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Predictors of blood pressure response in the SYMPLICITY HTN-3 trial.
MedLine Citation:
PMID:  25400162     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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.
CLINICALTRIALSGOV IDENTIFIER: NCT01418261.
Authors:
David E Kandzari; Deepak L Bhatt; Sandeep Brar; Chandan M Devireddy; Murray Esler; Martin Fahy; John M Flack; Barry T Katzen; Janice Lea; David P Lee; Martin B Leon; Adrian Ma; Joseph Massaro; Laura Mauri; Suzanne Oparil; William W O'Neill; Manesh R Patel; Krishna Rocha-Singh; Paul A Sobotka; Laura Svetkey; Raymond R Townsend; George L Bakris
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-11-16
Journal Detail:
Title:  European heart journal     Volume:  -     ISSN:  1522-9645     ISO Abbreviation:  Eur. Heart J.     Publication Date:  2014 Nov 
Date Detail:
Created Date:  2014-11-17     Completed Date:  -     Revised Date:  2014-11-18    
Medline Journal Info:
Nlm Unique ID:  8006263     Medline TA:  Eur Heart J     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.
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