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Renal denervation (RDN) significantly improved blood pressure and reduced medication burden in patients with uncontrolled hypertension. The win ratio analysis demonstrated RDN

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Area of Science:

  • Cardiovascular Medicine
  • Interventional Cardiology
  • Hypertension Management

Background:

  • Assessing device-based treatments for hypertension requires robust endpoints.
  • Traditional hypertension trials face challenges with variable blood pressure measures and medication changes.
  • Renal denervation (RDN) is a device-based treatment for uncontrolled hypertension.

Purpose of the Study:

  • To propose and apply a novel, prioritised endpoint framework using a win ratio analysis.
  • To determine the treatment benefit of RDN compared to sham control in patients with uncontrolled hypertension.
  • To evaluate the efficacy of RDN in the SPYRAL HTN-ON MED pilot study.

Main Methods:

  • Utilised data from the SPYRAL HTN-ON MED pilot study (sham-controlled, randomised trial).
  • Employed a prioritised hierarchical endpoint: 24-hour ambulatory systolic blood pressure (SBP), office SBP, and medication burden.
  • Extended generalised pairwise comparisons (win ratio) with clinically relevant thresholds for SBP changes (5 mmHg ambulatory, 10 mmHg office).

Main Results:

  • A total of 1,596 unmatched pairs were analysed.
  • The win ratio favoured RDN, with 1,050 'winner' pairs, 378 'loser' pairs, and 168 ties.
  • The overall win ratio for RDN was 2.78 (95% CI: 1.58 to 5.48; p<0.001), with a net benefit statistic of 0.42 (95% CI: 0.20 to 0.63).
  • Sensitivity analyses confirmed consistent results across different thresholds and adherence levels.

Conclusions:

  • The win ratio method effectively incorporates patient-oriented outcomes and prioritises clinical importance.
  • RDN demonstrated superiority over sham control in the SPYRAL HTN-ON MED pilot study based on the hierarchical endpoint.
  • This approach provides a more comprehensive assessment of treatment efficacy for device-based interventions in hypertension.