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Antoine SAUGUET, MD
Clinique PASTEUR, Toulouse, FRANCE
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Antoine SAUGUET Faculty disclosure I have no financial relationships to disclose.
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INTRODUCTION
FIRST STEP OPTIMAL MEDICAL THERAPY
Blood control sometimes poorly achieved with
progressive loss of renal function
SECOND STEP IDENTIFICATION OF PATIENTS WHO
WOULD BENEFIT FROM THE STENTING
PROCEDURE
POOR CORRELATION OF ANGIOGRAPHIC IMAGES
AND HEMODYNAMIC SIGNIFICANCE
DEGREE OF RENAL ARTERIE STENOSIS THAT
JUSTIFIES STENTING IS UNKNOW
Need for new tools
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RENAL ARTERY STENOSIS
66% 33% 1%
Atherosclerosis Fibromuscular
dysplasia Others
• anevrysmal
• Takayasu arteritis
• giant cells arteritis
• APLS
RENAL ARTERY STENOSIS ETIOLOGY
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RENAL ARTERY
FIBROMUSCULAR DYSPLASIA
Non inflammatory disease Mostly young females (30-50y)
Multiples locations Severe symptomatic hypertension
STRINGS OF BEADS
Trinquart L, Mounier-Vehier C, Sapoval M, et al.
Efficacy of revascularization for renal artery stenosis caused by fibromuscular dysplasia:
a systematic review and meta- analysis. Hypertension 2010;56:525-32.
Baseline characteristics
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Trinquart L, Mounier-Vehier C, Sapoval M, et al.
Efficacy of revascularization for renal artery stenosis caused by fibromuscular dysplasia:
a systematic review and meta- analysis. Hypertension 2010;56:525-32.
RENAL ARTERY
FIBROMUSCULAR DYSPLASIA
Blood pressure response to Renal angioplasty
All these blood pressure response are without treatment
INDICATION CLASS I LOE B
Uncontroled hypertension with mean baseline gradient > 20mmHg
Balloon angioplasty close to 100% success rate
less than 10% restenosis 10 years
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Massoud A, et al JACC june 23, 2009:2363-71
PREDICTION OF HTA IMPROVEMENT AFTER STENTING OF RENAL ARTERY STENOSIS
N=62 50-90% RA stenosis
Translesionnal pressure gradient, IVUS, angiographics parameters
Hyperhemia systolic gradient > 21mmHg only independant
Predictor of HTA improvement
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806 PATIENTS
ASTRAL STUDY
40% Intermediate
stenosis
Wheatley K, Ives N, Gray R et al. Revascularization versus medical therapy for renal-artery stenosis.
N Engl J Med 2009; 361: 1953–1962
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Wheatley K, Ives N, Gray R et al. Revascularization versus medical therapy for renal-artery stenosis.
N Engl J Med 2009; 361: 1953–1962
5 years follow up
ASTRAL STUDY
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5 years
follow up P=NS
Wheatley K, Ives N, Gray R et al. Revascularization versus medical therapy for renal-artery stenosis.
N Engl J Med 2009; 361: 1953–1962
ASTRAL STUDY
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CRITICISMS OF ASTRAL
Inexperienced operators 8% serious complication
2patients/center/y 79% technical success
No core lab
Primary endpoint was rate of renal function decline (40% had normal or
near normal baseline renal function)
Selection bias toward enrolling asymptomatic patients with non-
obstructive RAS (unlikely to benefit)
Only about 40 to 50% of the patients were treated with drugs that block
the pathway of the renin angiotensin aldosterone system
40% of patients have less than 70% stenosis
17% did not get stenting in RAS arm
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Stenting and Medical Therapy for Atherosclerotic Renal-Artery Stenosis
Cooper CJ et al. N Engl J Med 2014;370:13-22
CORAL STUDY Multicenter, open label randomized, controlled trial
Medical therapy alone vs MT + revascularization
Primary endpoint on clinical outcomes
INCLUSION CRITERIA
- TA> 155mmHg
- Systolic pressure gradient>20mmHg
- >80% <100% stenosis
Change during study SBP<155 inclusion
With normal BP, inclusion criteria on
Duplex echo, MRI
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Stenting and Medical Therapy for Atherosclerotic Renal-Artery Stenosis
Cooper CJ et al. N Engl J Med 2014;370:13-22
CORAL STUDY
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Stenting and Medical Therapy for Atherosclerotic Renal-Artery Stenosis
Cooper CJ et al. N Engl J Med 2014;370:13-22
5 YEARS
FOLLOW UP
LESS THAN 10% patient at 5y
CORAL STUDY
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Results: Systolic Blood Pressure
P = 0.03
C. Cooper, AHA 2013 Stenting and Medical Therapy for Atherosclerotic Renal-Artery Stenosis
Cooper CJ et al. N Engl J Med 2014;370:13-22
SIGNIFICANT REDUCTION OF 2mmHg in SBP with stenting
CORAL STUDY
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CRITICISMS WITH CORAL
Endpoints changed during the trial and very few patients remained for 5 years...Is this long enough for clinical endpoints evaluation?
Use of embolic protection device complicated the procedure and changed during the trial.
Patients with only 60% RAS were included in the trial.
A large number of screened patients were not enrolled in the trial suggesting an enrollment bias.
Stenting and Medical Therapy for Atherosclerotic Renal-Artery Stenosis
Cooper CJ et al. N Engl J Med 2014;370:13-22
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META ANALYSIS OF RANDOMIZED CLINICAL TRIALS
Treatment of atherosclerotic renovascular hypertension: review of observational studies and a meta-
analysis of randomized clinical trials Paola Caielli et al. Nephrol Dial Transplant (2014) 0:1-13
NUMBER OF ANTIHYPERTENSIVE DRUGS
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Treatment of atherosclerotic renovascular hypertension: review of observational studies and a meta-
analysis of randomized clinical trials Paola Caielli et al. Nephrol Dial Transplant (2014) 0:1-13
SYSTOLIC BLOOD PRESSURE RESPONSE
META ANALYSIS OF RANDOMIZED CLINICAL TRIALS
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Treatment of atherosclerotic renovascular hypertension: review of observational studies and a meta-
analysis of randomized clinical trials Paola Caielli et al. Nephrol Dial Transplant (2014) 0:1-13
DIASTOLIC BLOOD PRESSURE RESPONSE
META ANALYSIS OF RANDOMIZED CLINICAL TRIALS
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Hypertension Preservation of renal function
Congestive heart failure
Class IIa, LOE B Class IIa, LOE B Class I, LOE B
Percutaneous revascularization is reasonable for patients with hemodynamically significant RAS, accelerated HTN, resistant HTN, and malignant HTN
Percutaneous revacularization is reasonable for patients with RAS and progressive chronic kidney disease with bilateral RAS or a stenosis to a solitary functioning kidney
Percutaneous revascularization is indicated in patients with hemodynamically significant RAS (ie,>70% stenosis on angiography) and recurrent, unexplained pulmonary edema
ACC/AHA Guidelines on Indications for
Renal Artery Stenting ACC/AHA GUIDELINES ON INDICATIONS FOR RAS
Hirsch AT, Haskal ZJ, Hertzer NR et al. ACC/AHA 2005 guidelines for the management of patients
with peripheral arterial. J Am Coll Cardiol 2006; 47: 1239–1312
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CLINICAL FACTORS FAVORING MEDICAL THERAPY OR REVASCULARIZATION OF RAS
Controlled blood pressure with stable renal function
Advanced age or limited life expectancy
Extensive comorbidities that make revascularization risky
High risk for atheroembolic complications
Concomitant renal parenchymal disease
MEDICAL THERAPY AND SURVEILLANCE
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Progressive decline in glomerular filtration rate (GFR)
during treament of hypertension
Failure to achieve adequate blood pressure (BP) control
with optimal medical therapy
Rapid or recurrent decline in GFR in association with BP reduction
Decline in GFR with treatment with angiotensin converting enzyme inhibitors
or angiotensine receptor blockers
Recurrent congestive heart failure in patients with
adequate left ventricular function
REVASCULARIZATION + OPTIMAL MEDICAL THERAPY
CLINICAL FACTORS FAVORING MEDICAL THERAPY OR REVASCULARIZATION OF RAS
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TAKE HOME MESSAGE
• Many patients with renovascular occlusive disease can achieve adequate BP control with stable renal function for several years.
• Clinician need to identify subsets of patients who fail medical therapy and/or progress to develop high-risk clinical phenotypes
• Renal artery stenting should be reserved for those who fail medical therapy with hypertension and clinical events