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GALA Results Funding: Health Foundation, ESVS 3526 randomised (95 centres, 24 countries) GA LA 1753 allocated: 1628 GA 31 no anaesthesia - 92 cross-over 2 unknown 1773 allocated: 1655 LA 41 no anaesthesia - 75 cross-over 2 unknown 1752 for primary outcome 1771 for primary outcome 21 incomplete FU 19 no 1m physician form 21 incomplete FU 19 no 1m physician form Funding: Health Foundation, ESVS Baseline Data General Local 70 (sd 9) 69 (sd 9) Mean sys. BP (mmHG) 145 (sd 20) 145 (sd 20) Male 1232 (70%) 1256 (71%) Peripheral arterial disease 425 (24%) 446 (25%) Coronary heart disease 647 (37%) 627 (35%) Atrial fibrillation 124 (7%) 111 (6%) Diabetes 435 (25%) 437 (25%) Current/ex smoker 1403 (80%) 1416 (80%) Mean age (yrs) Funding: Health Foundation, ESVS Baseline Data (continued) General Local Asymptomatic carotid stenosis 685 (39%) 677 (38%) Mean % stenosis in artery for operation 81 (sd 11) 81 (sd 11) Contralateral carotid occlusion 150 (9%) 160 (9%) Funding: Health Foundation, ESVS Compliance – No Anaesthesia General (n=31) Local (n=41) Death before operation 1 1 Stroke before operation 1 1 Carotid artery occlusion 8 8 Too ill (unrelated to carotid disease) 7 6 Stenosis/symptoms too mild 4 11 Patient refused 9 13 Carotid stent instead 1 1 Reasons: Funding: Health Foundation, ESVS Compliance – Cross-overs General (n=92) Local (n=75) Medical decision 41 20 Administrative issues 15 9 Patient’s decision 29 44 Reason unknown 7 2 Reasons: Funding: Health Foundation, ESVS Conversions After Start of Anaesthesia After start of anaesthesia but pre-surgery N=17 Patient’s decision 6 Problem with position on table etc 3 Patient deteriorated after local block 8 After start of surgery N=52 Pain at operative site 9 Discomfort, anxiety, claustrophobia 25 Physiological instability 5 Protracted or difficult surgery 6 Neurological deterioration on cross-clamping 7 Funding: Health Foundation, ESVS 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 Funding: Health Foundation, ESVS Cranial nerve injuries & Wound haematoma General Local Cranial nerve injuries 184 (11%) 213 (12%) Wound haematoma 146 (8%) 150 (8%) Wound haematoma requiring reoperation 45 (3%) 40 (2%) Funding: Health Foundation, ESVS 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 Funding: Health Foundation, ESVS Primary outcome events 5% 4% 10 4 5 9 3% 2% 70 66 General Local 84/1752 (4.8%) 80/1771 (4.5%) 1% 0% Funding: Health Foundation, ESVS Other deaths MI (fatal or non-fatal) Stroke (fatal or non-fatal) 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 Funding: Health Foundation, ESVS Favours Local Survival analysis 14% . P=0.094 12% % of patients with event General Local 10% 8% 6% 4% 2% 0% Months since randomisation 0 6 Number at risk: General 1752 Local 1771 Funding: Health Foundation, ESVS 1241 1269 12 736 751 Length of Stay General Local Median days from admission to discharge 4 (IQR 3,7) 4 (IQR 3,6) Went to recovery room 1096 (70%) 1081 (69%) Mean hours in recovery room (across all pts admitted) 4.4 (sd 15) 3.8 (sd 10) Went to ITU 377 (24%) 340 (22%) Mean hours in ITU (across all pts admitted) 6.7 (sd 37) 5.2 (sd 14) Went to HDU 529 (34%) 542 (35%) Mean hours in HDU (across all pts admitted) 8.4 (sd 16) 8.2 (sd 15) Funding: Health Foundation, ESVS Quality of Life (UK patients) Values shown are mean (sd) General Local EuroQol utility 0.7 (0.3) 0.7 (0.3) SF-36 physical functioning 54 (30) 56 (29) Role function, physical 33 (41) 33 (41) Role function, emotional 53 (46) 56 (45) Social functioning 67 (30) 69 (30) Mental health 72 (22) 72 (21) Energy/vitality 48 (23) 49 (23) Pain 66 (27) 67 (27) General health perception 59 (23) 60 (23) Funding: Health Foundation, ESVS Subgroups (primary outcome) Subgroup General Local (%) (%) P Contralateral carotid occlusion Yes No 10.0% 5.0% 4.3% 4.5% 0.098 Age (years) >75 <=75 5.3% 4.6% 4.6% 4.5% 0.741 Baseline surgical High risk Medium Low 4.1% 4.6% 5.1% 4.9% 4.7% 4.2% 0.933 0.1 1 10 Odds ratio and 95% Confidence interval Favours LA Funding: Health Foundation, ESVS Favours GA Implications of GALA Stroke & Death OR (95% CI) Meta-analysis of 7 earlier trials 0.62 (0.24 to 1.59) GALA 0.88 (0.64 to 1.23) Meta-analysis including GALA 0.85 (0.63 to 1.16) 0.1 1 Favours Local Funding: Health Foundation, ESVS 10 Favours General