{"id":5274,"date":"2018-09-23T17:51:36","date_gmt":"2018-09-23T22:51:36","guid":{"rendered":"https:\/\/cardiologynownews.org\/?p=5274"},"modified":"2018-09-25T11:58:20","modified_gmt":"2018-09-25T16:58:20","slug":"corevalve-evolut-r-and-edwards-sapien-3-valves-reveal-equivalence-in-transcatheter-aortic-valve-implantation-tavi-in-a-head-to-head-comparison","status":"publish","type":"post","link":"https:\/\/cardiologynownews.org\/?p=5274","title":{"rendered":"Corevalve Evolut R (Medtronic) and Edwards Sapien 3 (Edward Lifesciences) Valves Reveal Equivalence in Transcatheter Aortic Valve Implantation (TAVI) in a Head-to-Head Comparison"},"content":{"rendered":"<p>Results from an <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/study\/NCT02737150\">open-label, multi-center, 2&#215;2 factorial design randomized trial powered for equivalence, comparing the self-expanding Corevalve Evolut R valve to balloon expandable Edwards Sapien 3 valve<\/a>, have shown that the two valves were equivalent to each other in terms of decreasing all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation (p=0.02).<a href=\"http:\/\/tv.clinicaltrialresults.org\/play.php?submission_id=2249\"> Trial results presented at the 2018 TCTMD conference held at San Diego, California<\/a>, also showed equivalence in a\u00a0comparison between general anesthesia vs local anesthesia (with conscious sedation) in terms of decreasing all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury (p=0.02).<!--more--><\/p>\n<p><b><img loading=\"lazy\" loading=\"lazy\" decoding=\"async\" class=\" wp-image-5278 alignleft\" src=\"https:\/\/cardiologynownews.org\/wp-content\/uploads\/2018\/09\/Dr_Thiele_190x285px_hhi_hzl.jpg\" alt=\"\" width=\"115\" height=\"173\" \/>&#8220;In patients with symptomatic aortic stenosis undergoing transfemoral TAVR the <\/b><b>self-expanding <\/b><b>Corevalve<\/b><b> Evolut R <\/b><b>valve is equivalent to the <\/b><b>balloon-expandable Edwards Sapien 3 <\/b><b>with respect to the composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days<\/b><b>.\u00a0<\/b><b>There may be a higher stroke rate with the <\/b><b>balloon-expandable <\/b><b>valve. The event rates were similar in patients enrolled in both arms of the trial. With respect to the valvle strategy, for the majority of patients both are very good third-generation valves.&#8221;-<a href=\"http:\/\/tv.clinicaltrialresults.org\/play.php?submission_id=2249\">Dr.\u00a0Holger Thiele, M.D. discussed with Dr. Tarek Nafee reporting live from TCT 2018, San Diego, California<\/a>.<\/b><\/p>\n<p>&nbsp;<\/p>\n<p>Transcatheter aortic valve implantation (TAVI) has emerged as a life-saving rescue strategy in patients with severe aortic valve stenosis who are considered to be high-risk surgical candidates. The <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02737150\">SOLVE-TAVI trial<\/a>, which compared two valve and two anesthesia strategies, enrolled 447 patients suffering from severe symptomatic aortic valve stenosis defined as aortic valve area (AVA) \u2264 1 cm\u00b2 or 0.6 cm\u00b2\/m\u00b2. All patients were \u2265 75 years of age, and\/or had a logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) \u226520%, indicating that all participants were high-risk surgical patients. The patients were randomized in a 1:1 fashion, with both the self-expanding\u00a0Evolut\u00a0group and the balloon-expandable Sapien 3 group enrolling 219 patients in each group with a mean age 82 years. Almost half the patients in each group were males. A transfemoral approach was used to do the valve replacement. Interestingly, the investigators were surprised by a higher pacemaker implantation rate (18%) for both the Evolut R strategy and for the Sapien 3 strategy than previously reported. Overall mortality was equivalently low among both groups, given the high-risk patient population. More patients assigned the balloon-expandable valve had a stroke vs. those assigned the self-expanding valve, when tested for superiority (4.7% vs. 0.5%; p for equivalence = .003; p for superiority = .01). The rationale of comparing general vs local anesthesia (with conscious sedation) stems from the belief that general anesthesia is safer while performing TAVI; the results from SOLVE-TAVI show that both general and local anesthesia are equally safe, and a minimalist approach can be adopted while managing this high-risk patient population.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Results from an open-label, multi-center, 2&#215;2 factorial design randomized trial powered for equivalence, comparing the self-expanding Corevalve Evolut R valve to balloon expandable Edwards Sapien 3 valve, have shown that the two valves were equivalent to each other in terms of decreasing all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation [&hellip;]<\/p>\n","protected":false},"author":31,"featured_media":5248,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[184,29,19,8],"tags":[47],"ppma_author":[1037],"class_list":{"0":"post-5274","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-clinical-trials","8":"category-conferences","9":"category-interventional-cardiology","10":"category-news","11":"tag-featured","12":"author-syed-hassan-kazmi-m-d"},"authors":[{"term_id":1037,"user_id":31,"is_guest":0,"slug":"syed-hassan-kazmi-m-d","display_name":"Syed Hassan Kazmi M.D.","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/881a91de1109832c36871c3643ef29a6202d992746b003f6e39200ec79a20398?s=96&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/5274","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/users\/31"}],"replies":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=5274"}],"version-history":[{"count":9,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/5274\/revisions"}],"predecessor-version":[{"id":5322,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/5274\/revisions\/5322"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/media\/5248"}],"wp:attachment":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=5274"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=5274"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=5274"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fppma_author&post=5274"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}