Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions最新文献

{"title":"Baseline Invasive Hemodynamics Identify Patients at Risk for Suboptimal Clinical Response After Percutaneous Atrial Septal Defect Closure.","authors":"Go Hashimoto, Kenji Makino, Yutsuki Tsukagoshi, Atsuhiro Saito, Sari Waga, Shiho Ide, Hiromasa Hayama, Hiroki Niikura, Hidehiko Hara","doi":"10.1002/ccd.70790","DOIUrl":"10.1002/ccd.70790","url":null,"abstract":"<p><strong>Background: </strong>Clinical responses after transcatheter atrial septal defect (ASD) closure are heterogeneous, and predictors of suboptimal response remain poorly defined.</p><p><strong>Aims: </strong>We aimed to determine whether pre-closure invasive hemodynamic parameters might predict clinical response after ASD closure.</p><p><strong>Methods: </strong>We retrospectively screened 223 consecutive patients undergoing percutaneous secundum ASD closure. After exclusion of 19 patients aged < 18 years, 204 adult patients were included. Clinical response was categorized as improved (n = 66), unchanged (n = 109), or suboptimal (n = 29; defined as persistent or newly apparent dyspnea and/or new initiation of diuretic therapy). Invasive hemodynamic parameters, including pulmonary capillary wedge pressure (PCWP), mean pulmonary artery pressure (mPAP), and pulmonary vascular resistance (PVR), were assessed before closure.</p><p><strong>Results: </strong>Patients with suboptimal clinical response accounted for 14.2% of the adult cohort and had higher baseline mPAP and PCWP than those with improved or unchanged response. Although PVR differed across groups, it was not independently associated with suboptimal response in the multivariable analysis. In the multivariable model, age (OR, 1.05 per year; 95% CI, 1.00-1.09; p = 0.032) and mPAP (OR, 1.10 per mmHg; 95% CI, 1.01-1.20; p = 0.025) were independently associated with suboptimal clinical response, whereas PCWP showed a borderline association. ROC analysis demonstrated moderate discriminative ability of mPAP (AUC, 0.794; 95% CI, 0.698-0.889; p < 0.001).</p><p><strong>Conclusions: </strong>Baseline invasive hemodynamic burden, particularly mPAP, was associated with suboptimal clinical response and may help identify patients at elevated risk after percutaneous ASD closure.</p>","PeriodicalId":520583,"journal":{"name":"Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions","volume":" ","pages":"1386-1396"},"PeriodicalIF":0.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148665431","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Concordance Between Randomized Controlled and Real-World Evidence for Distal Radial Access: A Structured Comparison of the DISCO RADIAL Trial and KODRA Study.","authors":"Gregory A Sgueglia, Adel Aminian, Yongcheol Kim, Juan F Iglesias, Bong-Ki Lee, Ivo Bernat, Sang Yeub Lee, Jin Bae Lee, Maarten A H van Leeuwen, Jun-Won Lee","doi":"10.1002/ccd.70832","DOIUrl":"10.1002/ccd.70832","url":null,"abstract":"<p><strong>Background: </strong>Distal radial access (DRA) has emerged as an alternative to conventional transradial access (TRA) for percutaneous coronary procedures, with potential advantages for reducing radial artery occlusion (RAO).</p><p><strong>Aim: </strong>To assess whether favorable outcomes observed in randomized trials are consistently reproduced in routine clinical practice.</p><p><strong>Methods: </strong>A structured comparative analysis was performed between the largest randomized controlled trial of DRA (DISCO RADIAL; 650 patients, 16 centers, strict selection criteria, experienced operators) and the largest real-world DRA registry (KODRA; 4977 consecutive patients, 14 centers, broader inclusion criteria, heterogeneous operator experience). Access-related outcomes were summarized using inverse variance-weighted estimates and analyzed using random-effects models to assess agreement across clinical settings, with absolute differences as the primary measure. Heterogeneity (I²) was reported descriptively.</p><p><strong>Results: </strong>Despite marked differences in study design, patient populations (body surface area 2.0 vs. 1.7 m²), and operator experience (100% vs. 70% with ≥ 100 DRA cases), concordance was remarkable. RAO at discharge was 0.18% (95% CI 0.07%-0.29%, I² = 0%). Overall crossover occurred in 6.8% (95% CI 6.1%-7.4%, I² = 0%), with same-side conventional TRA as predominant bailout (4.3%). Femoral access was required in only 1.3% of cases. No serious bleeding events occurred in either study. Minor bleeding and hematoma showed considerable heterogeneity (I² = 80%-98%), likely reflecting differences in surveillance and practice patterns. Sensitivity analyses confirmed the stability of crossover and RAO estimates.</p><p><strong>Conclusions: </strong>DRA demonstrates very low RAO rates, high procedural success, and favorable safety, with consistent performance across controlled and real-world settings, supporting its feasibility in routine clinical practice.</p>","PeriodicalId":520583,"journal":{"name":"Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions","volume":" ","pages":"1640-1651"},"PeriodicalIF":0.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148805316","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Stent Underexpansion Prediction Is Improved by Intravascular Ultrasound-Based Distance-Averaged Calcium Angles.","authors":"Jia-Jie Wang, Hang Liu, Yian Yao, Minyu Wu, Zi Ye, Hungchen Lin, Chengxing Liu, Fei Chen, Yan Lai, Xuebo Liu","doi":"10.1002/ccd.70804","DOIUrl":"10.1002/ccd.70804","url":null,"abstract":"<p><strong>Background: </strong>Calcified coronary lesion, assessed by intravascular ultrasound (IVUS)-based maximum calcium angle, is an important predictor for stent underexpansion.</p><p><strong>Aims: </strong>We aimed to determine whether the mean of all calcium angles measured within a specified distance from the maximum calcium site (distance-averaged) using IVUS was associated with stent underexpansion.</p><p><strong>Methods: </strong>Patients undergoing IVUS-guided percutaneous coronary intervention (PCI) with drug-eluting stent implantation between 2016 and 2022 in a single tertiary center were retrospectively analyzed. Pre-PCI IVUS was used to assess the angles of calcified plaque every 1 mm; a total of 11 calcium angles were measured within 5 mm of the maximum calcium site. The endpoint was percent stent expansion, and stent underexpansion was defined as percent stent expansion < 70%.</p><p><strong>Results: </strong>In the analysis of 87 stent underexpansions that occurred among 292 patients, distance-averaged calcium angles were significantly associated with stent underexpansion. Discrimination increased when using distance-averaged calcium angles instead of maximum calcium angle, with the area under the receiver operating characteristic curve (AUC) ranging from 0.75 (95% CI, 0.69-0.82) for 10 mm-averaged calcium angles to 0.77 (95% CI, 0.72-0.83) for 2 mm-averaged calcium angles (p < 0.05). Compared to 2 mm-averaged calcium angles, increasing measuring distance did not result in significant improvement in AUC.</p><p><strong>Conclusion: </strong>Distance-averaged calcium angles were associated with stent underexpansion. Compared with maximum calcium angle, distance-averaged calcium angles improved the prediction of stent underexpansion. Among these, 2 mm-averaged calcium angles may be a simpler, equally accurate approach to predicting stent underexpansion.</p>","PeriodicalId":520583,"journal":{"name":"Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions","volume":" ","pages":"1505-1512"},"PeriodicalIF":0.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148674969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Type 2 Diabetes Mellitus on Outcomes Following Transcatheter Aortic Valve Replacement: Insights From a Contemporary US Database.","authors":"Hritvik Jain, Nandan Patel, Muhammad Abdullah Naveed, Faizan Ahmed, Bala Pushparaji, Ashequl M Islam, Andrew M Goldsweig","doi":"10.1002/ccd.70786","DOIUrl":"10.1002/ccd.70786","url":null,"abstract":"","PeriodicalId":520583,"journal":{"name":"Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions","volume":" ","pages":"1457-1461"},"PeriodicalIF":0.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148674962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Treatment Response of Calcified Nodules and Nodular Calcified Lesions Using Mean Density on Coronary Computed Tomography Angiography.","authors":"Akito Setoguchi, Keita Iyama, Ryosuke Iwasaki, Saburo Kusumoto, Yoshiyuki Doi, Tatsuya Nunohiro, Masayoshi Takeno, Koji Maemura","doi":"10.1002/ccd.70770","DOIUrl":"10.1002/ccd.70770","url":null,"abstract":"<p><strong>Background: </strong>Calcified nodules (CN) and nodular calcifications (NC) present significant challenges during percutaneous coronary intervention (PCI) because of their protruding morphology and high rigidity, which often result in inadequate stent expansion and suboptimal procedural outcomes.</p><p><strong>Aims: </strong>This single-center retrospective study investigated whether coronary computed tomography angiography (CCTA)-derived mean density could predict stent expansion outcomes in CN/NC lesions identified using intravascular ultrasonography (IVUS).</p><p><strong>Methods: </strong>Forty-nine target vessels in 46 patients who underwent IVUS-guided PCI within 1 year of CCTA were analyzed. Univariate and multivariate linear regression analyses were performed to evaluate the associations between CCTA-derived calcification parameters, IVUS-derived stent expansion, and stent symmetry index. Group-based comparisons and receiver-operating characteristic curve analyses were performed as secondary analyses to identify poor stent expansion (< 90%).</p><p><strong>Results: </strong>Mean density was significantly associated with stent expansion in both univariable analysis and the multivariable mean density model adjusted for calcium arc, calcium thickness, and rotational atherectomy (β = -0.085; 95% confidence interval [CI], -0.152 to -0.019; p = 0.013). Mean density showed a moderate inverse correlation with both stent expansion (r = -0.415, p = 0.003) and the stent symmetry index (r = -0.292, p = 0.042). In the secondary analyses, receiver operating characteristic curve analysis indicated that a cutoff value of 514.93 Hounsfield units yielded an area under the curve of 0.80 in non-atherectomy cases.</p><p><strong>Conclusions: </strong>These findings suggest that CCTA-derived mean density may help guide lesion-specific interventional strategies and serve as a valuable, noninvasive preprocedural marker for assessing the mechanical difficulty of CN/NC lesions.</p>","PeriodicalId":520583,"journal":{"name":"Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions","volume":" ","pages":"1306-1316"},"PeriodicalIF":0.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13667316/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148612253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validation of an Automated Artificial Intelligence-Driven Planner for Transcatheter Aortic Valve Replacement.","authors":"Mark M P van den Dorpel, Lucas Uchoa de Assis, Jenna van Niekerk, Sophie Deckx, Matthew Sherman, Janelle Schrot, Anna Kozak, Isabella Kardys, Alexander Hirsch, Joost Daemen, Rutger Jan Nuis, Nicolas M Van Mieghem","doi":"10.1002/ccd.70785","DOIUrl":"10.1002/ccd.70785","url":null,"abstract":"<p><strong>Background: </strong>Preprocedural planning with multislice computed tomography (MSCT) is an essential prerequisite for successful transcatheter aortic valve replacement (TAVR). However, preprocedural planning is time-consuming and may contain clinically meaningful interobserver variability. Artificial intelligence (AI) based automated planning methods may provide anatomical MSCT measurements while reducing the time load required for the analysis. Previous studies on the validation of AI-based TAVR planning methods excluded anatomical variants or lacked data on actual TAVR prosthesis size agreement. Mimics for TAVR (Materialise, Leuven, Belgium) is a new, AI-driven TAVR planning platform based on patient-specific 3D anatomical models and automated measurements through a web-based user interface.</p><p><strong>Aims: </strong>To validate the Mimics for TAVR planning tool in clinical practice.</p><p><strong>Methods: </strong>Key planning assessments were performed on pre-TAVR MSCT datasets using Mimics for TAVR and a commercially available semi-automated software package. Agreement between the two planning methods was assessed using intraclass correlation coefficients and Bland-Altman plots.</p><p><strong>Results: </strong>A total of 126 consecutive patients (mean age 80 [74-85]; 56% male) who underwent MSCT as part of their TAVR work-up were included. Mimics for TAVR derived measurements showcased high accuracy and excellent agreement for the area of the aortic annulus (mean error ± SD: -1.9 ± 3.3%, ICC: 0.976 [95% CI: 0.966-0.984]), left ventricular outflow (-2.7 ± 3.8%, ICC: 0.970 [0.957-0.983]), sinotubular junction (-2.6 ± 4.2%, ICC: 0.953 [0.921-0.971]), coronary heights (LCA -3.5 ± 4.8%, ICC: 0.900 (0.859-0.928). RCA -3.9 ± 4.7%, ICC: 0.928 [0.898-0.949]) and membranous septum length (-5.0 ± 9.2%, ICC: 0.919 [0.880-0.940]). Mimics for TAVR assessment significantly reduced the time required for pre-TAVR analysis (1.03 ± 0.15 min vs. 9.55 ± 3.16 min per case, respectively (p = 0.001).</p><p><strong>Conclusion: </strong>The automated AI-driven Mimics for TAVR planner is an accurate alternative to existing semiautomated TAVR planning platforms and may enhance overall workflow efficiency.</p>","PeriodicalId":520583,"journal":{"name":"Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions","volume":" ","pages":"1473-1481"},"PeriodicalIF":0.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13667321/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148674929","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"One-Year Outcomes of High-Risk Percutaneous Coronary Interventions With Versus Without Mechanical Circulatory Support: Propensity Score-Matched Analysis.","authors":"Aleksandra Gąsecka, Arkadiusz Pietrasik, Tomasz Pawłowski, Jakub Michal Zimodro, Daniel Cieśla, Jerzy Sacha, Marek Grygier, Janusz Kochman, Mateusz Tajstra, Krzysztof Dyrbuś, Wojciech Wojakowski, Katarzyna Mizia-Stec, Andrzej Świątkowski, Paweł Francuz, Zbigniew Kalarus, Grzegorz Smolka, Mariusz Gąsior","doi":"10.1002/ccd.70749","DOIUrl":"10.1002/ccd.70749","url":null,"abstract":"<p><strong>Background: </strong>Impella is increasingly used as mechanical circulatory support (MCS) during high-risk percutaneous coronary interventions (HR-PCI). Registry-based data provide insights into the efficacy and safety of Impella-assisted HR-PCI.</p><p><strong>Aims: </strong>We aimed to evaluate 1-year outcomes of Impella-assisted HR-PCI compared to HR-PCI without MCS.</p><p><strong>Methods: </strong>One hundred and thirty-eight patients undergoing Impella-assisted PCI, included in the IMPELLA-PL registry, were propensity score-matched with controls from the retrospective CardioSilesia registry who underwent HR-PCI without MCS. Study endpoints included 1-year post-discharge all-cause mortality, myocardial infarction (MI), stroke, rehospitalization for heart failure (HF), and repeat coronary revascularization.</p><p><strong>Results: </strong>Clinical and angiographic characteristics were comparable in both groups, with higher rates of dyslipidemia (78.3% vs. 37.7%, p < 0.001), chronic kidney disease (39.9% vs. 16.7%, p < 0.001), and peripheral artery disease (34.1% vs. 8.0%, p < 0.001) in the IMPELLA-PL cohort. Intravascular ultrasound was more frequently used in the Impella-supported patients (44.2% vs. 25.4%, p = 0.002), while staged revascularization was more common among controls (30.4% vs. 15.9%, p = 0.007). At 1 year, rates of post-discharge all-cause mortality, stroke, and repeat coronary revascularization were similar in both groups. MI was less frequent in the IMPELLA-PL cohort (1.4% vs. 10.9%, p = 0.003), alongside a trend toward lower incidence of rehospitalizations for HF (9.4% vs. 18.1%, p = 0.055).</p><p><strong>Conclusions: </strong>Despite an unfavorable cardiovascular risk profile, patients who underwent Impella-assisted HR-PCI had similar 1-year post-discharge survival, with a lower rate of MI, compared to propensity score-matched controls who underwent HR-PCI without MCS. Impella may improve HR-PCI outcomes in selected patients, but further randomized controlled trials are required to confirm this finding.</p>","PeriodicalId":520583,"journal":{"name":"Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions","volume":" ","pages":"1268-1275"},"PeriodicalIF":0.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148611519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Primary Percutaneous Coronary Intervention Guided by High-Definition Intravascular Ultrasound (The SPECTRUM Study).","authors":"Frederik T W Groenland, Annemieke C Ziedses des Plantes, Tara Neleman, Jurgen M R Ligthart, Karen T Witberg, Rutger-Jan Nuis, Jeroen M Wilschut, Roberto Diletti, Wijnand K den Dekker, Isabella Kardys, Paul Cummins, Karim D Mahmoud, Nicolas M Van Mieghem, Joost Daemen","doi":"10.1002/ccd.70836","DOIUrl":"10.1002/ccd.70836","url":null,"abstract":"<p><strong>Background: </strong>Limited data are available on the use of intravascular ultrasound (IVUS) in patients presenting with ST-segment elevation myocardial infarction (STEMI).</p><p><strong>Aims: </strong>This study aimed to assess the impact of IVUS-guided primary percutaneous coronary intervention (PCI).</p><p><strong>Methods: </strong>SPECTRUM (NCT05007535) was a prospective, single-center, observational cohort study. STEMI patients presenting within 12 h after symptom onset with stable hemodynamics and undergoing primary PCI of a native culprit lesion (angiographic reference diameter ≥ 2.25 mm) were eligible. Pre-intervention, post-intervention and post-optimization (if applicable) HD-IVUS pullbacks were obtained per protocol. The primary endpoint was target vessel failure (TVF) at 12 months, a composite of cardiovascular death, target vessel myocardial infarction, and target vessel revascularization. The secondary endpoint was presence of IVUS-guided optimization.</p><p><strong>Results: </strong>A total of 200 STEMI patients were included. Mean age was 62.1 (±12.5) years, 69% were male, 11.0% had diabetes and the left anterior descending was the culprit vessel in 44.0%. IVUS-guided optimization was performed in 41.1%. Optimal PCI, based on predefined IVUS criteria, increased from 52.1% post intervention to 65.5% post optimization (p < 0.001). A stent-edge plaque burden > 50% was the main reason for not achieving optimal PCI results after IVUS-guided optimization (94.4%). TVF at 12 months occurred in 3.0% (95% CI 1.1%-6.4%).</p><p><strong>Conclusions: </strong>SPECTRUM is the first dedicated prospective study demonstrating the potential of IVUS to optimize outcomes in a primary PCI setting. IVUS guidance in primary PCI was safe, significantly increased the number of STEMI patients with an optimal PCI result and resulted in low rates of TVF at 12 months.</p>","PeriodicalId":520583,"journal":{"name":"Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions","volume":" ","pages":"1734-1742"},"PeriodicalIF":0.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13667331/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148868555","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Final 2-Year Results of the REFORM Study: A Randomized Trial of Biolimus DCB Versus Paclitaxel DCB for In-Stent Restenosis.","authors":"Daniel O'Callaghan, J J Coughlan, Fernando Alfonso, Joo-Yong Hahn, Manel Sabate, Ralph Toelg, Samuel Copt, Sean Fitzgerald, Marie-Claude Morice, Jasper Trevelyan, Darren Mylotte, Antonio Fernandez Ortiz, Rory Durand, Jochen Wöhrle, Franz Xever Kleber, Giuilo Stefanini, Himanshu Rai, Peter O'Kane, Robert A Byrne","doi":"10.1002/ccd.70800","DOIUrl":"10.1002/ccd.70800","url":null,"abstract":"<p><strong>Background: </strong>In the REFORM trial, treatment of coronary in-stent restenosis with a Biolimus A9™ drug-coated balloon (BCB) was found to be inferior with respect to in-segment percentage stenosis at 6-months in comparison to treatment with a standard paclitaxel coated paclitaxel-coated balloon (PCB).</p><p><strong>Aims: </strong>In this manuscript, the final prespecified 2-year clinical follow up follow-up of the REFORM trial is reported.</p><p><strong>Methods: </strong>The 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 (REFORM) was a multicenter, single blind, non-inferiority, randomized controlled trial comparing the BCB and PCB in the treatment of coronary in-stent restenosis (ISR). The primary angiographic endpoint of the trial was in-segment % diameter stenosis (%DS) at 6 months, which has previously been reported. A total clinical follow-up duration of 2 years was planned. Prespecified clinical outcomes at 2 years were: target lesion failure (TLF), target vessel failure (TVF), and their individual components.</p><p><strong>Results: </strong>At 24 months, complete follow-up data was available for 93% (n = 188) of the intention to treat (ITT) population. The mean age was 68.7 years, and patients were predominantly male (80.2%). Comorbidities were well balanced between the 2 groups, including diabetes mellitus, which was present in 31% of the BCB group and 29.2% of the PCB group. ISR lesions were predominantly DES-ISR in both groups (BCB 80.7% vs. PCB 85.1%). Through to 2 year follow up, target lesion failure (TLF) occurred in 36 of 135 patients (27.8%) of patients in the BCB group and in 15 of 67 patients (23.5%) in the PCB group (HR: 1.25; 95% CI: 0.69-2.29). Clinically driven target lesion revascularization (CD-TLR) occurred in 31 of 135 patients (24.2%) in the BCB group versus 13 of 67 patients (20.4%) in the PCB group (HR: 1.26; 95% CI: 0.66-2.40). Target vessel myocardial infarction and cardiac death were comparable in both groups.</p><p><strong>Conclusion: </strong>In patients with coronary ISR, the final 2-year results from the REFORM study show that TLF rates were 27.8% in the biolimus-coated balloon BCB group and 23.5% in the paclitaxel-coated balloon PCB group. However, given the limited sample size and wide confidence intervals, the present analysis does not permit reliable inference regarding comparative event rates between treatment strategies. The results should be interpreted against the background of demonstrated inferior angiographic performance of the biolimus DCB at 6 months.</p><p><strong>Trial registration: </strong>The trial was registered prospectively at www.</p><p><strong>Clinicaltrials: </strong>gov (identifier: NCT04079192).</p>","PeriodicalId":520583,"journal":{"name":"Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions","volume":" ","pages":"1609-1616"},"PeriodicalIF":0.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13667306/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148763387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sheath-to-Artery Diameter Ratio: A Robust Predictor of Early Access-Site Adverse Events in Percutaneous Procedures.","authors":"Eduardo Ismael Arteaga Chan, Claudia Lerma, Adriana Torres-Machorro","doi":"10.1002/ccd.70808","DOIUrl":"10.1002/ccd.70808","url":null,"abstract":"<p><strong>Background: </strong>Vascular access site complications (VASCs) remain an important source of morbidity following percutaneous interventions. Although the sheath-to-femoral artery ratio is a recognized risk factor in transcatheter aortic valve implantation (TAVI), its role across a broader range of femoral procedures is less well defined.</p><p><strong>Objective: </strong>To evaluate the association between the sheath‑to‑artery diameter (SHAD) ratio and early VASCs in patients undergoing femoral percutaneous interventions with sheaths > 6 Fr.</p><p><strong>Methods: </strong>A nested case-control study was performed within a retrospective cohort of 2660 consecutive patients. A total of 177 patients who developed VASCs within 7 days were identified and compared with 353 propensity score-matched controls without complications. The propensity score included age, sex, body mass index, hypertension, diabetes mellitus, peripheral artery disease, and prior femoral access. The SHAD ratio was calculated using pre‑procedural computed tomography angiography (CTA). Inter‑observer agreement for arterial diameter was excellent (intraclass correlation coefficient 0.94). Receiver operating characteristic analysis identified the optimal cutoff (Youden index), and multivariable logistic regression with backward stepwise selection was internally validated by bootstrap. Anatomical factors (calcification, tortuosity) were examined as potential confounders.</p><p><strong>Results: </strong>After matching, all baseline characteristics were well balanced (standardized differences < 0.10). The SHAD ratio was significantly higher in patients with VASCs than in controls (1.26 vs. 0.75; p < 0.001). A SHAD ratio ≥ 1.07 optimally predicted complications (AUC 0.83, 95% CI 0.80-0.87; sensitivity 82%; specificity 78%). In the final multivariable model, SHAD ≥ 1.07 remained the strongest independent predictor (OR 6.71, 95% CI 3.87-11.64; p < 0.001). Dual femoral access (OR 2.95, 95% CI 1.65-5.28) and procedural urgency (OR 1.98, 95% CI 1.18-3.32) also increased risk. Ultrasound‑guided puncture (OR 0.15, 95% CI 0.08-0.28) and fluoroscopy‑guided access (OR 0.14, 95% CI 0.07-0.26) were strongly protective. Anterior wall calcification was associated with a higher complication risk in univariable analysis but did not remain significant after adjustment for SHAD. Bootstrap internal validation yielded an optimism‑corrected AUC of 0.91 (95% CI 0.89-0.93), indicating good discrimination.</p><p><strong>Conclusions: </strong>A SHAD ratio ≥ 1.07 is a robust predictor of early VASCs across multiple large‑bore femoral interventions. Maintaining a sheath‑to‑artery relationship ≤ 1.0, together with image‑guided access, may substantially reduce complications. The incorporation of SHAD assessment into pre‑procedural planning is supported, pending external validation.</p>","PeriodicalId":520583,"journal":{"name":"Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions","volume":" ","pages":"1622-1629"},"PeriodicalIF":0.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13667344/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148804466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}