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Controversies in renal arterial interventions.

Controversies in renal arterial interventions. ACHILLES CHATZIIOANNOU, MD Assoc. Professor of Radiology American Board of Radiology. 60-year old male. Hypertension (180/100) 3 anti-HTN medications Cr: 2 ,1 mg/dl. Normotensive with one medication . Cr=1.1mg/dl. Herculink 6X18-mm.

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Controversies in renal arterial interventions.

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  1. Controversies in renal arterial interventions. ACHILLES CHATZIIOANNOU, MD Assoc. Professor of Radiology American Board of Radiology

  2. 60-year old male. • Hypertension (180/100) • 3 anti-HTN medications • Cr: 2,1 mg/dl

  3. Normotensive with one medication. Cr=1.1mg/dl Herculink 6X18-mm

  4. Renovascular Hypertension (RVH) • Classic studies by Goldblatt (1930): RAS is the cause of RVH. • RAS causing RVH: prevalence 3-5% of the hypertensive patients. • Atherosclerosis: 70-90% of RHV. FMD: 10-30% of RVH.

  5. Atherosclerotic disease • The prevalence of RAS is increasing because of population aging, and increased survival. • >60% RAS in 6.8% of individuals > 65y. • RAS in pts undergoing coronary DSA: 18%-20%. • RAS in pts undergoing peripheral DSA: 35%-50%.

  6. Fibromuscular Dysplasia (FMD) • Young patients –more commonly females. • Medial fibroplasia (80%). • Location: distal main renal artery, 25% into 1st order branches. • >50% of patients have bilateral disease. • Commonly asymptomatic (3%-6% in Transplant donors).

  7. Atherosclerotic disease • Patient 6th decade or older. • More often male. • The majority of the lesions are incidental findings. • Ostial lesions: within 1-cm from aorta. • Truncal lesions (less than 10%): more than 1-cm. • 50% have bilateral disease. • 12%-20% of stenoses>75% will progress to total occlusion within one year (?)

  8. Manifestations of Renovascular Disease (Textor SC, 2004)

  9. Endovascular treatment (PTA-stents) is always indicated in RAS? • 7660 interventions in 1996 • 18520 interventions in 2000 • 2.8-fold increase by interventional cardiologists (“drive-by”). Medicare data

  10. Δεκαετία του 1990... μη ελεγχόμενες μελέτες Σημαντική μείωση της Α.Π.8,9 Σταθεροποίηση την χρόνιας νεφρικής ανεπάρκειας10,11 Αγγειοπλαστική ή χρήση ενδοαυλικού νάρθηκα 364%12 8. Blum U et al. N Engl J Med 1997 9. Burket MW et al. Am Heart J 2000 10. Harden PN et al. Lancet 1997 11. Watson PS et al. Circulation 2000 12. Murphy TP et al. AJR Am J Roentgenol 2004

  11. Progressive nature of ARVD, progressing at the rate of 10% per year (45%-60% progression rate in 4-7 year f-u) • Pre-occlusive lesions (70-90%): risk of occlusion 40%. . Treat RAS whenever found (easier when early, avoid progression to occlusion). JVIR 2002

  12. Ischemic nephropathy • Progressive disease • Lesion progression 20% per year. • Renal atrophy 10% per year. • Artery occlusion 5% per year. • RAS is a marker of increased cardiovascular mortality, predictors: • Older age • Impaired renal function • Bilateral RAS

  13. Acute renal failure in patients with RAS • 1-14 days after the initiation of treatment with ACE inhibitors. • After the use of diuterics or other antihypertensive drugs. • After major surgery. • After the spontaneous progression of RAS to total occlusion.

  14. Results of revascularization for ischemic nephropathy • 32 patients with unexplained renal impairment and RAS were treated with renal artery stent. • In 70% of the patients the renal function improved or stabilized (p<0.007). Harden et al, Lancet 1997

  15. Results of revascularization for ischemic nephropathy • 33 patients with bilateral RAS or RAS in solitary kidney. • Follow up: 20±11 months. • Significant improvement in 72%; mild improvement in 28%. • Preservation of renal size in all patients. Watson et al. Circulation 2000

  16. Signs that a patient with ischemic nephropathy will benefit from revascularization • Normal distal arterioles. • Bilateral disease. • Recent onset of renal insufficiency. • Resistive Index (Doppler sonography) <80 • Extremely limited renal function (cr>2,5 mg/dl or 220 μmol/l)* *Uder M, Huke U CVIR 2005

  17. Percutaneous revascularization • Technical success:98-100% • Long term patency rate 85%-98% • Complications: • Mortality 1-3% • Major complications: 3-5% • Minor complications 10-20%

  18. An analysis of the pooled results of studies of conventional balloon angioplasty in 1118 patients • Hospital death 0.5% • Nephrectomy 0.3% • Renal surgery 2% • Occlusion of a side branch of the renal artery 2.2% • Cholesterol embolization 1.1% • Injury at the site of vascular access 2.3% The indications and results of PTA and stenting in renal artery stenosis. SeminVascSurg 1996;9:188-197

  19. Εν συνεχεία... Ελεγχόμενες τυχαιοποιημένες μελέτες13, 14, 15, 16, 17, 18 6έχουν πραγματοποιηθεί μέχρι τώρα.... και οι 6 απέτυχαν να δείξουν όφελος από την ενδαγγειακή θεραπεία της στένωσης της νεφρικής αρτηρίας 13. Van Jaarsveld BC et al. N Eng J Med 2000 14. Plouin PF et al. Hypertension 1998 15. Webster J et al. J Hum Hypertens 1998 16. The ASTRAL investigators. N Eng J Med 2009 17. Bax L et al. Ann Intern Med 2009 18. Cooper CJ. N Eng J Med 2014

  20. Evidence 3 randomized controlled trials compared medical treatment to percutaneousrenal revascularization: • DRASTIC: Dutch Renal Artery Stenosis Intervention Cooperative Study Group • EMMA: Essai Multicentrique Medicaments vs Angioplastie Study Group • SNRASCG: Scottish and Newcastle Renal Artery Stenosis Collaborative Group

  21. Conclusions • In patients whose blood pressure could be controlled with medical therapy alone, no trial was able to demonstrate a statistically significant difference in blood pressure between balloon angioplasty and medical therapy. • In patients with refractory hypertension to medical therapy, the results of the DRASTIC trial demonstrated that balloon angioplasty was better than medical therapy in respect of more efficient blood pressure control.

  22. Renal function No significant difference in serum creatinine or creatinine clearance between the two groups in any of the trials. • Nordman. Cochrane Library of Systematic Reviews. 2004:;vol 2

  23. “The majority of patients with significant RAS and hypertension or renal function loss can be treated medically without the risk of mortality or progression to end-stage disease”. Exceptions: Bilateral RAS; RAS in solitary kidney. 2X mortality risk; 1.5X risk of renal failure. Care if renal mass loss OR loss of renal function when ACE inhibitor is used!

  24. Angioplastyand Stentfor Renal Arterial Lesions • Multicenter Randomized clinical trial. • Approx 1000 pts will be randomized to optimal medical therapy or to stenting with optimal medical therapy

  25. Revascularization versus Medical Therapy for Renal-Artery Stenosis The ASTRAL Investigators Background Percutaneous revascularization of the renal arteries improves patency in atherosclerotic renovascular disease, yet evidence of a clinical benefit is limited. Methods In a randomized, unblinded trial, we assigned 806 patients with atherosclerotic renovascular disease either to undergo revascularization in addition to receiving medical therapy or to receive medical therapy alone. The primary outcome was renal function, as measured by the reciprocal of the serum creatinine level (a measure that has a linear relationship with creatinine clearance). Secondary outcomes were blood pressure, the time to renal and major cardiovascular events, and mortality. The median follow-up was 34 months. Results During a 5-year period, the rate of progression of renal impairment (as shown by the slope of the reciprocal of the serum creatinine level) was –0.07x10–3 liters per micromole per year in the revascularization group, as compared with –0.13x10–3 liters per micromole per year in the medical-therapy group, a difference favoring revascularization of 0.06x10–3 liters per micromole per year (95% confidence interval [CI], –0.002 to 0.13; P=0.06). Over the same time, the mean serum creatinine level was 1.6 µmol per liter (95% CI, –8.4 to 5.2 [0.02 mg per deciliter; 95% CI, –0.10 to 0.06]) lower in the revascularization group than in the medical-therapy group. There was no significant between-group difference in systolic blood pressure; the decrease in diastolic blood pressure was smaller in the revascularization group than in the medical-therapy group. The two study groups had similar rates of renal events (hazard ratio in the revascularization group, 0.97; 95% CI, 0.67 to 1.40; P=0.88), major cardiovascular events (hazard ratio, 0.94; 95% CI, 0.75 to 1.19; P=0.61), and death (hazard ratio, 0.90; 95% CI, 0.69 to 1.18; P=0.46). Serious complications associated with revascularization occurred in 23 patients, including 2 deaths and 3 amputations of toes or limbs. Conclusions We found substantial risks but no evidence of a worthwhile clinical benefit from revascularization in patients with atherosclerotic renovascular disease. Volume 361:1953-1962 November 2009

  26. Renal Function in Patients with Renal-Artery Stenosis Treated with Revascularization or Medical Therapy Alone The ASTRAL Investigators. N Engl J Med 2009;361:1953-1962

  27. Kaplan-Meier Curves for the Time to the First Renal and Cardiovascular Events The ASTRAL Investigators. N Engl J Med 2009;361:1953-1962

  28. Kaplan-Meier Curves for Overall Survival The ASTRAL Investigators. N Engl J Med 2009;361:1953-1962

  29. Systolic and Diastolic Blood Pressure The ASTRAL Investigators. N Engl J Med 2009;361:1953-1962

  30. ACC/AHA οδηγίες Ανθεκτική υπέρταση: ≥ 3 αντιϋπερτασικά

  31. Στένωση ΝΑ ≥ 60% • Α.Π. ≥ 155 mmHg + ≥ 2 αντιϋπερτασικά φάρμακα και/ή • GFR ≤ 60 ml/1.73 m2

  32. Stenting μετρίου βαθμού στένωσης της νεφρικής αρτηρίας δεν οδηγεί σε κλινική βελτίωση του ασθενούς λόγω της μεγάλης νεφρικής εφεδρίας σε αιμάτωση και οξυγόνωση19 Πειραματικά μοντέλα20 δείχνουν αύξηση της Α.Π. σε στενώσεις > 75% και επιδείνωση νεφρικής λειτουργίας > 80% 19.Arendhorst WJ, Navar LG. Diseases of kidney and urinary tract, 7th ed. Vol 1, Lippincott W&W 2001 20. Imanishi M et al. Angiology 1992

  33. Ενδείξεις επαναιμάτωσης νεφρικής αρτηρίας RI (DUS) < 0.8 DTPA Εκλεκτική αγγειογραφία της νεφρικής αρτηρίας Στένωση >75-80%

  34. Συμπερασματικά... Δυστυχώς, οι ενδείξεις για επαναιμάτωση του νεφρού δεν είναι ακόμη ξεκάθαρες (evidence- based). Στηριζόμενοι στις σημερινές κατευθυντήριες οδηγίες οδηγίες (guidelines), πιθανόν να υποβληθούν ασθενείς σε αγγειοπλαστική, χωρίς να το έχουν πραγματικά ανάγκη. Ο συνδυασμός των κλινικών οδηγιών με επεμβατικές και μη μεθόδους ελέγχου της νεφροπάθειας αυξάνει την πιθανότητα να βρούμε την υποκατηγορία των ασθενών με στένωση νεφρικής αρτηρίας που θα ωφεληθούν .

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