Philip A Kalra Lead Nephrologist for ASTRAL, Hope Hospital, Salford, UK, On behalf of the ASTRAL TMC...
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Transcript of Philip A Kalra Lead Nephrologist for ASTRAL, Hope Hospital, Salford, UK, On behalf of the ASTRAL TMC...
Philip A Kalra
Lead Nephrologist for ASTRAL, Hope Hospital, Salford, UK,
On behalf of the ASTRAL TMC and collaborators
UK MULTI-CENTRE TRIAL IN ATHEROSCLEROTIC RENOVASCULAR DISEASE
ASTRAL Angioplasty and STent for Renal Artery Lesions
ASTRAL Trial Schema
Diagnosis of ARVD (Unilateral or Bilateral)
Revascularisation not contraindicated
Uncertain whether to revasculariseRandomisation
No revascularisation
Medical Treatment only
Revascularisation
with angioplasty and/or stent
(and medical treatment)
PATIENT CHARACTERISTICS BY PATIENT CHARACTERISTICS BY RANDOMISED TREATMENTRANDOMISED TREATMENT
Revasc. Medical P-value
Mean age (range) 70 (42 – 86) 71 (43 – 88) 0.7
Male 63% 63% 0.9
Ex-smoker 52% 55% 0.3
Current 20% 22% 0.5
Diabetes 31% 29% 0.5
CHD 49% 48% 0.2
PVD 41% 40% 0.7
Stroke 18% 19% 0.4
Dialysis 0% 0.3% 0.5
LABORATORY DATA BY LABORATORY DATA BY RANDOMISED TREATMENTRANDOMISED TREATMENT
Revasc. Medical P-value
SCr (μmol/l) 179
(66 – 551)
178
(64 – 750)
0.9
Rapid increase in SCr 12% 12% 0.9
GFR (ml/min) 40.3
(5.4 – 124.5)
39.8
(7.1 – 121.7)
0.7
Urinary Protein (g/day) 0.54
(0 – 4.77)
0.72
(0 – 7.7)
0.2
Albumin:Creatinine ratio
70.2
(0 – 2740)
71.7
(0 – 2466)
0.9
LABORATORY DATA BY LABORATORY DATA BY RANDOMISED TREATMENTRANDOMISED TREATMENT
Revasc. Medical P-value
Systolic BP 149
(87 – 270)
152
(90 – 241)
0.07
Diastolic BP 76
(45 – 120)
76
(46 – 130)
0.6
Cholesterol
(mmol/l)
4.68
(0.1 – 14.8)
4.71
(1.9 – 9.6)
0.8
ANGIOGRAPHIC DATA BY ANGIOGRAPHIC DATA BY RANDOMISED TREATMENTRANDOMISED TREATMENT
Revasc. Medical P-value
% Stenosis 76% (40 – 100%) 75% (20 – 100%) 0.3
Renal length 9.7cm (6 – 14) 9.7cm (6 – 20) 0.5
Location of ostial/distal ARVD lesion
Left kidney 24% 20% 0.2
Right kidney 18% 17%
Both 50% 57%
Missing data 8% 6%
CONCOMITANT MEDICINE BY CONCOMITANT MEDICINE BY RANDOMISED TREATMENTRANDOMISED TREATMENT
Revasc. Medical P-value
Anti-hypertensives 97% 99% 0.2
Diuretic 70% 67%
Ca2 antagonist 61% 68%
Beta-blocker 46% 52%
ACE-I, A-II antagonist 47% 38%
Alpha-blocker 40% 37%
Mean no. anti-hypertensives 2.8 (1 - 6) 2.8 (1 - 6) 0.9
CONCOMITANT MEDICINE BY CONCOMITANT MEDICINE BY RANDOMISED TREATMENTRANDOMISED TREATMENT
Revasc. Medical P-value
Anti-platelets 76% 78% 0.5
Aspirin 91% 93%
Cholesterol lowering 80% 80% 1.0
Statin 96% 95%
Warfarin 11% 11% 1.0
SAFETY – IMMEDIATE POST-OP SAFETY – IMMEDIATE POST-OP COMPLICATIONSCOMPLICATIONS
• 24 patients experienced an immediate post-op complication– Revascularisation = 23 / 308 (7%)– Medical = 1 / 18 (6%)
• Most patients (88%) had one complication
MEAN CHANGE IN SCr BETWEEN MEAN CHANGE IN SCr BETWEEN BASELINE AND 1 YEARBASELINE AND 1 YEAR
0
50
100
150
< -70
-70 to
-51
-50 to
-31
-30 to
-11
-10 to
10
10 to
30
31 to
50
51 to
70
71 to
90
91 to
110
111
to 1
30
131
to 1
50>15
0
No
. of
pa
tie
nts
Revasc. Medical
Negative change = Improvement in SCr (i.e. reduction in SCr)
TIME TO FIRST OF MI, STROKE, VASCULAR DEATH TIME TO FIRST OF MI, STROKE, VASCULAR DEATH OR HOSPITALISATION FOR ANGINA, FLUID OR HOSPITALISATION FOR ANGINA, FLUID
OVERLOAD OR CARDIAC FAILUREOVERLOAD OR CARDIAC FAILURE
HR=0.90, 95% CI=0.66 to 1.15
PRE-SPECIFIED SUBGROUP PRE-SPECIFIED SUBGROUP ANALYSESANALYSES
Subgroup Groups
SCr ≤150, 151-249, ≥250μmol/l
GFR <30, 30-45, >45ml/min
Stenosis ≤70%, 71-89%, ≥90%
Renal Length ≤9, 9-10, >10cm
Rapid increase in SCr
Yes, No, Not Known
SUMMARYSUMMARY
• Currently no evidence of a benefit for revascularisation on renal function in the ARVD patients entered into ASTRAL – those in whom clinicians ‘uncertain’ of whether to revascularise
• Also no evidence of differences between the arms for any of the secondary endpoints (i.e. blood pressure, major events)
• No evidence of differences in treatment effect across the various subgroups
• Longer follow-up is needed• Plan to update meta-analysis published in NDT in 2003
to include ASTRAL and other trials