Predictors of blood pressure response in the SYMPLICITY HTN-3 trial.

Journal Article

Aims

The SYMPLICITY HTN-3 randomized, blinded, sham-controlled trial confirmed the safety of renal denervation (RDN), but did not meet its primary efficacy endpoint. Prior RDN studies have demonstrated significant and durable reductions in blood pressure. This analysis investigated factors that may help explain these disparate results.

Methods and results

Patients with resistant hypertension were randomized 2 : 1 to RDN (n = 364) or sham (n = 171). The primary endpoint was the difference in office systolic blood pressure (SBP) change at 6 months. A multivariable analysis identified predictors of SBP change. Additional analyses examined the influence of medication changes, results in selected subgroups and procedural factors. Between randomization and the 6-month endpoint, 39% of patients underwent medication changes. Predictors of office SBP reduction at 6 months were baseline office SBP ≥ 180 mmHg, aldosterone antagonist use, and non-use of vasodilators; number of ablations was a predictor in the RDN group. Non-African-American patients receiving RDN had a significantly greater change in office SBP than those receiving sham; -15.2 ± 23.5 vs. -8.6 ± 24.8 mmHg, respectively (P = 0.012). Greater reductions in office and ambulatory SBP, and heart rate were observed with a higher number of ablations and energy delivery in a four-quadrant pattern.

Conclusions

Post hoc analyses, although derived from limited patient cohorts, reveal several potential confounding factors that may partially explain the unexpected blood pressure responses in both the sham control and RDN groups. These hypothesis-generating data further inform the design of subsequent research to evaluate the potential role of RDN in the treatment of resistant hypertension. CLINICALTRIALS.GOV IDENTIFIER: NCT01418261.

Full Text

Duke Authors

Cited Authors

  • Kandzari, DE; Bhatt, DL; Brar, S; Devireddy, CM; Esler, M; Fahy, M; Flack, JM; Katzen, BT; Lea, J; Lee, DP; Leon, MB; Ma, A; Massaro, J; Mauri, L; Oparil, S; O'Neill, WW; Patel, MR; Rocha-Singh, K; Sobotka, PA; Svetkey, L; Townsend, RR; Bakris, GL

Published Date

  • January 2015

Published In

Volume / Issue

  • 36 / 4

Start / End Page

  • 219 - 227

PubMed ID

  • 25400162

Pubmed Central ID

  • 25400162

Electronic International Standard Serial Number (EISSN)

  • 1522-9645

International Standard Serial Number (ISSN)

  • 0195-668X

Digital Object Identifier (DOI)

  • 10.1093/eurheartj/ehu441

Language

  • eng