ASTRAL
Trial question
What is the role of percutaneous revascularization in patients with atherosclerotic renovascular disease?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
37.0% female
63.0% male
N = 806
806 patients (299 female, 507 male).
Inclusion criteria: patients with atherosclerotic renovascular disease.
Key exclusion criteria: requirement of surgical revascularization or high likelihood of requiring revascularization within 6 months, nonatheromatous CVD, or undergone previous revascularization for renal artery stenosis.
Interventions
N=403 revascularization (with angioplasty either alone or with stenting plus medical therapy with statins, antiplatelet agents, and optimal blood-pressure control).
N=403 medical therapy (statins, antiplatelet agents, and optimal blood-pressure control).
Primary outcome
Rate of decline in serum creatinine
-0.071
-0.131
0.0 ×10**-...
-0.0 ×10**-...
-0.1 ×10**-...
-0.1 ×10**-...
-0.1 ×10**-...
Revascularization
Medical
therapy
No significant
difference ↔
No significant difference in the rate of decline in serum creatinine (-0.071 ×10⁻³ L/mcmol/year vs. -0.131 ×10⁻³ L/mcmol/year; MD 0.06, 95% CI 0 to 0.13).
Secondary outcomes
No significant difference in renal events (22% vs. 22%; HR 0.97, 95% CI 0.67 to 1.4).
No significant difference in major CV events (49% vs. 51%; HR 0.94, 95% CI 0.75 to 1.19).
No significant difference in death (60% vs. 57%; HR 0.9, 95% CI 0.69 to 1.18).
Conclusion
In patients with atherosclerotic renovascular disease, revascularization was not superior to medical therapy with respect to the rate of decline in serum creatinine.
Reference
ASTRAL Investigators, Wheatley K, Ives N et al. Revascularization versus medical therapy for renal-artery stenosis. N Engl J Med. 2009 Nov 12;361(20):1953-62.
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