Safety and Efficacy of Renal Denervationin Patients Taking Antihypertensive Medications. Journal of the American College of Cardiology Kandzari, D. E., Townsend, R. R., Kario, K., Mahfoud, F., Weber, M. A., Schmieder, R. E., Pocock, S., Tsioufis, K., Konstantinidis, D., Choi, J., East, C., Lauder, L., Cohen, D. L., Kobayashi, T., Schmid, A., Lee, D. P., Ma, A., Weil, J., Agdirlioglu, T., Schlaich, M. P., Shetty, S., Devireddy, C. M., Lea, J., Aoki, J., Sharp, A. S., Anderson, R., Fahy, M., DeBruin, V., Brar, S., Bohm, M., SPYRAL HTN-ON MED Investigators, Wang, Y., Jay, D., McLaurin, B., Lomboy, C., Allaqaband, S., Jan, F., Gummadi, B., Litt, M., Garcia, F., Singh, J., Brown, A., Choi, J., Paul, A., Sharp, A., Coulson, J., Nanjundappa, A., Thakker, G., Campbell, J., Honton, B., Farah, B., Patel, M., Gutierrez, A., Tyson, C., Svetkey, L., Fudim, M., Pagidipati, N., Jones, S., Vemulapalli, S., Devireddy, C., Kulshreshtha, A., Wells, B., Lea, J., Batson, B., Wilkins, R., Sharif, F., Khair, A. M., Pallippattu, A. W., Alhmoudi, A. M., Gaffney, B., Cawley, C., Gorry, C., Hamed, H., Carron, J., Birrane, J., Rosseel, L., Lunardi, M., Cronin, M., McKittrick, M., Almagal, N., Khalid, N., Shehahd, Q., Shahzad, S., Fezzi, S., Tyulkin, S., Bel, X. A., Jolly, S., Yip, G., Schwalm, J., Tsang, M., Mehta, S., Lurz, P. C., Binner, C., Obradovic, D., Fahr, F., Richter, I., Rotta Detto Loria, J., Fengler, K., Rommel, K., Cuartas, M. M., Lerche, M., Hartung, P., Munch, P., Hollriegel, R., John, S., Otsuji, S., Kusumoto, H., Tamaru, H., Ishibuchi, K., Hasegawa, K., Sugimoto, K., Kakishita, M., Ishii, R., Takiuchi, S., Yasuda, S., Nakabayashi, S., Yamamoto, W., Higashino, Y., Shimatani, Y., Taniguchi, Y., Tsioufis, K., Kasiakogias, A., Konstantinidis, D., Andrikou, E., Konstantinou, K., Dimitriadis, K., Kalos, T., Cohen, D., Rene, G., Cohen, J., Bonanni, M., Denker, M., Wickramisinghe, R., Wilensky, R., Kobayashi, T., Anjan, V., Huan, Y., Haught, W. H., Krasnow, J., Vasquez, A., Gessler, C., Roth, C., Drenning, D., Velasquez, E., Soliman, G., Murphy, J., Jain, K., Butler, M., Kanitkar, M., Laney, P., Hunter, R., Cheng, S., Wright, T., Haught, W. H., Chapman, N., Arnold, A., Nowbar, A., Janmohamed, A., Corden, B., Cook, C., Rajkumar, C., Keene, D., Thompson, D., Seligman, H., Howard, J., Davies, J., Sweeney, M., Shun-Shin, M., Foley, M., Quaife, N., Al-Lamee, R., Hadjiphilippou, S., Sen, S., Ahmad, Y., Kario, K., Shimizu, H., Waki, H., Narita, K., Shimpo, M., Hoshide, S., Komori, T., Ogoyama, Y., Ogata, Y., Oba, Y., Bisharat, M., Lishmanov, A., Bisharat, M., Jeffords, T., Ghali, M., Chia, B., Onsrud, R., Rough, R., Aoki, J., Tomii, D., Mori, F., Kikushima, H., Ninomiya, K., Yahagi, K., Tanabe, K., Nakamura, K., Komiyama, K., Nakase, M., Asami, M., Setoguchi, N., Tanaka, T., Horiuchi, Y., Watanabe, Y., Feldman, D., Bergman, G., Sherifi, I., Kim, L., Amin, N., Minutello, R., Wong, S. C., McCullough, S., D'Souza, R., Sharp, A., Kurdi, H., D'Souza, R., Statton, S., Watkinson, T., Bertolet, B., Gupta, A., Blossom, B., Bell, C., Hill, D., Sierra, F., Johnson, J., Estess, J., Adams, J., McDuffie, K., Ferguson, L., Little, N., Ballard, R. D., Williams, R., Ikeda, W., Calhoun, W., Carroll, W., Singh, A., Hirsh, B., Meraj, P., Jauhar, R., Golwala, H., Rueda, J., Graham, K., Al-Hakim, R., Rope, R., Kandzari, D., Bahrami, D., Reedus, D., David, S., Rehman, I., Zakaria, K., Choksi, N., Kazziha, S., Kumar, S., Saba, S., Steigerwalt, S., Sirajeldin, Y., Hyder, O., Aronow, H., Connors, A., Shemin, D., Bent, C., Levy, T., Kodoth, V., Schlaich, M., Kiuchi, M., Carnagarin, R., Shetty, S., Torre, S., Levitt, H., Chen, L., Fan, S., Waxman, S., Porr, W., Mangos, G., Smyth, B., Lane, C., Sader, M., Patel, K. K., Rao, A., Milford, B., Ahluwalia, G., Sennott, J., Field, J., Jena, N., Loree, S., Graham, J., Al-Hesayen, A., Bagai, A., Shite, J., Kozuki, A., Suzuki, A., Masuko, E., Soga, F., Asada, H., Shibata, H., Nagoshi, R., Fujiwara, R., Kyo, S., Miyata, T., Kijima, Y., Weil, J., Griesinger, L., Hafer, L., Starick, R., Keil, S., Agdirlioglu, T., Desch, U., Saito, S., Koyama, E., Yamanaka, F., Yokoyama, H., Tobita, K., Shishido, K., Yamaguchi, M., Murakami, M., Moriyama, N., Takahashi, S., Mizuno, S., Yokota, S., Hayashi, T., Yamada, T., Yamagishi, T., Sugiyama, Y., Mashimo, Y., Tamaki, Y., Tanaka, Y., Lee, D., Ma, A., Yeung, A., Noel, T., Umana, E., Katopodis, J., Dixon, W., Walton, T., Rischin, A., Chee, A., Leaney, A., Fernando, H., Hopper, I., Bloom, J., Fairley, J., Stehli, J., Segan, J., Sharma, M., Fitzgerald, M., Papandony, M., Whyler, N., Noaman, S., Ali, S., Jefferson, B., Reyes, D., Johnston, T., Bohm, M., Hofling, A., Berger, A., Cremers, B., Millenaar, D., Mahfoud, F., Zivanovic, I., Lucic, J., Dederer, J., Lauder, L., Fischer, P., Kulenthiran, S., Ewen, S., Bewarder, Y., Schmieder, R., Bosch, A., Schmid, A., Ott, C., Kannenkeril, D., Akarca, E., Kistner, I., Kolwelter, J., Bihlmaier, K., Striepe, K., Karg, M., Gunes-Altan, M., Anna Friedrich, S. S., Jung, S., Dienemann, T., Ziakas, A., Kouparanis, A., Pagiantza, A., Peteinidou, E., Didagelos, M., Psochias, P. A., Shishehbor, M., Meade, A., Linetsky, E., Robinson, M., Kotter, J., Ziada, K., Kotter, J., Bachinsky, W., Garton, A., Stuck, J., Papademetriou, V., Chung, A., Li, P., Nagpal, S., Remetz, M., Shah, S., Lynch, S. 2023; 82 (19): 1809-1823
Abstract
BACKGROUND: Renal denervation (RDN) reduces blood pressure (BP) in patients with uncontrolled hypertension in the absence of antihypertensive medications.OBJECTIVES: This trial assessed the safety and efficacy of RDN in the presence of antihypertensive medications.METHODS: SPYRAL HTN-ON MED is a prospective, randomized, sham-controlled, patient- and assessor-blinded trial enrolling patients from 56 clinical centers worldwide. Patients were prescribed 1 to 3 antihypertensive medications. Patients were randomized to radiofrequency RDN or sham control procedure. The primary efficacy endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 6months between groups using a Bayesian trial design and analysis.RESULTS: The treatment difference in the mean 24-hour ambulatory systolic BP from baseline to 6months between the RDN group (n=206;-6.5± 10.7mmHg) and sham control group (n=131;-4.5 ± 10.3mmHg) was-1.9mmHg (95%CI:-4.4 to 0.5 mm Hg; P = 0.12). There was no significant difference between groups in the primary efficacy analysis with a posterior probability of superiority of 0.51 (Bayesian treatment difference:-0.03mmHg [95%CI:-2.82 to 2.77 mm Hg]). However, there were changes and increases in medication intensity among sham control patients. RDN was associated with a reduction in office systolic BP compared with sham control at 6months (adjusted treatment difference:-4.9mmHg; P = 0.0015). Night-time BP reductions and win ratio analysis also favored RDN. There was 1 adverse safety event among 253 assessed patients.CONCLUSIONS: There was no significant difference between groups in the primary analysis. However, multiple secondary endpoint analyses favored RDN over sham control. (SPYRAL HTN-ON MED Study [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]; NCT02439775).
View details for DOI 10.1016/j.jacc.2023.08.045
View details for PubMedID 37914510
