Hypothesis
- STA-MCA cortical branch anastomosis, in addition to best medical therapy, could significantly reduce subsequent ischemic events in patients with recently symptomatic hemodynamic cerebral ischemia from chronic occlusive lesions of the ICA or MCA.
Inclusion
- Hemodynamic cerebral ischemia was determined by measuring MCA perfusion at rest and, following acetazolamide administration, with 3D quantitative blood flow measurements (for example, PET, SPECT, or Xe CT).
- These patients with at least Stage I hemodynamic impairment were randomized to receive surgery plus medical therapy or medical therapy alone.
- Patient randomization was further dichotomized based on hemodynamic response to acetazolamide (for example, moderate or severe cerebral ischemia).
Design
- RCT
- N196
- Surgery (EC-IC bypass) + best medical therapy: 98
- Best medical therapy: 98
Outcome
- Surgical patients experienced a significant reduction in the study's primary end point (major stroke or death in the 2-year period after surgery) as compared with the medical patients with a mean follow-up period of 15 months (5.1% vs 14.3%, respectively; p = 0.046).
- Examination of the published Kaplan-Meier curves from the second interim analysis of JET shows no end points within the 1st month in the surgical group.
- There is no explicit mention whether the results include the 30-day postoperative morbidity and mortality rate, but it seems unlikely that this rate was 0 given that it was 12% in the original EC-IC bypass trial and 15% in COSS.
- We are not aware of publication of the final JET results.