Lower 24h ambulatory SBP at 3 years with renal denervation vs. sham

Long Term Effect of Renal Denervation on Blood Pressure Reduction In Patients On Antihypertension Medications: 3-year Efficacy Outcomes From The SPYRAL HTN-ON MED Pilot Study

Presented at ACC.22 by Prof. Felix Mahfoud, MD (Homburg, Germany)

Introduction and methods

Background

The SPYRAL HTN-ON MED study previously showed that renal denervation lowered BP at 6 months compared to a sham procedure in patients with uncontrolled hypertension on antihypertensive medications. This pre-specified analysis of the SPYRAL HTN-ON MED study evaluated long-term efficacy and safety outcomes at 36 months.

Methods

SPYRAL HTN-ON MED was a randomized, multicenter, sham-controlled trail. Eligible patients had uncontrolled hypertension with office SBP of 150 to 180 mmHg, office DBP ≥90 mmHg and 24h SBP 140 to <170 mmHg, despite being on 1 to 3 antihypertensive drugs with stable doses for at least 6 months. A total of 80 patients were randomized (1:1) to undergo radiofrequency renal denervation (n=38) or a sham control procedure (n=42), patients remained on antihypertensive drugs. Efficacy, safety and antihypertensive drug use was followed up to 36 months.

Main results

Efficacy

• Patients who had undergone renal denervation had significantly lower 24h SBP at 36 months compared with patients who had undergone the sham procedure (-18.7 mm Hg (SD 12.4) in the renal denervation group vs. –8.6 mmHg (14,6) in the sham control group; adjusted treatment difference [∆] -10.0 mmHg, 95% CI -16.6 to -3.3; P=0.0039).
• The proportion of patients who reached 24h SBP <140 mmHg at 36 months was greater in the renal denervation group compared with the sham control group (83.3% vs 43.8%, P=0.002)
• There were also significant reductions at 36 months in the renal denervation group compared with the sham control group in morning SBP ( -20.6 vs -9.7 mmHg, ∆ -11.0 mmHg, 95% CI -19.8 to -2.1; P=0.016), daytime SBP (-18.3 vs. -10.5 mmHg, ∆ -8.9 mmHg, 95% CI -16,5 to -1,2; P=0,024) and nighttime SBP (-19.3 vs. -6.6 mmHg, ∆ -11.8 mmHg, 95% CI -19.0 to -4.7; P=0.0017).
• Office SBP showed a similar trend at 36 months, but was not significantly different between groups (-20.9 vs. -12.5 mmHg, ∆ -8.2 mmHg, 95% CI -17.1 to -0.8; P=0.073).

Medication burden

• There was no significant difference in number of antihypertensive medications (P=0.76) or medication burden (P=0.26) between groups at 36 months.

Safety

• There were no safety issues associated with renal denervation at 36 months.

Conclusion

This pre-specified analysis of the SPYRAL HTN-ON MED study showed that radiofrequency renal denervation significantly reduced 24h SBP at 36 months compared with sham control. There were no safety issues associated with renal denervation at 36 months, and medication burden was similar between groups.

-Our coverage of ACC.22 is based on the information provided during the congress-

This analysis was simultaneously published in The Lancet.