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The Vessix Renal Denervation System (Boston Scientific, Natick, MA) consists of a radiofrequency generator and a balloon catheter mounted with a bipolar radiofrequency electrode array. The objective of the REDUCE-HTN Clinical Study is to evaluate the performance of the Vessix System in treating medication-resistant hypertension.
The REDUCE-HTN trial is a prospective, multicenter, single-arm study. Patients were required to have office-based systolic blood pressure (BP) ≥160 mmHg despite compliance with ≥3 antihypertensive medications at maximally tolerated doses. The primary efficacy endpoints were the 6-month reductions in office-based systolic and diastolic BPs, and reductions in systolic and diastolic BP as measured by 24-hour ambulatory monitoring. Acute safety (ie, freedom from renal artery dissection or perforation requiring stenting or surgery, renal artery infarction or embolus, cerebrovascular accident, myocardial infarction, or sudden cardiac death at the time of the procedure) and long-term safety, including renal artery patency and renal function, were assessed.
Mean baseline office BP was 182.4±18.4/100.1±14.0 mmHg among enrolled patients (N=146; age 58.5±10.5 years, 61% men, 27.4% with type 2 diabetes). No patients experienced any of the prespecified acute safety events. Among 139 patients with 6 month data, mean office BP was reduced to 157.7±23.8/89.4±15.7 mmHg; a reduction of 24.6±22.3/10.3±12.9 mmHg (p<0.0001). Mean baseline ambulatory BP was 153.0±15.1/87.5±13.2 mmHg (n=103); at 6 months it was reduced by 8.5±14.6/5.9±9.2 mmHg (n=67; p<0.0001). Renal artery patency by duplex ultrasound at 6 months was 99.1%. Mean estimated glomerular filtration rate (eGFR) changed -0.9±16.5 at 6 months, and 11% of patients (15/136) had a reduction in eGFR >25%. Six-month results for the full cohort of enrolled patients are expected to be available at the time of presentation.
Primary endpoint results from the REDUCE-HTN trial demonstrate that the Vessix System is an efficacious method for treating resistant hypertension. No acute safety endpoint events were observed and 6-month patency and renal function results are favorable.
↵∗ Indicates iMPACT Trial Accepted for Oral Presentation