DOI DOI https://doi.org/10.1007/s00392-021-01843-w
Introduction
Both, radiofrequency and ultrasound endovascular renal sympathetic denervation (RDN) have recently proven clinical efficacy for the treatment of arterial hypertension. In the recently published RADIOSOUND-HTN trial, we performed a head-to-head comparison of radiofrequency main renal artery ablation (RFM-RDN) with an additional side branch ablation (RFB-RDN) and ultrasound ablation of the main renal arteries (USM-RDN) with superior results for USM-RDN over RFM-RDN and indistinct results for RFB-RDN at the primary endpoint after 3 months. Herein, we present the 6, 12 and 24 months follow up results of this trial.
Both, radiofrequency and ultrasound endovascular renal sympathetic denervation (RDN) have recently proven clinical efficacy for the treatment of arterial hypertension. In the recently published RADIOSOUND-HTN trial, we performed a head-to-head comparison of radiofrequency main renal artery ablation (RFM-RDN) with an additional side branch ablation (RFB-RDN) and ultrasound ablation of the main renal arteries (USM-RDN) with superior results for USM-RDN over RFM-RDN and indistinct results for RFB-RDN at the primary endpoint after 3 months. Herein, we present the 6, 12 and 24 months follow up results of this trial.
Design and Methods
Patients with treatment resistant hypertension (daytime ambulatory blood pressure [ABPM] >135/85 mmHg despite treatment with at least 3 antihypertensive medication classes including a diuretic) were randomized in a 1:1:1 manner to receive either treatment with RFM-RDN, RFB-RDN or USM-RDN. Medication was kept stable up to 6 months after randomization. Afterwards, antihypertensive medication was escalated. After 6, 12 and 24 months, patients underwent repeated ABPM.
Results
Of the 120 subjects enrolled and randomized (mean age 64±9 years, 29% female), ABPM data at 6, 12 and 24 months was available for 102, 83 and 70 patients. Baseline 24h and daytime blood pressure (BP) values were balanced between the groups (147/83±11/10 vs. 149/28±10/12 vs. 151/83±12/12 mmHg and 151/86±12/11 vs. 152/85±11/13 vs. 153/85±13/13 mmHg, p = 0.32/0.89 and 0.54/0.92 respectively). Clinical characteristics and medical antihypertensive treatment (mean of 5.0±1.4 classes of antihypertensive drug classes and 4.9±1.4 vs. 5.1±1.3 vs. 4.9±1.6, p=0.72) did not differ significantly between the groups before randomization. After 6 months, 24h and daytime systolic BP values were significantly more reduced in the USM-RDN group than in the two other groups (-12.1±11.5 and -13.0±12.3 mmHg vs. -6.0±11.0 and -6.1±12.5 mmHg in the RFM-RDN group and
-4.8±11.5 and -5.0±12.2 mmHg in the RFB-RDN group, p = 0.017 and 0.015 respectively), while diastolic BP change did not differ between the groups. The difference for systolic BP changes persisted after adjustment for baseline BP values (p = 0.032 and 0.016 for 24h and daytime systolic BP). Following medication escalation, no difference was found between the groups after 12 and 24 months.
Patients with treatment resistant hypertension (daytime ambulatory blood pressure [ABPM] >135/85 mmHg despite treatment with at least 3 antihypertensive medication classes including a diuretic) were randomized in a 1:1:1 manner to receive either treatment with RFM-RDN, RFB-RDN or USM-RDN. Medication was kept stable up to 6 months after randomization. Afterwards, antihypertensive medication was escalated. After 6, 12 and 24 months, patients underwent repeated ABPM.
Results
Of the 120 subjects enrolled and randomized (mean age 64±9 years, 29% female), ABPM data at 6, 12 and 24 months was available for 102, 83 and 70 patients. Baseline 24h and daytime blood pressure (BP) values were balanced between the groups (147/83±11/10 vs. 149/28±10/12 vs. 151/83±12/12 mmHg and 151/86±12/11 vs. 152/85±11/13 vs. 153/85±13/13 mmHg, p = 0.32/0.89 and 0.54/0.92 respectively). Clinical characteristics and medical antihypertensive treatment (mean of 5.0±1.4 classes of antihypertensive drug classes and 4.9±1.4 vs. 5.1±1.3 vs. 4.9±1.6, p=0.72) did not differ significantly between the groups before randomization. After 6 months, 24h and daytime systolic BP values were significantly more reduced in the USM-RDN group than in the two other groups (-12.1±11.5 and -13.0±12.3 mmHg vs. -6.0±11.0 and -6.1±12.5 mmHg in the RFM-RDN group and
-4.8±11.5 and -5.0±12.2 mmHg in the RFB-RDN group, p = 0.017 and 0.015 respectively), while diastolic BP change did not differ between the groups. The difference for systolic BP changes persisted after adjustment for baseline BP values (p = 0.032 and 0.016 for 24h and daytime systolic BP). Following medication escalation, no difference was found between the groups after 12 and 24 months.
Conclusions
In this first randomized comparison of different devices for catheter based RDN, ultrasound RDN was superior to radiofrequency-based approaches after 6 months of follow up.
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