{"title":"Percutaneous Coronary Treatment With Bioadaptor Implant vs Drug-Eluting Stent","authors":"Shigeru Saito MD , Johan Bennett MD, PhD , Holger M. Nef MD, PhD , Mark Webster MD , Atsuo Namiki MD , Akihiko Takahashi MD, PhD , Tsunekazu Kakuta MD , Seiji Yamazaki MD , Yoshisato Shibata MD , Douglas Scott MD , Mathias Vrolix MD , Madhav Menon MD , Helge Möllmann MD, PhD , Nikos Werner MD, PhD , Antoinette Neylon MD , Zlatko Mehmedbegovic MD , Pieter C. Smits MD, PhD , Marie-Claude Morice MD , Stefan Verheye MD, PhD , BIOADAPTOR-RCT Collaborators","doi":"10.1016/j.jcin.2025.01.426","DOIUrl":"10.1016/j.jcin.2025.01.426","url":null,"abstract":"<div><h3>Background</h3><div>The sirolimus-eluting bioadaptor is a novel coronary implant that unlocks, separates, and maintains dynamic support of the vessel at the lesion site 6 months after percutaneous coronary intervention when the polymer coating covering the helical strands resorbs. This enables the bioadaptor to maintain the established flow lumen and to restore hemodynamic modulation of the artery, including cyclic pulsatility, vasomotion, and adaptive remodeling.</div></div><div><h3>Objectives</h3><div>The purpose of this study was to report the first randomized clinical evidence of the DynamX bioadaptor implant through 2 years compared with the Resolute Onyx contemporary drug-eluting stent.</div></div><div><h3>Methods</h3><div>This multicenter, single-blind, 1:1 randomized clinical trial was conducted at 34 hospitals in Japan, Europe, and New Zealand. The eligibility criterion was de novo coronary lesions in up to 2 vessels. The sample size was based on the primary endpoint, noninferiority of 12-month target lesion failure (TLF). The authors herein report 2-year outcomes.</div></div><div><h3>Results</h3><div>In total, 445 patients were enrolled; 3 patients treated for in-stent restenosis and 2 who did not receive the assigned study device because of randomization error were excluded from the analysis. In the per-protocol population of patients with de novo native coronary lesions treated with the assigned device (n = 440), 2-year Kaplan-Meier estimates of TLF and target vessel failure rates in the bioadaptor group were lower (1.8% [4 of 219] vs 5.5% [12 of 221], risk difference −3.6% [95% CI: −7.8% to −0.0%; <em>P</em> = 0.044], and 1.8% [4 of 219] vs 5.9% (13 of 221), risk difference −4.1% [95% CI: −7.2% to −1.0%; <em>P</em> = 0.027], respectively). One clinically driven target lesion revascularization occurred between 6 months and 2 years in the bioadaptor group, whereas 2 cardiovascular deaths and 4 clinically driven target lesion revascularizations occurred in the drug-eluting stent group. The 2-year rate of definite or probable device thrombosis was 0.0% vs 0.5% (n = 1) (<em>P</em> = 0.32), respectively.</div></div><div><h3>Conclusions</h3><div>This is the first report of 2-year outcomes comparing the bioadaptor implant with a contemporary drug-eluting stent. At 2-year follow-up, fewer TLF events were observed in patients treated with the bioadaptor. (The Elixir Bioadaptor vs. the Onyx Stent in De Novo Native Coronary Arteries [BIOADAPTOR RCT]; <span><span>NCT04192747</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 8","pages":"Pages 988-997"},"PeriodicalIF":11.7,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143585720","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jason Galo MD , Rafey Feroze MD , Marco Frazzetto MD, Gregory Rushing MD, Hamza Lodhi MD, Hitesh Raheja MD, Joseph Reed MD, Anene Ukaigwe MD, Steven J. Filby MD, Guilherme F. Attizzani MD
{"title":"Timing and Mechanism of Intraprocedural Conduction Disturbances in Transcatheter Aortic Valve Replacement With Evolut Platform","authors":"Jason Galo MD , Rafey Feroze MD , Marco Frazzetto MD, Gregory Rushing MD, Hamza Lodhi MD, Hitesh Raheja MD, Joseph Reed MD, Anene Ukaigwe MD, Steven J. Filby MD, Guilherme F. Attizzani MD","doi":"10.1016/j.jcin.2025.01.008","DOIUrl":"10.1016/j.jcin.2025.01.008","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 8","pages":"Pages 1079-1081"},"PeriodicalIF":11.7,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143567176","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Christopher S Dodgson, Haakon K Grøgaard, Øyvind H Lie
{"title":"Coronary Stent Embolization Into a Dissected Aortic Wall.","authors":"Christopher S Dodgson, Haakon K Grøgaard, Øyvind H Lie","doi":"10.1016/j.jcin.2025.03.013","DOIUrl":"https://doi.org/10.1016/j.jcin.2025.03.013","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":" ","pages":""},"PeriodicalIF":11.7,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144024585","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Giovanni Occhipinti, Andrea Alberto Ruberti, Omar Abdul-Jawad Altisent, Salvatore Brugaletta, Ander Regueiro
{"title":"In-Stent Restenosis After CTO PCI: A Diagnostic Twist.","authors":"Giovanni Occhipinti, Andrea Alberto Ruberti, Omar Abdul-Jawad Altisent, Salvatore Brugaletta, Ander Regueiro","doi":"10.1016/j.jcin.2025.02.019","DOIUrl":"https://doi.org/10.1016/j.jcin.2025.02.019","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":" ","pages":""},"PeriodicalIF":11.7,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143970064","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alfonso Jurado-Román, Ariana Gonzálvez-García, Santiago Jiménez-Valero, Guillermo Galeote, Raúl Moreno
{"title":"Reply: Intrastent Techniques in the ROLLER-COASTR-EPIC22 Trial: A Missing Piece of the Puzzle?","authors":"Alfonso Jurado-Román, Ariana Gonzálvez-García, Santiago Jiménez-Valero, Guillermo Galeote, Raúl Moreno","doi":"10.1016/j.jcin.2025.04.001","DOIUrl":"https://doi.org/10.1016/j.jcin.2025.04.001","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":" ","pages":""},"PeriodicalIF":11.7,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144119332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Reply: Who Is the True High-Bleeding-Risk Patient?","authors":"Carl-Emil Lim, Peter Ueda","doi":"10.1016/j.jcin.2025.03.026","DOIUrl":"https://doi.org/10.1016/j.jcin.2025.03.026","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":" ","pages":""},"PeriodicalIF":11.7,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143996470","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Henning Guthoff, Mohamed Abdel-Wahab, Won-Keun Kim, Jasmin Shamekhi, Helge Möllmann, Nicolas M Van Mieghem, Stefan Toggweiler, Tobias Rheude, Tobias Zeus, Tanja K Rudolph, Victor Mauri
{"title":"Clinical Impact of Balloon-Expandable vs Self-Expanding TAVR in Small Aortic Annuli.","authors":"Henning Guthoff, Mohamed Abdel-Wahab, Won-Keun Kim, Jasmin Shamekhi, Helge Möllmann, Nicolas M Van Mieghem, Stefan Toggweiler, Tobias Rheude, Tobias Zeus, Tanja K Rudolph, Victor Mauri","doi":"10.1016/j.jcin.2025.03.020","DOIUrl":"https://doi.org/10.1016/j.jcin.2025.03.020","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":" ","pages":""},"PeriodicalIF":11.7,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143965933","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}