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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 A ngioplasty and ST ent for R enal A rtery L esions. Philip A Kalra Lead Nephrologist for ASTRAL, Hope Hospital, Salford, UK, On behalf of the ASTRAL TMC and collaborators. ASTRAL Trial Schema.

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Philip A Kalra Lead Nephrologist for ASTRAL, Hope Hospital, Salford, UK, On behalf of the ASTRAL TMC and collaborators

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  1. UK MULTI-CENTRE TRIAL IN ATHEROSCLEROTIC RENOVASCULAR DISEASE • ASTRAL • Angioplasty and STent for Renal Artery Lesions Philip A Kalra Lead Nephrologist for ASTRAL, Hope Hospital, Salford, UK, On behalf of the ASTRAL TMC and collaborators

  2. ASTRAL Trial Schema No revascularisationMedical Treatment only Revascularisation with angioplasty and/or stent (and medical treatment) Diagnosis of ARVD (Unilateral or Bilateral)Revascularisation not contraindicated Uncertain whether to revasculariseRandomisation

  3. PATIENT CHARACTERISTICS BY RANDOMISED TREATMENT

  4. LABORATORY DATA BY RANDOMISED TREATMENT

  5. LABORATORY DATA BY RANDOMISED TREATMENT

  6. ANGIOGRAPHIC DATA BY RANDOMISED TREATMENT

  7. CONCOMITANT MEDICINE BY RANDOMISED TREATMENT

  8. CONCOMITANT MEDICINE BY RANDOMISED TREATMENT

  9. SAFETY – IMMEDIATE POST-OP COMPLICATIONS • 24 patients experienced an immediate post-op complication • Revascularisation = 23 / 308 (7%) • Medical = 1 / 18 (6%) • Most patients (88%) had one complication

  10. PLOT OF SCr OVER TIME

  11. MEAN CHANGE IN SCr BETWEEN BASELINE AND 1 YEAR Negative change = Improvement in SCr (i.e. reduction in SCr)

  12. MEAN CHANGE IN SCr

  13. MEAN CHANGE IN SYSTOLIC BP

  14. PLOT OF DIASTOLIC BP OVER TIME

  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. MORTALITY HR=0.92, 95% CI=0.68 to 1.26

  17. PRE-SPECIFIED SUBGROUP ANALYSES

  18. SUMMARY • 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

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