Kazuhiro Dan, Guy Witberg, Fumiharu Itabashi, Takuya Maeda, Yuetsu Kikuta, Kouya Okabe, Toru Tanigaki, Mamoru Nanasato, Yutaka Hikichi, Hiroyoshi Yokoi, Ran Kornowski, Hitoshi Matsuo
{"title":"Comparison of angiogram-based physiological assessment system sizing tool and intravascular ultrasound imaging measurements.","authors":"Kazuhiro Dan, Guy Witberg, Fumiharu Itabashi, Takuya Maeda, Yuetsu Kikuta, Kouya Okabe, Toru Tanigaki, Mamoru Nanasato, Yutaka Hikichi, Hiroyoshi Yokoi, Ran Kornowski, Hitoshi Matsuo","doi":"10.1016/j.carrev.2025.03.012","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.012","url":null,"abstract":"<p><strong>Background: </strong>The diagnostic performance of an angiogram-based physiological assessment system (FFRangio™, CathWorks) has been already demonstrated. Besides performing a functional assessment, the FFRangio system provides a 3-dimensional quantitative coronary angiogram-based sizing tool (FFRangioST) to measure lumen diameter and vessel length. We aim to compare the measurements obtained using FFRangioST against measurements obtained with intravascular ultrasound (IVUS) in patients undergoing percutaneous coronary intervention (PCI).</p><p><strong>Methods: </strong>We analyzed data from consecutive patients who underwent IVUS-guided PCI after FFRangio physiological assessment and FFRangioST assessment of lesion diameters and length from the Japan FFRangio clinical outcome registry (ClinicalTrials.gov. NCT05648396). For each lesion undergoing PCI, the correlation and mean difference for lesion length (LL), proximal reference diameter (RD) and distal RD as measured by FFRangioST/IVUS were assessed using pairwise comparisons, Pearson's correlation and Bland-Altman plots.</p><p><strong>Results: </strong>Our cohort included 121 lesions from 115 patients. The FFRangio value in this cohort was 0.60 ± 0.1 (mean ± standard deviation). Mean LL (mm) was 31.1 ± 13.9 and 30.3 ± 14.3 by FFRangioST and IVUS, respectively. Correlation between the LL measurements was r = 0.986 (p < 0.001). Proximal RD (mm) was 2.6 ± 0.5 and 3.2 ± 0.6 by FFRangioST and IVUS, respectively, with correlation of r = 0.756 (p < 0.001). Distal RD (mm) was 2.2 ± 0.5 and 2.7 ± 0.5 by FFRangioST and IVUS, respectively, with correlation of r = 0.832 (p < 0.001). After inflating the original FFRangioST diameter value by 25 %, the average difference between the IVUS and FFRangioST measurements was 0.02 mm and -0.02 mm, for proximal and distal RD, respectively.</p><p><strong>Conclusion: </strong>FFRangioST measurement has an excellent correlation with lesion length and high degree of correlation with a predictable coefficient (25 % inflation) with proximal and distal reference diameters when compared with IVUS measurement in PCI.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143732217","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}
Anirudh Palicherla, Athillesh Sivapatham, Monty Khela, Danielle B Dilsaver, Sriharsha Dadana, Abhishek Thandra, Venkata Mahesh Alla
{"title":"Trends and outcomes of concomitant tricuspid valve surgery with mitral valve surgery: A National Readmission Database study.","authors":"Anirudh Palicherla, Athillesh Sivapatham, Monty Khela, Danielle B Dilsaver, Sriharsha Dadana, Abhishek Thandra, Venkata Mahesh Alla","doi":"10.1016/j.carrev.2025.03.011","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.011","url":null,"abstract":"<p><strong>Background: </strong>Clinically significant tricuspid regurgitation (TR) affects nearly one-third of patients with mitral valve (MV) disease and portends higher morbidity and mortality. Concomitant tricuspid valve repair (TVr) is recommended during MV surgery (MVS) for patients with severe TR or moderate TR with tricuspid annular dilation or right-sided heart failure. This study assessed the frequency, trends, and outcomes of concomitant tricuspid valve surgery (TVS) in MVS patients in the United States.</p><p><strong>Methods: </strong>We analyzed index hospitalizations of patients undergoing MVS from the 2016-2020 Nationwide Readmissions Database (NRD), stratified by whether concomitant TVS was performed. Outcomes included inpatient mortality, length of stay (LOS), post-operative complications, and 30-day and 90-day all-cause readmissions. Inverse probability of treatment weighting (IPTW) controlled for selection bias. Outcomes were assessed using logistic regression and lognormal models.</p><p><strong>Results: </strong>Out of 63,047 weighted hospitalizations for MVS, 2627 (4.17 %) underwent concomitant TVS. TVS was associated with 67 % higher adjusted odds of in-hospital mortality (8.29 % vs. 5.14 %, aOR 1.67; 95 % CI: 1.33-2.10; p < 0.001) and 61 % higher odds of complications (40.94 % vs. 30.08 %, aOR 1.61; 95 % CI: 1.42-1.83; p < 0.001) compared to MVS alone. TVS was associated with 18 % longer hospital stay (12.17 days vs. 10.27 days, aOR 1.18; 95 % CI: 1.13-1.24) and higher odds of 90-day readmission (30.26 % vs. 25.58 %, aOR:1.26;95 % CI: 1.06-1.50).</p><p><strong>Conclusions: </strong>Concomitant tricuspid valve surgery in patients undergoing mitral valve surgery is associated with higher in-hospital mortality, complications, and readmissions. This early excess risk has to be weighed against potential long-term benefits.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143711583","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":"Cutting balloon versus standard balloon for lesion preparation of drug-coated balloon treatment in de-novo coronary artery lesions: Rationale and Design of the Randomized NATURE trial.","authors":"Masafumi Ono, Taku Asano, Masahiko Noguchi, Norihiro Kogame, Raisuke Iijima, Kohei Osakada, Kenji Ando, Takayuki Ishihara, Koji Nishida, Mamoru Nanasato, Kengo Tanabe, Takashi Muramatsu, Atsunori Okamura, Yoshihisa Kinoshita, Kiyoshi Hibi, Satoru Suwa, Nehiro Kuriyama, Kozo Okada, Gaku Nakazawa, Takashi Ashikaga, Yutaka Tadano, Hiroki Shiomi, Masato Nakamura, Akiyoshi Miyazawa, Satoshi Miyata, Kiyoko Uno, Kazushige Kadota, Ken Kozuma","doi":"10.1016/j.carrev.2025.03.009","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.009","url":null,"abstract":"<p><strong>Background: </strong>Drug-coated balloons (DCBs) have emerged as an alternative to drug-eluting stents (DESs) for percutaneous coronary intervention (PCI) in de novo coronary artery diseases (CADs). However, the optimal predilatation strategy prior to DCB dilatation has yet to be validated.</p><p><strong>Methods/design: </strong>The NATURE (Non-stent PCI with an appropriate dilatation by means of cutting balloon and drug-coated balloon in de novo lesion) study is a prospective, multi-center, randomized controlled trial designed to evaluate the safety and efficacy of a cutting balloon compared to standard balloons (semi-compliant or non-compliant balloons) for lesion preparation prior to DCB treatment in normal-sized vessels. The DCB treatment is performed with the guidance of intravascular ultrasound (IVUS) and fractional flow reserve (FFR). The study will enroll 200 patients with a single de novo coronary lesion (reference vessel diameter: 2.5-4.0 mm) at 18 sites. Patients are randomized 1:1 to undergo predilatation with either a cutting or standard balloons, followed by DCB dilatation. The primary endpoint is the success rate of optimal predilatation, as defined by the International DCB Consensus Group: no flow-limiting dissections, residual stenosis ≤30 %, and FFR >0.80. Secondary endpoints include in-segment late lumen loss (LLL) at 9 months, the incidence of bailout stenting, and clinical outcomes at 6 and 12 months.</p><p><strong>Summary: </strong>The NATURE study aims to address the critical gap in evidence regarding optimal predilatation for DCBs in de novo CADs. By utilizing state-of-the-art DCB treatment strategies, including cutting balloons, intravascular imaging, and physiological tools, this study is expected to provide meaningful insights for refining DCB-based PCI strategies.</p><p><strong>Clinical trial registration url: </strong>https://jrct.niph.go.jp/. Unique Identifier: jRCTs032230543.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143659203","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}
Josip A Borovac, Konstantin Schwarz, Adnan I Qureshi, Domenico D'Amario, Dejan Milasinovic, Maximillian Will, Dino Miric, Jaksa Zanchi, Frane Runjic, Anteo Bradaric, Mislav Lozo, Mihajlo Kovacic, Mladen I Vidovich, Chun Shing Kwok
{"title":"Timing of invasive coronary angiography, management, and in-hospital outcomes among patients with non-ST-segment elevation myocardial infarction: A comprehensive nationwide analysis.","authors":"Josip A Borovac, Konstantin Schwarz, Adnan I Qureshi, Domenico D'Amario, Dejan Milasinovic, Maximillian Will, Dino Miric, Jaksa Zanchi, Frane Runjic, Anteo Bradaric, Mislav Lozo, Mihajlo Kovacic, Mladen I Vidovich, Chun Shing Kwok","doi":"10.1016/j.carrev.2025.03.006","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.006","url":null,"abstract":"<p><strong>Background: </strong>The impact of timing of invasive coronary angiography (ICA) and management strategies on in-hospital outcomes among unselected all-comers with non-ST-segment elevation myocardial infarction (NSTEMI) presents an equipoise in clinical practice.</p><p><strong>Methods: </strong>Patients with NSTEMI from the US NIS database during 2016 to 2021 were included in the analysis. In-hospital outcomes were examined according to the timing of ICA - early (<24 h), intermediate (24-72 h), and delayed (>72 h). These outcomes included all-cause death, major adverse cardiovascular and cerebrovascular events (MACCE), major bleeding, reinfarctions, cardiovascular complications, and stroke.</p><p><strong>Results: </strong>A total of 4,238,570 admissions with NSTEMI were screened of which 1,811,545 (42.7 %) received ICA. Most of patients (48.9 %) received ICA during 2nd and 3rd day following admission, whereas 32.5 % and 18.6 % received early and delayed ICA, respectively. Percutaneous coronary intervention (PCI) was performed in 54.7 %, 47.8 %, and 37.1 % of cases among patients that underwent ICA <24 h, 24-72 h, and > 72 h, respectively. Patients receiving delayed ICA were more likely to be older, women, have more comorbidites and high-risk features. Compared to ICA <24 h, ICA performed at 24-72 h was associated with reduced odds of death (OR 0.80), MACCE (OR 0.85), reinfarction (OR 0.63), and cardiovascular complications (OR 0.89) with no difference concerning major bleeding and stroke.</p><p><strong>Conclusions: </strong><50 % of patients with NSTEMI in a contemporary nationwide US cohort receive ICA while 1 in 2 patients out of those receive PCI. ICA timing at 24-72 h appears to provide the optimal safety profile with respect to primary outcomes and complications.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143626472","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}
Deven R Rajagopal, Rishab Jayanthi, James P Stewart, Hassan S Sayegh, Peter B Flueckiger, Sara Mobasseri, Mani A Vannan, Vinod H Thourani, Pradeep K Yadav
{"title":"Evoque transcatheter tricuspid valve replacement in a patient with multiple right-sided leads using intracardiac echocardiography alone with the \"Back-Bend\" technique.","authors":"Deven R Rajagopal, Rishab Jayanthi, James P Stewart, Hassan S Sayegh, Peter B Flueckiger, Sara Mobasseri, Mani A Vannan, Vinod H Thourani, Pradeep K Yadav","doi":"10.1016/j.carrev.2025.03.010","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.010","url":null,"abstract":"","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143694017","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}
Luke P Dawson, Christopher C Y Wong, Daniel K Amponsah, William F Fearon
{"title":"FFR-guided complete or culprit-only revascularization in ST-elevation myocardial infarction: A systematic review and Meta-analysis.","authors":"Luke P Dawson, Christopher C Y Wong, Daniel K Amponsah, William F Fearon","doi":"10.1016/j.carrev.2025.03.008","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.008","url":null,"abstract":"","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143606673","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}
Marouane Boukhris, Amine Mamoun Boutaleb, Pierre Chenard, Giuseppe Colletti, Claudiu Ungureanu, Lorenzo Azzalini
{"title":"Two-step recanalization of chronic total occlusion with IVUS-guided antegrade fenestration re-entry.","authors":"Marouane Boukhris, Amine Mamoun Boutaleb, Pierre Chenard, Giuseppe Colletti, Claudiu Ungureanu, Lorenzo Azzalini","doi":"10.1016/j.carrev.2025.03.005","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.005","url":null,"abstract":"","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143665007","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}
Prasana Ramesh, Mohamed Zghouzi, Roshan Bista, Neel N Patel, Chidubem Ezenna, Timir K Paul, Aravinda Nanjundappa
{"title":"Comparing outcomes of endovascular intervention vs bypass surgery for patients with chronic/critical limb ischemia.","authors":"Prasana Ramesh, Mohamed Zghouzi, Roshan Bista, Neel N Patel, Chidubem Ezenna, Timir K Paul, Aravinda Nanjundappa","doi":"10.1016/j.carrev.2025.02.017","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.02.017","url":null,"abstract":"<p><strong>Background: </strong>Chronic Limb Threat Ischemia (CLTI) is a severe form of peripheral arterial disease characterized by various symptoms including nonhealing wounds, ulcers and gangrene ultimately leading to a possible amputation. Therefore, revascularization either through endovascular intervention (EVI) or surgical bypass (SB) is an important step in management. Literature review of various studies including Randomized clinical trials (RCTs), Meta-analysis and observational studies show varied results with some studies suggesting better outcomes with EVI while majority of the others favors superiority of SB. Our Systematic review and meta-analysis aims to ascertain underlying differences between the approaches.</p><p><strong>Methods: </strong>We performed a Meta-analysis of observational studies and RCTs following the PRISMA guidelines. We searched Pubmed, and Cochrane databases. After removing duplicates and studies that did not meet the inclusion criteria, 9 studies were included which comprised of 4 RCTs and 5 observational studies. Outcomes measured include limb salvage, amputation free survival and Mortality. Random effects were applied to calculate Odds ratio (OR) and 95 % confidence Intervals (CI).</p><p><strong>Results: </strong>A total of 6375 patients from 9 studies were included. The pooled analysis from the meta-analysis comparing Endovascular intervention vs Surgical Bypass showed no statistically significant difference between the outcomes. The Pooled OR was 0.990(95%CI 0.913-1.073). Additionally the heterogeneity among the studies was moderate (i<sup>2</sup> = 34.7 %) suggesting some variability in the study results but not enough to conclude a significant difference. Additionally subgroup analysis was performed for above-knee and infra popliteal interventions which yielded statistically similar results.</p><p><strong>Conclusions: </strong>Based on the results above, neither endovascular intervention nor bypass surgery showed superiority over the other for outcomes such as limb salvage, mortality and amputation free survival. Therefore, effectiveness of both interventions for revascularization is comparable.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630942","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}
Pedro E P Carvalho, Bruno Ramos Nascimento, Douglas M Gewehr, Andre Rivera, Mariana Clemente, Marcelo A P Braga, Lucas N Pansani, Lara Almeidinha, Nicole Felix, Thiago M A Veiga, Marco Barbanti, Pedro A Lemos, Marcos Antônio Marino, Maurizio Taramasso, Philippe Garot
{"title":"Optimal timing for percutaneous coronary intervention in patients undergoing transcatheter aortic valve replacement: A network meta-analysis.","authors":"Pedro E P Carvalho, Bruno Ramos Nascimento, Douglas M Gewehr, Andre Rivera, Mariana Clemente, Marcelo A P Braga, Lucas N Pansani, Lara Almeidinha, Nicole Felix, Thiago M A Veiga, Marco Barbanti, Pedro A Lemos, Marcos Antônio Marino, Maurizio Taramasso, Philippe Garot","doi":"10.1016/j.carrev.2025.03.007","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.007","url":null,"abstract":"<p><strong>Background: </strong>The optimal timing for percutaneous coronary intervention (PCI) in patients undergoing transcatheter aortic valve replacement (TAVR) is uncertain.</p><p><strong>Objectives: </strong>To compare different PCI timings in patients with CAD undergoing TAVR.</p><p><strong>Methods: </strong>MEDLINE, Embase, and Cochrane were systematically searched for studies comparing different timings of PCI in patients with aortic stenosis and coronary artery disease (CAD) undergoing TAVR. PCI in a staged procedure to TAVR and PCI concomitantly to TAVR were compared with TAVR alone without PCI. A frequentist random-effects network meta-analysis calculates the odds ratio (OR) with a 95 % confidence interval (CI). Treatments were ranked using P-score analysis.</p><p><strong>Results: </strong>Two randomized controlled trials and 24 observational studies comprising 10,901 patients with aortic stenosis and CAD were included. Compared with PCI and concomitant TAVR, staged PCI was associated with lower rates of stroke (OR 0.54; 95 % CI 0.37-0.78), myocardial infarction (OR 0.54; 95 % CI 0.31-0.91), and all-cause mortality at 30 days (OR 0.62; 95 % CI 0.41-0.95). In addition, a subgroup analysis showed that staged PCI performed after TAVR is associated with the lowest rates of all-cause mortality of all strategies. In P-score analysis, staged PCI presented the highest likelihood of preventing stroke and myocardial infarction.</p><p><strong>Conclusion: </strong>In patients with aortic stenosis and CAD undergoing TAVR, staged PCI is associated with lower rates of stroke, myocardial infarction, and short-term mortality compared with other timings.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143659206","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}
Kirstine Nørregaard Hansen, Akiko Maehara, Jens Trøan, Manijeh Noori, Mikkel Hougaard, Julia Ellert, Karsten Tange Veien, Anders Junker, Henrik Steen Hansen, Jens Flensted Lassen, Lisette Okkels Jensen
{"title":"Effect of optimal lesion preparation prior to implantation of a magnesium-based bioresorbable scaffold: 12-month results of the OPTIMIS study.","authors":"Kirstine Nørregaard Hansen, Akiko Maehara, Jens Trøan, Manijeh Noori, Mikkel Hougaard, Julia Ellert, Karsten Tange Veien, Anders Junker, Henrik Steen Hansen, Jens Flensted Lassen, Lisette Okkels Jensen","doi":"10.1016/j.carrev.2025.03.003","DOIUrl":"https://doi.org/10.1016/j.carrev.2025.03.003","url":null,"abstract":"<p><strong>Background: </strong>Lumen reduction after bioresorbable scaffold implantation has been reported. This study aimed to assess the influence of pre-dilatation with a scoring balloon versus a standard non-compliant balloon prior to implanting a magnesium-based Magmaris bioresorbable scaffold (MgBRS) on lumen measurements using optical coherence tomography (OCT) and on clinical outcomes after 12 months.</p><p><strong>Method: </strong>In the OPTIMIS-study (Optimal lesion preparation before implantation of a MgBRS in patients with coronary artery stenosis), patients were randomly assigned to pre-dilatation with a scoring balloon or a standard non-compliant balloon before MgBRS implantation. OCT was performed before and after scaffold implantation, and at 6- and 12-month follow-up. Clinical 12-month follow-up was performed for all 82 enrolled patients.</p><p><strong>Results: </strong>Serial pre- and post-procedural, 6- and 12-month OCT were available in 33 lesions (scoring: n = 16 vs. standard: n = 17). Minimal lumen area (MLA) (scoring 4.6 ± 0.5 mm<sup>2</sup> vs. standard 3.6 ± 0.5 mm<sup>2</sup>, p = 0.16) did not differ significantly at 12 months. In both the scoring and standard non-compliant balloon group, MLA changed significantly over time (post-procedure - 6-month - 12-month) (scoring balloon: 7.2 ± 1.8 mm<sup>2</sup>-5.1 ± 1.7 mm<sup>2</sup>-5.0 ± 1.9 mm<sup>2</sup>, p < 0.01, and standard non-compliant balloon: 6.2 ± 1.1 mm<sup>2</sup>-5.2 ± 1.5 mm<sup>2</sup>-5.3 ± 2.0 mm<sup>2</sup>, p < 0.01). No target lesion revascularizations (TLR) occurred in the scoring balloon group, compared to 7 TLR in the standard non-compliant balloon group within 12 months.</p><p><strong>Conclusion: </strong>In lesions treated with MgBRS, MLA did not differ significantly after 12 months among lesions pre-dilated with a scoring balloon compared to a standard non-compliant balloon. However, only lesions pre-dilated with a scoring balloon were free from TLR.</p>","PeriodicalId":47657,"journal":{"name":"Cardiovascular Revascularization Medicine","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143617485","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}