title: Renal Artery Stent Outcomes: Effect of Baseline Blood Pressure, Stenosis Severity, and Translesion Pressure Gradient.
abstract: BACKGROUND
  Multiple randomized clinical trials comparing renal artery stent placement plus medical therapy with medical therapy alone have not shown any benefit of stent placement. However, debate continues whether patients with extreme pressure gradients, stenosis severity, or baseline blood pressure benefit from stent revascularization.
  
  
  OBJECTIVE
  The study sought to test the hypothesis that pressure gradients, stenosis severity, and/or baseline blood pressure affects outcomes after renal artery stent placement.
  
  
  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.
  
  
  RESULTS
  There were no statistically significant differences in outcomes based on the examined variables nor were there any consistent nonsignificant trends.
  
  
  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]; NCT00081731).
authors.affiliation: Rhode Island Hospital, Providence, Rhode Island; Alpert Medical School of Brown University, Providence, Rhode Island. Electronic address: tmurphy@lifespan.org.
authors.forename: Timothy P
authors.initials: TP
authors.lastname: Murphy
authors.affiliation: University of Toledo, Toledo, Ohio.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Cooper
authors.affiliation: University of Virginia, Charlottesville, Virginia.
authors.forename: Alan H
authors.initials: AH
authors.lastname: Matsumoto
authors.affiliation: Harvard Clinical Research Institute, Boston, Massachusetts; Beth Israel Deaconess Medical Center, Boston, Massachusetts.
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
authors.affiliation: Harvard Clinical Research Institute, Boston, Massachusetts.
authors.forename: Karol M
authors.initials: KM
authors.lastname: Pencina
authors.affiliation: University of Michigan, Ann Arbor, Michigan.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Jamerson
authors.affiliation: Providence Sacred Heart Medical Center, Spokane, Washington; University of Washington School of Medicine, Seattle, Washington.
authors.forename: Katherine R
authors.initials: KR
authors.lastname: Tuttle
authors.affiliation: Marshall University, Huntington, West Virginia.
authors.forename: Joseph I
authors.initials: JI
authors.lastname: Shapiro
authors.affiliation: Harvard Clinical Research Institute, Boston, Massachusetts; Boston University School of Public Health, Boston, Massachusetts.
authors.forename: Ralph
authors.initials: R
authors.lastname: D'Agostino
authors.affiliation: Harvard Clinical Research Institute, Boston, Massachusetts; Boston University School of Public Health, Boston, Massachusetts.
authors.forename: Joseph
authors.initials: J
authors.lastname: Massaro
authors.affiliation: University of Texas Health Science Center, San Antonio, Texas.
authors.forename: William
authors.initials: W
authors.lastname: Henrich
authors.affiliation: Rhode Island Hospital, Providence, Rhode Island; Alpert Medical School of Brown University, Providence, Rhode Island.
authors.forename: Lance D
authors.initials: LD
authors.lastname: Dworkin
mesh_terms: D001794:Blood Pressure / Q000502:physiology; D015331:Cohort Studies; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000503:physiopathology / Q000628:therapy; D012078:Renal Artery Obstruction / Q000473:pathology / Q000503:physiopathology* / Q000628:therapy*; D051436:Renal Insufficiency, Chronic / Q000150:complications / Q000503:physiopathology / Q000628:therapy; D012720:Severity of Illness Index; D015607:Stents; D016019:Survival Analysis; D016896:Treatment Outcome
keywords: chronic kidney disease; hypertension; renal artery; stenosis; stent