The Guidelines Project, which is an initiative of the Brazilian Medical Association, aims to combine information from the medical field to standardize how to conduct and assist in the reasoning and decision-making of doctors. The information provided by this project must be critically evaluated by the physician responsible for the conduct that will be adopted, depending on the conditions and the clinical condition of each patient.
Summary of results:
RF-RDN compared with SHAM in blood pressure change for hypertension
Patient or population: HYPERTENSION
Context: Efficacy and safety
Intervention: RF-RDN
Comparison: SHAM.
| First Author/ Trial, Year (Ref. No.) | Patients (N) | Intervention (N) | Control (N) | Denervation Method | Outcomes | Follow-Up Duration (Months) | Participating Centers |
|---|---|---|---|---|---|---|---|
| Böhm M, et al. SPYRAL HTN-OFF MED Pivotal, 2020 (13) | Untreated patients over the 3–4 weeks before randomization. Clinic BP 150–179/≥90 mmHg and average 24-h ambulatory BP 140–16 mmHg. Mean age: 53 years. (N = 331; 80 patients from randomized Pilot trial and 251 patients from randomized pivotal trial) | RF-RDN (N = 166) | SHAM: Renal angiography (N = 165) | Radiofrequency technique (Multielectrode Symplicity SpiralTM ®) | Primary end point: change in mean 24-h systolic blood pressure Secondary end point: change in office SBP; changes in morning and nighttime BP Adverse events | 3 | 44 centers in Australia, Austria, Canada, Germany, Greece, Ireland, UK, and USA |
| Kandzari DE, et al. SPYRAL HTN-ON MED, 2023 (14) | Patients with 1–3 drugs from ≥6 weeks, uncontrolled (clinic BP 150–180/≥90 mmHg, 24-h BP 140–170 mmHg). Mean age: 53-55 years. (N = 337; 80 patients from randomized Pilot trial and 257 patients from randomized Expansion trial). | RF-RDN (N = 206) | SHAM: Renal angiography (N = 131) | Radiofrequency technique (Multielectrode Symplicity SpiralTM ®) | Primary end point: change in ambulatory blood pressure Secondary end point: office BP; changes in morning (daytime) and night-time BP Adverse Events | 6 | 56 clinical centers worldwide (USA, Germany, Japan, UK, Australia, Austria, and Greece) |
| Weber MA, et al. REDUCE HTN: REINFORCE, 2020 (15) | Patients with office SBP of 150 to 180 mmHg and average 24-h ambulatory SBP of 135 to 170 mmHg after medication washout. Mean age: 58 years | RF-RDN (N = 34) 8 weeks: no antihypertensive medications (unless rescue) 8 weeks to 6 months: add medication if office SBP ≥140 mmHg | SHAM: Renal Angiography (N = 17) 8 weeks: no antihypertensive medications (unless rescue) 8 weeks to 6 months: add medication if office SBP ≥140 mmHg | Radiofrequency technique (Vessix Renal Denervation® system transmits radiofrequency energy via bipolar electrodes). | Primary end point: Mean reduction in average 24-h ambulatory BP. Secondary end point: Daytime ambulatory Office BP Adverse events | 8 weeks 6 months: 12 months | 12 centers in USA |
| First Author/Year (Ref. #) | Randomization | Blind allocation | Double-blind | Outcome researcher blind | Losses | Prognostic characteristics | Appropriate outcomes | Intention-to-treat analysis | Sample size calculation | Early interruption | Risk of Bias | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Böhm M, 2020 13 | High | ||||||||||||
| Kandzari DE, 2023 14 | Low | ||||||||||||
| Weber MA, 2020 14 | High | ||||||||||||
| LEGEND | HIGH RISK | NOT INFORMED | LOW RISK | ||||||||||
Summary of results:
RF-RDN compared with SHAM in blood pressure change for hypertension
Patient or population: HYPERTENSION
Context: Efficacy and safety
Intervention: RF-RDN
Comparison: SHAM.
| Outcomes Number of participants (studies) | Mean Difference | Certainty |
|---|---|---|
| 24-h ambulatory systolic blood pressure – 2–3 months No. of participants: 719 (3 RCTs) | MD 2.5 lower(4 lower to 1 lower) |
|
| 24-h ambulatory systolic blood pressure – 6 months No. of participants: 388 (2 RCTs) | MD 2.33 lower (4.54 lower to 0.12 lower) |
|
| 24-h ambulatory diastolic blood pressure – 2–3 months No. of participants: 719 (3 RCTs) | MD 2.18 lower(3.17 lower to 1.2 lower) |
|
| 24-h ambulatory diastolic blood pressure – 6 months No. of participants: 388 (2 RCTs) | MD 1.07 lower(2.66 lower to 0.53 higher) |
|
| In-office systolic blood pressure – 2–3 months No. of participants: 719 (3 RCTs) | MD 4.48 lower(6.48 lower to 2.49 lower) |
|
| In-office systolic blood pressure – 6 months No. of participants: 388 (2 RCTs) | MD 5.7 lower(8.45 lower to 2.96 lower) |
|
| In-office diastolic blood pressure – 2–3 months No. of participants: 719 (3 RCTs) | MD 2.63 lower(3.86 lower to 1.4 lower) |
|
| In-office diastolic blood pressure – 6 months No. of participants: 388 (2 RCTs) | MD 2.03 lower(3.84 lower to 0.22 lower) |
|
| Outcome No. of participants (studies) | Relative effect(95%CI) | Potential absolute effects (95%CI) | Certainty | ||
|---|---|---|---|---|---|
| RF-RDN | SHAM | Difference | |||
| Serious adverse events No. of participants: 719 (3 RCTs) | RR 0.87(0.21–3.52) | 1.0% | 0.8%(0.2–3.4) | 0.1% fewer (0.8 fewer to 2.4 more) |
|
| GRADE Working Group grades of evidence |
| High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. |
| Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. |
| Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. |
| Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect. |
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