Medtronic unveils data on hypertension treatment preferences, launches SPYRAL AFFIRM study

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Medtronic today announced findings from a new study of patient preferences for the treatment of hypertension. The findings are set to be presented during the “What’s Novel in Interventional Hypertension” session at the 33rd Transcatheter Cardiovascular Therapeutics annual meeting (TCT 2021, 4–6 November, Orlando, USA and virtual)—the yearly scientific symposium of the Cardiovascular Research Foundation.

Medtronic has also announced the initiation of the SPYRAL AFFIRM study, evaluating the long-term safety, efficacy, and durability of the company’s Symplicity renal denervation (RDN) system—which uses a minimally invasive procedure that delivers radiofrequency energy to specific nerves near the kidneys that can become overactive and cause high blood pressure—in real-world patients with uncontrolled hypertension and comorbidities, such as diabetes, isolated systolic hypertension and chronic kidney disease (CKD).

Patient preference for the treatment of hypertension

For the first time, new data presented at TCT 2021 will quantify US patient preferences for considerations of interventional procedures in the treatment of high blood pressure, including treatment mode, effectiveness and risks, according to a Medtronic press release.

The study found that, in exchange for treatment risks, patients on average would require a minimal acceptable benefit of less than 2.5mmHg reduction in office-based systolic blood pressure. Additionally, on average, patients indicated a tolerance of at least 20% risk of adverse events (such as a vascular injury or drug side-effects) in exchange for being able to lower their office-based systolic blood pressure.

These findings suggest that, despite the risks of an intervention, patients may accept lower blood pressure reductions than those observed in published literature of the Medtronic Symplicity Spyral RDN procedure. Additionally, patients may be willing to tolerate risks higher than those observed in peer-reviewed published studies of Symplicity Spyral, the release adds.

The study also concluded that blood pressure reduction was the most important driver of patient preference over all other attributes like medication burden and treatment (including interventional treatment-related) risks.

When applying this model to a patient population that is interested in an interventional procedure without medication, up to 76.5% of patients would be willing to consider an interventional approach like RDN if they achieve a 10mmHg reduction in office-based systolic blood pressure. Including 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 10mmHg
  • 24.3% of patients would be willing to consider an interventional approach such as RDN with reductions in office blood pressure anticipated at 5mmHg
  • 6.9% of patients would be willing to consider an interventional approach such as RDN with reductions in office blood pressure anticipated at 2.5mmHg, 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, professor of cardiovascular medicine at State University of New York, Downstate Medical Center (Brooklyn, USA). “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.”

The study, which was designed based on the US Food and Drug Administration (FDA) Guidance for Patient Preference Information, surveyed 400 individuals in the USA who have high blood pressure (physician confirmed systolic office-based blood pressure greater than 140 mmHg), who were on up to three anti-hypertensive medications, and were not previously involved in a SPYRAL HTN [hypertension] study. The study uses a statistical method called a discrete choice experiment, often used to compare individuals’ preferences among two or more alternatives.

“The patient preference insights, combined with the breadth of real-world and randomised sham controlled trials we have for RDN, are aligned with the recent clinical consensus from the European Society of Hypertension, Society for Cardiovascular Angiography and Interventions, and National Kidney Foundation, that reinforce RDN as a potential treatment option for patients,” said Jason Weidman, senior vice president and president of the Coronary & Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic. “Patient preference data will be important to help physicians understand patients’ acceptable benefits and risks related to minimally invasive procedures for the treatment of hypertension.”

SPYRAL AFFIRM study launch

Separately, Medtronic announced that the first patient was enrolled at Piedmont Heart Institute in Atlanta, USA for the SPYRAL AFFIRM clinical study. Using a performance goal, this clinical study will enrol 1,000 real-world patients with uncontrolled hypertension and associated comorbidities, such as isolated systolic hypertension, diabetes, and CKD. SPYRAL AFFIRM will follow these patients for three years. This investigational device exemption (IDE) trial was approved by the FDA in June 2021 and will be conducted at 100 sites globally.

“Through the strong investment in our clinical programme, the AFFIRM study will expand RDN research into a variety of patient groups,” said Weidman. “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, real-world patients such as those with isolated systolic hypertension, diabetes and CKD.”

The SPYRAL AFFIRM clinical study is part of the SPYRAL HTN Global Clinical Program, adding to the safety and efficacy data for RDN, the release continues. Along with the real-world data from the Global Symplicity Registry, when combined with commercial experience, there have been more than 20,000 procedures performed with Medtronic RDN technology. The clinical programme is backed by the most rigorous and extensive patient experience studied in the presence and absence of medication, and in patients with high baseline cardiovascular risk.


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