New data from Medtronic Patient Preference study presented at TCT 2021; Medtronic adds to its clinical leadership for renal denervation with launch of the SPYRAL AFFIRM study
Medtronic also announced the initiation of the SPYRAL AFFIRM study, evaluating the long-term safety, efficacy, and durability of the Medtronic Symplicity™ Renal Denervation System in real-world patients with uncontrolled hypertension and comorbidities such as diabetes, isolated systolic hypertension, and chronic kidney disease.
Patient Preference in the Treatment of Hypertension: Interventional Treatments and Standard of Care
For the first time, new data presented at TCT 2021 quantified
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 Medtronic Symplicity Spyral Renal Denervation procedure1,2. Additionally, patients may be willing to tolerate risks higher than those observed in peer-reviewed published studies3 of Symplicity Spyral.
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 who is interested in an interventional procedure without medication, up to 76.5% of patients would be willing to consider an interventional approach such as 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 10 mmHg.
- 24.3% of patients would be willing to consider an interventional approach such as RDN with reductions in office blood pressure anticipated at 5 mmHg.
- 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 mmHg, the minimal acceptable benefit.
"This novel, patient preference study is particularly valuable for a new procedure like renal denervation, because it demonstrates that for patients, lowering blood pressure, even by a small amount, is meaningful," said Dr.
The study, which was designed based on the FDA Guidance for Patient Preference Information, surveyed 400 individuals in the
"The patient preference insights, combined with the breadth of real world and randomized sham controlled trials we have for renal denervation, are aligned with the recent clinical consensus from the
SPYRAL AFFIRM Study Launch
Separately, Medtronic announced that the first patient was enrolled at
"Through the strong investment in our clinical program, 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 chronic kidney disease."
The SPYRAL AFFIRM clinical study is part of the SPYRAL HTN Global Clinical Program, adding to the safety and efficacy data for RDN. Along with the real-world data from the Global Symplicity Registry,4 when combined with commercial experience, there have been more than 20,000 procedures performed with Medtronic RDN technology. The clinical program is backed by the most rigorous and extensive patient experience studied in the presence2 and absence1 of medication and in patients with high baseline cardiovascular risk.4
About the Medtronic Symplicity™ Renal Denervation System
The Medtronic RDN procedure uses a minimally invasive procedure that delivers radiofrequency energy to specific nerves near the kidneys that can become overactive and cause high blood pressure. Approved for commercial use in more than 60 countries around the world, the Symplicity Spyral renal denervation system is limited to investigational use in
About Medtronic
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Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the
1 Kandzari et al. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial.
2 Bӧhm M, Kario K, Kandzari DE, Mahfoud F, Weber MA, Schmieder RE, et al., SPYRAL HTN-OFF MED Pivotal Investigators. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial.
3 Townsend et al. Review and meta-analysis of renal artery damage following percutaneous renal denervation with radiofrequency renal artery ablation. EuroIntervention 2020; 16: 89-96.
4 Mahfoud F, et al. Renal Denervation in High-Risk Patients with Hypertension. J Am Coll Cardiol. 2020; 75(23): 2879-88.
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