An Implantable Device for Resistant Hypertension Performs Well in a Randomized Trial

Baroreflex activation therapy safely lowered systolic blood pressure in patients who had hypertension despite taking an average of five antihypertensive drugs.


Patients lack treatment options when hypertension persists despite optimal drug therapy. At the American College of Cardiology Scientific Sessions in March 2011, investigators presented promising findings from the manufacturer-sponsored, double-blind Rheos Pivotal Trial of a surgically implantable baroreflex activation therapy (BAT) device. These results have now been published.

One month after implantation, 265 device recipients were randomized 2:1 to immediate activation (group A) or delayed activation 6 months later (group B), with blinding maintained during a total follow-up of 12 months. All patients had blood pressures (BPs) ?160/80 mm Hg despite adherence to maximum tolerated doses of at least three antihypertensive agents, including a diuretic. On average, patients had received 5.2 medications for 21 months.

In group A, 88% of patients had sustained drops in systolic BP of >10 mm Hg at 12 months, surpassing the prespecified objective performance criterion (OPC) of 65% (P<0.001). In the entire cohort, the rate of freedom from procedural complications within 30 days after implantation was 75%, short of the prespecified OPC of 82%. Procedural complications were most often related to carotid sinus lead placement, and most resolved completely. The rate of freedom from adverse BAT-related events between day 30 and month 6 was 92% in group A and 89% in group B (P<0.001 for noninferiority). Hypertensive emergencies occurred in 5% and 8% of groups A and B, respectively. Overall, the rate of freedom from major hypertension- and device-related adverse events from day 30 to month 12 was 87%, surpassing the prespecified OPC of 72% (P<0.001).


Citation(s):

Bisognano JD et al. Baroreflex activation therapy lowers blood pressure in patients with resistant hypertension: Results from the double-blind, randomized, placebo-controlled Rheos Pivotal Trial. J Am Coll Cardiol 2011 Aug 9; 58:765.