Long-term safety and efficacy of renal sympathetic denervation in comparison to a population-based cohort: a propensity-matching approach.

Abstract

Objective: To evaluate the long-term changes in risk of cardiovascular outcomes and blood pressure (BP) in hypertensive patients treated with renal sympathetic denervation (RDN) as compared to hypertensive controls from a population-based cohort.

Methods: This prospective cohort study included patients with office systolic blood pressure (SBP) at least 140 mmHg and/or diastolic BP at least 90 mmHg. Patients treated with RDN were matched to hypertensive controls from the population-based Rotterdam Study using one-to-many variable-ratio propensity score matching. The primary safety outcome was a composite endpoint of myocardial infarction, coronary revascularization, stroke, renal failure and mortality. The primary efficacy outcome was the 5-year change in office SBP.

Results: A total of 53 RDN patients were matched to 238 population-based controls. Median age [25th-75th percentile] was 60.5 [56.5-68.4] years (46% female). Baseline BP ±SD was 166.1/95.5 ± 20.6/10.9 mmHg. Patients were prescribed 2.8 [1.5-4.5] defined daily dosages of antihypertensive drugs. The incidence of the primary safety outcome was similar among the RDN group and the control group at 5 years [13 vs. 18%; hazard ratio 0.93; 95% confidence interval (CI) 0.36-2.38; P  = 0.87]. The 5-year change in SBP was -12.0 [-18.0, -6.0] mmHg in the RDN group ( P  < 0.001) and -14.9 [-22.5 to -7.3] mmHg in the control group ( P  < 0.001), with no significant between-group difference [2.9 (-6.6 to 12.4) mmHg; P  = 0.55].

Conclusion: Patients with uncontrolled hypertension undergoing RDN did not have a significantly lower risk for future adverse cardiovascular events as compared to hypertensive controls from a population-based study. No difference in office BP was observed at 5 years. While real-world observational data could provide valuable insights, randomized trials are needed to confirm the role of RDN in improving long-term outcomes.