Multipl
e randomiz
ed clinical trials comparing r
enal art
ery st
ent plac
em
ent plus m
edical th
erapy with m
edical th
erapy alon
e hav
e not shown any b
en
efit of st
ent plac
em
ent. How
ev
er, d
ebat
e continu
es wh
eth
er pati
ents with
extr
em
e pr
essur
e gradi
ents, st
enosis s
ev
erity, or bas
elin
e blood pr
essur
e b
en
efit from st
ent r
evascularization.
ec_2">Objectives
The study sought to test the hypothesis that pressure gradients, stenosis severity, and/or baseline blood pressure affects outcomes after renal artery stent placement.
ec_3">Methods
Using data from 947 patients with a history of hypertension or chronic kidney disease from the largest randomized trial of renal artery stent placement, the CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) study, we performed exploratory analyses to determine if subsets of patients experienced better outcomes after stent placement than the overall cohort. We examined baseline stenosis severity, systolic blood pressure, and translesion pressure gradient (peak systolic and mean) and performed interaction tests and Cox proportional hazards analyses for the occurrence of the primary endpoint through all follow-up, to examine the effect of these variables on outcomes by treatment group.
ec_4">Results
There were no statistically significant differences in outcomes based on the examined variables nor were there any consistent nonsignificant trends.
ec_5">Conclusions
Based on data from the CORAL randomized trial, there is no evidence of a significant treatment effect of the renal artery stent procedure compared with medical therapy alone based on stenosis severity, level of systolic blood pressure elevation, or according to the magnitude of the trans-stenotic pressure gradient. (Benefits of Medical Therapy Plus Stenting for Renal Atherosclerotic Lesions [CORAL]; ef0010" class="interref" data-locatorType="https" data-locatorKey="//clinicaltrials.gov/ct2/show/NCT00081731">NCT00081731)