Renal artery stenosis angioplasty and stenting
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Yazan Daaboul, Serge Korjian, Vishnu Vardhan Serla M.B.B.S. [2]
Overview
Randomized controlled trials such as ASTRAL (Angioplasty and Stenting for Renal Artery Lesions)[1] and CORAL [2]have not demonstrated a benefit of percutaneous revascularization over medical therapy among patients with unilateral renal artery stenosis. 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.[2]
Landmark Studies
The 2009 ASTRAL (Angioplasty and Stenting for Renal Artery Lesions) trial was an unblinded trial which 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]
According to the trial, the rate of progression was statistically better among patients who underwent revascularization, with a rate of progression reaching -0.13x10-3 L/mmol/year, compared to only -0.07x10-3 L/mmol/year among those received pharmacologic 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] Finally, 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]
The ASTRAL trial has been mentioned in the 2011 ACCF/AHA Focused Update of the Guideline for the Management of Patients With Peripheral Artery Disease that intends to update the previous 2005 guideline with new emerging data on new discoveries.[3] There was a complilation of 2005 and 2011 ACC/AHA Guidelines made in 2013, where they updated medical therapy of PAD, but no changes were actually made to renal arterial disease. [4]
Asymptomatic Patients
The 2013 ACC/AHA guidelines update[4] showed class C evidence to revascularize asymptomatic patients only with hemodynamically significant RAS or with solitary viable kidney. Nonetheless, the report mentioned no known benefit or risk at the time for such procedure in asymptomatic patients.[4]
Hypertension
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.[4]
Impaired Renal Function
Revascularization was recommended with level B evidence for patients with RAS and progressive kidney disease, for those with bilateral RAS or one solitary viable kidney. For patients with CKD and unilateral RAS, percutaneous revascularization was still considered reasonable, but with a level C evidence.[4]
Congestive Heart Failure
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.[4]
Unstable Angina
There was level B evidence to recommend revascularization among patients known to have unstable angina with hemodynamically significant RAS.[4]
Intervention
Stent implantation was indicated in the ostial RAS lesion that meet criteria for intervention. Aorto-ostial lesions are the most common location for atherosclerosis in RAS and are susceptible to vascular recoil. As such, this specific location was considered to be not appropriately managed with balloon angioplasty alone[5][6][7] and requires stent implantation.[8][9] Large post-stent minimal lumen diameter were considered superior to its smaller counterpart, similar to that observed in coronary stenting. Nonetheless, given new emerging data since the publication of the ACC/AHA guidelines in 2005, and supported by 2014 CORAL studies, the role of angioplasty and intervention might altogether be obsolete.[10]
2013 ACC/AHA Practice Guidelines for the Management of Patients With Peripheral Arterial Disease (Lower Extremity, Renal, Mesenteric, and Abdominal Aortic) (DO NOT EDIT)[4]
Indications for Revascularization of Asymptomatic Stenosis (DO NOT EDIT)[4]
| Class IIb |
| "1. Percutaneous revascularization may be considered for 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)" |
Hypertension (DO NOT EDIT)[4]
| 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 (DO NOT EDIT)[4]
| 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)" |
| Class IIb |
| "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 (DO NOT EDIT)[4]
| 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)" |
| Class IIa |
| "1. Percutaneous revascularization is reasonable for patients with hemodynamically significant RAS and unstable angina (see text). (Level of Evidence: B)" |
Catheter-Based Interventions (DO NOT EDIT)[4]
| 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 1.3 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
- ↑ 2.0 2.1 Murphy TP, Cooper CJ, Dworkin LD, Henrich WL, Rundback JH, Matsumoto AH; et al. (2005). "The Cardiovascular Outcomes with Renal Atherosclerotic Lesions (CORAL) study: rationale and methods". J Vasc Interv Radiol. 16 (10): 1295–300. doi:10.1097/01.RVI.0000176301.69756.28. PMID 16221898.
- ↑ Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss LK; et al. (2011). "2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine, and Society for Vascular Surgery". J Vasc Surg. 54 (5): e32–58. doi:10.1016/j.jvs.2011.09.001. PMID 21958560.
- ↑ 4.00 4.01 4.02 4.03 4.04 4.05 4.06 4.07 4.08 4.09 4.10 4.11 4.12 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.
- ↑ Brawn LA, Ramsay LE (1987). "Is "improvement" real with percutaneous transluminal angioplasty in the management of renovascular hypertension?". Lancet. 2 (8571): 1313–6. PMID 2890911.
- ↑ Cicuto KP, McLean GK, Oleaga JA, Freiman DB, Grossman RA, Ring EJ (1981). "Renal artery stenosis: anatomic classification for percutaneous transluminal angioplasty". AJR Am J Roentgenol. 137 (3): 599–601. doi:10.2214/ajr.137.3.599. PMID 6456652.
- ↑ Martin LG, Cork RD, Kaufman SL (1992). "Long-term results of angioplasty in 110 patients with renal artery stenosis". J Vasc Interv Radiol. 3 (4): 619–26. PMID 1446123.
- ↑ Rocha-Singh KJ, Mishkel GJ, Katholi RE, Ligon RA, Armbruster JA, McShane KJ; et al. (1999). "Clinical predictors of improved long-term blood pressure control after successful stenting of hypertensive patients with obstructive renal artery atherosclerosis". Catheter Cardiovasc Interv. 47 (2): 167–72. doi:10.1002/(SICI)1522-726X(199906)47:2<167::AID-CCD7>3.0.CO;2-R. PMID 10376497.
- ↑ Radermacher J, Chavan A, Bleck J, Vitzthum A, Stoess B, Gebel MJ; et al. (2001). "Use of Doppler ultrasonography to predict the outcome of therapy for renal-artery stenosis". N Engl J Med. 344 (6): 410–7. doi:10.1056/NEJM200102083440603. PMID 11172177.
- ↑ Cooper CJ, Murphy TP, Cutlip DE, Jamerson K, Henrich W, Reid DM; et al. (2014). "Stenting and medical therapy for atherosclerotic renal-artery stenosis". N Engl J Med. 370 (1): 13–22. doi:10.1056/NEJMoa1310753. PMID 24245566.