Three‐Year Durability of Radiofrequency Renal Denervation: SPYRAL HTN‐ON MED

Figure 1. SPYRAL HTN‐ON MED patient flowchart through 36 months. After the primary end point ascertainment at 6 months, sham control patients were allowed to cross over to undergo the RDN procedure without having to requalify per the original enrolment criteria. Percentages show proportion of patients with observed outcomes. Follow‐up by phone was permitted for sham control patients after the primary end point. ABPM indicates 24‐hour ambulatory blood pressure measures; ITT, intention‐to‐treat; and SPYRAL HTN‐ON MED, Global Clinical Study of Renal Denervation With the Symplicity Spyral Multielectrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy.

Figure 2. Antihypertensive medication intake and systolic BP changes in RDN and sham control groups through 36 months. The number of antihypertensive medications and the medication burden (accounting for number, class, and dose)±SD are plotted in (A) at baseline and 36 months. The RDN group is shown in blue, and the sham control group is shown in gray. The plotted data are based on drug testing information if available; otherwise, prescribed information is used. In (B), the 24‐hour ambulatory, morning (7 am to 9 am), daytime (9 am to 9 pm), nighttime (1 am to 6 am), and office‐visit systolic BP changes ±SD from baseline are plotted for the RDN and sham control groups. Comparisons of medication intake and BP changes were conducted by ANCOVA. For BP measures, comparisons were adjusted for baseline BP, with 95% CIs in brackets. BP indicates blood pressure; and RDN, renal denervation.

Figure 3. Hourly ambulatory blood pressure at baseline and 36 months between RDN and sham control groups. Hourly ambulatory systolic BPs at baseline and 36 months in the RDN (blue) and sham control groups (gray). BP indicates blood pressure; and RDN, renal denervation.

Figure 4. Distribution of office systolic BP in the RDN group versus sham control group through 36 months. The proportion of patients in the indicated office systolic BP ranges at baseline and 36 months. Distribution comparisons between RDN and sham control groups were conducted via Fisher's exact tests. BP indicates blood pressure; and RDN, renal denervation.

Figure 5. Distribution of office systolic BP among crossover patients before and after the RDN procedure. The proportion of patients in the indicated office systolic BP ranges at baseline, 6 months after randomization, the last measure before crossover, and 36 months after crossover. Distribution comparison between time points was conducted via McNemar–Bowker test. BP indicates blood pressure; and RDN, renal denervation.