Key result
Radiofrequency renal denervation results in zero confirmed renal artery stenosis or reinterventions through long-term follow-up.
Why the study?
Although renal denervation reduces blood pressure in uncontrolled hypertension, a potential long-term concern is the development of de novo renal artery stenosis secondary to vascular injury.
Does radiofrequency renal denervation cause long-term vascular injury or clinically significant renal artery stenosis in patients with uncontrolled hypertension?
RCT (n=610)
Randomized
Does radiofrequency renal denervation cause long-term vascular injury or clinically significant renal artery stenosis in patients with uncontrolled hypertension?
Radiofrequency renal denervation demonstrates long-term vascular safety with virtually no clinically significant renal artery stenosis or need for reintervention at over one year of follow-up, with duplex ultrasound showing the highest non-invasive technical adequacy for core lab evaluation.
Provides reassuring vascular safety signal for renal denervation; leaves open confirmation in larger real-world cohorts.
Summary: Background: Renal denervation (RDN) safely reduces blood pressure (BP) in patients with uncontrolled hypertension. A potential long-term concern is the development of de novo renal artery stenosis (RAS) secondary to vascular injury. This study assesses the long-term vascular safety and incidence of RAS in patients treated with radiofrequency RDN from the SPYRAL HTN-OFF MED and -ON MED trials. Patients and methods: All patients underwent renal angiograms for assessment of the renal anatomy prior to randomization. Patients with RAS >50% were excluded from enrollment. At long-term follow-up (439+/−288 days), patients underwent duplex ultrasound imaging (DUS), computerized tomography angiography (CTA), and/or magnetic resonance angiography (MRA). Independent core labs evaluated all images. Clinically significant RAS was predefined as a stenosis ≥70%, confirmed by angiography. Results: A total of 610 patients were treated with RDN in the SPYRAL trials. At least one imaging modality was performed in 557 of the 610 patients (91%): 329 patients underwent DUS imaging, 230 underwent CTA, 148 underwent MRA, and 15 underwent renal angiography. With one possible exception, no clinically significant RAS was detected. No patients had renal artery reintervention. The proportion of images fulfilling pre-specified criteria for technical adequacy by the core lab was 100% (angiography), 87.5% (DUS), 80.6% (CTA), and 32.4% MRA. Conclusions: RF RDN appears to be safe, without confirmed vascular injury or RAS among 557 patients who had long-term imaging. Diagnostic utility of imaging modalities determined by specific criteria for technical adequacy for core lab evaluation was lowest with MRA and highest with DUS.
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Mahfoud et al. (2026) conducted an RCT in Uncontrolled hypertension (n=610). Radiofrequency renal denervation (RDN) was evaluated on Clinically significant renal artery stenosis (≥70% confirmed by angiography) or renal artery reintervention. Radiofrequency renal denervation resulted in 0% confirmed clinically significant renal artery stenosis and 0% reinterventions among 557 patients imaged at 439 days.
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