Initial studies showed a blood pressure significant reduction to 3 years in patients with resistant hypertension, while the SIMPLICITY HTN -3 with a larger number of patients compared to a group with “Sham” procedure (renal angiography with conscious sedation) could not confirm the results.
The aim of this study was to evaluate the possible confounding factors that could have affected the efficacy results. The analysis showed that 80 % of patients in both groups were receiving a stable drug therapy for at least 6 months prior to randomization. 40% of patients also in both groups received an adjustment of medication at follow up. Subgroup analysis according to patient race (African American versus non-African American) showed a significant drop in pressure in the non- African group (-15.2 versus -8.6, P = 0.012). In addition, there were differences according to the number of quadrants underwent denervation, whereas it was expected, the largest decrease in pressure was observed in those who received denervation in a greater number of quadrants.
Conclusion
We identified potential confounding factors such as changes in antihypertensive medication, differences in the study population and variability in process technique.
David Kandzari
2014-05-23
Title: Symplicity HTN-3: insights from the subgroup analysis