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GALA Results

GALA Results

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GALA Results

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  1. GALA Results

  2. Baseline Data

  3. Baseline Data (continued)

  4. Compliance – No Anaesthesia

  5. Compliance – Cross-overs

  6. Conversions After Start of Anaesthesia

  7. 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

  8. Cranial nerve injuries &Wound haematoma

  9. 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

  10. 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

  11. 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

  12. Survival analysis

  13. Length of Stay

  14. Quality of Life (UK patients)Values shown are mean (sd)

  15. Subgroups (primary outcome)

  16. 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