Practice Update: Cardiology

CONFERENCE COVERAGE 18

ESC 2017: Renal Denervation Lowers Blood Pressure in Hypertensive Patients Not Taking AntihypertensiveMedication – SPYRAL HTN-OFFMED Trial Renal denervation has been shown to lower blood pressure in hypertensive patients not taking antihypertensive medication. This outcome of the international, multicenter, prospective, randomized, sham-controlled SPYRAL HTN-OFF MED trial was reported at the 2017 European Society of Cardiology (ESC) Congress, from August 26–30. M ichael Boehm, MD, PhD, of the University of Saarland, Homburg/ Saar, Germany, explained that respectively, vs declines of 2.3 and 0.3 mmHg (neither significant) in the sham arm, respectively. 0.4 mmHg, respectively (neither significant). Decreases in systolic and diastolic office and 24-h blood pressure were confirmed by directly comparing between the renal denervation and sham groups.

renal denervation is a minimally invasive catheter-based procedure that delivers energy to the nerves in the kidneys. It was developed to treat resistant hypertension. Coinvestigator David Kandzari, MD, of the Piedmont Heart Institute, Atlanta, Georgia, said, “After SYMPLICITY HTN-3, we learned a lot about the procedure itself, medication adherence, and which patients may have less response to the renal denervation procedure – these insights have been incorporated into the revised clinical approach in the SPYRAL HTN program.” He continued, “With this new approach and protocol design, coupled with new technology that allows more consistent circumferential treatment and easier access into the distal anatomy, based on these compelling results we are confident that we’ve addressed the issues of previous renal denervation trials appropriately.” SPYRAL HTN-OFF MED was designed to evaluate the safety and blood pressure- lowering efficacy of the multi-electrode Symplicity Spyral renal denervation system. The study included patients with uncontrolled hypertension who were drug- naïve or stopped taking antihypertensive medications at least 4 weeks prior to randomization. Uncontrolled hypertension was defined as an office systolic blood pressure 150– 180 mmHg and diastolic blood pressure >90 mmHg, and a 24-h mean systolic blood pressure 140–170 mmHg. Patients were randomized to renal denervation in the main renal arteries and branches or to a sham procedure. Blood pressure was measured at baseline and 3 months, and compared within each treatment group. Dr. Boehm presented 3-month results of the first 80 patients, 38 of whom received renal denervation and 42 the sham procedure. Compared to baseline, at 3 months after the procedure, office-based systolic and diastolic blood pressure had declined by 10.0 mmHg (P < .001) and 5.3 mmHg (P = .008) in the renal denervation arm,

Regarding 24-h ambulatory blood pressure vs baseline, systolic and diastolic blood pressure of patients undergoing renal denervation decreased by 5.5 mmHg (P = .04) and 4.8mmHg (P < .001), respectively. In the sham control arm, systolic and diastolic blood pressure decreased by 0.5 and

No major safety events were reported in either arm, even with the revised procedural approach. The latter increased the total number of ablations and included denervation in the branch arteries.

PRACTICEUPDATE CARDIOLOGY