Author + information
- Mark I. Davis, MD,
- Kristian B. Filion, PhD,
- Mark J. Eisenberg, MD, MPH,
- Jonathan Afilalo, MD, MSc,
- Ernesto L. Schiffrin, MD, PhD and
- Dominique Joyal, MD∗ ()
- ↵∗Department of Medicine, Jewish General Hospital, McGill University, 3755 Cote-Ste-Catherine Road, Montreal, Quebec H3T 1E2, Canada
We thank Dr. Jin and colleagues for their comments and interest in our paper (1). They disagreed with the meta-analysis of data from 2 randomized, controlled trials (RCTs) combined with those from an observational study in our analysis of controlled studies. Our decision to pool these data is supported by an opinion paper published in the American Journal of Epidemiology (2). Moreover, the pooled data for these 3 studies was consistent; all 3 included studies demonstrated statistically significant benefits with renal artery denervation (RDN) and their meta-analyses produced I2 measures ranging from 0% to 60%. We agree that the included studies were of variable quality, but we preferred to include all available data. In doing so, we provided the reader with a more complete understanding of the current state of this literature.
Dr. Jin and colleagues also point out typographical errors in Figure 2. They are correct that the numbers across the rows for Symplicity HTN-2 and the Pokushalov et al. (3) study were inverted for the 6-month systolic blood pressure (BP) analysis. However, this labeling error had no effect on the results of our meta-analysis. There was an error in the SD in the study by Pokushalov et al. (3) in our Figure 2, but re-analysis revealed that this did not appreciably affect our results. In addition, Jin et al. correctly identified a typographical error where the sentence should read “follow-up rate of <70% at 6 months” instead of “>70%.” With regard to SYMPLICITY HTN-1, the data were obtained from Table 1, which included the baseline BP and SD, and Figure 1A, which provided the change in BP at each time interval with the corresponding 95% confidence interval (4).
We acknowledged in our paper that the available literature consisted of many small studies and discussed the need for further RCTs in this area. We also acknowledged that the analysis of uncontrolled studies included studies with ambulatory BP measurements and studies with office BP measurements. This variability in BP measurement was reported in Table 1 of our paper and was the rationale behind sensitivity analyses restricted to studies that examined ambulatory BP response.
The goal of our systematic review and meta-analysis was to present and analyze the currently available data regarding the efficacy and safety of this intervention to allow operators and programs to make informed decisions regarding the appropriateness of its use in patients with resistant hypertension. Our conclusion was not that RDN should be used in routine clinical practice but rather that there remains a need for large RCTs with long-term follow-up to confirm and build on the observed efficacy and safety of RDN.
- 2013 American College of Cardiology Foundation
- Davis M.I.,
- Filion K.B.,
- Zhang D.,
- et al.
- Pokushalov E.,
- Romanov A.,
- Corbucci G.,
- et al.