S-35-6: long-term reduction in morning and nighttime blood pressure after renal denervation: 36-month results from spyral htn-on med pilot trial

Objective: Elevated morning and nighttime blood pressures (BP) are associated with increased risk of cardiovascular events such as stroke. Furthermore, those with resistant hypertension (hypertension despite > = 3 antihypertensive medications) are at particular risk. We compared the long-term changes in morning, daytime and nighttime blood pressure (BP) in patients prescribed > = 3 antihypertensive medications 36 months after radiofrequency renal denervation (RDN) vs. sham control in the SPYRAL HTN-ON MED pilot trial. Design and method: The SPYRAL HTN-ON MED pilot trial enrolled patients with uncontrolled hypertension and office systolic BP (SBP) between 150 and < 180 mmHg, office diastolic BP > = 90 mmHg and mean ambulatory SBP between 140 and < 170 mmHg, with 1–3 prescribed antihypertensive medications. Patients were randomized 1:1 to RDN or sham control. Long-term safety and efficacy of the RDN procedure was assessed at 36 months through collection of adverse events and BP assessment. Differences in BP changes were compared between RDN and sham control using ANCOVA, adjusting for baseline measurements. Results: There were 80 patients randomized to RDN (N = 38) or sham control (N = 42). The number of antihypertensive medications at baseline was 2.13 ± 1.40 for RDN vs 1.98 ± 1.14 for sham control (p = 0.59). At 36 months, RDN patients were prescribed 3.03 ± 1.20 antihypertensive medications compared to 3.05 ± 1.43 in sham control (p = 0.76). Major adverse events through 36 months were rare in both groups, and there were no renal artery re-interventions or major vascular complications. Baseline morning (7:00–9:00 AM), daytime (9:00AM-9:00PM) and night-time (1:00–6:00 AM) SBP measurements for patients prescribed 3 or more antihypertensive medications at 36 months were similar between RDN and sham control (Figure). However, morning and night-time SBP were significantly reduced from baseline for the RDN group compared to sham control (morning SBP: -23.9 vs. -8.0 mmHg, p = 0.029; night-time SBP: -20.8 vs. -7.2 mmHg, p = 0.001; ( Figure ). Difference in daytime SBP was not significantly different between groups (-19.6 vs. -13.7 mmHg, p = 0.13). Additional analyses of BP reduction in patients with varying antihypertensive medication burden will be presented for the first time at ISH 2022. Conclusions: Morning and nighttime SBP were significantly reduced in patients prescribed at least 3 antihypertensive medications at 36 months in the SPYRAL HTN-ON MED pilot trial after RDN compared to sham control. The results suggest RDN has significant benefit when the risk of cardiovascular events is highest.