<div class="OutlineElement Ltr SCXW89106796 BCX0"> <p class="Paragraph SCXW89106796 BCX0" xml:lang="EN-US" lang="EN-US" paraid="176765070" paraeid="{1f34e22a-999a-4ca8-96a2-be657e1593ce}{220}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW89106796 BCX0"><span class="NormalTextRun SCXW89106796 BCX0">Data from the<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW89106796 BCX0">SirPAD</span><span class="NormalTextRun SCXW89106796 BCX0"><span> </span>trial show that angioplasty with sirolimus-coated balloons has better clinical outcomes compared with uncoated balloons in patients with<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW89106796 BCX0">infrainguinal</span><span class="NormalTextRun SCXW89106796 BCX0"><span> </span>artery disease receiving endovascular treatment.</span></span><span class="EOP Selected SCXW89106796 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW89106796 BCX0"> <p class="Paragraph SCXW89106796 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1664318455" paraeid="{fb6446c2-3d24-43e0-a133-239b53f0e26d}{7}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW89106796 BCX0"><span class="NormalTextRun SCXW89106796 BCX0">Stefano Barco, MD, PhD, of the University Hospital Zurich, Swizterland, presented these results on Monday during a late-breaking clinical trial session at the American College of Cardiology (ACC) 2026 Scientific Sessions</span><span class="NormalTextRun SCXW89106796 BCX0"><span> </span>in New Orleans.</span></span><span class="EOP Selected SCXW89106796 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW89106796 BCX0"> <p class="Paragraph SCXW89106796 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1953720007" paraeid="{476a2d65-d601-4089-bc2c-ae44ddf2c384}{49}"><span class="NormalTextRun SCXW89106796 BCX0">The results were simultaneously published in a manuscript online in the<span> </span></span><span class="NormalTextRun SCXW89106796 BCX0">New England Journal of Medicine</span><span class="NormalTextRun SCXW89106796 BCX0">.</span><span class="EOP Selected SCXW89106796 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW89106796 BCX0"> <p class="Paragraph SCXW89106796 BCX0" xml:lang="EN-US" lang="EN-US" paraid="615875428" paraeid="{b11be7e3-4642-41c8-b387-fcf0a27df5a2}{36}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW89106796 BCX0"><span class="NormalTextRun SCXW89106796 BCX0">Data on the use of endovascular devices for reducing major adverse limb events (MALE) in patients with<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW89106796 BCX0">infrainguinal</span><span class="NormalTextRun SCXW89106796 BCX0"><span> </span>artery disease is limited.<span> </span></span></span><span class="EOP Selected SCXW89106796 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW89106796 BCX0"> <p class="Paragraph SCXW89106796 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1467874624" paraeid="{8da58d9c-7350-45dc-a53a-74cb5934ddeb}{40}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW89106796 BCX0"><span class="NormalTextRun SCXW89106796 BCX0">Investigators in the prospective, open-label, noninferiority<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW89106796 BCX0">SirPAD</span><span> </span><span class="NormalTextRun SCXW89106796 BCX0">(Major Adverse Limb Events in Patients<span> </span></span><span class="NormalTextRun SCXW89106796 BCX0">With</span><span> </span><span class="NormalTextRun SpellingErrorV2Themed SCXW89106796 BCX0">Femoro</span><span class="NormalTextRun SCXW89106796 BCX0">-popliteal and Below-the-knee Peripheral Arterial Disease Treated<span> </span></span><span class="NormalTextRun SCXW89106796 BCX0">With</span><span class="NormalTextRun SCXW89106796 BCX0"><span> </span>Either Sirolimus-coated Balloon or Standard Uncoated Balloon Angioplasty)<span> </span></span><span class="NormalTextRun SCXW89106796 BCX0">trial</span><span> </span><span class="NormalTextRun SCXW89106796 BCX0">randomized patients 1:1 to receive angioplasty with a sirolimus-coated balloon or an uncoated balloon.<span> </span></span></span><span class="EOP Selected SCXW89106796 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW89106796 BCX0"> <p class="Paragraph SCXW89106796 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1096626971" paraeid="{2fd9ce91-98ea-45d7-9673-e20397d96deb}{52}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW89106796 BCX0"><span class="NormalTextRun SCXW89106796 BCX0">A composite of unplanned major amputation on the target limb, endovascular revascularization of the target lesion and surgical revascularization of the target lesion for critical limb ischemia</span><span> </span><span class="NormalTextRun SCXW89106796 BCX0">within 1-year post-procedure (MALE) was the primary endpoint in this study.</span></span><span class="EOP Selected SCXW89106796 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW89106796 BCX0"> <p class="Paragraph SCXW89106796 BCX0" xml:lang="EN-US" lang="EN-US" paraid="326531331" paraeid="{3c417ce1-a82d-414b-90cd-cc1e476c2cee}{75}"><span class="NormalTextRun SCXW89106796 BCX0">All-cause death was the primary safety endpoint in this study.</span><span class="EOP Selected SCXW89106796 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW89106796 BCX0"> <p class="Paragraph SCXW89106796 BCX0" xml:lang="EN-US" lang="EN-US" paraid="2056839621" paraeid="{e8ee2e54-6d78-42b0-9b09-c8086f6222f7}{212}"><span class="NormalTextRun SCXW89106796 BCX0">A total of 1,252 patients were included in the trial (median age=75 years; 35.1% women; n=626 for sirolimus and n=626 for uncoated).</span><span class="EOP Selected SCXW89106796 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW89106796 BCX0"> <p class="Paragraph SCXW89106796 BCX0" xml:lang="EN-US" lang="EN-US" paraid="20924016" paraeid="{47a809cd-29d3-4d58-80c9-75db8bc804cc}{61}"><span class="NormalTextRun SCXW89106796 BCX0">In the sirolimus group, 8.8% of patients experienced a primary endpoint event, and this number was 15% in the uncoated balloon group (p<0.001 for noninferiority, p=0.009 for superiority).</span><span class="EOP Selected SCXW89106796 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW89106796 BCX0"> <p class="Paragraph SCXW89106796 BCX0" xml:lang="EN-US" lang="EN-US" paraid="693641096" paraeid="{2d8377a0-1add-454d-a79e-018f402a9335}{118}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW89106796 BCX0"><span class="NormalTextRun SCXW89106796 BCX0">A notable secondary outcome was a composite of any</span><span class="NormalTextRun SCXW89106796 BCX0"><span> </span>unplanned target-limb amputation or target-lesion revascularization for critical or noncri</span><span class="NormalTextRun SCXW89106796 BCX0">tical limb ischemia, and this occurred in 23.0% of sirolimus patients and 30.8% of uncoated balloon patients (p=0.002).</span></span><span class="EOP Selected SCXW89106796 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW89106796 BCX0"> <p class="Paragraph SCXW89106796 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1700595549" paraeid="{057d008f-2f41-4cda-a7c1-b0e3d4d5b7bd}{95}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW89106796 BCX0"><span class="NormalTextRun SCXW89106796 BCX0">In the sirolimus group, 11.8% of patients died, while 12.8% of patients died in the uncoated balloon group (p=0.67).</span><span class="NormalTextRun SCXW89106796 BCX0"><span> </span>Adverse events were similar between sirolimus and uncoated balloon patients.</span></span><span class="EOP Selected SCXW89106796 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW89106796 BCX0"> <p class="Paragraph SCXW89106796 BCX0" xml:lang="EN-US" lang="EN-US" paraid="2054647258" paraeid="{e420baea-3d57-4aeb-8e15-13887ce21bbb}{203}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW89106796 BCX0"><span class="NormalTextRun SCXW89106796 BCX0">Overall, patients with infrainguinal artery disease benefit more from sirolimus-coated balloon angiography versus uncoated balloon. Patients who receive the sirolimus-coated balloon h</span><span class="NormalTextRun SCXW89106796 BCX0">ave lower rates of MALE,<span> </span></span><span class="NormalTextRun SCXW89106796 BCX0">amputation</span><span class="NormalTextRun SCXW89106796 BCX0"><span> </span>and TLF.</span></span><span class="EOP Selected SCXW89106796 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW89106796 BCX0"> <p class="Paragraph SCXW89106796 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1766846047" paraeid="{b72e2d60-62c1-4833-b394-33eee2a31a18}{84}"><strong><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun MacChromeBold SCXW89106796 BCX0"><span class="NormalTextRun SCXW89106796 BCX0">This study was funded by </span><span class="NormalTextRun SCXW89106796 BCX0">Concept Medical</span> <span class="NormalTextRun SCXW89106796 BCX0">an</span><span class="NormalTextRun SCXW89106796 BCX0">d</span> <span class="NormalTextRun SCXW89106796 BCX0">t</span><span class="NormalTextRun SCXW89106796 BCX0">he U</span><span class="NormalTextRun SCXW89106796 BCX0">ni</span><span class="NormalTextRun SCXW89106796 BCX0">v</span><span class="NormalTextRun SCXW89106796 BCX0">er</span><span class="NormalTextRun SCXW89106796 BCX0">sity</span> <span class="NormalTextRun SCXW89106796 BCX0">of</span> <span class="NormalTextRun SCXW89106796 BCX0">Zu</span><span class="NormalTextRun SCXW89106796 BCX0">r</span><span class="NormalTextRun SCXW89106796 BCX0">i</span><span class="NormalTextRun SCXW89106796 BCX0">ch.</span></span><span class="EOP Selected SCXW89106796 BCX0" data-ccp-props="{}"> </span></strong></p> </div> <div class="OutlineElement Ltr SCXW89106796 BCX0"> <p class="Paragraph SCXW89106796 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1351944633" paraeid="{d86d398c-e58b-4977-87e0-4831f6030430}{152}"><strong><span class="NormalTextRun SCXW89106796 BCX0">Source:</span><span class="EOP Selected SCXW89106796 BCX0" data-ccp-props="{}"> </span></strong></p> </div> <div class="OutlineElement Ltr SCXW89106796 BCX0"> <p class="Paragraph SCXW89106796 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1138427241" paraeid="{d86d398c-e58b-4977-87e0-4831f6030430}{193}"><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW89106796 BCX0"><span class="NormalTextRun SCXW89106796 BCX0">Barco S, Engelberger RP, Held U, et al. Sirolimus-coated balloon angioplasty for<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW89106796 BCX0">infrainguinal</span><span class="NormalTextRun SCXW89106796 BCX0"><span> </span>artery disease.<span> </span></span></span><em><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun SCXW89106796 BCX0"><span class="NormalTextRun SCXW89106796 BCX0">N</span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW89106796 BCX0"> Engl</span><span class="NormalTextRun SCXW89106796 BCX0"> J Med</span></span></em><span class="NormalTextRun SCXW89106796 BCX0">. 2026 March 30 (Article in Press).</span><span class="EOP Selected SCXW89106796 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW89106796 BCX0"> <p class="Paragraph SCXW89106796 BCX0" xml:lang="EN-US" lang="EN-US" paraid="72468504" paraeid="{177a3fe5-61e8-4587-b2ee-dd3b9474b86a}{174}"><strong><span data-contrast="auto" xml:lang="EN-US" lang="EN-US" class="TextRun MacChromeBold SCXW89106796 BCX0"><span class="NormalTextRun SCXW89106796 BCX0">Image Credit: Screenshot by Bailey G. Salimes, </span><span class="NormalTextRun SCXW89106796 BCX0">CRTonline</span><span class="NormalTextRun SCXW89106796 BCX0">.org.</span></span><span class="EOP Selected SCXW89106796 BCX0" data-ccp-props="{}"> </span></strong></p> </div>