Renal artery stenosis angioplasty and stenting
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor-In-Chief: Shivam Singla, M.D.[2]
Overview
Randomized controlled trials such as ASTRAL (Angioplasty and Stenting for Renal Artery Lesions) and CORAL have not demonstrated a benefit of percutaneous revascularization over medical therapy among patients with unilateral renal artery stenosis (RAS). These trials have been criticized, however, because they did not enroll those patients who in observational data derived the greatest benefit, namely those patients who have a short duration of hypertension, patients who are resistant to medical therapy for hypertension, and patients who have recurrent flash pulmonary edema. For instance, in the ASTRAL trial, patients had hypertension for 5 years. Likewise, the mean number of antihypertensive agents was only 2.1 in the CORAL trial, and patients who were recently hospitalized with congestive heart failure were excluded from the CORAL trial.
Landmark Studies
ASTRAL Trial
- The 2009 ASTRAL (Angioplasty and Stenting for Renal Artery Lesions) trial was an unblinded trial that randomized 806 patients with RAS for 5 years to either revascularization and medical therapy or medical therapy alone in a 1:1 ratio.
- Renal angioplasty was associated with significant risk and very little benefit in ASTRAL.[1]
- The rate of increase in creatinine was better among patients who underwent revascularization at -0.07x10-3 L/mmol/year vs -0.13x10-3 L/mmol/year among those treated with medical therapy.
- Similarly, the mean serum creatinine was lower in the revascularization group; but the number of renal events was similar. Nonetheless, the reduction in blood pressure was better with medical therapy.[1] Furthermore, cardiovascular events and death were not significantly different; but the rates of serious complications during revascularization were high, involving 23 patients and including 2 deaths and 3 amputations.[1]
CORAL Trial
- In the 2013 CORAL trial, 947 patients with atherosclerotic renal-artery stenosis who had either chronic kidney disease or persistent systolic hypertension on > or = to 2 antihypertensive drugs were randomized to either renal-artery stenting + medical therapy or medical therapy alone.
- After a median follow-up of 43 months, the primary endpoint (the composite of either death from cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or the need for renal-replacement therapy) did not differ between the strategies: 35.1% and 35.8%; 0.94; 95% confidence interval [CI], 0.76 to 1.17; P=0.58, for stenting + medical therapy vs medical therapy alone); nor did any of the components of the primary endpoint (including mortality).
- There was a modest benefit in systolic blood pressure reduction in the stented group (−2.3 mm Hg; 95% CI, −4.4 to −0.2; P=0.03).
Indications for Renal Angioplasty or Stenting
Based upon the modest data observed in the above observational studies, the following are considered reasonable indications for percutaneous intervention:[2][3] [4]
- Failure of medical therapy with persistent hypertension or a decline in renal function while on medical therapy
- Revascularization was recommended by ACC/AHA guidelines, with class B evidence, in hypertensive patients who have hemodynamically significant RAS, malignant, resistant, and/or accelerated hypertension, and among those with unexplained unilateral small kidneys or intolerance to anti-hypertensive medications.[5]
- Refractory heart failure and or recurrent flash pulmonary edema
- Revascularization was indicated at level B evidence in patients with hemodynamically significant RAS and recurrent congestive heart failure of undefined cause or in cases of sudden flash pulmonary edema with unexplained etiology, as well as for unstable angina.[5]
- Brief duration of hypertension preceding diagnosis of renal artery stenosis
Management of Patients With Peripheral Artery Disease (Compilation of 2005 and 2011 ACCF/AHA Guideline Recommendations) : A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines[6]
| Indications for Revascularization of Asymptomatic Stenosis | Class IIb
"1. Percutaneous revascularization may be considered for the treatment of an asymptomatic bilateral or a solitary viable kidney with a hemodynamically significant RAS. (Level of Evidence: C)" "2. The usefulness of percutaneous revascularization of an asymptomatic unilateral hemodynamically significant RAS in a viable kidney is not well established and is presently clinically unproven. (Level of Evidence: C)"
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| Hypertension | Class IIa
"1. Percutaneous revascularization is reasonable for patients with hemodynamically significant RAS and accelerated hypertension, resistant hypertension, malignant hypertension, hypertension with an unexplained unilateral small kidney, and hypertension with intolerance to medication. (Level of Evidence: B)" |
| Preservation of Renal
Function |
Class IIa
"1. Percutaneous revascularization is reasonable for patients with RAS and progressive chronic kidney disease with bilateral RAS or a RAS to a solitary functioning kidney. (Level of Evidence: B)" "1. Percutaneous revascularization may be considered for patients with RAS and chronic renal insufficiency with unilateral RAS. (Level of Evidence: C)" |
| Impact of RAS on
Congestive Heart Failure and Unstable Angina |
Class I
"1. Percutaneous revascularization is indicated for patients with hemodynamically significant RAS and recurrent, unexplained congestive heart failure or sudden, unexplained pulmonary edema (see text). (Level of Evidence: B)" "1. Percutaneous revascularization is reasonable for patients with hemodynamically significant RAS and unstable angina (see text). (Level of Evidence: B)"
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| Endovascular
Treatment for RAS |
Class I
"1. Renal stent placement is indicated for ostial atherosclerotic RAS lesions that meet the clinical criteria for intervention. (Level of Evidence: B)" "2. Balloon angioplasty with bail-out stent placement if necessary is recommended for fibromuscular dysplasia lesions. (Level of Evidence: B)" |
References
- ↑ 1.0 1.1 1.2 ASTRAL Investigators. Wheatley K, Ives N, Gray R, Kalra PA, Moss JG; et al. (2009). "Revascularization versus medical therapy for renal-artery stenosis". N Engl J Med. 361 (20): 1953–62. doi:10.1056/NEJMoa0905368. PMID 19907042. Review in: Ann Intern Med. 2010 Feb 16;152(4):JC-26
- ↑ Ritchie J, Green D, Chrysochou C, Chalmers N, Foley RN, Kalra PA (2014). "High-risk clinical presentations in atherosclerotic renovascular disease: prognosis and response to renal artery revascularization". Am J Kidney Dis. 63 (2): 186–97. doi:10.1053/j.ajkd.2013.07.020. PMID 24074824.
- ↑ Kalra PA, Chrysochou C, Green D, Cheung CM, Khavandi K, Sixt S; et al. (2010). "The benefit of renal artery stenting in patients with atheromatous renovascular disease and advanced chronic kidney disease". Catheter Cardiovasc Interv. 75 (1): 1–10. doi:10.1002/ccd.22290. PMID 19937777.
- ↑ Gray BH, Olin JW, Childs MB, Sullivan TM, Bacharach JM (2002). "Clinical benefit of renal artery angioplasty with stenting for the control of recurrent and refractory congestive heart failure". Vasc Med. 7 (4): 275–9. PMID 12710843.
- ↑ 5.0 5.1 Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH; et al. (2013). "Management of patients with peripheral artery disease (compilation of 2005 and 2011 ACCF/AHA guideline recommendations): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines". Circulation. 127 (13): 1425–43. doi:10.1161/CIR.0b013e31828b82aa. PMID 23457117.
- ↑ Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss L; et al. (2013). "Management of patients with peripheral artery disease (compilation of 2005 and 2011 ACCF/AHA Guideline Recommendations): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines". J Am Coll Cardiol. 61 (14): 1555–70. doi:10.1016/j.jacc.2013.01.004. PMC 4492473. PMID 23473760.