February 5, 2024Open Access
Impact of Antihypertensive Medication Changes After Renal Denervation Among Different Patient Groups: SPYRAL HTN-ON MED
Key Result
Renal denervation significantly reduced office and 24-hour systolic BP compared with sham in non-US patients, while increased medication burden in the US sham cohort diluted the overall effect.
Study Design
Type
RCT (n=337)
Blinding
blinded
Randomization
randomized
Multicenter
Yes
Structured PICO
Does renal denervation reduce blood pressure and antihypertensive medication burden in patients with hypertension on 1 to 3 antihypertensive drugs across different geographic subpopulations?
P
Population
337 patients with hypertension prescribed 1 to 3 antihypertensive drugs. 187 (54%) were enrolled outside the United States, and 156 (46%) were US patients, including 60 (18%) Black Americans.
I
Intervention
Renal denervation (RDN) using the Symplicity Spyral Multi-electrode Renal Denervation System
C
Comparator
Sham procedure
O
Outcome
Changes in antihypertensive medication and office and 24-hour mean systolic blood pressure at 6 monthssurrogate
Geographic differences in antihypertensive medication adjustments, particularly increased medication burden in the US sham cohort, may have confounded the blood pressure lowering effect of renal denervation in the overall trial population.
Limitations
- Increased antihypertensive drug burden in the US sham cohort, especially among Black Americans, may have diluted the treatment effect in the combined trial population.
Abstract
BACKGROUND: The SPYRAL HTN-ON MED (Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications)trial showed significant office and nighttime systolic blood pressure (BP) reductions in patients with hypertension following renal denervation (RDN) compared with sham-control patients, despite similar 24-hour BP reductions. We compared antihypertensive medication and BP changes among prespecified subpopulations. METHODS: The multicenter, randomized, sham-controlled, blinded SPYRAL HTN-ON MED trial (n=337) evaluated BP changes after RDN compared with a sham procedure in patients with hypertension prescribed 1 to 3 antihypertensive drugs. Most patients (n=187; 54%) were enrolled outside the United States, while 156 (46%) US patients were enrolled, including 60 (18%) Black Americans. RESULTS: Changes in detected antihypertensive drugs were similar between RDN and sham group patients in the outside US cohort, while drug increases were significantly more common in the US sham group compared with the RDN group. Patients from outside the United States showed significant reductions in office and 24-hour mean systolic BP at 6 months compared with the sham group, whereas BP changes were similar between RDN and sham in the US cohort. Within the US patient cohort, Black Americans in the sham control group had significant increases in medication burden from baseline through 6 months ( P =0.003) but not in the RDN group ( P =0.44). CONCLUSIONS: Patients enrolled outside the United States had minimal antihypertensive medication changes between treatment groups and had significant office and 24-hour BP reductions compared with the sham group. Increased antihypertensive drug burden in the US sham cohort, especially among Black Americans, may have diluted the treatment effect in the combined trial population. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02439775.