Sonolysis in risk reduction of symptomatic and silent brain infarctions during coronary stenting (SONOREDUCE): Randomized, controlled trial

Int J Cardiol. 2018 Sep 15:267:62-67. doi: 10.1016/j.ijcard.2018.05.101. Epub 2018 May 26.

Abstract

Background: Silent brain infarcts can be detected on magnetic resonance imaging (MRI) in ~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 differences were 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.

Keywords: Angioplasty; Coronary artery; Ischemic lesion; Sonolysis; Stenting; Stroke.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / adverse effects*
  • Angioplasty, Balloon, Coronary / methods
  • Asymptomatic Diseases
  • Brain / diagnostic imaging
  • Brain Infarction* / diagnosis
  • Brain Infarction* / etiology
  • Brain Infarction* / physiopathology
  • Brain Infarction* / psychology
  • Cognition
  • Elective Surgical Procedures / adverse effects
  • Elective Surgical Procedures / methods
  • Female
  • Humans
  • Magnetic Resonance Imaging / methods
  • Male
  • Middle Aged
  • Neurologic Examination / methods
  • Postoperative Complications* / diagnosis
  • Postoperative Complications* / etiology
  • Postoperative Complications* / physiopathology
  • Postoperative Complications* / psychology
  • Risk Assessment
  • Thrombolytic Therapy* / adverse effects
  • Thrombolytic Therapy* / methods
  • Treatment Outcome
  • Ultrasonic Therapy* / adverse effects
  • Ultrasonic Therapy* / methods