November 20, 2025Hypertension Research1 citationsOpen Access
Sex stratified analysis of patients with resistant hypertension from the Global SYMPLICITY Registry of renal denervation
Key Result
Following renal denervation, women and men with resistant hypertension achieved comparable and significant reductions in blood pressure at 36 months, though women in the highest baseline systolic blood pressure tertile had a higher rate of cardiac death.
Study Design
Type
Observational (n=2,502)
Blinding
Open-label
Multicenter
Yes
Structured PICO
Does radiofrequency renal denervation reduce blood pressure and improve outcomes differently in women compared to men with resistant hypertension?
P
Population
2,502 patients with uncontrolled resistant hypertension (office systolic blood pressure ≥140 mmHg, ≥3 antihypertensive drugs) referred for renal denervation from the Global SYMPLICITY Registry DEFINE. Mean age 60.2 years, 42% women, multinational.
I
Intervention
Radiofrequency renal denervation (RDN) using single-electrode Symplicity Flex or 4-electrode Symplicity Spyral catheter
C
Comparator
Men with resistant hypertension undergoing renal denervation (propensity-matched comparison)
O
Outcome
Changes in blood pressure, clinical outcomes (all-cause death, cardiac death, stroke, myocardial infarction), and quality of life (QoL) at 36 monthssurrogate
In a real-world global registry, renal denervation provided comparable and significant long-term blood pressure reductions in both women and men with resistant hypertension, despite women presenting with a higher-risk baseline phenotype.
Main Result
Effect estimate: 3.6 mmHg difference
Absolute Event Rate: -19% vs -22%
p-value: p=0.031
Limitations
- Not a randomized study to compare outcomes in men vs. women
- Outcome data are likely to be under-reported
- Enrollment based on local referral patterns with preferences biased towards men
- Follow-up data were not available consistently in all patients
- Date of hypertension diagnosis only available for a subset of the cohort
- Secondary causes for hypertension or white coat hypertension were not excluded
- Adherence to prescribed antihypertensive medications was not objectively assessed
Abstract
Our aim was a sex-specific analysis to characterize the phenotype for women with resistant hypertension (rHTN), an understudied population, referred for renal denervation (RDN) from the Global SYMPLICITY Registry DEFINE (N = 3332 patients). For this analysis, 2502 patients with uncontrolled hypertension (office systolic blood pressure (SBP) ≥140 mmHg, ≥3 antihypertensive drugs) were referred for RDN. Age at baseline was 18-88 years for men and 21-89 years for women. We used propensity score matching to account for demographic differences at baseline identified by multivariate regression analysis. Changes in BP, outcomes (all-cause death, cardiac death, stroke, myocardial infarction), and quality of life (QoL) after 36 months were assessed. Women had fewer comorbidities at baseline but had higher BP and worse QoL, anxiety, and depression compared to men. After propensity matching to minimize bias, BP changes were comparable by sex, and BP was significantly reduced from baseline following RDN. Women ≥55 years of age with resistant hypertension had a greater reduction in BP compared with women 178 mmHg), cardiac death was more prevalent in women (6.1%) than men (1.7%). Our sex-stratified analysis of the global registry allowed a longitudinal assessment, providing important insights into the phenotype of resistant hypertension in women. We identified sex-specific differences that highlight the need for early detection and management of hypertension in women.