Table 2. Safety Outcomes: Major Adverse Event Rates (Patient-Level, Nonhierarchical)^a.

Events	No. (%)
	uRDN (n = 293)	Sham (n = 213)
30-d Events
All-cause mortalityb	1 (0.3)	0 (0)
New-onset ESKD (eGFR<15 mL/min/m2 or need for kidney replacement therapy)	0 (0)	0 (0)
Significant embolic event resulting in end-organ damage	0 (0)	0 (0)
Kidney artery perforation or dissection requiring an invasive intervention	0 (0)	0 (0)
Major vascular complications requiring surgical repair, interventional procedure, thrombin injection, or blood transfusionc	1 (0.3)	0 (0)
Hospitalization for hypertensive or hypotensive crisisc	1 (0.3)	0 (0)
Hospitalization for major cardiovascular or hemodynamic-related eventsd	1 (0.3)	0 (0)
New-onset stroke	0 (0)	0 (0)
New-onset myocardial infarction	0 (0)	0 (0)
6-mo Events
New-onset kidney artery stenosis >70%	0 (0)	0 (0)

Abbreviations: eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease; IV, intravenous; uRDN, ultrasound-based renal denervation.

^a Five major adverse events occurred in 3 of 293 patients (1.0%) in the uRDN arm. Multiple events occurred in a single patient (2 vascular complications and a hospitalization for hypotension).

^b The patient was well at 1 week outpatient follow-up; on postprocedure day 13, the patient was diagnosed with prostate carcinoma. On day 21, patient was found deceased at home.

^c The patient was diagnosed with a pseudoaneurysm treated with IV thrombin injection; the patient also received IV fluids for symptomatic hypotension. On postprocedure day 15, the patient was readmitted and was diagnosed with a deep venous thrombosis that was treated.

^d The patient had a vasovagal response postprocedure reversed after administration of fluids and atropine, and the patient was admitted for monitoring.