Trial Overview

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  • Derriford Hosp, Plymouth Medical Left 100 Yes Yes 90 Yes Yes Hull Royal Inf Revascularisation Left 100 Yes Yes 0 No No Arrowe Park Hosp, Wirral Medical Left 100 Yes Yes 60 Yes Yes 635 Gosford Hospital, Australia Revascularisation Right 80 Yes Yes 100 Yes Yes The method of diagnosis for these patients were unknown (n=1), MRA (n=1) and CT (n=2).
  • Trial Overview

    1. 1. Philip A Kalra Lead Nephrologist for ASTRAL, Hope Hospital, Salford, UK, On behalf of the ASTRAL TMC and collaborators <ul><ul><li>UK MULTI-CENTRE TRIAL IN ATHEROSCLEROTIC RENOVASCULAR DISEASE </li></ul></ul><ul><ul><li>ASTRAL </li></ul></ul><ul><ul><li>A ngioplasty and ST ent for R enal A rtery L esions </li></ul></ul>
    2. 2. ASTRAL Trial Schema Diagnosis of ARVD (Unilateral or Bilateral) Revascularisation not contraindicated Uncertain whether to revascularise Randomisation No revascularisation Medical Treatment only Revascularisation with angioplasty and/or stent (and medical treatment)
    3. 3. PATIENT CHARACTERISTICS BY RANDOMISED 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
    4. 4. LABORATORY DATA BY RANDOMISED TREATMENT Revasc. Medical P-value SCr ( μ mol/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
    5. 5. LABORATORY DATA BY RANDOMISED 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
    6. 6. ANGIOGRAPHIC DATA BY RANDOMISED 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%
    7. 7. CONCOMITANT MEDICINE BY RANDOMISED TREATMENT Revasc. Medical P-value Anti-hypertensives 97% 99% 0.2 Diuretic 70% 67% Ca 2 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
    8. 8. CONCOMITANT MEDICINE BY RANDOMISED 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
    9. 9. SAFETY – IMMEDIATE POST-OP COMPLICATIONS <ul><li>24 patients experienced an immediate post-op complication </li></ul><ul><ul><li>Revascularisation = 23 / 308 (7%) </li></ul></ul><ul><ul><li>Medical = 1 / 18 (6%) </li></ul></ul><ul><li>Most patients (88%) had one complication </li></ul>
    10. 10. PLOT OF SCr OVER TIME
    11. 11. MEAN CHANGE IN SCr BETWEEN BASELINE AND 1 YEAR Negative change = Improvement in SCr (i.e. reduction in SCr)
    12. 12. MEAN CHANGE IN SCr
    13. 13. MEAN CHANGE IN SYSTOLIC BP
    14. 14. PLOT OF DIASTOLIC BP OVER TIME
    15. 15. TIME TO FIRST OF MI, STROKE, VASCULAR DEATH OR HOSPITALISATION FOR ANGINA, FLUID OVERLOAD OR CARDIAC FAILURE HR=0.90, 95% CI=0.66 to 1.15
    16. 16. MORTALITY HR=0.92, 95% CI=0.68 to 1.26
    17. 17. PRE-SPECIFIED SUBGROUP ANALYSES 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
    18. 18. SUMMARY <ul><li>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 </li></ul><ul><li>Also no evidence of differences between the arms for any of the secondary endpoints (i.e. blood pressure, major events) </li></ul><ul><li>No evidence of differences in treatment effect across the various subgroups </li></ul><ul><li>Longer follow-up is needed </li></ul><ul><li>Plan to update meta-analysis published in NDT in 2003 to include ASTRAL and other trials </li></ul>

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