SYMPLICITY HTN-3 trial on renal denervation does not meet primary efficacy endpoint
Renal denervation failed to achieve its primary efficacy end point in the SYMPLICITY HTN-3 trial, a phase 3 study testing catheter-based renal denervation for the treatment of resistant hypertension.
The primary safety endpoint related to the incidence of major adverse events one month after randomisation and renal artery stenosis up to six months was met, and the Data Safety Monitoring Board concluded that there were no safety concerns.
Previous studies showed promising results of the renal denervation procedure. The SYMPLICITY HTN-3 trial is the most rigorous renal denervation clinical trial conducted to date, and the first of its kind to include a sham-control group. It evaluates the safety and effectiveness the investigational Symplicity renal denervation system in patients with treatment-resistant hypertension and systolic blood pressure higher than 160 mmHg in the United States. 535 patients were randomised to receive the investigational treatment or no treatment. The primary efficacy endpoint was change in office blood pressure from baseline to six months.
Follow-up for all patients randomized in the trial will continue as planned out to five years.
In light of the product's demonstrated safety profile, including the SYMPLICITY HTN-3 findings, no specific action is currently indicated for patients who have had the renal denervation procedure with the Symplicity system.
Medtronic intends to formulate a panel of independent advisors 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.
Press release Medtronic, January 9, 2014