Bottom line
- Excellent bypass graft patency and improved cerebral hemodynamics
- 98% at the 30 day post-operative
- STA-MCA anastomosis did not provide an overall benefit on ipsilateral two-year stroke recurrence, mainly due to a much better than expected stroke recurrence rate (22.7%) in the medical group in the trial, but also because of a significant peri-operative stroke rate (15%)
- Stopped prematurely due to high perioperative stroke rates.
Design
- Prospective, 1:1 randomized, open-label, blinded-adjudication treatment trial
- N
- Surgical group (n97)
- 92 STA-MCA bypass
- 1 OA-MCA bypass
- Non-surgical group (n98)
Aim
- To determine if superficial temporal artery-middle cerebral artery (STA-MCA) bypass, when added to the best medical therapy, would reduce subsequent ipsilateral stroke in patients with complete internal carotid artery (ICA) occlusion and an elevated oxygen extraction fraction (OEF) in the cerebral hemisphere distal to the occlusion.
Surgical technique
- STA-MCA cortical branch anastomosis.
- If the STA was not suitable for anastomosis to the MCA, the occipital artery (OA) could be used in place of the STA.
- All surgical patients were placed on 81 mg or 325 mg of aspirin daily prior to the bypass procedure.
- Surgeons decision
- All other peri-operative issues, such as anticonvulsants, antibiotics, choice of anesthetic agents, intraoperative hemodynamic monitoring and peri-operative fluid loading were left to the discretion of the operating surgeon.
- Details of the surgical technique used for the STAMCA anastomosis, such as using running or interrupted 10-0 prolene or nylon sutures, a straight or elliptical incision in the MCA cortical branch, and preparation of the STA graft, were left to the discretion of the operating surgeon.
- The STA-MCA cortical branch anastomosis was done using the best STA branch and the best MCA cortical branch.
- Only one anastomosis was done.
- Following surgery, all patients were left on 81 mg or 325 mg of aspirin for at least 30 days.
- Thereafter, when deemed appropriate by their neurosurgeon, patients were returned to the anti-thrombotic treatment preferred by their physicians.
- Doppler ultrasound examination was used to determine post-operative STA-MCA bypass patency at follow-up visits.
Exclusion
- Patients with an “unsuitable” STA (diameter < 1 mm) were excluded from the study.
- Complete occlusion of an ICA
- TIA or ischemic stroke in the hemispheric territory of an occluded internal carotid artery in the preceding 120 days
Outcome
- Trial was terminated early for futility.
- Primary end point: (1) all stroke and death from surgery through 30 days after surgery or 30 days after randomization for nonsurgical and (2) ipsilateral ischemic stroke within 2 years of randomization.
- 98% bypass patency rate at the 30 day post-operative visit.
- Mean Oxygen Extraction Fraction ratio in the surgical group improved from 1.258 at baseline to 1.109 at the 30-60 day post-operative repeat PET scan
- High 15% stroke rate within 30 days in surgical group
Made with Bullet