The pivotal SYMPLICITY HTN-3 trial evaluating the use of Medtronic's renal denervation system in patients with treatment-resistant hypertension failed to meet its primary efficacy endpoint, the company announced Thursday.
No specific numbers were provided, but the announcement confirms rumors that renal denervation was no better than no intervention for lowering office systolic blood pressure through 6 months among patients who continued taking their anti-hypertensives.
The trial's data safety monitoring board, however, determined that the trial did meet its primary safety endpoint, the rate of major adverse events a month after randomization and renal artery stenosis through 6 months.
'We felt it was important that we share the top-line results with the medical community and with patients as soon as we could,' one of the co-principal investigators of the trial, Deepak Bhatt, MD, MPH, of Brigham and Women's Hospital in Boston, said in an email to MedPage Today. 'We are still analyzing the large amount of data from the trial, and once we have a full understanding of the results and implications to the field, we will submit for peer review, presentation, and publication.'
Bhatt said the American College of Cardiology meeting coming up at the end of March would likely be the earliest that the full results could be available.
In recent years, concerns have been raised that the magnitude of the blood pressure reductions seen in renal denervation studies without control groups would not hold up in controlled trials, and those concerns now appear to be well founded.
SYMPLICITY HTN-3, which randomized 535 patients with treatment-resistant hypertension and a starting systolic blood pressure over 160 mm Hg, had a control group.
'Based on these clinical trial findings, Medtronic intends to formulate a panel of independent advisers made up of physicians and researchers who will be asked to make recommendations about the future of the global hypertension clinical trial program, as well as provide advice on continued physician and patient access to the SYMPLICITY technology in countries with regulatory approvals,' the company said in a press release.
Pending that review, Medtronic will halt three trials currently being conducted to support regulatory approval: SYMPLICITY HTN-4 in the U.S., which enrolled its first patient in November, HTN-Japan, and HTN-India. Other studies -- including the Global SYMPLICITY post-market surveillance registry and studies looking at renal denervation for other conditions -- will continue.
The disappointing results of SYMPLICITY HTN-3 follow the announcement last month that the pivotal trial for St. Jude Medical's renal denervation system -- EnligHTN-IV -- was stopped after enrolling fewer than 10 patients because of anticipated recruitment difficulties.
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