title: Twelve-month results of the rapid renal sympathetic denervation for resistant hypertension using the OneShotTM ablation system (RAPID) study.
abstract: OBJECTIVE
  Renal denervation has emerged as a treatment option for patients with drug-resistant hypertension. This study was designed to assess the safety and effectiveness of the OneShotª Renal Denervation System.
  
  
  RESULTS
  RAPID is a prospective, multicentre, single-arm study which enrolled 50 patients at 11 clinical sites in Europe and New Zealand. Eligible patients had an office systolic blood pressure (SBP) ≥160 mmHg and were on a stable regimen of ≥3 antihypertensive medications including a diuretic. The primary safety endpoints were acute procedural safety at discharge and chronic procedural safety at six months. The primary effectiveness endpoint was the rate of office SBP reduction ≥10 mmHg at six months compared to baseline. While not a predefined endpoint, change in 24-hour ambulatory BP was evaluated. The mean baseline office SBP and diastolic BP measurements were 181.6±20.8 and 95.5±15.5 mmHg, respectively. Patients were on a mean of 5.1 antihypertensive medications at baseline. The mean office BP decreased by -20/-8 mmHg (p<0.0001/p=0.0002), and -22/-8 mmHg (p<0.0001/p=0.0014), from baseline to six and 12 months, respectively. The 24-hour ABPM was also significantly reduced by -11/-6 mmHg at six months compared to baseline (p=0.0085/p=0.037). There were no serious adverse events (SAE) at discharge related to groin and vascular access complication or renal artery injury or SAE/adverse device effects at six months.
  
  
  CONCLUSIONS
  The results of the RAPID study demonstrate safe delivery of RF energy by the OneShot Renal Denervation System for renal sympathetic denervation and sustained efficacy, as evidenced by a significant reduction in office and 24-hour ABPM for six months, which was sustained up to 12 months. ClinicalTrials.gov Identifier: NCT01520506.
authors.affiliation: Middelheim Hospital, Antwerp, Belgium.
authors.forename: Stefan
authors.initials: S
authors.lastname: Verheye
authors.forename: John
authors.initials: J
authors.lastname: Ormiston
authors.forename: Martin W
authors.initials: MW
authors.lastname: Bergmann
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.forename: Arne
authors.initials: A
authors.lastname: Schwindt
authors.forename: Nikos
authors.initials: N
authors.lastname: Werner
authors.forename: Britta
authors.initials: B
authors.lastname: Vogel
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D018660:Blood Pressure Monitoring, Ambulatory; D017115:Catheter Ablation / Q000295:instrumentation* / Q000379:methods; D015331:Cohort Studies; D005060:Europe; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D011446:Prospective Studies; D012077:Renal Artery / Q000294:innervation / Q000601:surgery*; D013562:Sympathectomy / Q000295:instrumentation* / Q000379:methods; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents