CORAL
Trial question
What is the role of renal artery stenting in people with atherosclerotic renal artery stenosis and hypertension or CKD?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
50.0% female
50.0% male
N = 931
931 patients (466 female, 465 male).
Inclusion criteria: people with atherosclerotic renal artery stenosis and either systolic hypertension while taking ≥ 2 antihypertensive drugs or CKD.
Key exclusion criteria: renal artery stenosis due to FMD, CKD from a cause other than ischemic nephropathy or associated with a serum creatinine level > 4.0 mg/dL, kidney length < 7 cm, and a lesion that could not be treated with the use of a single stent.
Interventions
N=459 renal artery stenting plus medical therapy (placement of a Palmaz Genesis stent (Cordis) plus candesartan, hydrochlorothiazide, and atorvastatin-amlodipine).
N=472 medical therapy alone (with candesartan, hydrochlorothiazide, and atorvastatin-amlodipine).
Primary outcome
Adverse cardiovascular and renal events
35.1%
35.8%
35.8 %
26.8 %
17.9 %
8.9 %
0.0 %
Renal artery stenting plus medical
therapy
Medical therapy
alone
No significant
difference ↔
No significant difference in adverse cardiovascular and renal events (35.1% vs. 35.8%; HR 0.94, 95% CI 0.76 to 1.17).
Secondary outcomes
No significant difference in death from any cause (13.7% vs. 16.1%; HR 0.8, 95% CI 0.58 to 1.12).
No significant difference in stroke (3.5% vs. 4.9%; HR 0.68, 95% CI 0.36 to 1.28).
No significant difference in progressive renal insufficiency (16.8% vs. 18.9%; HR 0.86, 95% CI 0.64 to 1.17).
Conclusion
In people with atherosclerotic renal artery stenosis and either systolic hypertension while taking ≥ 2 antihypertensive drugs or CKD, renal artery stenting plus medical therapy was not superior to medical therapy alone with respect to adverse cardiovascular and renal events.
Reference
Cooper CJ, Murphy TP, Cutlip DE et al. Stenting and medical therapy for atherosclerotic renal-artery stenosis. N Engl J Med. 2014 Jan 2;370(1):13-22.
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