New research reveals: Up to 35 Million Americans could be eligible for RDN¹

Renal denervation (RDN) therapy has emerged as a promising adjunctive treatment for patients with uncontrolled hypertension. Despite the availability of effective medications, approximately 75% of U.S. adults with hypertension still struggle to maintain controlled blood pressure.¹ A similar situation is observed across Europe, where a substantial proportion of patients also fail to achieve target blood pressure levels despite pharmacological therapy, highlighting a shared need for innovative treatment strategies like RDN.²

RDN, a catheter-based procedure targeting renal nerves, has shown efficacy in reducing blood pressure in multiple randomized controlled trials (RCTs). While up to 30% of patients may not experience a meaningful reduction in blood pressure following renal denervation, those who do—particularly individuals with severely elevated baseline values—often achieve substantial and clinically significant improvements.

Scope of the Research¹

A recent research published in JACC: Cardiovascular Interventions by Watson et al. (2025) aimed to quantify the number of U.S. adults potentially eligible for RDN therapy. Using data from five cycles of the National Health and Nutrition Examination Survey (NHANES) spanning 2009–2020 in the U.S and Europe, researchers analyzed hypertension prevalence and applied four different eligibility criteria:

1. Sham-controlled RCTs
   1. Eligibility: 2.05% (~2.3 million adults)
2. S. Single-arm Registry Studies
   1. Eligibility: 16.9% (~19 million adults)
3. SCAI 2023 Position Statement
   1. Eligibility: 22.6% (~25 million adults)
   2. Focuses on resistant hypertension, inability to add medications, and cardiovascular comorbidities.
4. FDA-approved Indication
   1. Eligibility: 31.6% (~36 million adults)
   2. Broadest criteria, raising concerns about over-treatment.

Key Findings¹

• The study identified 113.8 million U.S. adults with hypertension.
• Depending on the criteria used, between 2.3 million and 36 million could be eligible for RDN.
• The FDA’s broad labeling could result in over 10 million patients receiving RDN without meaningful benefit due to non-responsiveness.
• Compared to RDN, only 4.75% of patients qualify for spironolactone under AHA guidelines, highlighting the expansive reach of RDN eligibility.

Clinical and Economic Implications¹

While RDN has demonstrated safety and potential long-term benefits, the lack of tools to predict patient responsiveness poses a significant challenge. Treating non-responders could lead to unnecessary procedures and substantial economic burden. The study underscores the need for:

• Improved patient selection tools
• Refined clinical guidelines
• Further research into predictors of RDN response

References: