Account for Clinical Heterogeneity in Assessment of Catheter-based Renal Denervation among Resistant Hypertension Patients: Subgroup Meta-analysis
Xiao-Han Chen1, Sehee Kim2, Xiao-Xi Zeng3, Zhi-Bing Chen4, Tian-Lei Cui1, Zhang-Xue Hu1, Yi Li5, Ping Fu3
1 Department of Nephrology, Kidney Research Institute, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China
2 Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan 48109, USA
3 Department of Nephrology, Kidney Research Institute, West China Hospital, Sichuan University; West China Biostatistics and Cost-benefit Analysis Center of Sichuan University, Chengdu, Sichuan 610041, China
4 Department of Burn and Plastic Surgery, Chengdu Second People's Hospital, Chengdu, Sichuan 610017, China
5 Department of Biostatistics, University of Michigan School of Public Health; Kidney Epidemiology and Cost Center, University of Michigan, Ann Arbor, Michigan 48109, USA
Department of Nephrology, Kidney Research Institute, West China Hospital, Sichuan University, Chengdu, Sichuan 610041; West China Biostatistics and Cost-benefit analysis center of Sichuan University, Chengdu, Sichuan 610041
Source of Support: None, Conflict of Interest: None
Background: Catheter-based renal denervation (RDN) is a novel treatment for resistant hypertension (RH). A recent meta-analysis reported that RDN did not significantly reduce blood pressure (BP) based on the pooled effects with mild to severe heterogeneity. The aim of the present study was to identify and reduce clinical sources of heterogeneity and reassess the safety and efficacy of RDN within the identified homogeneous subpopulations.
Methods: This was a meta-analysis of 9 randomized clinical trials (RCTs) among patients with RH up to June 2016. Sensitivity analyses and subgroup analyses were extensively conducted by baseline systolic blood pressure (SBP) level, antihypertensive medication change rates, and coronary heart disease (CHD).
Results: In all patients with RH, no statistical differences were found in mortality, severe cardiovascular events rate, and changes in 24-h SBP and office SBP at 6 and 12 months. However, subgroup analyses showed significant differences between the RDN and control groups. In the subpopulations with baseline 24-h SBP ≥155 mmHg (1 mmHg = 0.133 kPa) and the infrequently changed medication, the use of RDN resulted in a significant reduction in 24-h SBP level at 6 months (P = 0.100 and P= 0.009, respectively). Subgrouping RCTs with a higher prevalent CHD in control showed that the control treatment was significantly better than RDN in office SBP reduction at 6 months (P < 0.001).
Conclusions: In all patients with RH, the catheter-based RDN is not more effective in lowering ambulatory or office BP than an optimized antihypertensive drug treatment at 6 and 12 months. However, among RH patients with higher baseline SBP, RDN might be more effective in reducing SBP.