"Renal-Artery Stenting versus Medical Therapy for Atherosclerotic Renal-Artery Stenosis".The New England Journal of Medicine. 2013.
Links to original sources: Wiki Journal Post Full Journal Article
Contents 1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9 Criticisms 10 Funding 11 Further Reading
In patients with atherosclerotic renal-artery stenosis and hypertension or chronic kidney disease, does renal-artery stenting in addition to medical therapy improve clinical outcomes compared to medical therapy alone?
In a population with atherosclerotic renal-artery stenosis and either hypertension or chronic kidney disease, the addition of renal-artery stenting to comprehensive medical therapy did not improve clinical outcomes including cardiovascular and renal events.
The efficacy of renal-artery stenting for managing atherosclerotic renal-artery stenosis remained uncertain despite earlier randomized trials showing no benefit for kidney function. The Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) study was designed to evaluate the impact of renal-artery stenting on reducing adverse cardiovascular and renal events when added to contemporary medical therapy.
Not addressed directly by guidelines at the time of the study publication.
Multicenter, open-label, randomized, controlled trial N=947 patients with atherosclerotic renal-artery stenosis Medical therapy alone (n=480) Medical therapy plus renal-artery stenting (n=467) Median follow-up: 43 months Analysis: Intention-to-treat
Inclusion Criteria Patients with severe renal-artery stenosis who had systolic hypertension while taking two or more antihypertensive drugs or chronic kidney disease
Exclusion Criteria Renal-artery stenosis due to fibromuscular dysplasia Chronic kidney disease from a cause other than ischemic nephropathy or a serum creatinine level >4.0 mg/dL Kidney length <7 cm Lesions that could not be treated with a single stent
Baseline Characteristics Medications at baseline and follow-up: antihypertensive drugs, antiplatelet therapy, statins, and medications for diabetes control Mean number of antihypertensive medications: 2.1±1.6 Target blood pressure: <140/90 mm Hg or <130/80 mm Hg in diabetes or chronic kidney disease
Participants were randomized to either medical therapy alone or stenting plus medical therapy. Medical therapy included angiotensin II type-1 receptor blocker candesartan, with or without hydrochlorothiazide, amlodipine–atorvastatin, and other guideline-directed medications for blood pressure and lipid management. The stent group underwent placement of a Palmaz Genesis stent and were given antiplatelet therapy before the procedure.
Primary Outcome Composite end point of death from cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or need for permanent renal-replacement therapy. No difference between groups (35.1% for stent group vs. 35.8% for medical therapy alone; hazard ratio 0.94; 95% CI, 0.76 to 1.17; P=0.58)
No significant difference between groups in rates of individual primary end point components or all-cause mortality. Modest but significant reduction in systolic blood pressure (−2.3 mm Hg; 95% CI, −4.4 to −0.2; P=0.03) favoring stent group.
Patients enrolled could have renal-artery stenosis of 60% or more, and the debate about the severity of stenosis necessary for intervention is ongoing. Patients with fibromuscular dysplasia were not included. Some patients deemed eligible were not enrolled due to physician's preference, possibly affecting generalizability.
Supported by grants from the National Heart, Lung, and Blood Institute of the National Institutes of Health. Medications were donated by AstraZeneca and Pfizer; supplemental financial support was provided by Cordis and Pfizer.
Full text of the original NEJM article.