title: Roll-in experience from the Cardiovascular Outcomes with Renal Atherosclerotic Lesions (CORAL) study.
abstract: OBJECTIVE
  To describe the experience and results from the roll-in phase of the Cardiovascular Outcomes with Renal Atherosclerotic Lesions (CORAL) study.
  
  
  METHODS
  The CORAL roll-in database was used to describe the baseline characteristics of the patients in the roll-in cohort, all of whom underwent renal artery stent placement; to evaluate CORAL site performance; to compare estimates of lesion (stenosis) severity made by site interventionalists with the central CORAL angiographic core laboratory readings; and to report outcomes after renal artery stent placement. During the roll-in phase, 239 patients (mean age, 70.2 y ± 9.0; 49% male) underwent renal artery stent procedures. Angiographic core laboratory analysis of renal arteriograms was done, and participants were followed at 1 month and 9 months.
  
  
  RESULTS
  Major angiographic complications were identified in 28 (13%) subjects. Kidney function remained unchanged at the short (2-4 weeks) follow-up interval. Improvement in systolic blood pressure with use of distal embolic protection devices (n = 161) did not show any clinical benefit over nonuse of such devices (n = 78) in this small series. At 9 months, there were significantly more endpoints reported by site in subjects with bilateral renal artery stenosis (P = .01) and prior history of stroke (P = .03).
  
  
  CONCLUSIONS
  In the roll-in phase of the CORAL study, a significant number of angiographic complications were identified. No effect was seen on estimated glomerular filtration rate after renal artery stent placement, but systolic blood pressure decreased significantly.
authors: Vascular Disease Research Center, Rhode Island Hospital, Gerry 337, 593 Eddy Street, Providence, RI 02903. Electronic address: tmurphy@lifespan.org.
authors: Timothy P
authors: TP
authors: Murphy
authors: Division of Cardiology, University of Toledo, Toledo, Ohio.
authors: Christopher J
authors: CJ
authors: Cooper
authors: Division of Cardiology, Beth Israel Deaconess Hospital, Boston; Harvard Clinical Research Institute, Boston.
authors: Donald E
authors: DE
authors: Cutlip
authors: Department of Radiology, University of Virginia, Charlottesville, Virginia.
authors: Alan
authors: A
authors: Matsumoto
authors: Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan.
authors: Kenneth
authors: K
authors: Jamerson
authors: Interventional Institute, Holy Name Medical Center, Teaneck, New Jersey.
authors: John
authors: J
authors: Rundback
authors: Division of Cardiology, Massachusetts General Hospital, Boston.
authors: Kenneth A
authors: KA
authors: Rosenfield
authors: University of Texas Health Sciences at San Antonio, San Antonio, Texas.
authors: William
authors: W
authors: Henrich
authors: Joan C. Edwards School of Medicine, Marshall University, Huntington, West Virginia.
authors: Joseph
authors: J
authors: Shapiro
authors: Harvard Clinical Research Institute, Boston; Department of Biostatistics, Boston University, Boston, Massachusetts.
authors: Joseph
authors: J
authors: Massaro
authors: Harvard Clinical Research Institute, Boston.
authors: Chen-Hsing
authors: CH
authors: Yen
authors: Division of Cardiology, University of Toledo, Toledo, Ohio.
authors: Holly
authors: H
authors: Burtch
authors: Harvard Clinical Research Institute, Boston.
authors: Claudia
authors: C
authors: Thum
authors: National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland.
authors: Diane
authors: D
authors: Reid
authors: Division of Nephrology, Rhode Island Hospital, Gerry 337, 593 Eddy Street, Providence, RI 02903.
authors: Lance
authors: L
authors: Dworkin
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation; D050197:Atherosclerosis / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D001794:Blood Pressure; D002983:Clinical Competence; D016208:Databases, Factual; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy; D007668:Kidney / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010043:Outcome and Process Assessment, Health Care; D018579:Patient Selection; D012078:Renal Artery Obstruction / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D051436:Renal Insufficiency, Chronic / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy; D012720:Severity of Illness Index; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome