GALATrialResults.pptVIP

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2016-01-04 发布于湖北
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GALATrialResults.ppt

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GALATrialResults.ppt

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: 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 Cranial nerve injuries Wound haematoma 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 Primary outcome events Primary outcome events Survival analysis Length of Stay Quality of Life (UK patients)Values shown are mean (sd) Subgroups (primary outcome) Implications of GALA Stroke Death 3526 randomised (95 centres, 24 countries) GA 1753 allocated: 1628 ? GA 31 no anaesthesia - 92 cross-over 2 unknown LA 1773 allocated: 1655 ? LA 41 no anaesthesia - 75 cross-over 2 unknown 1752 for primary outcome 21 incomplete FU 19 no 1m physician form 1771 for primary outcome 21 incomplete FU 19 no 1m physician form 1416 (80%) 1403 (80%) Current/ex smoker 437 (25%) 435 (25%) Diabetes 111 (6%) 124 (7%) Atrial fibrillation 627 (35%) 647 (37%) Coronary heart disease 446 (25%) 425 (24%) Peripheral arterial disease 1256 (71%) 1232 (70%) Male 145 (sd 20) 145 (sd 20) Mean sys. BP (mmHG) 69 (sd 9) 70 (sd 9) Mean age (yrs) Local General 160 (9%) 150 (9%) Contralateral carotid occlusion 81 (sd 11) 81 (sd 11) Mean % stenosis in artery for operation 677 (38%) 685 (39%) Asymptomatic carotid stenosis Local General 1 1 Carotid stent instead 13 9 Patient