Table 5. Summary of three second-generation renal denervation randomized sham-controlled proof-of-concept trials.

	SPYRAL HTN-OFF MED	RADIANCE-HTN SOLO	SPYRAL HTN-ON MED
Patients (n)	80	146	80
Age (years)	54	54	53
System applied	SPYRAL (Medtronic)	PARADISE (ReCor Medical)	SPYRAL (Medtronic)
Inclusion criteria	Office SBP ≥ 150 and < 180 mmHg, office DBP ≥ 90 mmHg, and 24-h SBP ≥ 140 and < 170 mmHg, no antihypertensive meds	Daytime ambulatory BP ≥ 135/85 mmHg and < 170/105 mmHg, no anti-hypertensive meds	Office SBP ≥ 150 and < 180 mmHg, office DBP ≥ 90 mmHg; and 24-h SBP ≥ 140 and < 170 mmHg, 1-3 antihypertensive meds
Baseline office BP (mmHg)*	162/101 ± 7/7	155/100 ± 14/8	164/101 ± 7/7
Baseline 24-h BP (mmHg)*	153/99 ± 8/8	144/88 ± 9/6	152/98 ± 7/8
No. of antihypertensive meds*	0	0	000.2.2 ± 0.9
Change 24-h SBP vs. sham (mmHg), # months of f/u	-4.6 (-9.2 to 0.1), 3	-4.1 (-7.1 to -1.2), 2	-7.0 (-12.0 to -2.1), 6
Change 24-h SBP vs. baseline (mmHg), # months of f/u	-5.5 (-9.1 to -2.0), 3	-7.0 (-9.0 to -5.0), 2	-9.0 (-12.7 to -5.3), 6
Change office SBP vs. sham (mmHg), # months of f/u	-7.1 (-13.2 to -1.1), 3	-6.5 (-11.3 to -1.8), 2	-6.6 (-12.4 to -0.9), 6
Change office SBP vs. baseline (mmHg), # months of f/u	-10.0 (-15.1 to -4.9), 3	-10.8 (-13.9 to -7.7), 2	-9.4 (-13.5 to -5.3), 6
Major adverse events (%)	0	0	0

BP, blood pressure; DBP, diastolic blood pressure; f/u, follow-up; SBP, systolic blood pressure.

* Mean ± standard deviation, ^# Mean (95% confidence interval).