article55

CORAL

"Renal-Artery Stenting versus Medical Therapy for Atherosclerotic Renal-Artery Stenosis".The New England Journal of Medicine. 2013.

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

Clinical Question

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?

Bottom Line

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.

Major Points

Guidelines

Not addressed directly by guidelines at the time of the study publication.

Design

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

Population

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

Interventions

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.

Outcomes

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)

Secondary Outcomes
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.

Criticisms

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.

Funding

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.