Robert A. Byrne MB BCh, PhD , Joo-Yong Hahn MD, PhD , Peter O’Kane MD , Manel Sabaté MD , Ralph Toelg MD , Samuel Copt PhD , Sean Fitzgerald MB BCh , Marie-Claude Morice MD , Jasper Trevelyan MD , Darren Mylotte MD , Antonio Fernandez Ortiz MD, PhD , Himanshu Rai PhD , Rory Durand MB BCh , Jochen Wöhrle MD , Franz Xever Kleber MD , Giuilo Stefanini MD , Fernando Alfonso MD, PhD
{"title":"Randomized Trial of Biolimus DCB for In-Stent Restenosis","authors":"Robert A. Byrne MB BCh, PhD , Joo-Yong Hahn MD, PhD , Peter O’Kane MD , Manel Sabaté MD , Ralph Toelg MD , Samuel Copt PhD , Sean Fitzgerald MB BCh , Marie-Claude Morice MD , Jasper Trevelyan MD , Darren Mylotte MD , Antonio Fernandez Ortiz MD, PhD , Himanshu Rai PhD , Rory Durand MB BCh , Jochen Wöhrle MD , Franz Xever Kleber MD , Giuilo Stefanini MD , Fernando Alfonso MD, PhD","doi":"10.1016/j.jcin.2024.11.026","DOIUrl":"10.1016/j.jcin.2024.11.026","url":null,"abstract":"<div><h3>Background</h3><div>In recent years, drug-coated balloon (DCB) angioplasty has become an established treatment option for the treatment of coronary in-stent restenosis (ISR).</div></div><div><h3>Objectives</h3><div>The aim of this study was to compare the angiographic and clinical performance of the Biolimus A9–coated balloon (BCB; Biosensors Europe) with that of the paclitaxel-coated balloon (PCB; SeQuent Please, Braun Melsungen).</div></div><div><h3>Methods</h3><div>REFORM (Prospective, Randomized, Non-Inferiority Trial to Determine the Safety and Efficacy of the Biolimus A9™ Drug Coated Balloon for the Treatment of In-Stent Restenosis: First-in-Man Trial) was a multicenter, assessor-blinded, noninferiority, 2:1 randomized controlled trial comparing the BCB and the PCB for the treatment of coronary ISR. The primary endpoint was in-segment percentage diameter stenosis at 6 months. Secondary endpoints included target lesion failure. The trial was registered prospectively at ClinicalTrials.gov (<span><span>NCT04079192</span><svg><path></path></svg></span>).</div></div><div><h3>Results</h3><div>A total of 202 patients were randomized at 20 centers in 6 countries, with 135 in the BCB group and 67 in the PCB group. The mean patient age was 68.5 ± 10 years. At 6 months, in-segment percentage diameter stenosis was 43.3% ± 22.9% in the BCB group compared with 31.4% ± 17.7% in the PCB group (95% CI for the difference: 4.9%-18.8%; prespecified noninferiority margin 12%, noninferiority <em>P</em> = 0.48). At 1 year, target lesion failure was observed in 23.7% of patients in the BCB group vs 17.1% in the PCB group (HR: 1.44; 95% CI: 0.72-2.88; <em>P</em> = 0.28).</div></div><div><h3>Conclusions</h3><div>In patients with ISR, the REFORM study failed to demonstrate noninferiority of the investigational biolimus DCB compared with the standard paclitaxel DCB.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 5","pages":"Pages 654-662"},"PeriodicalIF":11.7,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364698","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}
Takao Sato MD , Mitsuaki Matsumura PhD , Kei Yamamoto MD , Yoichiro Sugizaki MD , Evan Shlofmitz DO , Jeffrey W. Moses MD , Omar K. Khalique MD , Susan V. Thomas MPH , Sarah Malik MD , Ali Dakroub MD , Mandeep Singh BS , Doosup Shin MD , David J. Cohen MD, MSc , Gary S. Mintz MD , Richard A. Shlofmitz MD , Allen Jeremias MD, MSc , Ziad A. Ali MD, DPhil , Akiko Maehara MD
{"title":"A Revised Optical Coherence Tomography–Derived Calcium Score to Predict Stent Underexpansion in Severely Calcified Lesions","authors":"Takao Sato MD , Mitsuaki Matsumura PhD , Kei Yamamoto MD , Yoichiro Sugizaki MD , Evan Shlofmitz DO , Jeffrey W. Moses MD , Omar K. Khalique MD , Susan V. Thomas MPH , Sarah Malik MD , Ali Dakroub MD , Mandeep Singh BS , Doosup Shin MD , David J. Cohen MD, MSc , Gary S. Mintz MD , Richard A. Shlofmitz MD , Allen Jeremias MD, MSc , Ziad A. Ali MD, DPhil , Akiko Maehara MD","doi":"10.1016/j.jcin.2024.12.001","DOIUrl":"10.1016/j.jcin.2024.12.001","url":null,"abstract":"<div><h3>Background</h3><div>Severe calcification is the morphology most strongly associated with stent underexpansion.</div></div><div><h3>Objectives</h3><div>The aim of this study was to revise an optical coherence tomography (OCT)–derived calcium score to predict stent underexpansion in severely calcified lesions (angle >270°) using a point-based system.</div></div><div><h3>Methods</h3><div>A retrospective observational study was conducted in which 250 de novo lesions undergoing OCT-guided stenting, with angiographically visible calcium and optical coherence tomographic maximum superficial calcium angle >270°, not subjected to atherectomy or specialty balloon treatment before stent implantation, were randomly divided into derivation (n = 167) and validation (n = 83) cohorts. The endpoint was stent expansion (minimum stent area/average of reference luminal area) at the maximum calcium deposition site, and stent expansion <70% was considered underexpansion.</div></div><div><h3>Results</h3><div>Stent underexpansion was present in 19.6% of lesions (49 of 250). In the multivariable linear regression model, the morphologic characteristics associated with stent expansion in the derivation cohort were: 1) calcium >270° with a length longer than 3 mm (regression coefficient = −10.3; 95% CI: −17.8 to −2.8; <em>P</em> = 0.007); 2) calcium angle of 360° (regression coefficient = −15.5; 95% CI: −25.2 to −5.8; <em>P</em> = 0.002); and 3) minimum calcium thickness >0.30 mm (regression coefficient = −12.4; 95% CI: −19.1 to −5.6; <em>P</em> = 0.0004). In the validation cohort, the calcium score (range: 0-3) was significantly correlated with stent expansion (regression coefficient = −9.1; 95% CI: −12.6 to −6.1; <em>P</em> < 0.0001).</div></div><div><h3>Conclusions</h3><div>This revised OCT-derived calcium score can serve as a reliable tool for identifying severely calcified lesions at risk for stent underexpansion.</div></div>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":"18 5","pages":"Pages 622-633"},"PeriodicalIF":11.7,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143592368","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}
Hector M Garcia-Garcia, Kayode Kuku, Paulo G P Ziemer, Pablo Rubio, Carlos A Bulant, Priti Shah, Gary S Mintz, Carlo Di Mario, Ron Waksman, Pablo J Blanco
{"title":"Automated Intravascular Ultrasound Calcium Detection: Derivation and Validation of \"The Calcigram\".","authors":"Hector M Garcia-Garcia, Kayode Kuku, Paulo G P Ziemer, Pablo Rubio, Carlos A Bulant, Priti Shah, Gary S Mintz, Carlo Di Mario, Ron Waksman, Pablo J Blanco","doi":"10.1016/j.jcin.2025.02.004","DOIUrl":"10.1016/j.jcin.2025.02.004","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":" ","pages":""},"PeriodicalIF":11.7,"publicationDate":"2025-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604901","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}
Natasha Corballis, Ioannis Merinopoulos, Tharusha Gunawardena, Rajkumar Natarajan, Upul Wickramarachchi, Allan Clark, Vassilios S Vassiliou, Simon Eccleshall
{"title":"Short-Term Safety of Drug-Coated Balloons Compared to Drug-Eluting Stents in De Novo Coronary Disease.","authors":"Natasha Corballis, Ioannis Merinopoulos, Tharusha Gunawardena, Rajkumar Natarajan, Upul Wickramarachchi, Allan Clark, Vassilios S Vassiliou, Simon Eccleshall","doi":"10.1016/j.jcin.2025.01.439","DOIUrl":"https://doi.org/10.1016/j.jcin.2025.01.439","url":null,"abstract":"","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":" ","pages":""},"PeriodicalIF":11.7,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143673862","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}
Francesco Bianchini, Enrico Romagnoli, Cristina Aurigemma, Lazzaro Paraggio, Antonino Buffon, Francesco Fracassi, Mattia Lunardi, Luigi Cappannoli, Emiliano Bianchini, Andrea Zito, Carlo Trani, Francesco Burzotta
{"title":"COMPARISON OF STENT GEOMETRY ACHIEVED BY DIFFERENT SIDE-BRANCH BALLOONING TECHNIQUES FOR BIFURCATION PROVISIONAL STENTING: THE CRABBIS TRIAL.","authors":"Francesco Bianchini, Enrico Romagnoli, Cristina Aurigemma, Lazzaro Paraggio, Antonino Buffon, Francesco Fracassi, Mattia Lunardi, Luigi Cappannoli, Emiliano Bianchini, Andrea Zito, Carlo Trani, Francesco Burzotta","doi":"10.1016/j.jcin.2025.02.007","DOIUrl":"https://doi.org/10.1016/j.jcin.2025.02.007","url":null,"abstract":"<p><strong>Background: </strong>\"Stepwise provisional stenting\" is the most adopted approach for percutaneous coronary interventions (PCI) in bifurcation lesions. During these procedures, side-branch (SB) may deserve treatment, but the best ballooning technique is still undetermined.</p><p><strong>Objectives: </strong>To compare the stent configurations obtained by two SB ballooning sequences after the main vessel (MV) stent implantation: proximal-optimization-technique (POT)+kissing-balloon-inflation+final POT (PKP) versus POT+isolated-SB-dilation+final POT (PSP).</p><p><strong>Methods: </strong>We conducted a 1:1 prospective, randomized, single-center trial to compare bifurcation PCI performed with either PKP or PSP in left main or large (SB diameter >2.75 mm) coronary bifurcations (NCT05559424). The achieved stent configurations (in terms of expansion, apposition and eccentricity at five different bifurcation segments) were evaluated using optical coherence tomography (OCT) in the MV. The pre-defined primary study endpoint was minimum stent expansion (MSE) at the distal MV segment.</p><p><strong>Results: </strong>A total of 60 patients undergoing bifurcation PCI according to \"stepwise provisional stenting\" were enrolled (30 randomized to PKP and 30 to PSP). At post-intervention OCT, MSE at the distal-MV segment was significantly higher with PKP as compared with PSP (99.3±12.7% vs. 83.8±19.5%;p<0.001). Additional relevant findings included higher rate of malapposition in the bifurcation core and distal-MV with PSP and improved SB scaffolding with PKP. No significant differences in terms of stent eccentricity were noted between PSP and PKP in all the segments analyzed.</p><p><strong>Conclusions: </strong>The results of the present randomized trial show that during stepwise provisional stenting in left main or large bifurcations, the PKP ballooning sequence is associated with better stent configuration compared to the PSP.</p>","PeriodicalId":14688,"journal":{"name":"JACC. Cardiovascular interventions","volume":" ","pages":""},"PeriodicalIF":11.7,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604904","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}