“Primary results from the SPYRAL HTN-OFF MED trial provide biological proof of principle for the efficacy of catheter-based renal denervation to reduce blood pressure in patients with hypertension not treated with antihypertensive medications,” noted researchers presenting the trial’s findings during the ESC Congress 2017 in Barcelona. The study was simultaneously published in The Lancet.

The multicenter, international trial randomly assigned 80 patients from the U.S., Europe, Japan and Australia who were either drug-naïve or had discontinued their antihypertensive medications to either renal denervation (n = 38) or sham control (n = 42). Patients were followed for up to three months and the primary endpoint was change in 24-hour blood pressure at the end of the follow-up period. Drug surveillance was done to ensure patient compliance with absence of antihypertensive medication

Results showed a significant decrease from baseline to three months in office and 24-hour ambulatory blood pressure in the renal denervation group, while no significant changes were noted in the sham-control group. Researchers highlighted that the mean difference between the groups favored renal denervation for three-month change in both office and 24-hour blood pressure. There were no major adverse events reported in either group.

“This novel trial differs substantially from previous renal denervation trials in terms of the hypertensive population enrolled, the renal denervation technique used, and the absence of concomitant antihypertensive medications,” researchers wrote. “To our knowledge, this is the first rigorously done sham controlled clinical trial to assess blood pressure reduction in hypertensive patients in the absence of antihypertensive medications.”

Looking ahead, results from SPYRAL HTN-OFF Med are expected to inform the design of a larger, pivotal trial addressing the role of renal denervation in treatment of hypertension. ACC.org Editor-in-Chief Kim A. Eagle, MD, MACC, comments that “due to the small numbers of patients enrolled in this trial, it remains unclear if this invasive strategy will find a clinical niche in the treatment of hypertension.”

In an accompanying editorial comment, Michel Azizi, MD, notes that “More studies are needed with the Spyral and other catheters and using different technologies (e.g., highly focused ultrasound), not only to support these preliminary results but also to investigate whether an escape phenomenon might occur in hypertension in the long term (reports exist of renal nerve regrowth after catheter-based renal denervation in animal models) and the unknown risk of de-novo renal artery stenoses associated with the new catheters.”

Keywords: ESC Congress, ESC2017, Antihypertensive Agents, Blood Pressure, Blood Pressure Monitoring, Ambulatory, Japan, Hypertension, Blood Pressure Determination, Denervation, Kidney, Patient Compliance, Australia, Europe

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