{"id":41011,"date":"2014-01-09T16:00:15","date_gmt":"2014-01-09T21:00:15","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=voices&p=41011"},"modified":"2014-01-09T16:00:15","modified_gmt":"2014-01-09T21:00:15","slug":"pivotal-renal-denervation-trial-fails-to-show-efficacy","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2014\/01\/09\/pivotal-renal-denervation-trial-fails-to-show-efficacy\/","title":{"rendered":"Pivotal Renal Denervation Trial Fails to Show Efficacy"},"content":{"rendered":"

Medtronic announced today<\/a>\u00a0that the\u00a0SYMPLICITY HTN-3 trial<\/a>\u00a0of its much-anticipated \u00a0renal denervation device had failed to meet its primary efficacy endpoint.\u00a0Renal denervation has been widely touted as a breakthrough product that could dramatically lower blood pressure by as much as 30 mm Hg, allowing physicians to cure the most severe form of high blood pressure, resistant hypertension.<\/p>\n

“SYMPLICITY HTN-3 met its primary safety endpoint related to the incidence of major adverse events one month following randomization and renal artery stenosis to six months,” said Deepak Bhatt, the co-principal investigator of the trial, in the\u00a0Medtronic\u00a0press release. “Importantly, however, the trial did not meet its primary efficacy endpoint.” To demonstrate efficacy in the trial, blood pressure in the treatment arm would have needed to be 10 mm Hg lower than in the control arm.<\/p>\n

Medtronic\u00a0said that because no safety concerns emerged in the trial, “no specific action is currently indicated for patients who have had the renal denervation procedure with the Symplicity system.” The company said it will assemble a panel of independent advisors “to make recommendations about the future of the global hypertension clinical trial program.” \u00a0Until then\u00a0Medtronic\u00a0said it would suspend enrollment in ongoing trials, including the\u00a0SYMPLICITY HTN-4 trial studying renal denervation in patients with less severe forms of hypertension. Symplicity will still be available in\u00a0Europe\u00a0and other markets where it has been approved and the company will continue its global post-market surveillance registry as well as studies that are evaluating other non-hypertension indications for the device.<\/p>\n

Wells Fargo\u00a0analyst Larry Biegelsen said that the news means that that\u00a0Medtronic\u00a0is unlikely to gain U.S. approval for the device without first running another trial.<\/p>\n

Until recently the forecast for\u00a0renal denervation had been\u00a0<\/a>e<\/a>xtremely optimistic.\u00a0More realistic expectations began to appear in 2013. Last\u00a0summer,\u00a0a paper published in\u00a0<\/a>Hear<\/a>t<\/a><\/em>\u00a0showed that the large reductions in blood pressure seen in earlier clinical trials of renal denervation were likely a product of serious flaws in the design of these trials. Until SYMPLICITY HTN-3, the renal denervation trials had been largely\u00a0uncontrolled, unblinded, and had utilized office-based blood pressure measurements rather than the far more reliable and consistent ambulatory blood pressure monitoring. The senior author of the\u00a0Heart<\/em>\u00a0paper, Darrel Francis, \u00a0predicted that\u00a0“people are going to be severely disappointed” by the results of\u00a0SYMPLICITY HTN-3.<\/p>\n

In December, St. Jude confirmed<\/a>\u00a0that it had halted enrollment in its\u00a0EnligHTN IV trial, which was the pivotal trial for its own renal-denervation device.\u00a0\u00a0Renal-denervation products are currently available in\u00a0Europe and elsewhere\u00a0from\u00a0Medtronic, St. Jude Medical,\u00a0Boston Scientific,\u00a0Covidien, Recor, and\u00a0Terumo.<\/p>\n

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Medtronic announced today\u00a0that the\u00a0SYMPLICITY HTN-3 trial\u00a0of its much-anticipated \u00a0renal denervation device had failed to meet its primary efficacy endpoint.\u00a0Renal denervation has been widely touted as a breakthrough product that could dramatically lower blood pressure by as much as 30 mm Hg, allowing physicians to cure the most severe form of high blood pressure, resistant hypertension. […]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,9],"tags":[454,581,921],"class_list":["post-41011","post","type-post","status-publish","format-standard","hentry","category-general","category-interventional-cardiology","tag-hypertension","tag-renal-denervation","tag-resistant-hypertension"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/41011","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=41011"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/41011\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=41011"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=41011"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=41011"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}