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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.

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Presentation on theme: "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."— Presentation transcript:

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 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

3 Rationale for RCTs in ARVD Very common condition : annual rate of ARVD diagnosis 3x between High level of associated co-morbidity and mortality Revascularization procedures frequently performed (eg 16% of newly diagnosed Medicare patients : Kidney Int 2005; 68 : ) 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 Diagnosis of significant ARVD (Unilateral or Bilateral) Revascularization not contraindicated Uncertain whether to revascularize Randomisation No revascularization Medical Treatment only Revascularization with angioplasty and/or stent (and medical treatment)

6 RECRUITMENT ASTRAL opened to recruitment in September 2000 September 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 7 x bigger than the next largest trial (van Jaarsveld (n=106)

8 PATIENT CHARACTERISTICS BY RANDOMISED TREATMENT Revasc.MedicalP-value Mean age (range)70 (42 – 86)71 (43 – 88)0.7 Male63% 0.9 Ex-smoker52%55%0.3 Current smoker20%22%0.5 Diabetes31%29%0.5 CHD49%48%0.2 PVD41%40%0.7 Stroke18%19%0.4 Dialysis0%0.3%0.5

9 LABORATORY and BP DATA BY RANDOMISED TREATMENT Revasc.MedicalP-value SCr (μmol/l) 88 μmol/l = 1 mg/dl 179 (66 – 551) 178 (64 – 750) 0.9 Rapid increase in SCr12% 0.9 GFR (ml/min)40.3 (5.4 – 124.5) 39.8 (7.1 – 121.7) 0.7 Albumin:Creatinine ratio70.2 (0 – 2740) 71.7 (0 – 2466) 0.9 Systolic BP (mm Hg)149 (87 – 270) 152 (90 – 241) 0.07 Diastolic BP (mm Hg)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

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

11 ANGIOGRAPHIC DATA BY RANDOMISED TREATMENT Revasc.MedicalP-value % Stenosis76% (40 – 100%)75% (20 – 100%)0.3 Renal length9.7cm (6 – 14)9.7cm (6 – 20)0.5 Location of ostial/distal ARVD lesion Left kidney24%20%0.2 Right kidney18%17% Both50%57% Missing data8%6%

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

13 CONCOMITANT MEDICINE BY RANDOMISED TREATMENT Revasc.MedicalP-value Anti-hypertensives97%99%0.2 Diuretic70%67% Ca 2 antagonist61%68% Beta-blocker46%52% ACE-I, A-II antagonist47%38% Alpha-blocker40%37% Mean no. anti-hypertensives2.8 (1 - 6) 0.9

14 CONCOMITANT MEDICINE BY RANDOMISED TREATMENT Revasc.MedicalP-value Anti-platelets76%78%0.5 Aspirin91%93% Cholesterol lowering80% 1.0 Statin96%95% Warfarin11% 1.0

15 COMPLIANCE WITH RANDOMISED TREATMENT NRevasc. Successful Attempted but Failed Not Attempted Revasc (82%)*1744 Medical40318 (4.4%)11 *Revascularization forms not yet returned for 34 patients who were randomised to revascularization

16 REVASCULARIZATION PROCEDURE Revasc.Medical Intervention PerformedN=308N=13 Angioplasty plus stent201 (65%)8 (62%) Stent only86 (28%)5 (38%) Balloon angioplasty21 (7%)0 (-) Unilateral259 (84%)11 (85%) Bilateral49 (16%)2 (15%)

17 SAFETY – IMMEDIATE POST-OP COMPLICATIONS (in 24 (7%) patients) ComplicationN=321 Stent misplacement requiring additional stent10 (3%) Renal arterial perforation or dissection4 (1%) Renal artery thrombosis or occlusion1 (0.3%) Renal embolisation2 (0.6%) Non-renal embolisation1 (0.3%) Stent embolisation3 (1%) Distal stent retrieval or deployment1 (0.3%) Balloon rupture1 (0.3%) Need for surgical rescue0 (-) Access vessel damage6 (2%)

18 SAFETY – POST-OP COMPLICATIONS >24 HRS AFTER REVASCULARIZATION ComplicationRevasc. (N=254) Local infection at puncture site1 (0.4%) Groin haemorrhage or haematoma25 (10%) Pseudoaneurysm2 (0.8%) Deterioration in renal function26 (10%) If deterioration in renal function – maximum SCr whilst in hospital N=24 Mean (SD)319 (145) Range

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 Revasc. (N=369) Medical (N=380) P-Value Myocardial Infarction22 (6%)30 (8%)0.3 Hospitalisation for Angina24 (7%)29 (8%)0.5 Hospitalisation for Fluid Overload / Cardiac Failure 44 (12%)55 (14%)0.3 Stroke19 (5%)18 (5%)0.8 Coronary Artery Procedure (CABG or PCTA) 9 (2%)12 (3%)0.6 Other Arterial Procedures51 (14%)38 (10%)0.1 No. Events/No. Patients*109 / / * 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 Cause of Death (not mutually exclusive*) Revasc. (N=79) Medical (N=81) Vascular (Heart Failure/MI/Stroke)3033 Renal Failure614 Infection / Pneumonia1110 Cancer119 Other42 Not Stated/Not Known2326 * 14 patients have multiple causes of death

31 CONCOMITANT MEDICINE AT 1 YEAR BY RANDOMISED TREATMENT Revasc.MedicalP-value Anti-hypertensives98%99%0.2 Diuretic67%69% Beta-blocker47%54% ACE-I, ARB48% (47%) 41% (37%) Anti-platelet therapy84% (76%) 81% (78%) 0.4 Warfarin9% 1.0 Cholesterol lowering86% (80%) 88% (80%) 0.4

32 PRE-SPECIFIED SUBGROUP ANALYSES SubgroupGroups SCr150, , 250μmol/l GFR 45ml/min Stenosis70%, 71-89%, 90% Renal Length9, 9-10, >10cm Rapid increase in SCr Yes, No, Not Known

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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