<div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" paraid="1088812477" paraeid="{8ef39db6-62c8-4fee-aecd-e5d081fddc65}{10}"><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">A novel sirolimus drug-eluting balloon (DEB)<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">is<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">noninferior to a<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">standard<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">care control strategy for<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">in-stent restenosis (ISR)</span><span class="NormalTextRun SCXW16975475 BCX0">, consisting of approved drug-eluting stents (DES) or balloon angioplasty (BA), a new study f</span><span class="NormalTextRun SCXW16975475 BCX0">in</span><span class="NormalTextRun SCXW16975475 BCX0">d</span><span class="NormalTextRun SCXW16975475 BCX0">s</span><span class="NormalTextRun SCXW16975475 BCX0">.</span></span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" paraid="1906298479" paraeid="{8ef39db6-62c8-4fee-aecd-e5d081fddc65}{12}"><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">However, the novel DEB –<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW16975475 BCX0">MedAlliance's</span><span> </span><span class="NormalTextRun SCXW16975475 BCX0">SELUTION SLR 014</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>device –<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">failed to</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>prove itself noninferior to DES for single-layer ISRs in target lesion failure at 12 months. </span></span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" paraid="1607626359" paraeid="{8ef39db6-62c8-4fee-aecd-e5d081fddc65}{14}"><span class="NormalTextRun SCXW16975475 BCX0">The findings were published Monday online ahead of print in the<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">Journal of the American College of Cardiology</span><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">, led by Donald E. Cutlip, MD, from<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">Harvard Medical<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">Schoo</span><span class="NormalTextRun SCXW16975475 BCX0">l</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>and the</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>Baim Institute for Clinical Research,<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">both in<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">Boston</span><span class="NormalTextRun SCXW16975475 BCX0">.</span></span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" paraid="1698400356" paraeid="{8ef39db6-62c8-4fee-aecd-e5d081fddc65}{16}"><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">The researchers noted that, while DESs are the recommended treatment for coronary ISR<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">—</span><span> </span><span class="NormalTextRun SCXW16975475 BCX0">demonstrating</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>superiority over plain BA</span><span class="NormalTextRun SCXW16975475 BCX0">,<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">brachytherapy</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>and<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">bare metal stent (</span><span class="NormalTextRun SCXW16975475 BCX0">BMS</span><span class="NormalTextRun SCXW16975475 BCX0">)</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>for prevention of recurrent<span> </span></span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW16975475 BCX0">ISR</span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW16975475 BCX0"> </span><span> </span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW16975475 BCX0">—</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>they are not used in more than 20% of cases. </span></span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" paraid="1226771041" paraeid="{8ef39db6-62c8-4fee-aecd-e5d081fddc65}{18}"><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">"T</span><span class="NormalTextRun SCXW16975475 BCX0">here are concerns about placement of multiple layers of metallic stents, including an increased risk for<span> </span></span><span class="NormalTextRun SpellingErrorV2Themed SCXW16975475 BCX0">neoatherosclerosis</span><span class="NormalTextRun SCXW16975475 BCX0">, recurrent target lesion revascularization, loss of vasomotor reactivity, and late thrombosi</span><span class="NormalTextRun SCXW16975475 BCX0">s," the researchers noted.</span></span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" paraid="1147263680" paraeid="{8ef39db6-62c8-4fee-aecd-e5d081fddc65}{20}"><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">And while</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>paclitaxel-coated balloons have shown<span> </span></span></span><a class="Hyperlink SCXW16975475 BCX0" href="https://pubmed.ncbi.nlm.nih.gov/26139054/" target="_blank" rel="noreferrer noopener"><span class="NormalTextRun SCXW16975475 BCX0" data-ccp-charstyle="Hyperlink">superior results</span></a><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>compared with BA, they have been<span> </span></span><a class="Hyperlink SCXW16975475 BCX0" href="https://pubmed.ncbi.nlm.nih.gov/38460161/" target="_blank" rel="noreferrer noopener"><span class="NormalTextRun SCXW16975475 BCX0" data-ccp-charstyle="Hyperlink">inferior</span></a><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>to repeat DES use for treatment of DES ISR</span><span class="NormalTextRun SCXW16975475 BCX0">, the researchers said. </span></span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" paraid="1044684446" paraeid="{8ef39db6-62c8-4fee-aecd-e5d081fddc65}{22}"><span class="NormalTextRun SCXW16975475 BCX0">They added that using sirolimus as an alternative agent for balloon catheter delivery is "of interest" given its broad therapeutic window, "but development has been delayed by technical challenges for drug delivery and tissue uptake," they added.</span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" paraid="2033575879" paraeid="{8ef39db6-62c8-4fee-aecd-e5d081fddc65}{24}"><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">The current clinical trial, known as<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">SELUTION4ISR</span><span class="NormalTextRun SCXW16975475 BCX0">, therefore set out to assess the safety and efficacy of the SELUTION SLR 014 novel sirolimus-eluting balloon compared with U.S. standard of care across 48 sites<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">in</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>the U.S., Canada</span><span class="NormalTextRun SCXW16975475 BCX0">,</span><span> </span><span class="NormalTextRun SCXW16975475 BCX0">Europe</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>and Brazil.</span></span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" paraid="352949297" paraeid="{8ef39db6-62c8-4fee-aecd-e5d081fddc65}{26}"><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">In line with current treatment norms, randomization of the total<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">390</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>patients</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>in the per protocol group,</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>in the control arm was limited to 20% to be given a BA (n = 39) and the<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">remainder</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>(n = 154) receiving a DES. A total 197 received the novel DEB</span><span class="NormalTextRun SCXW16975475 BCX0">.</span></span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" paraid="527375804" paraeid="{8ef39db6-62c8-4fee-aecd-e5d081fddc65}{28}"><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">At baseline,</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>the DEB group had a median age of 68 years vs 71 in the control group, the majority were male (82% in DEB vs 74% in control), while most had hypertension (93% each) and hypercholesterolemia (91% in DEB vs 89% in control).</span></span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" paraid="414532612" paraeid="{8ef39db6-62c8-4fee-aecd-e5d081fddc65}{30}"><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">The patients had either 1 (78% in each group) or 2 stents (22% in each group), respectively, while most had<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">previous</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>DES at the target lesion (88% in DEB vs 92% in control).</span></span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" paraid="2065874623" paraeid="{8ef39db6-62c8-4fee-aecd-e5d081fddc65}{32}"><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">The 1-year target lesion failure (TLF) primary endpoint<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">—</span><span> </span><span class="NormalTextRun SCXW16975475 BCX0">including<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization</span><span> </span><span class="NormalTextRun SCXW16975475 BCX0">—</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>occurred in 32 (16.2%) of the DEB group and in 28 (14.5%) of the total 193 patients in the control group (difference: 1.7%; 95% credible interval: -5.5% to 8.9%; posterior probability of noninferiority: 98%). </span></span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" paraid="1781277862" paraeid="{8ef39db6-62c8-4fee-aecd-e5d081fddc65}{34}"><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">Noninferiority was<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">established</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>if the upper limit of the 2- sided 95% credible interval was smaller than 10%</span><span class="NormalTextRun SCXW16975475 BCX0">.</span></span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" paraid="164872502" paraeid="{8ef39db6-62c8-4fee-aecd-e5d081fddc65}{36}"><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">A sequential secondary hypothesis test was</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>also</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>performed comparing DEB with DES in patients with single-layer ISR</span><span class="NormalTextRun SCXW16975475 BCX0">. </span></span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" paraid="1160144198" paraeid="{8ef39db6-62c8-4fee-aecd-e5d081fddc65}{38}"><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">In the secondary analysis,<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">TLF occurred in 22 (14.2%) of 155 patients included in the DEB group for that protocol versus 9 (6.5%) of the 138 patients included in the DES control group (difference: 7.7%; 95% credible interval: 0.6% to 14.6%; posterior probability of noninferiority: 76.07%). </span></span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1760459979" paraeid="{d7f637c8-29a2-436b-ac6c-a3b67389331b}{255}"><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">The researchers found there was a significant interaction<span> </span></span><span class="NormalTextRun AdvancedProofingIssueV2Themed SCXW16975475 BCX0">on the basis of</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>operator<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">selection</span><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>of DES vs BA. It trended higher for<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">DEB compared with DES (15.3% vs 7.1%; difference: 8.1%; 95% credible interval: 1.4%-15.0%) and lower for DEB compared with BA (23.6% vs 43.6%; difference: 23.7%; 95% credible interval: − 41.4% to − 1.5%; P</span><span> </span><span class="NormalTextRun SCXW16975475 BCX0">for interaction = 0.0026).</span></span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" paraid="1541077814" paraeid="{8ef39db6-62c8-4fee-aecd-e5d081fddc65}{44}"><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">"</span><span class="NormalTextRun SCXW16975475 BCX0">There were no differences in safety, with similar</span><span> </span><span class="NormalTextRun SCXW16975475 BCX0">rates of mortality, MI, stent thrombosis and bleeding in each group</span><span class="NormalTextRun SCXW16975475 BCX0">," the researchers<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">concluded</span><span class="NormalTextRun SCXW16975475 BCX0">.</span></span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" paraid="939776351" paraeid="{8ef39db6-62c8-4fee-aecd-e5d081fddc65}{47}"><strong><span class="NormalTextRun SCXW16975475 BCX0">Source:</span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></strong></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" paraid="1555613951" paraeid="{8ef39db6-62c8-4fee-aecd-e5d081fddc65}{49}"><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">Cutlip DE, Mehran R, Sharma S, et al.<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0">Sirolimus-Eluting Balloon vs Repeat Drug-Eluting Stent or Balloon Angioplasty for Coronary In-Stent Restenosis</span><span class="NormalTextRun SCXW16975475 BCX0">.<span> </span></span></span><em><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">J Am Coll </span><span class="NormalTextRun SpellingErrorV2Themed SCXW16975475 BCX0">Cardiol</span></span></em><span class="NormalTextRun SCXW16975475 BCX0"><span> </span>2026;<span> </span></span><a class="Hyperlink SCXW16975475 BCX0" href="https://doi.org/10.1016/j.jacc.2026.03.021" target="_blank" rel="noreferrer noopener"><span data-contrast="none" xml:lang="EN-GB" lang="EN-GB" class="TextRun Underlined SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0" data-ccp-charstyle="Hyperlink">DOI:<span> </span></span><span class="NormalTextRun SCXW16975475 BCX0" data-ccp-charstyle="Hyperlink">10.1016/j.jacc.2026.03.021</span></span></a><span class="NormalTextRun SCXW16975475 BCX0">.</span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></p> </div> <div class="OutlineElement Ltr SCXW16975475 BCX0"> <p class="Paragraph SCXW16975475 BCX0" xml:lang="EN-US" lang="EN-US" paraid="1361532437" paraeid="{1c5ad37a-b260-421c-8b5a-f7ad573d1d1f}{28}"><strong><span data-contrast="auto" xml:lang="EN-GB" lang="EN-GB" class="TextRun MacChromeBold SCXW16975475 BCX0"><span class="NormalTextRun SCXW16975475 BCX0">Image Credit: </span><span class="NormalTextRun SCXW16975475 BCX0">Lawrenson25/peopleimages.com</span><span class="NormalTextRun SCXW16975475 BCX0"> – stock.adobe.com</span></span><span class="EOP SCXW16975475 BCX0" data-ccp-props="{}"> </span></strong></p> </div>