Bipolar radiofrequency renal denervation with the vessix catheter in patients with resistant hypertension: 2-year results from the reduce-HTN trial.

BACKGROUND The Vessix Renal Denervation System (Boston Scientific, Marlborough, MA) consists of an over-the-wire low-pressure balloon catheter with an array of bipolar radiofrequency electrodes. Primary endpoint results of the REDUCE-HTN trial showed significant blood pressure reductions and a low major adverse event rate 6 months following treatment with the Vessix system. Office blood pressure measurements and safety monitoring continues through 2 years post-treatment. METHODS The REDUCE-HTN trial is a prospective, multicenter, single- arm study. Patients were required to have an office-based systolic blood pressure >=160 mmHg despite treatment with >=3 antihypertensive medications at maximally tolerated doses. RESULTS Among enrolled patients (N=146), mean baseline office blood pressure was 182.4+/-18.4/100.1+/-14.0mmHg and ambulatory blood pressure was 152.9+/-15.2/87.5+/-13.3 mmHg. Among 94 patients with 18 month data, mean office blood pressure was reduced to 157.2+/-24.6/86.9+/-14.8mmHg; a reduction of 27.1+/-20.4/11.2+/-11.4mmHg (P<.0001). Eighty percent of those (75/94) responded to treatment with a reduction in office systolic blood pressure >=10 mmHg at 18 months. The rate of procedure-related serious adverse events was 5.6% at 6 months, with no new procedure- or devicerelated serious adverse events reported between 6 and 18months of followup. Final 2-year efficacy and safety data will be available at the time of presentation. CONCLUSIONS Eighteen-month data available to date from the REDUCE-HTN study support the safety and efficacy of renal denervation with the Vessix system to treat resistant hypertension, with potential for sustained blood pressure reductions through 2 years.