Renal Denervation and SPYRAL HTN-ON MED Two-Year Outcomes

High blood pressure (BP) continues to be one of the leading preventable causes of cardiovascular events worldwide. There are therapeutic strategies other tan pharmacological management, such as renal denervation (RDN), that have regained interest following the publishing of recent findings.  

The SPYRAL HTN-ON MED was a randomized global blinded trail assessing the use of a RDN device (Symplicity SPYRAL) in hypertensive patients (in office systolic BP >150 mmHg or 24-hr ambulatory systolic BP >140 mmHg), in treatment with at least one antihypertensive drug (1 to 3 drugs). The main goal was to assess sustained safety and efficacy or RDN vs. a sham control group. 

337 patients with uncontrolled high BP were included and the intervention was assessed both by in-office and ambulatory BP, antihypertensive drug burden, and the occurrence of safety-related events.

At 2 years, RDN patients presented a significantly higher reduction in ambulatory (−12.1 vs −7.0 mmHg; p=0.039) and in office systolic BP (−17.4 vs −9.0 mmHg; p=0.0034) vs sham patients, despite lower increase in drug burden. 

It is worth noting that after 6 months there was high crossover (50%) from the sham group. However, differences in BP were consistent after sensitivity analysis and adjustments per patients, which represents a relevant methodologic strength vs crossover rate. 

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As regards safety, the procedure showed a favorable profile, there were no cases of significant renal arteries stenosis or relevant differences in major clinical adverse events between the groups. Major adverse event rate was low, and there was no significant deterioration of renal function. 

Mid-term data published by this study support the use of RDN as a complementary tool to drug management, especially in patients with resistant hypertension or long term adherence challenges. 

Conclusion

The SPYRAL HTN-ON MED has shown that renal denervation might offer long term sustained and clinically significant high blood pressure reduction, even in patients on drug therapy. All this with a good safety profile and with no significant increase in major adverse events. 

Original Title: Long-Term Safety and Efficacy of Renal Denervation: 24-Month Results From the SPYRAL HTN-ON MED Trial.

Reference: Kandzari DE, Mahfoud F, Townsend RR, Kario K, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Liu M, DeBruin V, Brar S, Böhm M. Long-Term Safety and Efficacy of Renal Denervation: 24-Month Results From the SPYRAL HTN-ON MED Trial. Circ Cardiovasc Interv. 2025 Jul;18(7):e015194. doi: 10.1161/CIRCINTERVENTIONS.125.015194. Epub 2025 May 20. PMID: 40391448; PMCID: PMC12244969.