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Renal Artery Stenosis : Does It Matter Any More?

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Renal Artery Stenosis : Does It Matter Any More? Renal Artery Stenosis : does it matter any more? Philip A Kalra Consultant and Honorary Professor in Nephrology, Salford Royal Hospital and University of Manchester, UK Lead Nephrologist : ASTRAL trial UK lead : CORAL trial Talk outline Current outcomes for patients with ARVD Rationale for renal revascularization RCT of renal revascularization in atherosclerotic RAS Large single centre studies in high-risk patients Techniques for identifying responders to revascularization Atherosclerotic renovascular disease FMD Epidemiology of incident ARVD in US citizens aged > 65 years Kidney Int 2005; 68(1):293-301 Prevalence 54 cases per 1000 = 0.54% Incidence 37 cases per 1000 per year New-onset clinical events after ARVD diagnosis (% per year): ARVD Non-ARVD (n=5875) (n=1,085,250) AHD 30.6 7.4 CHF 19.6 5.7 RRT 2.9 0.1 Death 16.3 6.4 CVS co-morbidity and ARVD 45% 40% 35% 30% 25% 20% % with RAS 15% 10% 5% 0% CAD CCF PVD AAA CVA Harding Olin MacDowall Choudri Kuroda JASN 1990 Lancet 1998 BMJ 1990 AmJ Med 1990 Stroke 2000 Salford Renovascular database Outcomes of 563 ARVD patients (RAS > 50%) compared to 909 all-cause CKD patients (CRISIS study - patients with ARVD excluded) eGFR 33 ml/min in both groups; DM in 29% (ARVD) vs 36% Other CKD ARVD Survival – non-dialysis CKD Other CKD ARVD Survival after haemodialysis start D Vassallo et al, Kidney Blood Pressure Research, 2016 Cohort years End stage kidney Cardiovascular Mortality disease events (% per year) (% per year) (% per year) 1986-2000 4.0 6.4 15.9 (n=265) 2001-2004 4.7 8.2 15.4 (n=235) 2005-2008 2.9 6.5 10.7 (n=287) 2009-2014 2.9 6.0 13.8 (n=85) Clinical presentations of ARVD that merit consideration of renal revascularization Cardiac Renal ‘Flash’ pulmonary Acute kidney injury oedema Prevention of severe Improve ‘congestion’ RAS → RAO (cardio-renal disease) ‘Rapid’ deterioration Pre-coronary or in renal function carotid surgery Patients who need Blood pressure RAA blockade but Control of severe intolerant hypertension Case 1 : 76 yrs old male Bilateral 90% RAS – 2 x attempts at revascularization 5 yrs earlier by cardiologists in London referred with deteriorating renal function BP 127/53 on verapamil, candersartan, indapamide Urine PCR 2 g/mol USS kidneys : right 9.5cm, left 10 cm creatinine eGFR – 2 yrs earlier 147 46 – May 2011 203 31 – August 219 26 Renal revascularization August 2011 ml/min 50 45 40 35 30 25 eGFR 20 15 10 5 0 2009 Aug-11 Case 2 Male aged 53 Hypertension (175/90) Serum creatinine 180mol/l Kidney sizes : L 9.8cm; R 11.3cm Angiogram : L 80% RAS; R normal Randomised to revascularization in ASTRAL Case 2 : Follow-up Feb 2001 290 mol/l March 2001 369 mol/l April 2001 535 mol/l May 2001 997 mol/l June 2001 commenced dialysis RCTs in ARVD Level 1 evidence now derived from the following RCTs in ARVD : - EMMA study (49 patients) – Plouin et al, 1998 - DRASTIC (106) – Van Jaarsfeld et al, 2000 - Scottish and Newcastle (55) – Webster et al, 1998 - STAR (160) – Beutler et al, 2009 - ASTRAL (806) – N Eng J Med, 2009 - CORAL (947) – N Eng J Med, 2013 Many single and multi-centre prospective and retrospective studies showing benefit of revascularization in a proportion of patients New England Journal of Medicine 2009; 361 : 1953-62 LABORATORY and BP DATA BY RANDOMISED TREATMENT Revasc. Medical P-value SCr (μmol/l) 179 178 0.9 88 μmol/l = 1 mg/dl (66 – 551) (64 – 750) Rapid increase in SCr 12% 12% 0.9 GFR (ml/min) 40.3 39.8 0.7 (5.4 – 124.5) (7.1 – 121.7) Albumin:Creatinine ratio 70.2 71.7 0.9 (0 – 2740) (0 – 2466) Systolic BP (mm Hg) 149 152 0.07 (87 – 270) (90 – 241) Diastolic BP (mm Hg) 76 76 0.6 (45 – 120) (46 – 130) Cholesterol (mmol/l) 4.68 4.71 0.8 (0.1 – 14.8) (1.9 – 9.6) Average RAS = 76%; 20% non-compliance with revascularization Change in renal function Change in Systolic blood pressure Macrovascular events Survival A Randomized Multicenter Clinical Trial of Renal Artery Stenting in Preventing Cardiovascular and Renal Events: Results of the CORAL Study Christopher J. Cooper, M.D., Timothy P. Murphy, M.D., Donald E. Cutlip, M.D., Kenneth Jamerson, M.D., William Henrich, M.D., Diane M. Reid, M.D., David J. Cohen, M.D., M.Sc., Alan H. Matsumoto, M.D., Michael Steffes, M.D., Michael R. Jaff, D.O., Martin R. Prince, M.D., Ph.D., Eldrin F. Lewis, M.D., Katherine R. Tuttle, M.D., Joseph I. Shapiro, M.D., M.P.H., John H. Rundback, M.D., Joseph M. Massaro, Ph.D., Ralph B. D’Agostino, Sr., Ph.D., and Lance D. Dworkin, M.D., on behalf of the CORAL Investigators CORAL : Inclusion criteria and primary outcome measure INCLUSION CRITERIA PRIMARY OUTCOME Clinical Syndrome: • Composite of major • Hypertension ≥2 anti-hypertensive cardiovascular or renal events: medications, OR – Cardiovascular or Renal • Renal dysfunction defined as Stage 3 Death or greater CKD – Stroke -AND- – Myocardial Infarction – Heart Failure Hospitalization Atherosclerotic Renal Artery Stenosis: – Progressive Renal • Angiographic: ≥ 60% and < 100%, OR Insufficiency • Duplex: systolic velocity of >300 – Permanent Renal cm/sec, OR Replacement Therapy • Core lab approved MRA, OR • Core lab approved CTA Screening and Enrollment Baseline Characteristics Baseline Characteristics of the Study Population According to Treatment Group Characteristic Stent + Medical Medical • No significant N = 459 N = 472 differences in clinical Age (years) 69.3 ± 9.4 69.0 ± 9.0 and angiography Male gender (%) 51.0 48.9 characteristics White race (%) 91.5 90.9 Black race (%) 7.0 7.0 • Approximately 20% Body mass index (kg/m2) 28.2 ± 5.3 28.7 ± 5.7 global ischemia Systolic blood pressure (mmHg) 149 ± 23.2 150.4 ± 23.0 • Stenosis severity Estimate GFR (ml/minute) 58.0 ± 23.4 57.4 ± 21.7 similar to FDA Medical history and risk factors (%) approval trials 1-3 Diabetes 32.4 34.3 Prior myocardial infarction 26.5 30.2 1. Rocha-Singh K et. al. ASPIRE-2. JACC History of heart failure 12.0 15.1 2005;46:776-83 Smoking in past year 28.0 32.2 2. Rocha-Singh K et. al. RENAISSANCE. CCI 2008;72:853-62 Angiography 3. Jaff MR, et. al. HERCULES. CCI % stenosis (core lab) 67.3 ± 11.4 66.9 ± 11.9 2012;80:343-50 % stenosis (investigator) 72.5 ± 14.6 74.3 ± 13.1 Global ischemia (%) 20.0 16.2 Bilateral disease (%) 22.0 18.1 Results: Primary Endpoint Clinical Events Stent plus medical therapy Medical therapy Stent + Medical Therapy 35.1%, 3-years Medical Therapy 35.8%, 3-years HR 0.94 [0.76-1.17], p = 0.58 Results: Secondary Endpoints CV + Renal Death Stroke Myocardial Infarction P=ns P=ns P=ns Heart Failure Progressive Renal Insufficiency Renal Replacement P=ns P=ns P=ns US Medicare : Trends in revascularization 1992-2010 RR 1.4 1.2 1 ASTRAL published 0.8 ↓ 0.6 0.4 0.2 0 1992 1994 1996 1998 2000 2002 2010 In 2004 approx 30,000 renal stent procedures performed annually in US Limitations of the large RCTs ASTRAL – Power calculation based on limited data in a study with selection bias (Harden et al, Lancet, 1998) – 20% non-compliance with revascularization – large proportion had mild and ‘asymptomatic’ RAS; many probably clinically insignificant – Concern that trial entry criteria led to many patients being revascularized outside the trial CORAL – Largely lower risk hypertensive population; eGFR 58 ml/min – Many higher-risk patients excluded (despite radiology core lab) What have we learned from the RCTs? Revascularization does not improve outcomes in majority of unselected patients with ARVD These conclusions only apply to the patient phenotype included in the studies Some patients do benefit from revascularization – who are they and can we reliably identify them? Don’t forget the benefits of But at least no more ‘drive-by’ medical therapy shootings! Our favourite cases 65 yr old lady with 3 episodes of acute pulmonary oedema in 12 months BP 220/88 on 3 agents Echo – moderate to severe systolic dysfunction (EF 35%) and LVH Claudication; right carotid stenosis but no history of IHD ↓GFR from 60 to 22 ml/min in 15 months MRA bilateral 80-90% RAS; right kidney 9 cm, left 11cm Changes in isoSK-GFR and GFR cardiac MR parameters (ml/min) 35 Pre- 4 30 revasc months 25 EF (%) 42 53 20 15 Pre Post 10 LVEDV 200 106 5 (ml) 0 Left Right LV mass 201 133 GFR GFR (g) Am J Kid Dis 2014; 63(2) : 186-97 ‘High-risk’ ARVD phenotypes (RAS > 50%): Ritchie J et al, Am J Kid Dis 2014; 63(2) : 186-197 Salford RVD database : Prospectively collected data on all diagnosed ARVD patients 1998 to current (n>900) Revascularization performed according to physician preference; on clinical grounds; or RCT randomisation High-risk categorisation : – Acute pulmonary oedema : rapid onset cardiac decompensation; no alternative aetiology – ‘Resistant hypertension’ : >140/90 despite 3 or more agents – Deteriorating renal function : creatinine 1.2x or 100 umol/l > baseline within previous 6 months Low-risk = none of the above Recommendations for renal revascularization Haemodynamically significant RAS with: – Recurrent unexplained congestive heart failure (Class I, evidence level B) – Resistant / malignant hypertension (Class IIa, evidence level B) – Progressive CKD and bilateral RAS (Class Iia, 2005 evidence level B). Effect of revascularization in patients with ARVD and high-risk clinical features: a single-center observational study (DM Vassallo et al) ARVD database 1986 – current (894 patients) Patients with >70% unilateral or bilateral renal artery stenosis together with one or more high-risk presentations (n=131; 15%) : - flash pulmonary oedema – severe hypertension (SBP >160, DBP >100, on > 3 anti-BP meds) – rapidly deteriorating renal function
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