Table 1.
Landmark trials and primary outcomes
| Study (Date) | Design | Sample size | RDN (N) | Control (N) | Catheter | Ablation method | Primary outcome | Longest follow-up |
|---|---|---|---|---|---|---|---|---|
| SYMPLICITY HTN -1 (2009)11 | Open-label | 153 | 153 | N/A | Symplicity flex | Monoelectrode radiofrequency | Change in office SBP at 6 months: SBP −22 mmHg (95% CI −32 to −12 mmHg), P < 0.001 |
36 mos |
| SYMPLICITY HTN-2 (2010)13 | Open-label, parallel, RCT | 190 | 52 | 54 | Symplicity flex | Monoelectrode radiofrequency | Change in mean office SBP at 6 months: RDN −32 ± 23 mmHg vs. control 1 ± 21 mmHg, P < 0.0001 | 6 mos |
| SYMPLICITY HTN-3 (2014)16 | RCT, double-blinded, multicenter | 1441 | 364 | 171 | Symplicity flex | Monoelectrode radiofrequency | Change in office SBP at 6 months: RDN −14.1 ± 23.9 mmHg vs. sham −11.7 ± 25.9 mmHg, P = 0.26 | 12 mos |
| SPYRAL HTN-OFF MED (2017)23 | RCT, sham-controlled | 1519 | 166 | 165 | Symplicity spyral | Multielectrode radiofrequency | Change in 24-h ambulatory SBP at 3 months: RDN −5.5 mmHg (95% CI −9.1 to −2.0 mmHg) vs. sham −0.5 mmHg (95% CI −3.9 to 2.9 mmHg), P = 0.0414 | 12 mos |
| SPYRAL HTN-ON MED (2018)25 | RCT, double-blinded, sham-controlled | 467 | 38 | 42 | Symplicity spyral | Multielectrode radiofrequency | Change in 24-h ambulatory SBP at 6 months: RDN −9.0 mmHg (95% CI −12.7 to −5.3 mmHg) vs. sham −1.6 mmHg (95% CI −5.2 to 2.0 mmHg), P = 0.0051 | 36 mos |
| RADIANCE-HTN SOLO (2018)29 | RCT, single-blinded, sham-controlled | 803 | 73 | 73 | PARADISE | Ultrasound | Change in daytime SBP at 2 months baseline-adjusted SBP difference vs. sham −6.3 mmHg [95% CI −9.4 to −3 mmHg], P < 0.001 | 12 mos |
| RADIOSOUND-HTN (2019)37 | 3-armed RCT, single-blinded | 1884 | 39 (Main) 39 (Branch) 42 |
-- | Symplicity spyral Symplicity spyral PARADISE |
Multielectrode radiofrequency Multielectrode radiofrequency Ultrasound |
Change in daytime SBP at 3 months: radiofrequency-based RDN of main renal artery −6.5 ± 10.3 mmHg vs. radiofrequency-based RDN of main renal artery and branches −8.3 ± 11.7 mmHg vs. ultrasound-based RDN −13.2 ± 13.7 mmHg; overall change −9.5 ± 12.3 mmHg (P < 0.001) | 3 mos |
| RADIANCE-HTN TRIO (2021)33 | RCT, single-blinded sham-controlled | 989 | 69 | 67 | PARADISE | Ultrasound | Change in daytime ambulatory SBP at 2 months significantly greater in RDN than sham median between-group difference −4.5 mmHg ([95% CI −8.5 to 0.3], P = 0.022) | 6 mos |
| REQUIRE (2021)36 | RCT, single-blinded sham-controlled | 411 | 72 | 71 | PARADISE | Ultrasound | Change in 24-h ambulatory SBP at 3 months was not significantly different between 2 groups (between-group difference at 3 mos: −0.1, 95% CI −5.5, 5.3; P = 0.971) | 3 mos |
CI, confidence interval; N/A; not available; RCT, randomized controlled trial; RDN, renal sympathetic denervation; SBP, systolic blood pressure.