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GALA Results. Baseline Data. Baseline Data (continued). Compliance – No Anaesthesia. Compliance – Cross-overs. Conversions After Start of Anaesthesia. Perioperative Adverse Events. 4 GA, 9 LA patients: anaesthesia initiated but no CEA: Randomised to GA:
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Perioperative Adverse Events • 4 GA, 9 LA patients: anaesthesia initiated but no CEA: • Randomised to GA: • Failure to intubate, severe bronchospasm after intubation, hypoxia with high BP, AF • Randomised to LA: • Cardiac event (patient received GA), chest pain, bradycardia, very high BP, vagal reaction followed by hypertension, • epileptic seizures, loss of consciousness (poss. because agent was injected into vertebral artery), • respiratory insufficiency due to presumed phrenic nerve blockade, • signs of cerebral ischaemia during awake testing
Primary Outcome • Stroke (including Retinal Infarction) • MI • Death within 30 days of anaesthesia • or within 30 days of randomisation for few patients who were not anaesthetised • Analysis intention-to-treat
5% 10 5 4 4% 9 Other deaths 3% MI (fatal or non-fatal) 2% 70 66 Stroke (fatal or non-fatal) 1% 0% General 84/1752 (4.8%) Local 80/1771 (4.5%) Primary outcome events
Stroke 3 (-10 to +16) MI -4 (-8 to +2) Death (any cause) 4 (-3 to +12) Stroke or death 4 (-9 to +18) Stroke, MI or death 3 (-11 to +17) -20 -10 0 10 20 Events prevented/1000 (95% CI) Favours General Favours Local Primary outcome events
OR (95% CI) 0.62 (0.24 to 1.59) 0.88 (0.64 to 1.23) 0.85 (0.63 to 1.16) Meta-analysis of 7 earlier trials GALA Meta-analysis including GALA Favours Local Favours General Implications of GALA Stroke & Death