Sonolysis in risk reduction of symptomatic and silent brain infarctions during coronary stenting (SONOREDUCE): Randomized, controlled trial
Abstract
Background: Silent brain infarcts can be detected on magnetic resonance imaging (MRI) in similar to 22% of patients after coronary angioplasty and stenting (CS). The effect of periprocedural sonolysis on the risk of new brain infarcts during CS was examined.
Methods: Patients undergoing elective CS were allocated randomly to a bilateral sonolysis group (70 patients, 58 men; mean age, 59.9 years) or a control group (74 patients, 45 men; mean age, 65.5 years). Neurologic examination, cognitive function tests, and brain MRI were performed prior to intervention and at 24 h after CS.
Neurologic examination and cognitive function tests were repeated at 30 days after CS. Results: No significant differenceswere observed in the number of patients with new infarcts (25.7 vs. 18.9%, P = 0.423), the number of lesions (1.3 +/- 1.0 vs. 2.9 +/- 5.3, P = 0.493), lesion volume (0.16 +/- 0.34 vs. 0.28 +/- 0.60 mL, P = 0.143), and the number of patients with new ischemic lesions in the insonated MCA territories (18.6vs. 17.6%, P = 0.958) between the sonolysis group and the control group.
There were no cases of stroke, transient ischemic attack, myocardial infarction, or death in the two groups. Intracranial bleeding was reported only in 1 patient in the control group (0 vs. 1.4%, P = 0.888).
Clock-drawing test scores at 30 days were significantly higher in the sonolysis group than in the control group (median 3.0 vs. 2.5, P = 0.031). Conclusions: Sonolysis does not reduce the risk of new brain infarcts after CS.
The effect of sonolysis on number and volume of ischemic lesions and cognitive function should be assessed in further studies.