EurointerventionPub Date : 2025-08-18DOI: 10.4244/EIJ-D-25-00200
Björn Redfors, Mahesh V Madhavan, Ajay J Kirtane, William F Fearon, Robert W Yeh, David J Cohen, Rasha Al-Lamee, Allen Jeremias, Guy Witberg, Rahul P Sharma, Alexandra Popma, Amir Kaki, Alejandro Froimovich, Martin B Leon
{"title":"FFRangio-guided versus pressure wire-guided PCI: design and rationale of the multicentre, randomised ALL-RISE trial.","authors":"Björn Redfors, Mahesh V Madhavan, Ajay J Kirtane, William F Fearon, Robert W Yeh, David J Cohen, Rasha Al-Lamee, Allen Jeremias, Guy Witberg, Rahul P Sharma, Alexandra Popma, Amir Kaki, Alejandro Froimovich, Martin B Leon","doi":"10.4244/EIJ-D-25-00200","DOIUrl":"10.4244/EIJ-D-25-00200","url":null,"abstract":"<p><p>Wire-based indices of coronary physiology are the gold standard for guiding revascularisation decisions in patients with coronary artery disease and angiographically intermediate coronary stenoses. FFRangio is a novel angiography-based technology for assessing the functional significance of epicardial coronary stenoses without pressure wires or hyperaemic stimulus. The primary objective of the Advancing Cath Lab Results with FFRangio Coronary Physiology Assessment trial (ALL-RISE; ClinicalTrials.gov: NCT05893498) is to compare clinical outcomes in patients with chronic coronary syndromes or non-ST-segment elevation acute coronary syndromes undergoing coronary angiography with ≥1 coronary lesion suitable for physiological assessment. Patients will be randomised to FFRangio-guided or to pressure wire-guided treatment. The primary endpoint is the occurrence of major adverse cardiovascular events (MACE) at 1 year (a composite of all-cause death, myocardial infarction, or unplanned clinically driven revascularisation), assessed for non-inferiority of FFRangio-based versus pressure wire-based guidance. If non-inferiority is met, reflex superiority guidance will be tested. Secondary endpoints include periprocedural and early complications up to 30 days, individual components of MACE at 1 year, patient-reported health status, procedural resource utilisation and healthcare-related costs, and operator-assessed usability of the FFRangio and pressure wire systems. With a sample size of 1,924 patients, the study has 82.7% power to assess non-inferiority with a non-inferiority margin of 3.5%. The ALL-RISE trial will provide prospective clinical outcomes data on the relative safety, efficacy, and cost-effectiveness of a workflow using FFRangio as compared with pressure wire-based approaches for coronary lesion assessment among patients being considered for percutaneous coronary intervention.</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 16","pages":"961-969"},"PeriodicalIF":9.5,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12346859/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144876863","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EurointerventionPub Date : 2025-08-18DOI: 10.4244/EIJ-D-25-00396
Michael Haude, Adrian Wlodarczak, René J van der Schaaf, Jan Torzewski, Bert Ferdinande, Javier Escaned, Juan F Iglesias, Johan Bennett, Gabor Toth, Michael Joner, Ralph Toelg, Marcus Wiemer, Göran Olivecrona, Paul Vermeersch, Ron Waksman
{"title":"Clinical outcomes of the third-generation resorbable magnesium scaffold for coronary artery lesions: three-year results of the BIOMAG-I study.","authors":"Michael Haude, Adrian Wlodarczak, René J van der Schaaf, Jan Torzewski, Bert Ferdinande, Javier Escaned, Juan F Iglesias, Johan Bennett, Gabor Toth, Michael Joner, Ralph Toelg, Marcus Wiemer, Göran Olivecrona, Paul Vermeersch, Ron Waksman","doi":"10.4244/EIJ-D-25-00396","DOIUrl":"10.4244/EIJ-D-25-00396","url":null,"abstract":"","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":" ","pages":"971-973"},"PeriodicalIF":9.5,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12337764/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144112764","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EurointerventionPub Date : 2025-08-18DOI: 10.4244/EIJ-E-25-00036
Hector M Garcia-Garcia
{"title":"\"He who has eyes to see, let him see\".","authors":"Hector M Garcia-Garcia","doi":"10.4244/EIJ-E-25-00036","DOIUrl":"10.4244/EIJ-E-25-00036","url":null,"abstract":"","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 16","pages":"889-891"},"PeriodicalIF":9.5,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12337763/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144876856","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EurointerventionPub Date : 2025-08-18DOI: 10.4244/EIJ-D-24-00996
Michael K W Lichtenberg, Andrew Holden, Dierk Scheinert, Andrej Schmidt, Jos C van den Berg, Michael Piorkowski, Klaus Hertting, Marcus Thieme, Martin Andrassy, Christian Wissgott, Larry E Miller, Thomas Zeller
{"title":"Retrievable scaffold therapy before paclitaxel drug-coated balloon angioplasty in infrapopliteal arteries: one-year outcomes of the DEEPER OUS Study.","authors":"Michael K W Lichtenberg, Andrew Holden, Dierk Scheinert, Andrej Schmidt, Jos C van den Berg, Michael Piorkowski, Klaus Hertting, Marcus Thieme, Martin Andrassy, Christian Wissgott, Larry E Miller, Thomas Zeller","doi":"10.4244/EIJ-D-24-00996","DOIUrl":"10.4244/EIJ-D-24-00996","url":null,"abstract":"","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 16","pages":"974-976"},"PeriodicalIF":9.5,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12346858/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144876867","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EurointerventionPub Date : 2025-08-18DOI: 10.4244/EIJ-D-25-00125
Axelle Merieau, Julien Plessis, Virginie Nael, Vincent Letocart, Thibaut Manigold, Pierre-Guillaume Piriou, Robin Le Ruz, Karine Warin Fresse, Patrice Guerin
{"title":"A randomised controlled trial of the Cathpax AIR radioprotection cabin during cardiology procedures.","authors":"Axelle Merieau, Julien Plessis, Virginie Nael, Vincent Letocart, Thibaut Manigold, Pierre-Guillaume Piriou, Robin Le Ruz, Karine Warin Fresse, Patrice Guerin","doi":"10.4244/EIJ-D-25-00125","DOIUrl":"10.4244/EIJ-D-25-00125","url":null,"abstract":"","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 16","pages":"979-981"},"PeriodicalIF":9.5,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12341797/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144876857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EurointerventionPub Date : 2025-08-18DOI: 10.4244/EIJ-D-25-00131
James M McCabe, Shauna Newton, Barbara A Danek, David Elison, Christine J Chung, Richard Sheu, Srdjan Jelacic, Gregory J Condos, Ester Canovas, Adam B Greenbaum, Vasilis C Babaliaros, Robert J Lederman, G Burkhard Mackensen
{"title":"SESAME technique: septal scoring along the midline endocardium.","authors":"James M McCabe, Shauna Newton, Barbara A Danek, David Elison, Christine J Chung, Richard Sheu, Srdjan Jelacic, Gregory J Condos, Ester Canovas, Adam B Greenbaum, Vasilis C Babaliaros, Robert J Lederman, G Burkhard Mackensen","doi":"10.4244/EIJ-D-25-00131","DOIUrl":"10.4244/EIJ-D-25-00131","url":null,"abstract":"<p><strong>Background: </strong>The management of interventricular septal hypertrophy is an area of rapidly increasing interest, spurred by continued challenges with transcatheter mitral valve replacement (TMVR) and the management of obstructive hypertrophic cardiomyopathy (oHCM).</p><p><strong>Aims: </strong>We sought to evaluate the reproducibility of septal scoring along the midline endocardium (SESAME), a novel transcatheter intervention designed to replicate surgical myotomy.</p><p><strong>Methods: </strong>This single-centre, retrospective review included all patients who underwent the SESAME procedure at the University of Washington from January 2022 to September 2024.</p><p><strong>Results: </strong>A total of 54 consecutive patients underwent SESAME at our institution: 47 prior to TMVR, 6 for oHCM, and 1 for a subaortic membrane. Technical success was achieved in 100% of patients. In pre-TMVR patients, the median neo-left ventricular outflow tract (LVOT) and the median skirt neo-LVOT areas gained were 146 (first quartile [Q1]: 76.5, third quartile [Q3]: 286.3) mm<sup>2</sup> and 54 (Q1: 32.8, Q3: 100.2) mm<sup>2</sup>, respectively. In the oHCM population, invasive resting and provocable LVOT gradients immediately decreased from 59 (Q1: 32, Q3: 99) mmHg to 10 (Q1: 5, Q3: 19) mmHg and from 121 (Q1: 53, Q3: 205) mmHg to 34 (Q1: 16, Q3: 56) mmHg, respectively. The median echo gradients decreased from 62 (Q1: 53, Q3: 64) mmHg at baseline to 6 (Q1: 6, Q3: 8) mmHg at 30 days. Among the pre-TMVR population, there were 2 procedural deaths from free-wall rupture early in the experience and 3 restrictive ventricular septal defects that did not require intervention. Three patients (5.5%) required a pacemaker. Procedural complications significantly decreased after the first 10 cases in 2022 (p<0.01).</p><p><strong>Conclusions: </strong>Our study corroborates the feasibility and efficacy of SESAME for prohibitive surgical risk patients needing septal reduction therapy prior to TMVR or for treatment of oHCM or a subaortic membrane.</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 16","pages":"942-951"},"PeriodicalIF":9.5,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12337767/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144876868","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EurointerventionPub Date : 2025-08-18DOI: 10.4244/EIJ-D-24-01086
Teresa Bastante, David Del Val, Fernando Alfonso
{"title":"Erosion-like plaque image during coronary vasospasm.","authors":"Teresa Bastante, David Del Val, Fernando Alfonso","doi":"10.4244/EIJ-D-24-01086","DOIUrl":"10.4244/EIJ-D-24-01086","url":null,"abstract":"","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 16","pages":"982-983"},"PeriodicalIF":9.5,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12337762/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144876862","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EurointerventionPub Date : 2025-08-18DOI: 10.4244/EIJ-D-24-01065
Frans B Mensink, Jonathan Los, Mohamed M Reda Morsy, Rohit M Oemrawsingh, Clemens von Birgelen, Alexander J J Ijsselmuiden, Martijn Meuwissen, Jin M Cheng, Diederik F van Wijk, Pieter C Smits, Valeria Paradies, Dirk J van Wijk, Himanshu Rai, Tim J F Ten Cate, Cyril Camaro, Peter Damman, Lokien X van Nunen, Aukelien C Dimitriu-Leen, Marleen H van Wely, Aysun Cetinyurek-Yavuz, Robert A Byrne, Niels van Royen, Robert-Jan M van Geuns
{"title":"Changes in non-culprit coronary lesions with PCSK9 inhibitors: the randomised, placebo-controlled FITTER trial.","authors":"Frans B Mensink, Jonathan Los, Mohamed M Reda Morsy, Rohit M Oemrawsingh, Clemens von Birgelen, Alexander J J Ijsselmuiden, Martijn Meuwissen, Jin M Cheng, Diederik F van Wijk, Pieter C Smits, Valeria Paradies, Dirk J van Wijk, Himanshu Rai, Tim J F Ten Cate, Cyril Camaro, Peter Damman, Lokien X van Nunen, Aukelien C Dimitriu-Leen, Marleen H van Wely, Aysun Cetinyurek-Yavuz, Robert A Byrne, Niels van Royen, Robert-Jan M van Geuns","doi":"10.4244/EIJ-D-24-01065","DOIUrl":"10.4244/EIJ-D-24-01065","url":null,"abstract":"<p><strong>Background: </strong>Prolonged lipid-lowering therapy has demonstrated its ability to induce plaque regression and improve the plaque morphology of mild atherosclerotic lesions.</p><p><strong>Aims: </strong>This trial aimed to assess the short-term effect of evolocumab in addition to high-intensity statin therapy (HIST) on relevant non-culprit coronary artery lesions using fractional flow reserve (FFR) measurements and multimodality intracoronary imaging.</p><p><strong>Methods: </strong>Patients with an acute coronary syndrome (ACS) and relevant multivessel disease were randomised to receive either evolocumab or placebo for 12 weeks in addition to HIST. Patients underwent serial FFR and intravascular ultrasound (IVUS)-near-infrared spectroscopy imaging of a non-culprit vessel. The primary endpoints were the differences in the change in FFR and in the maximum lipid core burden index within any 4 mm segment (maxLCBI<sub>4mm</sub>). The secondary endpoints were the differences in the change in IVUS-derived atheroma volume parameters.</p><p><strong>Results: </strong>Among 150 patients (mean age 64.2±8.5 years; 27 [18.0%] female) randomised to evolocumab (n=74) or placebo (n=76), 143 underwent follow-up coronary angiography. After 12 weeks of treatment, the adjusted mean change in FFR was 0.00 (95% confidence interval [CI]: -0.02 to 0.02) with evolocumab versus 0.01 (95% CI: -0.01 to 0.03) with placebo (adjusted mean difference: -0.01, 95% CI: -0.03 to 0.01; p=0.6). The adjusted mean change in the maxLCBI<sub>4mm</sub> was -27.8 (95% CI: -72.2 to 16.6) for evolocumab-treated patients versus -35.6 (95% CI: -82.5 to 11.4) for placebo-treated patients (adjusted mean difference: 7.8, 95% CI: -40.9 to 56.4; p=0.8). No between-group differences in any IVUS-derived parameter were found.</p><p><strong>Conclusions: </strong>In patients with ACS and relevant non-culprit coronary artery lesions, the addition of evolocumab to HIST for 12 weeks, compared to placebo, did not result in improvement of FFR or maxLCBI<sub>4mm</sub>. (ClinicalTrials.gov: NCT04141579).</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 16","pages":"910-920"},"PeriodicalIF":9.5,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12337765/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144876859","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}