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Endovascular denervation lowers blood pressure (RADIANCE-HTN SOLO)
Clinical Question
Does endovascular denervation lower blood pressure in the absence of medication in patients with moderate hypertension?
Bottom line
In this study of highly selected patients with moderate hypertension, patients treated with renal denervation had modestly lower blood pressure and were more likely to remain medication-free after 2 months than those who'd had sham denervation. Whether this persists over time or if outcomes are improved remains to be seen. 1b
Reference
Study design: Randomized controlled trial (single-blinded)
Funding: Industry
Setting: Outpatient (specialty)
Synopsis
In this industry-sponsored study, researchers randomized patients with moderate hypertension to receive endovascular renal denervation (n = 74) or sham therapy (n = 72). The patients had to be aged between 18 years and 75 years and have a combined systolic-diastolic hypertension that was between 140/90 mm Hg and 180/110 mm Hg while taking 0 to 2 antihypertensive medications OR less than 140/90 mm Hg while taking 1 or 2 antihypertensives. All patients stopped taking their antihypertensives for 4 weeks before undergoing ambulatory blood pressure monitoring and renal artery imaging. Patients who had subsequent daytime ambulatory systolic blood pressure between 135 mm Hg and 170 mm Hg and diastolic blood pressure between 85 mm Hg and 105 mm Hg, and who also had "suitable renal artery anatomy" then underwent selective renal artery angiography. During the renal angiography, the patients either underwent immediate endovascular ultrasound nerve ablation or sham treatment. Patients were asked to stay off medication and to monitor their blood pressure at home. After 2 months, the patients underwent 24-hour ambulatory blood pressure monitoring. The research protocol included a drug titration protocol if the average home blood pressure readings were higher than 135 mm Hg systolic or 85 mm Hg diastolic. After 2 months, the denervated patients' systolic and diastolic blood pressures declined an average of 6.3 and 2.6 mm Hg more than the control patients. Additionally, 41 (55%) of 74 denervated patients and 57 (79%) of 72 control patients received antihypertensive treatment (number needed to treat = 5; 95% CI 3 - 12). The authors report that no one experienced adverse events. The authors also note that other studies have not shown denervation to be more effective than sham therapy and give lame excuses to justify why their technology is better.
Reviewer
Henry C. Barry, MD, MS
Professor
Michigan State University
East Lansing, MI
Comments
La différence entre les patients qui ont eu la procédure et ceux qui ne l´ont pas eu ne semble vraiment pas énorme et à 2 mois post-opératoire ce n’est pas assez long pour être convaincu que les patients ne vont pas avoir besoin d’anti-hypertenseur à nouveau.
Can't understand why this nonsense was picked for a POEM
protocol received ethics approval ???
Another example of medical intervention ‘overkill’ for minimal gain. Ethics of study seems questionable as well.
I need to know if the patients who underwent endovascular denervation lived longer or had fewer MI's or strokes than patients who underwent sham denervation.
good poem
Last sentence seems inappropriate or at least vague
Excellent
It would be so much easier if everyone just ate better food, exercised regularly and didn't smoke.