Transcript Controversies in renal arterial interventions.

Controversies in renal arterial
interventions.
ACHILLES CHATZIIOANNOU, MD
Assoc. Professor of Radiology
American Board of Radiology
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60-year old
male.
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Hypertension
(180/100)
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3 anti-HTN
medications
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Cr: 2,1 mg/dl
•Normotensive with one medication.
•Cr=1.1mg/dl
Herculink 6X18-mm
Renovascular Hypertension (RVH)
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Classic studies by Goldblatt (1930): RAS is the
cause of RVH.
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RAS causing RVH: prevalence 3-5% of the
hypertensive patients.
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Atherosclerosis: 70-90% of RHV. FMD: 10-30%
of RVH.
Atherosclerotic disease
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The prevalence of RAS is increasing because
of population aging, and increased survival.
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>60% RAS in 6.8% of individuals > 65y.
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RAS in pts undergoing coronary DSA: 18%20%.
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RAS in pts undergoing peripheral DSA: 35%50%.
Fibromuscular Dysplasia (FMD)
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Young patients –more
commonly females.
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Medial fibroplasia
(80%).
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Location: distal main
renal artery, 25% into
1st order branches.
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>50% of patients have
bilateral disease.
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Commonly
asymptomatic (3%-6%
in Transplant donors).
Atherosclerotic disease
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Patient 6th decade or older.
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More often male.
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The majority of the lesions are
incidental findings.
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Ostial lesions: within 1-cm
from aorta.
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Truncal lesions (less than
10%): more than 1-cm.
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50% have bilateral disease.
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12%-20% of stenoses>75%
will progress to total occlusion
within one year (?)
Manifestations of Renovascular Disease
(Textor SC, 2004)
Renal Artery
Stenosis
Incidental
RAS
Renovascular
Hypertension
Ischemic
Nephropathy
Accelerated
CV Disease
CHF
Stroke
Endovascular treatment (PTA-stents)
is always indicated in RAS?
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7660 interventions in 1996
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18520 interventions in 2000
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2.8-fold increase by interventional
cardiologists (“drive-by”).
Medicare data
Δεκαετία του 1990... μη ελεγχόμενες μελέτες
Αγγειοπλαστική ή χρήση
ενδοαυλικού νάρθηκα
Σημαντική μείωση της Α.Π.8,9
Σταθεροποίηση την χρόνιας νεφρικής ανεπάρκειας10,11
% αύξηση του stenting των νεφρικών αρτηριών στις ΗΠΑ
μεταξύ 1996 - 2000
500
364%12
300
100
-100
1996
2000
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
Treat RAS whenever found (easier when
early, avoid progression to occlusion).
1.
Progressive nature of ARVD,
progressing at the rate of 10% per
year (45%-60% progression rate in 47 year f-u)
2.
Pre-occlusive lesions (70-90%): risk
of occlusion 40%. .
JVIR 2002
Ischemic nephropathy
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Progressive disease
– Lesion progression 20% per year.
– Renal atrophy 10% per year.
– Artery occlusion 5% per year.
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RAS is a marker of increased cardiovascular
mortality, predictors:
– Older age
– Impaired renal function
– Bilateral RAS
Acute renal failure in patients with RAS
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1-14 days after the initiation of treatment
with ACE inhibitors.
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After the use of diuterics or other
antihypertensive drugs.
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After major surgery.
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After the spontaneous progression of
RAS to total occlusion.
Results of revascularization for ischemic
nephropathy
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32 patients with unexplained renal
impairment and RAS were treated with
renal artery stent.
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In 70% of the patients the renal function
improved or stabilized (p<0.007).
Harden et al, Lancet
1997
Results of revascularization for ischemic
nephropathy
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33 patients with bilateral RAS or RAS in
solitary kidney.
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Follow up: 20±11 months.
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Significant improvement in 72%; mild
improvement in 28%.
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Preservation of renal size in all patients.
Watson et al. Circulation 2000
Signs that a patient with ischemic nephropathy
will benefit from revascularization
1.
Normal distal arterioles.
2.
Bilateral disease.
3.
Recent onset of renal insufficiency.
4.
Resistive Index (Doppler sonography) <80
5.
Extremely limited renal function (cr>2,5
mg/dl or 220 μmol/l)*
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*Uder M, Huke U CVIR 2005
Percutaneous revascularization
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Technical success:98-100%
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Long term patency rate 85%-98%
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Complications:
– Mortality 1-3%
– Major complications: 3-5%
– Minor complications 10-20%
An analysis of the pooled results of studies of
conventional balloon angioplasty in 1118
patients
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Hospital death 0.5%
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Nephrectomy 0.3%
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Renal surgery 2%
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Occlusion of a side branch of the renal artery
2.2%
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Cholesterol embolization 1.1%
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Injury at the site of vascular access 2.3%
The indications and results of PTA and stenting in renal artery stenosis.
SeminVasc Surg 1996;9:188-197
Εν συνεχεία... Ελεγχόμενες
τυχαιοποιημένες μελέτες13, 14, 15, 16, 17, 18
6 έχουν 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
Evidence
3 randomized controlled trials compared medical
treatment to percutaneous renal
revascularization:
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DRASTIC: Dutch Renal Artery Stenosis
Intervention Cooperative Study Group
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EMMA: Essai Multicentrique Medicaments vs
Angioplastie Study Group
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SNRASCG: Scottish and Newcastle Renal
Artery Stenosis Collaborative Group
Conclusions
1.
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.
2.
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.
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
“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 endstage 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!
Angioplasty and Stent for
Renal Arterial Lesions
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Multicenter Randomized clinical trial.
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Approx 1000 pts will be randomized to
optimal medical therapy or to stenting
with optimal medical therapy
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 medicaltherapy 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
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
Kaplan-Meier Curves for the Time to the First Renal and Cardiovascular Events
The ASTRAL Investigators. N Engl J Med 2009;361:1953-1962
Kaplan-Meier Curves for Overall Survival
The ASTRAL Investigators. N Engl J Med 2009;361:1953-1962
Systolic and Diastolic Blood Pressure
The ASTRAL Investigators. N Engl J Med 2009;361:1953-1962
Νεφρική
λειτουργία
•25% των ασθενών με φυσιολογική νεφρική λειτουργία
•15% των ασθενών με οριακά φυσιολογική νεφρική λειτουργία
•“uncertainty principle” όσον αφορά την τυχαιοποίηση...
ACC/AHA οδηγίες
Υπέρταση
Στένωση ΝΑ
Εμπειρία
επεμβατιστών
•Μέσος όρος αντιϋπερτασικών φαρμάκων 2.8%
•Αόριστο ‘best medical treatment”
•41% των ασθενών ≤ 70%
•Εκτίμηση της στένωσης «με το μάτι» και όχι από πιστοποιημένο
εργαστήριο
•65% των κέντρων τυχαιοποίησαν < 1 ασθενή / έτος
•9% επιπλοκές από το stenting vs 2% άλλων μελετών
Ανθεκτική υπέρταση: ≥ 3
αντιϋπερτασικά
Συντηρητική
θεραπεία
μόνο
Συντηρητική
θεραπεία +
stenting
νεφρικής
αρτηρίας
• Στένωση ΝΑ ≥ 60%
• Α.Π. ≥ 155 mmHg + ≥ 2 αντιϋπερτασικά φάρμακα
και/ή
• GFR ≤ 60 ml/1.73 m2
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
Ενδείξεις επαναιμάτωσης νεφρικής αρτηρίας
RI (DUS) < 0.8
DTPA
Εκλεκτική
αγγειογραφία
της νεφρικής
αρτηρίας
Στένωση >75-80%
Συμπερασματικά...
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Δυστυχώς, οι ενδείξεις για επαναιμάτωση του
νεφρού δεν είναι ακόμη ξεκάθαρες (evidencebased).
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Στηριζόμενοι στις σημερινές κατευθυντήριες οδηγίες
οδηγίες (guidelines), πιθανόν να υποβληθούν
ασθενείς σε αγγειοπλαστική, χωρίς να το έχουν
πραγματικά ανάγκη.
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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 .