The randomised Oslo study of renal denervation vs. Antihypertensive drug adjustments: efficacy and safety through 7 years of follow-up

Figures & data

Figure 1. Flowchart illustrating the outline of the Oslo RDN study and the two groups; the Renal Denervation group, and the Drug Adjustment group. The box containing ‘1 y + drug adjustment’ denotes in the RDN group the start of drug adjustment in this group. The dotted lines illustrate a planned follow-up visit 10 years after randomisation.

Table 1. Group characteristics at randomisation.

	RDN (n = 9)	DRUG ADJ (n = 10)	p Value
Age in years	57.0 (10.9)	62.7 (5.1)	.16
Gender, % female	22	0	.21
Body mass index, kg/m^2	29.0 (5.3)	30.0 (5.3)	.72
Coronary artery disease (%)	11	60	.06
Diabetes mellitus (%)	22	30	1.00
Peripheral arterial disease (%)	0	10	1.00
History of stroke (%)	11	10	1.00
Hypercholesterolemia (%)	22	40	.63

Data are presented as mean (SD) or percentages.

RDN: renal denervation group, DRUG ADJ: drug adjustment group.

Table 2. Group comparisons of use of antihypertensive agents during 7 years of follow-up.

	Baseline			6 months			3 years			7 years
	RDN	DRUG ADJ.	p Value	RDN	DRUG ADJ.	p Value	RDN	DRUG ADJ.	p Value	RDN	DRUG ADJ.	p Value
Number of antihypertensive agents	6.0 (2.1)	5.0 (1.4)	.50	5.8 (2.3)	6.0 (1.4)	.45	5.1 (2.0)	5.4 (1.5)	.60	3.9 (2.3)	4.7 (1.5)	.49
Angiotensin II receptor blockers (%)	100	70	.21	89	70	.58	67	70	1.00	56	66	1.00
Angiotensin-converting enzyme inhibitors (%)	33	30	1.00	33	30	1.00	33	30	1.00	33	22	1.00
Calcium channel blockers (%)	89	70	.58	89	80	1.00	78	70	1.00	77	77	1.00
α-1 blockers (%)	56	20	.17	66	50	.65	67	30	.18	44	11	.29
β-blockers (%)	56	90	.14	56	70	.65	44	80	.37	22	77	.06
Centrally acting sympatholytics (%)	56	40	.66	56	40	.66	33	40	1.00	11	33	.58
Vasodilators (%)	0	20	.47	0	30	.47	0	20	.47	0	33	.21
Diuretics* (%)	100	100	1.00	89	100	1.00	100	90	1.00	88	55	.29
Aldosterone antagonists (%)	33	60	.37	22	50	.17	33	50	.65	22	33	1.00
Direct Renin inhibitors (%)	22	0	.21	22	0	.21	11	0	.47	0	0	N/A
Other potassium-sparing diuretics (%)	11	0	.47	11	50	.47	11	40	.30	0	33	.21

Data are presented as mean (SD) or percentages of the patients in each group using the specified class of antihypertensive drug.

RDN: renal denervation group: DRUG ADJ: drug adjustment group.

*Loop Diuretics and Thiazides.

Figure 2. Long-term Office Blood Pressure in each of the two groups. The x-axis plots time, with each study visit marked separately. The y-axis denotes blood pressure in mmHg and is truncated. The blue lines indicate the systolic (upper line with circular points) and diastolic (lower line with square points) blood pressure of the Renal Denervation group. The red lines with (opposite) triangular symbols indicate the same for the Drug Adjustment group. The asterisk denotes statistical difference between the groups at the corresponding visit.

Figure 3. Long-term daytime Ambulatory Blood Pressure in each of the two groups. The x-axis plots time, with each study visit marked separately. The y-axis denotes blood pressure in mmHg and is truncated. The blue lines indicate the systolic (upper line with circular points) and diastolic (lower line with square points) blood pressure of the Renal Denervation group. The red lines with (opposite) triangular symbols indicate the same for the Drug Adjustment group. The asterisk denotes statistical difference between the groups at the corresponding follow-up visit.

Table 3. Group comparisons of blood pressure, demographic variables, biochemistry and renal function during 7 years of follow-up.

	Baseline			6 months			3 years			7 years
	RDN	DRUG ADJ.	p Value	RDN	DRUG ADJ.	p Value	RDN	DRUG ADJ.	p Value	RDN	DRUG ADJ.	p Value
Body mass index (kg/m^2)	29.0 (5.3)	30.0 (5.3)	.72	29.4 (5.4)	30.6 (5.1)	.50	29.7 (6.4)	30.5 (5.6)	.60	30.2 (6.7)	31.0 (5.8)	.78
Office systolic BP (mmHg)	156 (12.6)	160 (14.0)	.55	148 (7.4)	132 (10.2)	.001	147 (21.5)	148 (32.6)	.91	155 (19.3)	146 (20.9)	.39
Office diastolic BP (mmHg)	91 (14.9)	88 (12.7)	.59	89 (7.9)	77 (7.5)	.004	88 (11.5)	86 (11.8)	.64	93 (12.9)	85 (9.0)	.14
Ambulatory 24 h systolic BP (mmHg)	149 (9.3)	151 (11.7)	.71	139 (10.5)	130 (11.6)	.11	137 (13.4)	132 (14.8)	.47	140 (13.4)	133 (13.8)	.33
Ambulatory 24 h diastolic BP (mmHg)	89 (7.2)	85 (6.5)	.19	83 (3.4)	74 (6.7)	.003	81 (10.5)	77 (6.0)	.34	83 (9.6)	78 (7.2)	.22
Ambulatory daytime systolic BP (mmHg)	152 (10.4)	152 (11.7)	.98	142 (10.3)	133 (11.3)	.08	139 (16.1)	134 (14.9)	.46	145 (14.8)	137 (13.4)	.27
Ambulatory daytime diastolic BP (mmHg)	93 (7.7)	88 (8.2)	.17	86 (4.4)	77 (8.0)	.008	83 (12.1)	80 (6.6)	.42	87 (10.3)	82 (8.1)	.28
Ambulatory night-time systolic BP (mmHg)	141 (9.4)	146 (15.9)	.44	132 (11.5)	123 (13.0)	.11	130 (11.4)	128 (15.1)	.69	127 (12.0)	125 (15.4)	.85
Ambulatory night-time diastolic BP (mmHg)	82 (7.2)	79 (4.5)	.29	76 (4.8)	67 (5.8)	.002	75 (9.3)	72 (6.4)	.34	74 (9.8)	70 (9.0)	.43
Hemoglobin (g/dL)	15.4 (1.3)	15.1 (1.3)	.66	14.2 (1.6)	13.8 (1.4)	.57	14.9 (1.4)	15.0 (1.3)	.86	15.0 (1.2)	14.9 (1.4)	.90
Serum total cholesterol (mmol/L)	5.1 (0.8)	4.4 (0.8)	.09	4.5 (0.8)	5.2 (3.5)	.84	4.5 (0.8)	4.4 (1.4)	.74	3.9 (0.7)	3.6 (0.6)	.33
Serum HDL (mmol/L)	1.2 (0.3)	1.4 (0.2)	.40	1.1 (0.3)	1.2 (0.3)	.73	1.2 (0.2)	1.3 (0.4)	.66	1.2 (0.2)	1.2 (0.2)	.75
Serum LDL (mmol/L)	3.6 (0.8)	2.7 (0.8)	.02	2.9 (0.8)	2.6 (1.2)	.48	3.0 (0.8)	2.7 (1.2)	.56	2.4 (0.7)	2.1 (0.5)	.25
Serum triglycerides (mmol/L)	1.3 (0.5)	1.2 (0.5)	.79	1.2 (0.6)	1.6 (0.6)	.14	1.5 (0.6)	1.5 (1.0)	.60	1.4 (0.3)	1.4 (0.6)	.96
Serum potassium (mmol/L)	3.7 (0.4)	3.9 (0.3)	.18	3.7 (0.3)	3.8 (0.3)	.34	4.0 (0.5)	4.0 (0.4)	.95	4.0 (0.5)	3.9 (0.3)	.89
Serum CRP (mg/L)	2.4 (1.7)	3.3 (2.5)	.41	3.1 (4.6)	2.5 (3.1)	.60	2.5 (2.1)	4.8 (5.0)	.22	2.2 (1.2)	7.1 (6.9)	.05
Serum creatinine (µmol/L)	91.6 (6.7)*	88.9 (12.2)	.68	92.0 (12.3)*	101.0 (22.0)	.25	89.8 (12.6)*	93.7 (20.8)	.60	87.4 (11.7)*	105.8 (36.5)	.26
Calculated eGFR by CKD-EPI (mL/min/1.73 m^2)	90.1 (10.0)*	89.1 (6.6)	.80	90.4 (11.5)*	85.0 (9.4)	.28	91.3 (10.7)*	87.8 (8.4)	.45	76.3 (14.2)*	66.9 (22.3)	.33
Urine albumin/creatinine ratio (mg/mmol)	2.4 (3.0)	2.0 (2.4)	.44	1.5 (2.1)	1.2 (1.3)	.78	1.5 (2.1)	4.1 (5.0)	.70	3.3 (4.4)	5.8 (11.1)	.55

Data presented as mean (SD). Significant p values in bold print.

*1 Outlier omitted.

RDN: renal denervation group; DRUG ADJ: drug adjustment group; BP: blood pressure: HDL: high-density lipoprotein; LDL: low-density lipoprotein: CRP: C-reactive protein; eGFR: estimated glomerular filtration rate: CKD-EPI: Chronic Kidney Disease Epidemiology Collaboration.