{"id":12267,"date":"2025-06-06T12:36:52","date_gmt":"2025-06-06T17:36:52","guid":{"rendered":"https:\/\/shockwavemedical.com\/education\/bali-makes-big-waves-demonstrating-ivl-benefit-in-first-randomized-trial\/"},"modified":"2026-02-19T12:03:31","modified_gmt":"2026-02-19T18:03:31","slug":"bali-makes-big-waves-demonstrating-ivl-benefit-in-first-randomized-trial","status":"publish","type":"post","link":"https:\/\/shockwavemedical.com\/de\/education\/bali-makes-big-waves-demonstrating-ivl-benefit-in-first-randomized-trial\/","title":{"rendered":"BALI Makes Big Waves Demonstrating IVL Benefit in First Randomized Trial Showing Superiority Over Conventional Balloon-based Strategy"},"content":{"rendered":"\n<section id=\"block_5983b1b13a5d36d5604d0abf9d2247a2\" class=\"block block--wysiwyg wysiwyg_styles u-bgColorNone container\">\n\t<div class=\"u-wysiwyg u-animation\">\n\t\t<h3>Unique Randomized Controlled Trial (RCT) Design Relevant for Clinical Practice<\/h3>\n<p>The BALI study is the first randomized study that examines the potential advantages of a routine Intravascular Lithotripsy (IVL) strategy versus conventional lesion preparation strategies in a rigorous, intracoronary imaging-guided, all-comers population with severely calcified lesions representative of real-world clinical practice.<\/p>\n<ul>\n<li>Recognizing that many calcium tools are complementary and atherectomy is a critical tool to be able to cross lesions, BALI compared 99 patients treated with IVL, 101 patients undergoing conventional balloon-based lesion preparation strategies, including cutting, scoring, ultra-high pressure balloons, and non-compliant (NC) balloons, but not IVL, across nine sites in Denmark, Norway, Estonia and Belgium.<\/li>\n<li>Rotational atherectomy was utilized in 31% of patients in the IVL arm and 42% of patients in the conventional lesion preparation arm only to facilitate balloon crossing.<\/li>\n<\/ul>\n<p><a name=\"summary\"><\/a>Watch the BALI Trial Summary to learn why this study is important and for details on the study design and results.<\/p>\n<div class=\"video\"><iframe title=\"YouTube video player\" data-src=\"https:\/\/www.youtube.com\/embed\/Cg0Ss-j-fkQ?si=sPIhYpfE_3oMqpvR\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" class=\"lazyload\" data-load-mode=\"1\"><\/iframe><\/div>\n<h3>Routine use of IVL Strategy Found Superior to Conventional Approaches<\/h3>\n<ul>\n<li>2\/3 of patients with routine IVL were free of the primary endpoint, compared with approximately 1\/2 of patients with conventional treatment arm, leading the BALI investigators to determine that at one year, a <strong>routine IVL strategy was the superior calcium modification strategy<\/strong>.\n<ul>\n<li><span data-contrast=\"auto\">The primary endpoint of procedural failure (stent implantation with a residual area stenosis of \u226520%) or target vessel failure (CD, TVMI CD-TLR) at one year occurred in 35% of IVL patients and in 52% of conventional preparation patients (<\/span><i><span data-contrast=\"auto\">p<\/span><\/i><sub><i><span data-contrast=\"auto\">superiority<\/span><\/i><\/sub><span data-contrast=\"auto\"> = 0.02).<\/span><span data-ccp-props=\"{\"201341983\":0,\"335559739\":0,\"335559740\":240}\">\u00a0<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<table style=\"border-collapse: collapse; width: 100%; height: 192px;\">\n<tbody>\n<tr style=\"height: 24px;\">\n<td style=\"width: 25%; height: 24px;\"><\/td>\n<td style=\"width: 25%; height: 24px;\">Lithotripsy (n=99)<\/td>\n<td style=\"width: 25%; height: 24px;\">Conventional (n=101)<\/td>\n<td style=\"width: 25%; height: 24px;\"><em>p<\/em><\/td>\n<\/tr>\n<tr style=\"height: 24px;\">\n<td style=\"width: 25%; height: 24px; text-align: left;\"><strong>Primary Endpoint<\/strong><\/td>\n<td style=\"width: 25%; height: 24px;\"><strong>35.4%<\/strong><\/td>\n<td style=\"width: 25%; height: 24px;\"><strong>51.5%<\/strong><\/td>\n<td style=\"width: 25%; height: 24px;\"><strong>0.02<\/strong><\/td>\n<\/tr>\n<tr style=\"height: 24px;\">\n<td style=\"width: 25%; padding-left: 40px; height: 24px; text-align: left;\">Failed or no stent delivery<\/td>\n<td style=\"width: 25%; height: 24px;\">1.0%<\/td>\n<td style=\"width: 25%; height: 24px;\">0.0%<\/td>\n<td style=\"width: 25%; height: 24px;\">\u2013<\/td>\n<\/tr>\n<tr style=\"height: 24px;\">\n<td style=\"width: 25%; padding-left: 40px; height: 24px; text-align: left;\">Residual area stenosis \u226520% (OCT)<\/td>\n<td style=\"width: 25%; height: 24px;\">32.3%<\/td>\n<td style=\"width: 25%; height: 24px;\">44.6%<\/td>\n<td style=\"width: 25%; height: 24px;\">\u2013<\/td>\n<\/tr>\n<tr style=\"height: 24px;\">\n<td style=\"width: 25%; padding-left: 40px; height: 24px; text-align: left;\">Target vessel failure at 1 year<\/td>\n<td style=\"width: 25%; height: 24px;\">4.0%<\/td>\n<td style=\"width: 25%; height: 24px;\">10.9%<\/td>\n<td style=\"width: 25%; height: 24px;\">\u2013<\/td>\n<\/tr>\n<tr style=\"height: 24px;\">\n<td style=\"width: 25%; padding-left: 80px; height: 24px; text-align: left;\">Cardiac death<\/td>\n<td style=\"width: 25%; height: 24px;\">0.0%<\/td>\n<td style=\"width: 25%; height: 24px;\">1.0%<\/td>\n<td style=\"width: 25%; height: 24px;\">\u2013<\/td>\n<\/tr>\n<tr style=\"height: 24px;\">\n<td style=\"width: 25%; padding-left: 80px; height: 24px; text-align: left;\">Myocardial infarction<\/td>\n<td style=\"width: 25%; height: 24px;\">3.0%<\/td>\n<td style=\"width: 25%; height: 24px;\">5.9%<\/td>\n<td style=\"width: 25%; height: 24px;\">\u2013<\/td>\n<\/tr>\n<tr style=\"height: 24px;\">\n<td style=\"width: 25%; padding-left: 80px; height: 24px; text-align: left;\">Clinically driven revascularization<\/td>\n<td style=\"width: 25%; height: 24px;\">4.0%<\/td>\n<td style=\"width: 25%; height: 24px;\">5.0%<\/td>\n<td style=\"width: 25%; height: 24px;\">\u2013<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p><a name=\"trial\"><\/a>Watch Dr. Niels Thue Olsen, MD, PhD, Clinical Associate Professor at the University of Copenhagen, and Chief Medical Officer at Shockwave Medical, Nick West, discuss more about the BALI study.<\/p>\n<div class=\"video\"><iframe title=\"YouTube video player\" data-src=\"https:\/\/www.youtube.com\/embed\/xJ_MqDGYlTI?si=rDNqNtyfzH_uSYFJ\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" class=\"lazyload\" data-load-mode=\"1\"><\/iframe><\/div>\n<h4>Key Takeaway<\/h4>\n<p>In patients undergoing percutaneous coronary intervention (PCI) for severely calcified coronary lesions, <strong>the use of lithotripsy before stent implantation reduced the incidence of procedural failure or target vessel failure at one year<\/strong>, without an increased risk of adverse events.<\/p>\n<p><a class=\"btn--primary\" href=\"https:\/\/www.jacc.org\/doi\/10.1016\/j.jcin.2025.09.028\" target=\"_blank\" rel=\"nofollow noopener sponsored\">Read The Publication<\/a><\/p>\n<hr \/>\n<p><span class=\"legal_copy\">Dr. Niels Thue Olsen is a paid consultant of Shockwave Medical. <\/span><\/p>\n<p><span class=\"legal_copy\">Views expressed are those of the authors and not necessarily those of Shockwave Medical. <\/span><\/p>\n\t<\/div>\n\t<\/section>","protected":false},"excerpt":{"rendered":"<p>BALI is the first real-world superiority trial to evaluate the routine use of an IVL strategy vs conventional balloon-based strategies with the use of intravascular imaging.<\/p>\n","protected":false},"author":19,"featured_media":12264,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":[207,210],"meta":{"_acf_changed":false,"content-type":"","footnotes":""},"categories":[3],"tags":[],"disease-state":[161],"education-topic":[433],"product-tag":[253],"specialty":[297,330,346],"technology":[318],"class_list":["post-12267","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-unkategorisiert","disease-state-coronary-artery-disease-de","education-topic-clinical-evidence-de-2","format-article-de","format-video-de","product-tag-shockwave-c2-de","specialty-fellows-residents-de","specialty-interventional-cardiologists-de","specialty-vascular-surgeons-de","technology-coronary-ivl-de"],"acf":[],"_links":{"self":[{"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/posts\/12267","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/users\/19"}],"replies":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/comments?post=12267"}],"version-history":[{"count":2,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/posts\/12267\/revisions"}],"predecessor-version":[{"id":13432,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/posts\/12267\/revisions\/13432"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/media\/12264"}],"wp:attachment":[{"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/media?parent=12267"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/categories?post=12267"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/tags?post=12267"},{"taxonomy":"disease-state","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/disease-state?post=12267"},{"taxonomy":"education-topic","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/education-topic?post=12267"},{"taxonomy":"format","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/format?post=12267"},{"taxonomy":"product-tag","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/product-tag?post=12267"},{"taxonomy":"specialty","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/specialty?post=12267"},{"taxonomy":"technology","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/technology?post=12267"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}