Hypertension is the leading modifiable risk factor for cardiovascular disease and remains a major global health challenge, affecting more than one billion adults worldwide.
Despite the proven efficacy of lifestyle interventions and antihypertensive (AH) medications, treatment adherence remains suboptimal, and a significant proportion of patients continue to have persistently uncontrolled blood pressure (BP). This highlights the need for additional therapeutic options to achieve and maintain adequate BP control.
Catheter-based renal denervation (RDN) is a minimally invasive procedure recommended by clinical guidelines that targets the sympathetic nerves surrounding the renal arteries, offering an innovative approach for the treatment of hypertension. Multiple sham-controlled randomized trials and international registries have demonstrated the safety and efficacy of RDN, both in patients receiving and not receiving antihypertensive medications.
Although recent pooled analyses and meta-analyses conducted across diverse populations and using different technologies suggest a consistent and sustained BP-lowering effect, a systematic evaluation of the long-term efficacy and safety of RDN using the latest-generation Symplicity Spyral multielectrode radiofrequency (RF) catheter remains necessary.
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The objective of this study was to evaluate changes in blood pressure and the durability of clinical efficacy at 36 months following treatment with the Symplicity Spyral multielectrode system.
A pooled analysis was performed including 2,137 patients from four studies within the SPYRAL program: the Global SYMPLICITY Registry (GSR), DEFINE, SPYRAL First-In-Human (FIH), and the randomized SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED trials.
Regarding the results, treated patients demonstrated significant and sustained reductions in blood pressure despite a slightly lower medication burden compared with baseline. Office systolic blood pressure (OSBP) was reduced by −18.1 ± 23.4 mmHg (p < 0.0001), while 24-hour ambulatory systolic blood pressure (ASBP) decreased by −13.3 ± 17.6 mmHg (p < 0.0001). In addition, a modest reduction in antihypertensive medication use was observed, decreasing from 3.8 ± 2.1 medications at baseline to 3.5 ± 1.9 medications at 36 months.
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The benefit was consistent throughout the entire circadian cycle, with significant reductions observed during both daytime and nighttime periods. A key finding was that nearly 9 out of 10 patients (87.6%) experienced a clinically meaningful benefit at 3 years. This benefit was defined as meeting at least one of the following criteria: an OSBP reduction ≥10 mmHg, a 24-hour ASBP reduction ≥5 mmHg, or a reduction of at least one antihypertensive medication.
With regard to long-term safety, the procedure demonstrated a favorable safety profile, with a low incidence of adverse events. Renal artery stenosis was observed in only 0.1% of evaluated patients (1 out of 1,000). No renal artery reinterventions or stent implantations were required following treatment with the Spyral system. Furthermore, renal function remained stable throughout follow-up, with a mean estimated glomerular filtration rate (eGFR) of 78.1 mL/min/1.73 m² at baseline compared with 75.6 mL/min/1.73 m² at 36 months.
Conclusion: Symplicity Spyral renal denervation maintains sustained blood pressure reduction and a favorable safety profile at 3 years
The results demonstrate that radiofrequency renal denervation (RF-RDN) using the Symplicity Spyral catheter provides durable and clinically meaningful blood pressure reduction across a broad range of patients with hypertension. These findings support shared decision-making between physicians and patients, particularly among those seeking to reduce medication burden or achieve better long-term blood pressure control.
