Impact of Antihypertensive Medication Changes After Renal Denervation Among Different Patient Groups: SPYRAL HTN-ON MED.

Autor:	Townsend RR; Pereleman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.)., Ferdinand KC; Tulane University School of Medicine, New Orleans, LA (K.C.F.)., Kandzari DE; Piedmont Heart Institute, Atlanta, GA (D.E.K.)., Kario K; Department of Cardiovascular Medicine, Jichi Medical University School of Medicine, Tochigi, Japan (K.K.)., Mahfoud F; Universitätsklinikum des Saarlandes, Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin, Saarland University, Homburg, Germany (F.M., M.B.)., Weber MA; SUNY Downstate College of Medicine, New York, NY (M.A.W.)., Schmieder RE; University Hospital Erlangen, Germany (R.E.S.)., Pocock S; London School of Hygiene & Tropical Medicine, United Kingdom (S.P.)., Tsioufis K; National and Kapodistrian University of Athens Hippocratio Hospital, Greece (K.T.)., David S; Ascension Providence Hospital, Southfield, MI (S.D., S.S.)., Steigerwalt S; Ascension Providence Hospital, Southfield, MI (S.D., S.S.)., Walton A; The Alfred Hospital, Melbourne, Australia (A.W., I.H.)., Hopper I; The Alfred Hospital, Melbourne, Australia (A.W., I.H.)., Bertolet B; North Mississippi Health Services, Tupelo (B.B.)., Sharif F; University of Galway Ireland (F.S.)., Fengler K; Heart Center of Leipzig, Germany (K.F.)., Fahy M; Medtronic, Santa Rosa, CA (M.F., D.A.H., S.B.)., Hettrick DA; Medtronic, Santa Rosa, CA (M.F., D.A.H., S.B.)., Brar S; Medtronic, Santa Rosa, CA (M.F., D.A.H., S.B.)., Böhm M; Universitätsklinikum des Saarlandes, Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin, Saarland University, Homburg, Germany (F.M., M.B.).
Jazyk:	angličtina
Zdroj:	Hypertension (Dallas, Tex. : 1979) [Hypertension] 2024 May; Vol. 81 (5), pp. 1095-1105. Date of Electronic Publication: 2024 Feb 05.
DOI:	10.1161/HYPERTENSIONAHA.123.22251
Abstrakt:	Background: The SPYRAL HTN-ON MED (Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications)trial showed significant office and nighttime systolic blood pressure (BP) reductions in patients with hypertension following renal denervation (RDN) compared with sham-control patients, despite similar 24-hour BP reductions. We compared antihypertensive medication and BP changes among prespecified subpopulations. Methods: The multicenter, randomized, sham-controlled, blinded SPYRAL HTN-ON MED trial (n=337) evaluated BP changes after RDN compared with a sham procedure in patients with hypertension prescribed 1 to 3 antihypertensive drugs. Most patients (n=187; 54%) were enrolled outside the United States, while 156 (46%) US patients were enrolled, including 60 (18%) Black Americans. Results: Changes in detected antihypertensive drugs were similar between RDN and sham group patients in the outside US cohort, while drug increases were significantly more common in the US sham group compared with the RDN group. Patients from outside the United States showed significant reductions in office and 24-hour mean systolic BP at 6 months compared with the sham group, whereas BP changes were similar between RDN and sham in the US cohort. Within the US patient cohort, Black Americans in the sham control group had significant increases in medication burden from baseline through 6 months ( P =0.003) but not in the RDN group ( P =0.44). Conclusions: Patients enrolled outside the United States had minimal antihypertensive medication changes between treatment groups and had significant office and 24-hour BP reductions compared with the sham group. Increased antihypertensive drug burden in the US sham cohort, especially among Black Americans, may have diluted the treatment effect in the combined trial population. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02439775. Competing Interests: Disclosures R.R. Townsend is a consultant for Medtronic, Cytel, Novartis, Regeneron, and Janssen. He also receives royalties from UpToDate. K.C. Ferdinand is a consultant for Medtronic, Novartis, and Janssen. D.E. Kandzari reports institutional research/grant support from Biotronik, Boston Scientific, Cardiovascular Systems, Inc, Orbus Neich, Teleflex, Medtronic, and Ablative Solutions and personal consulting honoraria from Cardiovascular Systems, Inc, Medtronic, and Abbott Vascular. K. Kario receives personal fees from Medtronic during the conduct of the study; grants from A&D, Omron Healthcare, Fukuda Denshi, CureApp, Sanwa Kagaku Kenkyusho, Teijin Pharma, Boehringer Ingelheim Japan, and Fukuda Lifetec; consulting fees from A&D, JIMRO, Omron Healthcare, CureApp, Terumo, and Fukuda Denshi; honoraria from Otsuka Pharmaceuticals and Omron Healthcare; and participation in Advisory Board of Fukuda Denshi, outside the submitted work. F. Mahfoud is supported by Deutsche Gesellschaft für Kardiologie, Deutsche Forschungsgemeinschaft (SFB TRR219), and Deutsche Herzstiftung. He has received scientific support from Ablative Solutions, Medtronic, and ReCor Medical and speaker honoraria/consulting fees from Ablative Solutions, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Inari, Medtronic, Merck, ReCor Medical, Servier, and Terumo. M.A. Weber has received consulting fees from Medtronic, ReCor Medical, Ablative Solutions, Johnson & Johnson, and Urovant. R.E. Schmieder reports grants and personal fees from Medtronic, ReCor Medical, and Ablative Solutions. S. Pocock reports personal fees from Medtronic outside the submitted work. K. Tsioufis reports institutional research/grant support from Medtronic and ReCor Medical and personal consulting honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Medtronic, ReCor Medical, Servier, WinMedica, and ELPEN. A. Walton is a proctor, on the medical advisory board, and has received grant support from Medtronic, Edwards, and Abbott. I. Hopper has received honoraria from Boehringer Ingelheim, Eli Lilly, AstraZeneca, and Vifor. B. Bertolet serves on the Medtronic Renal Denervation Advisory Committee as a consultant. F. Sharif is supported by Science Foundation Ireland Research Infrastructure (17/RI/5353) and is a consultant and advisory board member for Medtronic. K. Fengler received institutional grants from Medtronic, ReCor Medical, and Biotronic. M. Fahy, D.A. Hettrick, and S. Brar are employees of Medtronic. M. Böhm is supported by the Deutsche Forschungsgemeinschaft (German Research Foundation; TTR 219, project number 322900939) and reports personal fees from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Medtronic, Novartis, ReCor Medical, Servier, and Vifor during the conduct of the study. The other authors report no conflicts.
Databáze:	MEDLINE
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