Medtronic Unveils Data on Hypertension Treatment Preferences and Launches SPYRAL AFFIRM Study
Medtronic today announced the results of a new study on patient preferences for the treatment of hypertension. The results are expected to be presented at the “What’s Novel in Interventional Hypertension” session at the 33rd Annual Meeting of Transcatheter Cardiovascular Therapeutics (TCT 2021, November 4-6, Orlando, USA and Virtual) – the annual scientific symposium of the Cardiovascular Research Foundation.
Medtronic also announced the launch of the SPYRAL AFFIRM study, evaluating the safety, efficacy and long-term durability of the company’s Symplicity Renal Denervation System (RDN), which uses a minimally invasive procedure that delivers energy. radio frequency to specific nerves near the kidneys. which can become overactive and cause high blood pressure – in real world patients with uncontrolled hypertension and co-morbidities, such as diabetes, isolated systolic hypertension, and chronic kidney disease (CRF).
Patient preference for the treatment of hypertension
For the first time, new data presented at TCT 2021 will quantify U.S. patient preferences for interventional procedures in the treatment of high blood pressure, including mode of treatment, efficacy and risks, according to a Medtronic press release.
The study found that in exchange for the risks associated with the treatment, patients would need, on average, a minimum acceptable benefit of less than 2.5 mmHg reduction in systolic blood pressure in the office. In addition, on average, patients indicated a tolerance of at least 20% to the risk of adverse events (such as vascular injury or side effects of a drug) in exchange for the possibility of lowering their blood pressure. systolic blood pressure in the office.
These results suggest that, despite the risks of an intervention, patients may accept reductions in blood pressure less than those seen in the published literature of the Medtronic Symplicity Spyral RDN procedure. Additionally, patients may be willing to tolerate higher risks than those seen in published and peer-reviewed studies of Symplicity Spyral, the statement added.
The study also concluded that the reduction in blood pressure was the most important factor in patient preference over all other attributes such as drug load and treatment risks (including treatment risks. interventional).
When applying this model to a patient population interested in an interventional drug-free procedure, up to 76.5% of patients would be willing to consider an interventional approach like RDN if they achieve a reduction of 10 mmHg systolic blood pressure in the office. Including the maximum acceptable risk of 20%:
- 5% of patients would be willing to consider an interventional approach such as NDR with reductions in office blood pressure expected to 10 mmHg
- 3% of patients would be willing to consider an interventional approach such as NDR with reductions in office blood pressure expected to 5 mmHg
- 9% of patients would be willing to consider an interventional approach such as NDR with reductions in office blood pressure expected to 2.5 mmHg, the minimum acceptable benefit
“This new study on patient preferences is particularly useful for a new procedure like RDN, because it demonstrates that, for patients, lowering blood pressure, even slightly, is significant,” said Michael Weber, professor of cardiovascular medicine. at the State University. of New York, Downstate Medical Center (Brooklyn, USA). “For the first time, these results give us quantitative information about treatment preferences for hypertension. Importantly, patients are very open to the idea of a medical intervention, such as RDN, with improvements demonstrated in controlling their hypertension. “
The study, which was designed based on the United States Food and Drug Administration (FDA) guidelines for patient preference information, interviewed 400 people in the United States who have high blood pressure ( doctor confirmed office systolic blood pressure greater than 140 mmHg), who were taking up to three antihypertensive drugs and had never participated in a SPYRAL HTN [hypertension] to study. The study uses a statistical method called the discrete choice experiment, often used to compare the preferences of individuals between two or more alternatives.
“The information on patient preferences, combined with the breadth of real-world fictitious randomized controlled trials we have for RDN, aligns with the recent clinical consensus of the European Hypertension Society, Angiography Society and cardiovascular and National Kidney Foundation interventions, which strengthen RDN as a potential treatment option for patients, ”said Jason Weidman, senior vice president and president of the Coronary & Renal Denervation business, who is part of Medtronic’s cardiovascular portfolio. “Data on patient preferences will be important in helping physicians understand the acceptable patient benefits and risks associated with minimally invasive procedures for the treatment of hypertension. “
Launch of the SPYRAL AFFIRM study
In addition, Medtronic announced that the first patient is enrolled at the Piedmont Heart Institute in Atlanta, United States, for the SPYRAL AFFIRM clinical study. Using a performance goal, this clinical study will enroll 1,000 real-world patients with uncontrolled hypertension and associated comorbidities, such as isolated systolic hypertension, diabetes and CRF. SPYRAL AFFIRM will follow these patients for three years. This investigational device exemption trial (IDE) was approved by the FDA in June 2021 and will be conducted at 100 sites worldwide.
“With the strong investment in our clinical program, the AFFIRM study will expand RDN research to a variety of patient groups,” Weidman said. “The AFFIRM clinical study adds to our body of evidence for RDN and will help us further answer questions about the use of this procedure in more complex and real patients, such as those with isolated systolic hypertension,” diabetes and CRF. “
The SPYRAL AFFIRM clinical study is part of the global SPYRAL HTN clinical program, adding to the safety and efficacy data of RDN, publication continues. In addition to real-world data from the Global Symplicity Registry, combined with business experience, over 20,000 procedures have been performed with Medtronic RDN technology. The clinical program is based on the most rigorous and extensive patient experience studied in the presence and absence of drugs, and in patients with high baseline cardiovascular risk.