothrombolysis added to primary PCI improve recanalization rates and reduce infarct size in patients with first STEMI?
RCT (n=303)
randomized
Does sonothrombolysis added to primary PCI improve recanalization rates and reduce infarct size in patients with first STEMI?
Absolute Event Rate: 48% vs 20%
p-value: p=<0.001
Sonothrombolysis using high mechanical index impulses and intravenous microbubbles added to primary PCI improves pre-PCI recanalization, reduces infarct size, and improves systolic function in patients with first STEMI.
BACKGROUND Preclinical studies have demonstrated that high mechanical index (MI) impulses from a diagnostic ultrasound transducer during an intravenous microbubble infusion (sonothrombolysis) can restore epicardial and microvascular flow in acute ST-segment elevation myocardial infarction (STEMI). OBJECTIVES This study tested the clinical effectiveness of sonothrombolysis in patients with STEMI. METHODS Patients with their first STEMI were prospectively randomized to either diagnostic ultrasound-guided high MI impulses during an intravenous Definity (Lantheus Medical Imaging, North Billerica, Massachusetts) infusion before, and following, emergent percutaneous coronary intervention (PCI), or to a control group that received PCI only (n = 50 in each group). A reference first STEMI group (n = 203) who arrived outside the randomization window was also analyzed. Angiographic recanalization before PCI, ST-segment resolution, infarct size by magnetic resonance imaging, and systolic function (LVEF) at 6 months were compared. RESULTS ST-segment resolution occurred in 16 (32%) high MI PCI versus 2 (4%) PCI-only patients before PCI, and angiographic recanalization was 48% in high MI/PCI versus 20% in PCI only and 21% in the reference group (p < 0.001). Infarct size was reduced (29 ± 22 g high MI/PCI vs. 40 ± 20 g PCI only; p = 0.026). LVEF was not different between groups before treatment (44 ± 11% vs. 43 ± 10%), but increased immediately after PCI in the high MI/PCI group (p = 0.03), and remained higher at 6 months (p = 0.015). Need for implantable defibrillator (LVEF ≤30%) was reduced in the high MI/PCI group (5% vs. 18% PCI only; p = 0.045). CONCLUSIONS Sonothrombolysis added to PCI improves recanalization rates and reduces infarct size, resulting in sustained improvements in systolic function after STEMI. (Therapeutic Use of Ultrasound in Acute Coronary Artery Disease; NCT02410330).
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Mathias et al. (2019) conducted an RCT in ST-segment elevation myocardial infarction (STEMI) (n=303). Sonothrombolysis (diagnostic ultrasound-guided high MI impulses during intravenous microbubble infusion) vs. PCI only was evaluated on Angiographic recanalization before PCI (p=<0.001). Sonothrombolysis added to PCI significantly improved angiographic recanalization before PCI (48% vs 20%; P<0.001) and reduced infarct size compared to PCI alone in patients with first STEMI.