title: Significant reduction in systolic blood pressure following renal artery stenting in patients with uncontrolled hypertension: results from the HERCULES trial.
abstract: BACKGROUND
  Atherosclerotic renal artery stenosis (ARAS) causes hypertension (HTN) and threatens renal function (RF). The HERCULES Trial is a prospective, multicenter trial of renal stenting in patients with uncontrolled HTN and ARAS evaluating the safety and effectiveness of the RX Herculink Elite Renal Stent System (Abbott Vascular, Santa Clara, CA).
  
  
  METHODS
  A total of 202 patients (241 total lesions; 78 bilateral lesions) were enrolled between August 2007 and October 2009. The primary endpoint was 9-month binary restenosis determined by duplex ultrasound and/or angiography. Secondary endpoints included changes in blood pressure, antihypertensive medications, and RF between baseline and 9 months. Brain natriuretic peptide (BNP) was measured at baseline, 24 hr and 30 days postprocedure.
  
  
  RESULTS
  Mean systolic blood pressure (SBP) at baseline was 162 mm Hg. Nearly 70% of patients were receiving three or more antihypertensive medications (mean 3.4 medications per patient). Baseline serum creatinine was 1.2 ± 0.4 and 61.5% of subjects had estimated glomerular filtration <60. The restenosis rate was 10.5% at 9 months. The study device, procedure, and clinical success rates were 96.0, 99.2, and 98.0%, respectively. Freedom from major adverse events was 94.8%. At 9 months, the mean SBP significantly decreased (mean 145, paired t test P < 0.0001) after stenting with no change in medications. There was no correlation between SBP reduction and baseline BNP or BNP reduction.
  
  
  CONCLUSIONS
  HERCULES demonstrates clinically and statistically significant SBP reduction in patients with uncontrolled HTN, low in-stent restenosis, and complication rates. This study highlights that when appropriate patients are selected for renal artery stenting, impressive reductions in blood pressure may be anticipated. Although the magnitude of absolute reduction in SBP was related to baseline SBP, elevated baseline BNP levels were not predictive of reduction in SBP. Further studies for predictors of clinical response following percutaneous renal revascularization are needed.
authors.affiliation: The Vascular Center, Massachusetts General Hospital, Boston, Massachusetts, USA. mjaff@partners.org
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
authors.forename: Mark
authors.initials: M
authors.lastname: Bates
authors.forename: Timothy
authors.initials: T
authors.lastname: Sullivan
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Popma
authors.forename: Xingyu
authors.initials: X
authors.lastname: Gao
authors.forename: Margo
authors.initials: M
authors.lastname: Zaugg
authors.forename: Patrick
authors.initials: P
authors.lastname: Verta
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D000959:Antihypertensive Agents / Q000627:therapeutic use; D050197:Atherosclerosis / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D015415:Biomarkers / Q000097:blood; D001794:Blood Pressure / Q000187:drug effects; D003404:Creatinine / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D006978:Hypertension, Renovascular / Q000097:blood / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D008297:Male; D020097:Natriuretic Peptide, Brain / Q000097:blood; D011446:Prospective Studies; D012008:Recurrence; D012078:Renal Artery Obstruction / Q000097:blood / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D000959:Antihypertensive Agents; D015415:Biomarkers; D020097:Natriuretic Peptide, Brain; D003404:Creatinine