Abstract P154: Win Ratio Methodology Demonstrates Consistency Of Benefit Across Different Blood Pressure Reduction Thresholds Following Renal Denervation In The Spyral Htn-on Med Pilot Study

Abstract

Objective: The win ratio is a statistical methodology to evaluate clinical trial outcomes using multiple hierarchical endpoints. We applied the win ratio to patients in SPYRAL HTN-ON MED pilot study to quantify potential differences in renal denervation (RDN) efficacy utilizing different blood pressure (BP) reduction thresholds. Methods: In the SPYRAL HTN-ON MED pilot study, patients were enrolled with office systolic BP (OSBP) ≥150 mmHg and <180 mmHg, office diastolic BP ≥90 mmHg, and mean 24-hour ambulatory systolic BP (ASBP) ≥140 mmHg and <170 mmHg despite 1 to 3 antihypertensive medications. Patients were randomized 1:1 to RDN or sham procedure. For the win ratio analysis, each RDN patient was compared with every sham control patient in the opposing group first according to ASBP to determine “win”, “lose” or “tie” with a threshold of 5 mmHg. Then, ties from the ASBP comparison underwent the comparison using OSBP with a threshold of 10 mmHg. Any tie for a pair comparing OSBP resulted in comparison of any reduction in anti-hypertensive medication burden. The win ratio analysis was repeated using thresholds of 3.5 mmHg for ASBP change, 5 mmHg for OSBP change and any net change in medication burden. Results: The calculated win ratio favored RDN: 2.78 (95% CI: 1.58, 5.48, p<0.001), using thresholds of 5 mmHg for ASBP change, 10 mmHg for OSBP change, and any net change in medication burden, all at 6 months. To test the sensitivity of the analysis, the BP thresholds were changed to 3.5 mmHg for ASBP and 5 mmHg for OSBP, and the win ratio analysis was repeated, resulting in a win ratio again in favor of RDN of 2.68 [1.58, 5.00], p<0.001. Conclusions: Win ratio methodology applied to the SPYRAL HTN-ON MED pilot study demonstrated that RDN was associated with a 2.6-2.8 times greater likelihood of BP or drug reduction compared with sham patients when evaluated across different BP reduction thresholds at 6 months.