Predictors of BP Response in the Symplicity HTN-3 Trial
Predictors of BP Response in the Symplicity HTN-3 Trial
The failure of RDN to significantly reduce blood pressure in a well-conducted study provides an opportunity to redefine methods of study and endpoints that may more carefully reveal its potential. The purpose of these analyses was to critically examine the results of the SYMPLICITY HTN-3 trial in the context of both existing RDN data and clinical trial design, systematically explore hypotheses related to confounding variables identified in either substudy or review of procedural technique, and directly address outstanding issues that have been postulated in the medical community as reasons for lack of efficacy. As this report represents both pre-specified and post hoc analyses from the SYMPLICITY HTN-3 trial, an important limitation is that these results are derived from more limited patient cohorts and from a trial that did not meet its primary efficacy endpoint. Thus, subgroup analyses should be considered exploratory and hypothesis-generating to inform the design of future RDN investigation. However, findings from these analyses will considerably influence both preclinical investigation and performance of clinical trials related to further RDN study.
Conclusions
The failure of RDN to significantly reduce blood pressure in a well-conducted study provides an opportunity to redefine methods of study and endpoints that may more carefully reveal its potential. The purpose of these analyses was to critically examine the results of the SYMPLICITY HTN-3 trial in the context of both existing RDN data and clinical trial design, systematically explore hypotheses related to confounding variables identified in either substudy or review of procedural technique, and directly address outstanding issues that have been postulated in the medical community as reasons for lack of efficacy. As this report represents both pre-specified and post hoc analyses from the SYMPLICITY HTN-3 trial, an important limitation is that these results are derived from more limited patient cohorts and from a trial that did not meet its primary efficacy endpoint. Thus, subgroup analyses should be considered exploratory and hypothesis-generating to inform the design of future RDN investigation. However, findings from these analyses will considerably influence both preclinical investigation and performance of clinical trials related to further RDN study.