Download GALA Trial Results

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