Confounding Factors in Renal Denervation Trials Revisiting Old and Identifying New Challenges in Trial Design of Device Therapies for Hypertension

Kandzari DE, Mahfoud F, Bhatt DL, Boehm M, Weber MA, Townsend RR, Hettrick DA, Schmieder R, Tsioufis K, Kario K (2020)

Publication Type: Journal article, Review article

Publication year: 2020

Journal

Hypertension American Heart Association

Book Volume: 76

Pages Range: 1410-1417

Journal Issue: 5

DOI: 10.1161/HYPERTENSIONAHA.120.15745

Abstract

Recent randomized sham-controlled trials have demonstrated significant blood pressure reductions following renal denervation (RDN) in patients with hypertension, both in the presence and absence of antihypertensive therapy. These new data encouraged us to revisit previously published insights into potential clinical trial confounding factors that informed the design and conduct of forthcoming trials. Initially identified confounders related to procedural technique, medication variability, and selected patient subgroups have been addressed in contemporary trial design. Regarding procedural method and technology, blood pressure reductions may be improved by ensuring circumferential lesion creation in the distal renal arteries and branch vessels. Safety of the RDN procedure has been demonstrated in multiple independent meta-analyses including thousands of treated patients with low reported rates of renal vessel complications and maintenance of renal function. However, a newer generation of RDN trials has also introduced insights related to medication adherence, patient selection, and the definition of treatment response. Evolving evidence indicates that RDN therapy may be considered in higher risk populations of uncontrolled hypertension regardless of ethnicity and in patients expressing a strong preference for a nondrug therapy option. Despite advances in procedural technique and clinical trial conduct, inconsistent antihypertensive-drug adherence behavior remains perhaps the most critical clinical trial design issue for device-based hypertension therapies. As the balance in clinical equipoise increasingly favors RDN, justification of sham-controlled trial designs will be revisited, and novel study designs may be required to evaluate the safety and efficacy of novel devices and procedures intended to address the escalating prevalence of poorly controlled hypertension.

Authors with CRIS profile

Roland Schmieder Professur für Innere Medizin (Nephrologie)

Involved external institutions

Universität des Saarlandes (UdS) DE Germany (DE) Jichi Medical University / 自治医科大学 JP Japan (JP) Piedmont Healthcare US United States (USA) (US) National and Kapodistrian University of Athens GR Greece (GR) SUNY Downstate Medical Center US United States (USA) (US) Harvard University US United States (USA) (US) University of Pennsylvania US United States (USA) (US) Medtronic US United States (USA) (US)

How to cite

APA:

Kandzari, D.E., Mahfoud, F., Bhatt, D.L., Boehm, M., Weber, M.A., Townsend, R.R.,... Kario, K. (2020). Confounding Factors in Renal Denervation Trials Revisiting Old and Identifying New Challenges in Trial Design of Device Therapies for Hypertension. Hypertension, 76(5), 1410-1417. https://doi.org/10.1161/HYPERTENSIONAHA.120.15745

MLA:

Kandzari, David E., et al. "Confounding Factors in Renal Denervation Trials Revisiting Old and Identifying New Challenges in Trial Design of Device Therapies for Hypertension." Hypertension 76.5 (2020): 1410-1417.

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