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Clinical Question
Does catheter-based renal denervation decrease blood pressure in hypertensive patients who are not taking antihypertensive drugs?
Bottom line
In this study, catheter-based renal denervation modestly decreased the average systolic blood pressure more effectively than a sham procedure. The authors don't report how many patients would no longer be classified as having hypertension as a result. Larger studies with longer follow-up are needed to see if patients are better off as a result 1b
Reference
Study design: Randomized controlled trial (single-blinded)
Funding: Industry
Setting: Outpatient (specialty)
Synopsis
The SPYRAL HTN-OFF MED Pivotal (Aren't acronyms supposed to make the name easier to remember?) was an industry-funded multinational randomized trial. The researchers recruited adults, 20 to 80 years of age, who had an office systolic blood pressure (SBP) between 150 mmHg and 180 mmHg and a diastolic blood pressure (DBP) 90 mmHg or higher, and were then found to have an average SBP between 140 mmHg and 170 mmHg using 24-hour ambulatory blood pressure monitoring. The patients had to be free of medication for at least 4 weeks before enrollment. The researchers randomized the patients to receive catheter-based renal denervation (n = 166) or a sham procedure (n = 165). Although the personnel performing these procedures knew which intervention they were administering, the patients and study staff did not. The patients were evaluated every 2 weeks after the intervention for up to 3 months. After 3 months, the patients who received denervation experienced an average 3.9 mmHg lowering of SBP compared with sham-treated patients on ambulatory monitoring and 6.5 mmHg with office readings. During this brief follow-up period, there were no deaths and one patient in each group was hospitalized: one for hypertensive crisis (denervation group) and one for a stroke (sham group). The authors do not report what proportion of patients no longer met the diagnostic criteria for hypertension.
Reviewer
Henry C. Barry, MD, MS
Professor
Michigan State University
East Lansing, MI
Comments
helpful
helpful
A promising idea
This study doesn't knock one's socks off. Maximum 7mmHg benefit to an invasive procedure?
But what a great concept to have a single surgical intervention replace the need to ingest drugs for decades.
Perhaps this is the wrong intervention, or it hasn't been perfected. Or perhaps there is a better way to chose those for whom this procedure is more likely to work. That is the real goal, isn't it.
The guidelines on antihypertensive choice are based on generalizations about which "type of people" are most likely to benefit (or suffer) from which type of drug. One day there may be a reliable test to say Sally will respond to ACE inhibition. Don't let Dale near a CaChBlocker"