Medtronic Highlights Efforts to Tackle Hypertension With Patient Preference Data Presentation and SPYRAL AFFIRM Study Commencement

November 9, 2021— Medtronic recently announced data from their Patient Preferences for the Treatment of Hypertension study that suggest patients may have a tolerance for some risk of adverse events, such as vascular injury or drug side effects, in exchange for being able to lower their office-based systolic blood pressure. The study specifically noted that patients, on average, would need a minimal acceptable benefit of < 2.5 mm Hg reduction in office-based systolic blood pressure. The data were presented at last week’s TCT 2021 conference.

According to the company, blood pressure reduction was indicated as the leading driver of patient preference for treating hypertension compared with other attributes such as medication burden or treatment risks.

The study was designed based on the FDA Guidance for Patient Preference Information and surveyed 400 individuals in the United States with high blood pressure (> 140 mm Hg). Individuals who were surveyed were also on up to three antihypertensive medications and not previously involved in a SPYRAL HTN study. Medtronic noted that the study used a statistical method called a discrete choice experiment, which is often used to compare individuals’ preferences among two or more alternatives.

Medtronic noted that among patients interested in an interventional procedure without medication, up to 76.5% of patients would be willing to consider an interventional approach such as renal denervation (RDN) if it could achieve a 10 mm Hg reduction in office-based systolic blood pressure. When factoring in the maximum acceptable risk of 20%:

• 76.5% of patients would be willing to consider an interventional approach such as RDN with reductions in office blood pressure anticipated at 10 mm Hg.
• 24.3% of patients would be willing to consider an interventional approach such as RDN with reductions in office blood pressure anticipated at 5 mm Hg.
• 6.9% of patients would be willing to consider an interventional approach such as RDN with reductions in office blood pressure anticipated at 2.5 mm Hg, the minimal acceptable benefit.

“This novel, patient preference study is particularly valuable for a new procedure like RDN because it demonstrates that for patients, lowering blood pressure, even by a small amount, is meaningful,” said Michael Weber, MD, in Medtronic’s press release. “For the first time, these results give us quantitative insights into hypertension treatment preferences—importantly, patients are very open to considering a medical intervention procedure, such as RDN, with demonstrated improvements in the control of their high blood pressure.” Dr. Weber is Professor of Cardiovascular Medicine at the State University of New York, Downstate Medical Center.

In related news regarding RDN, Medtronic’s SPYRAL AFFIRM study, which will evaluate the safety, efficacy, and durability of the company’s Symplicity RDN system, enrolled its first patient at Piedmont Heart Institute in Atlanta, Georgia. SPYRAL AFFIRM will include up to 1,000 real-world patients from 100 sites globally who have uncontrolled hypertension and comorbidities such as diabetes, isolated systolic hypertension, and chronic kidney disease. The patients will be followed for 3 years.

SPYRAL AFFIRM is an investigational device exemption study approved by FDA in June 2021 and part of Medtronic’s SPYRAL HTN Global Clinical Program investigating the safety and efficacy data for RDN. The Symplicity Spyral RDN system has been approved for commercial use in more than 60 countries but is limited to investigational use in the United States, Japan, and Canada.