title: Objective performance goals of safety and blood pressure efficacy for clinical trials of renal artery bare metal stents in hypertensive patients with atherosclerotic renal artery stenosis.
abstract: OBJECTIVE
  To provide safety and performance goals for prospective single-arm trials of bare metal renal artery stenting in patients with resistant hypertension associated with high grade atherosclerotic renal artery stenosis.
  
  
  BACKGROUND
  To date, there have been no US Pre-Market Approval (PMA) bare metal renal stent device trials which have focused on improvement of blood pressure control as a primary effectiveness endpoint.
  
  
  METHODS
  Analysis of subject-level data from three large industry sponsored pre-market approval (PMA) trials was performed. Hypertensive patients (≥ 155 mmHg) with a ≥ 50% atherosclerotic renal artery stenosis were included. Thirty day and 9-month systolic and diastolic blood pressure measurements, renal function and 9-month duplex ultrasound assessment of renal artery patency were analyzed.
  
  
  RESULTS
  Initial data analysis of 600 patients from the 3 PMA trials identified 286 patients who met inclusion criteria. The mean baseline systolic blood pressure was 177.8 ± 19.3 mmHg with a mean 68.1% diameter renal artery stenosis. Nine months after successful stenting, the mean SBP was 156.7 ± 24.1 mmHg; the 9 month restenosis rate was 14.4%.
  
  
  CONCLUSIONS
  Based on the statistical modeling of these data and a priori established performance criteria, the co-primary endpoints of 9 month reduction in blood pressure and in-stent restenosis are proposed. The reduction in blood pressure will be analyzed as a continuous variable and will be compared to this performance goal.
authors.affiliation: Prairie Education and Research Cooperative, Springfield, Illinois 62794-9420, USA. ksingh@prairieheart.com
authors.forename: Krishna J
authors.initials: KJ
authors.lastname: Rocha-Singh
authors.forename: Victor
authors.initials: V
authors.lastname: Novack
authors.forename: Michael
authors.initials: M
authors.lastname: Pencina
authors.forename: Ralph
authors.initials: R
authors.lastname: D'Agostino
authors.forename: Gary
authors.initials: G
authors.lastname: Ansel
authors.forename: Kenneth
authors.initials: K
authors.lastname: Rosenfield
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D001794:Blood Pressure; D001795:Blood Pressure Determination; D016009:Chi-Square Distribution; D002986:Clinical Trials as Topic / Q000592:standards*; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D006978:Hypertension, Renovascular / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D015233:Models, Statistical; D015337:Multicenter Studies as Topic / Q000592:standards*; D010043:Outcome and Process Assessment, Health Care / Q000592:standards*; D061214:Patient Safety; D011446:Prospective Studies; D012008:Recurrence; D012042:Registries; D012078:Renal Artery Obstruction / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D012107:Research Design / Q000592:standards*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex