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ACC/SCAI 2008 : Disclosures

ACC/SCAI 2008 : Disclosures. Funding for ASTRAL Medtronic MRC KR-UK No members of the ASTRAL TMC or collaborators have any pecuniary or advisory affiliation with Medtronic. UK MULTI-CENTRE TRIAL IN ATHEROSCLEROTIC RENOVASCULAR DISEASE ASTRAL

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ACC/SCAI 2008 : Disclosures

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  1. ACC/SCAI 2008 : Disclosures Funding for ASTRAL • Medtronic • MRC • KR-UK No members of the ASTRAL TMC or collaborators have any pecuniary or advisory affiliation with Medtronic

  2. 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

  3. Rationale for RCTs in ARVD • Very common condition : annual rate of ARVD diagnosis ↑3x between 1992-2004 • High level of associated co-morbidity and mortality • Revascularization procedures frequently performed (eg 16% of newly diagnosed Medicare patients : Kidney Int 2005; 68 : 293-301) • Revascularization not without some risk • 4 previous RCTs investigating revascularization – all small (largest 106 patients) and inconclusive • Uncertainty regarding renal functional, CVS events and mortality outcomes

  4. Main questions asked within ASTRAL What is the effect of renal revascularization upon Renal functional outcome(rate of change of renal function over follow-up – reciprocal creatinine plot; 750 patients for 80% power to show 20% difference) Secondary end-points • Survival • Other (CVS) macrovascular events • Blood pressure control • Cardiac function and structure (sub-study)

  5. ASTRAL Trial Schema No revascularizationMedical Treatment only Revascularization with angioplasty and/or stent (and medical treatment) Diagnosis of significant ARVD (Unilateral or Bilateral)Revascularization not contraindicated Uncertain whether to revascularizeRandomisation

  6. RECRUITMENT • ASTRAL opened to recruitment in September 2000 • September 2000 - October 2007, 806 patients randomised into the trial from 58 centres (4 in Australasia) • 403 revascularization (+ medical therapy) • 403 medical management • Current mean follow-up 27 months

  7. Trial Comparison Over 7x bigger than the next largest trial (van Jaarsveld (n=106)

  8. PATIENT CHARACTERISTICS BY RANDOMISED TREATMENT

  9. LABORATORY and BP DATA BY RANDOMISED TREATMENT

  10. PATIENT CHARACTERISTICS – GFR Mean = 40 ml/min (Range: 5.4 – 124.5)

  11. ANGIOGRAPHIC DATA BY RANDOMISED TREATMENT

  12. PATIENT CHARACTERISTICS – Percent Stenosis Mean = 76% (Range: 20% – 100%)

  13. CONCOMITANT MEDICINE BY RANDOMISED TREATMENT

  14. CONCOMITANT MEDICINE BY RANDOMISED TREATMENT

  15. COMPLIANCE WITH RANDOMISED TREATMENT *Revascularization forms not yet returned for 34 patients who were randomised to revascularization

  16. REVASCULARIZATION PROCEDURE

  17. SAFETY – IMMEDIATE POST-OP COMPLICATIONS (in 24 (7%) patients)

  18. SAFETY – POST-OP COMPLICATIONS >24 HRS AFTER REVASCULARIZATION

  19. PLOT OF SCr OVER TIME

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

  21. MEAN CHANGE IN SCr

  22. PLOT OF RECIPROCAL SCr OVER TIME

  23. PLOT OF SYSTOLIC BP OVER TIME

  24. MEAN CHANGE IN SYSTOLIC BP

  25. PLOT OF DIASTOLIC BP OVER TIME

  26. TIME TO FIRST RENAL EVENT(ARF, Dialysis, Transplant, Nephrectomy, Renal Death) HR=0.98, 95% CI=0.66 to 1.48

  27. VASCULAR EVENTS - OVERALL * Not including coronary or other arterial procedures

  28. 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

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

  30. MORTALITY * 14 patients’ have multiple causes of death

  31. CONCOMITANT MEDICINE AT 1 YEAR BY RANDOMISED TREATMENT

  32. PRE-SPECIFIED SUBGROUP ANALYSES

  33. MEAN CHANGE IN SCr AT 1 YEAR STRATIFIED BY BASELINE SCr

  34. MEAN CHANGE IN SCr AT 1 YEAR STRATIFIED BY RAPID INCREASE IN SCr

  35. ASTRAL Summary (1) • Currently no evidence of a benefit for revascularization on renal function in the ARVD patients entered into ASTRAL – those in whom clinicians ‘uncertain’ of whether to revascularize • Also no evidence of differences between the arms for any of the secondary endpoints (i.e. blood pressure, major events, mortality) • No evidence of differences in treatment effect across the various subgroups – for renal functional end-point only

  36. ASTRAL Summary (2) • Minor differences in some parameters at 4 years (Creatinine, SBP, CVS events) but longer follow-up is needed to assess significance • Some individuals do benefit – how can we identify these? • Cardiac sub-studies (results due November 2008)

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