Circulation: Cardiovascular Interventions最新文献

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Impact of a Chronic Total Occlusion on Outcomes After FFR-Guided PCI or Coronary Bypass Surgery: A FAME 3 Substudy. 慢性全闭塞对 FFR 引导的 PCI 或冠状动脉搭桥手术后疗效的影响:FAME 3 子研究。
IF 6.1 1区 医学
Circulation: Cardiovascular Interventions Pub Date : 2024-11-01 Epub Date: 2024-11-06 DOI: 10.1161/CIRCINTERVENTIONS.124.014300
Hisao Otsuki, Kuniaki Takahashi, Frederik M Zimmermann, Kreton Mavromatis, Adel Aminian, Nikola Jagic, Jan-Henk E Dambrink, Petr Kala, Philip MacCarthy, Nils Witt, Yuhei Kobayashi, Tatsunori Takahashi, Y Joseph Woo, Alan C Yeung, Bernard De Bruyne, Nico H J Pijls, William F Fearon
{"title":"Impact of a Chronic Total Occlusion on Outcomes After FFR-Guided PCI or Coronary Bypass Surgery: A FAME 3 Substudy.","authors":"Hisao Otsuki, Kuniaki Takahashi, Frederik M Zimmermann, Kreton Mavromatis, Adel Aminian, Nikola Jagic, Jan-Henk E Dambrink, Petr Kala, Philip MacCarthy, Nils Witt, Yuhei Kobayashi, Tatsunori Takahashi, Y Joseph Woo, Alan C Yeung, Bernard De Bruyne, Nico H J Pijls, William F Fearon","doi":"10.1161/CIRCINTERVENTIONS.124.014300","DOIUrl":"10.1161/CIRCINTERVENTIONS.124.014300","url":null,"abstract":"<p><strong>Background: </strong>The clinical impact of a chronic total occlusion (CTO) in patients with 3-vessel coronary artery disease undergoing fractional flow reserve-guided percutaneous coronary intervention (PCI) with current-generation drug-eluting stents or coronary artery bypass grafting (CABG) is unclear.</p><p><strong>Methods: </strong>The FAME 3 trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 3) compared fractional flow reserve-guided PCI with CABG in patients with 3-vessel coronary artery disease. The primary end point was major adverse cardiac and cerebrovascular events, a composite of death, myocardial infarction, stroke, or repeat revascularization at 1 year. In this substudy, the 3-year outcomes were analyzed in patients with or without a CTO.</p><p><strong>Results: </strong>Of the patients randomized to PCI or CABG in the FAME 3 trial, 305 (21%) had a CTO. In the PCI arm, revascularization of the CTO was attempted in 61% with a procedural success rate of 88%. The incidence of major adverse cardiac and cerebrovascular events at 3 years was not significantly different between those with or without a CTO in both the PCI (15.2% versus 20.1%; adjusted hazard ratio, 0.62 [95% CI, 0.38-1.03]; <i>P</i>=0.07) and the CABG (13.0% versus 12.9%; adjusted hazard ratio, 0.96 [95% CI, 0.55-1.66]; <i>P</i>=0.88) arms. In those without a CTO, PCI was associated with a significantly higher risk of major adverse cardiac and cerebrovascular events compared with CABG (adjusted hazard ratio, 1.61 [95% CI, 1.20-2.17]; <i>P</i><0.01) but not in those with a CTO (adjusted hazard ratio, 1.21 [95% CI, 0.64-2.28]; <i>P</i>=0.56; <i>P</i><sub>interaction</sub>=0.31).</p><p><strong>Conclusions: </strong>The presence of a CTO did not significantly impact the treatment effect of PCI versus CABG at 3 years in patients with 3-vessel coronary artery disease.</p><p><strong>Clinical trial registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT02100722.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e014300"},"PeriodicalIF":6.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582240","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}
引用次数: 0
Transcatheter Mitral Valve Replacement Using Annular Reduction by Cinching With TEER in the Commissure (ARCTIC). 使用瓣环缩紧术和充盈试验(TEER)进行经导管二尖瓣置换术(ARCTIC)。
IF 6.1 1区 医学
Circulation: Cardiovascular Interventions Pub Date : 2024-11-01 Epub Date: 2024-11-06 DOI: 10.1161/CIRCINTERVENTIONS.124.014224
Gregory J Condos, David Elison, Logan L Vincent, Rafael Harari, Cristina Sanina, Srdjan Jelacic, Richard Sheu, Christine J Chung, Gabriel S Aldea, G Burkhard Mackensen, James M McCabe
{"title":"Transcatheter Mitral Valve Replacement Using Annular Reduction by Cinching With TEER in the Commissure (ARCTIC).","authors":"Gregory J Condos, David Elison, Logan L Vincent, Rafael Harari, Cristina Sanina, Srdjan Jelacic, Richard Sheu, Christine J Chung, Gabriel S Aldea, G Burkhard Mackensen, James M McCabe","doi":"10.1161/CIRCINTERVENTIONS.124.014224","DOIUrl":"10.1161/CIRCINTERVENTIONS.124.014224","url":null,"abstract":"<p><strong>Background: </strong>Mitral annular calcification with valve dysfunction remains a challenging syndrome. Operative risk is high, and available transcatheter therapies are limited.</p><p><strong>Methods: </strong>This study describes our initial experience with a novel procedure to address large mitral annuli when no surgical or trial-based transcatheter mitral valve replacement device is available. The rationale was to shorten the intercommissural distance using commissural mitral transcatheter edge-to-edge repair (TEER) followed by valve-in-mitral annular calcification transcatheter mitral valve replacement with a balloon-expandable aortic valve platform. Patients with long intercommissural distances and large mitral annulus areas were selected based on a high perceived risk of transcatheter valve embolization. Patients underwent mitral TEER with MitraClip in a commissural position, followed immediately by transseptal transcatheter mitral valve replacement with a 29 mm SAPIEN 3 valve.</p><p><strong>Results: </strong>Thirteen patients were included. Median intercommissural distance and annular area were 39.1 mm and 930 mm<sup>2</sup>, respectively. Commissural mitral TEER was successful in all patients with no instances of single leaflet detachment. In 10 of 13 instances, an NTW device size was used. In 12 of 13 patients, valve implantation was successful, including 1 case that required a second valve for atrial positioning of the first valve. In 1 case, frank valve embolization into the left atrium occurred. Among the 12 successful cases, paravalvular leak was 1+ or less, and there were no instances of paravalvular leak adjacent to the TEER device.</p><p><strong>Conclusions: </strong>In patients with large annuli and sufficient annular calcium, a hybrid mitral TEER and valve replacement with the SAPIEN platform can be successfully used to facilitate transcatheter mitral valve replacement.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e014224"},"PeriodicalIF":6.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11573076/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582259","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}
引用次数: 0
Enhancing Coronary Revascularization Decisions: The Promising Role of Large Language Models as a Decision-Support Tool for Multidisciplinary Heart Team. 加强冠状动脉血运重建决策:大型语言模型作为多学科心脏团队决策支持工具的前景广阔。
IF 6.1 1区 医学
Circulation: Cardiovascular Interventions Pub Date : 2024-11-01 Epub Date: 2024-11-06 DOI: 10.1161/CIRCINTERVENTIONS.124.014201
Karin Sudri, Iris Motro-Feingold, Roni Ramon-Gonen, Noam Barda, Eyal Klang, Paul Fefer, Sergei Amunts, Zachi Itzhak Attia, Mohamad Alkhouli, Amitai Segev, Michal Cohen-Shelly, Israel Moshe Barbash
{"title":"Enhancing Coronary Revascularization Decisions: The Promising Role of Large Language Models as a Decision-Support Tool for Multidisciplinary Heart Team.","authors":"Karin Sudri, Iris Motro-Feingold, Roni Ramon-Gonen, Noam Barda, Eyal Klang, Paul Fefer, Sergei Amunts, Zachi Itzhak Attia, Mohamad Alkhouli, Amitai Segev, Michal Cohen-Shelly, Israel Moshe Barbash","doi":"10.1161/CIRCINTERVENTIONS.124.014201","DOIUrl":"10.1161/CIRCINTERVENTIONS.124.014201","url":null,"abstract":"<p><strong>Background: </strong>While clinical practice guidelines advocate for multidisciplinary heart team (MDHT) discussions in coronary revascularization, variability in implementation across health care settings remains a challenge. This variability could potentially be addressed by language learning models like ChatGPT, offering decision-making support in diverse health care environments. Our study aims to critically evaluate the concordance between recommendations made by MDHT and those generated by language learning models in coronary revascularization decision-making.</p><p><strong>Methods: </strong>From March 2023 to July 2023, consecutive coronary angiography cases (n=86) that were referred for revascularization (either percutaneous or surgical) were analyzed using both ChatGPT-3.5 and ChatGPT-4. Case presentation formats included demographics, medical background, detailed description of angiographic findings, and SYNTAX score (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery; I and II), which were presented in 3 different formats. The recommendations of the models were compared with those of an MDHT.</p><p><strong>Results: </strong>ChatGPT-4 showed high concordance with decisions made by the MDHT (accuracy 0.82, sensitivity 0.8, specificity 0.83, and kappa 0.59), while ChatGPT-3.5 (0.67, 0.27, 0.84, and 0.12, respectively) showed lower concordance. Entropy and Fleiss kappa of ChatGPT-4 were 0.09 and 0.9, respectively, indicating high reliability and repeatability. The best correlation between ChatGPT-4 and MDHT was achieved when clinical cases were presented in a detailed context. Specific subgroups of patients yielded high accuracy (>0.9) of ChatGPT-4, including those with left main disease, 3 vessel disease, and diabetic patients.</p><p><strong>Conclusions: </strong>The present study demonstrates that advanced language learning models like ChatGPT-4 may be able to predict clinical recommendations for coronary artery disease revascularization with reasonable accuracy, especially in specific patient groups, underscoring their potential role as a supportive tool in clinical decision-making.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e014201"},"PeriodicalIF":6.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582229","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}
引用次数: 0
Symptomatic Benefit of SESAME According to Phenotype. 根据表型确定 SESAME 的症状效益。
IF 6.1 1区 医学
Circulation: Cardiovascular Interventions Pub Date : 2024-11-01 Epub Date: 2024-10-24 DOI: 10.1161/CIRCINTERVENTIONS.124.014440
Hiroki A Ueyama, Robert J Lederman, Errol K Inci, John C Lisko, Joe X Xie, Isida Byku, George S Hanzel, Adam B Greenbaum, Vasilis C Babaliaros, Patrick T Gleason
{"title":"Symptomatic Benefit of SESAME According to Phenotype.","authors":"Hiroki A Ueyama, Robert J Lederman, Errol K Inci, John C Lisko, Joe X Xie, Isida Byku, George S Hanzel, Adam B Greenbaum, Vasilis C Babaliaros, Patrick T Gleason","doi":"10.1161/CIRCINTERVENTIONS.124.014440","DOIUrl":"10.1161/CIRCINTERVENTIONS.124.014440","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e014440"},"PeriodicalIF":6.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11576234/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496236","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}
引用次数: 0
Validation of the Valve Academic Research Consortium High Bleeding Risk Definition in Patients Undergoing TAVR. 瓣膜学术研究联盟对接受 TAVR 患者高出血风险定义的验证。
IF 6.1 1区 医学
Circulation: Cardiovascular Interventions Pub Date : 2024-10-30 DOI: 10.1161/CIRCINTERVENTIONS.124.014800
Marisa Avvedimento, Pedro Cepas-Guillén, Julien Ternacle, Marina Urena, Alberto Alperi, Asim Cheema, Gabriela Veiga, Luis Nombela-Franco, Victoria Vilalta, Giovanni Esposito, Francisco Campelo-Parada, Ciro Indolfi, Maria Del Trigo, Antonio Muñoz-Garcia, Nicolás Manuel Maneiro-Melón, Lluis Asmarats, Ander Regueiro, David Del Val, Vicenç Serra, Vincent Auffret, Thomas Modine, Guillaume Bonnet, Jules Mesnier, Gaspard Suc, Pablo Avanzas, Effat Rezaei, Victor Fradejas-Sastre, Gabriela Tirado-Conte, Eduard Fernandez-Nofrerias, Anna Franzone, Thibaut Guitteny, Sabato Sorrentino, Juan Francisco Oteo, Jorge Nuche, Lola Gutiérrez-Alonso, Eduardo Flores Umanzor, Fernando Alfonso, Andrea Monastyrski, Maxime Nolf, Mélanie Côté, Roxana Mehran, Marie-Claude Morice, Davide Capodanno, Philippe Garot, Josep Rodés-Cabau
{"title":"Validation of the Valve Academic Research Consortium High Bleeding Risk Definition in Patients Undergoing TAVR.","authors":"Marisa Avvedimento, Pedro Cepas-Guillén, Julien Ternacle, Marina Urena, Alberto Alperi, Asim Cheema, Gabriela Veiga, Luis Nombela-Franco, Victoria Vilalta, Giovanni Esposito, Francisco Campelo-Parada, Ciro Indolfi, Maria Del Trigo, Antonio Muñoz-Garcia, Nicolás Manuel Maneiro-Melón, Lluis Asmarats, Ander Regueiro, David Del Val, Vicenç Serra, Vincent Auffret, Thomas Modine, Guillaume Bonnet, Jules Mesnier, Gaspard Suc, Pablo Avanzas, Effat Rezaei, Victor Fradejas-Sastre, Gabriela Tirado-Conte, Eduard Fernandez-Nofrerias, Anna Franzone, Thibaut Guitteny, Sabato Sorrentino, Juan Francisco Oteo, Jorge Nuche, Lola Gutiérrez-Alonso, Eduardo Flores Umanzor, Fernando Alfonso, Andrea Monastyrski, Maxime Nolf, Mélanie Côté, Roxana Mehran, Marie-Claude Morice, Davide Capodanno, Philippe Garot, Josep Rodés-Cabau","doi":"10.1161/CIRCINTERVENTIONS.124.014800","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.124.014800","url":null,"abstract":"<p><p><b>Background:</b> The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) has recently introduced a consensus document that outlines risk factors to identify high bleeding risk (HBR) in patients undergoing transcatheter aortic valve replacement (TAVR). The objective of the present study was to evaluate the prevalence and predictive value of the VARC-HBR definition in a contemporary, large-scale TAVR population. <b>Methods:</b> Multicenter study including 10,449 patients undergoing TAVR. Based on consensus, twenty-one clinical and laboratory criteria were identified and classified as major or minor. Patients were stratified as at low, moderate, high, and very high bleeding risk according to VARC-HBR definition. The primary endpoint was the rate of BARC type 3 or 5 bleeding at 1 year, defined as the composite of peri-procedural (within 30 days) or late (after 30 days) bleeding. <b>Results:</b> Patients with at least one VARC-HBR criterion (n=9,267, 88.7%) had a higher risk of BARC 3 or 5 bleeding, proportional to the severity of risk assessment (10.8%, 16.1%, and 24.6% for moderate, high, and very high-risk groups, respectively). However, a comparable rate of bleeding events was observed in the low-risk and moderate-risk groups. The area under ROC curve was 0.58. Patients with VARC-HBR criteria also exhibited a gradual increase in 1-year all-cause mortality, with an up to 2-fold increased mortality risk for high and very high-risk groups (HR: 1.33, 95% CI: 1.04-1.70; and HR: 1.97, 95% CI: 1.53-2.53, respectively). <b>Conclusions:</b> The VARC-HBR consensus offered a pragmatic approach to guide bleeding risk stratification in TAVR. The results of the present study would support the predictive validity of the newly definition and promote its application in clinical practice to minimize bleeding risk and improve patient outcomes.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":""},"PeriodicalIF":6.1,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544095","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}
引用次数: 0
Impacts of Hospital Volume and Patient-Hospital Distances on Outcomes of Older Adults Receiving Percutaneous Microaxial Ventricular Assist Devices for Cardiogenic Shock. 医院容量和患者-医院距离对接受经皮微轴心室辅助装置治疗心源性休克的老年人预后的影响。
IF 6.1 1区 医学
Circulation: Cardiovascular Interventions Pub Date : 2024-10-29 DOI: 10.1161/CIRCINTERVENTIONS.124.014738
Atsuyuki Watanabe, Yoshihisa Miyamoto, Hiroki Ueyama, Hiroshi Gotanda, Jacob C Jentzer, Navin K Kapur, Ulrich P Jorde, Yusuke Tsugawa, Toshiki Kuno
{"title":"Impacts of Hospital Volume and Patient-Hospital Distances on Outcomes of Older Adults Receiving Percutaneous Microaxial Ventricular Assist Devices for Cardiogenic Shock.","authors":"Atsuyuki Watanabe, Yoshihisa Miyamoto, Hiroki Ueyama, Hiroshi Gotanda, Jacob C Jentzer, Navin K Kapur, Ulrich P Jorde, Yusuke Tsugawa, Toshiki Kuno","doi":"10.1161/CIRCINTERVENTIONS.124.014738","DOIUrl":"10.1161/CIRCINTERVENTIONS.124.014738","url":null,"abstract":"<p><p><b>Background:</b> Percutaneous microaxial ventricular assist devices (pVAD) have the potential to reduce mortality of patients with cardiogenic shock (CS). However, the association between the distribution of pVAD-performing centers and outcomes of CS has not been explored. <b>Methods:</b> This observational study included Medicare fee-for-service beneficiaries aged 65-99 years treated with pVAD for CS from 2016 to 2020 and examined the associations between patient outcomes and two exposure variables: hospitals' procedure volumes of pVAD and patient-hospital distances (in quintiles [Qn]). We developed Cox proportional hazard regression for 180-day mortality and heart failure (HF) readmission rates and multivariable logistic regression for in-hospital outcomes, adjusting for patient demographics, comorbidities, concomitant treatments, and hospital characteristics, including CS volume, teaching status, and the ability to perform extracorporeal membrane oxygenation. <b>Results:</b> A total of 6,637 patients with CS underwent pVAD at 1,041 hospitals, with the annualized hospital volume ranging widely from 0.3 to 55.6 cases/year. Patients treated at higher-volume centers experienced lower 180-day mortality compared with patients treated at lower-volume centers (Qn1=reference; Qn2: adjusted hazard ratio [aHR], 0.88; 95% confidence interval [CI], 0.79-0.97; Qn3: aHR, 0.88; 95% CI, 0.79-0.98; Qn4: aHR, 0.88; 95% CI, 0.78-0.99; Qn5: aHR, 0.84; 95% CI, 0.74-0.95; p-for-trend, 0.026), while we found no evidence that patient-hospital distances were associated with mortality (Qn1=reference; Qn2: adjusted hazard ratio [aHR], 0.99; 95% confidence interval [CI], 0.89-1.09; Qn3: aHR, 0.94; 95% CI, 0.85-1.04; Qn4: aHR, 1.01; 95% CI, 0.92-1.11; Qn5: aHR, 0.91; 95% CI, 0.82-1.01; p-for-trend, 0.160). We found no evidence that the hospital volume and patient-hospital distances were associated with in-hospital bleeding, intracranial hemorrhage, or renal replacement therapy initiation. <b>Conclusions:</b> Hospital volume was more strongly associated with mortality than patient-hospital distances, suggesting that rational distribution of pVAD-performing centers while ensuring adequate procedure volumes may optimize patient mortality.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":""},"PeriodicalIF":6.1,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142521178","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}
引用次数: 0
Comparison of Ultrathin- Versus Thin-Strut Stents in Patients With High Bleeding Risk PCI: Results From the COMPARE 60/80 HBR Trial: An Open-Label, Randomized, Controlled Trial. PCI 高出血风险患者使用超薄支架与薄支架的比较:COMPARE 60/80 HBR 试验结果:一项开放标签、随机对照试验。
IF 6.1 1区 医学
Circulation: Cardiovascular Interventions Pub Date : 2024-10-01 DOI: 10.1161/CIRCINTERVENTIONS.123.014042
Pieter C Smits, Pim A L Tonino, Sjoerd H Hofma, Jan-Peter van Kuijk, Fabrizio Spano, Amar Al Mafragi, Ron Pisters, Jawed Polad, Kris Bogaerts, Rohit M Oemrawsingh, Valeria Paradies
{"title":"Comparison of Ultrathin- Versus Thin-Strut Stents in Patients With High Bleeding Risk PCI: Results From the COMPARE 60/80 HBR Trial: An Open-Label, Randomized, Controlled Trial.","authors":"Pieter C Smits, Pim A L Tonino, Sjoerd H Hofma, Jan-Peter van Kuijk, Fabrizio Spano, Amar Al Mafragi, Ron Pisters, Jawed Polad, Kris Bogaerts, Rohit M Oemrawsingh, Valeria Paradies","doi":"10.1161/CIRCINTERVENTIONS.123.014042","DOIUrl":"10.1161/CIRCINTERVENTIONS.123.014042","url":null,"abstract":"<p><strong>Background: </strong>No randomized data exist on ultrathin-strut stents in patients at high bleeding risk (HBR) undergoing an abbreviated dual antiplatelet therapy after coronary stenting. The aim of this study was to compare the safety and effectiveness of the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent with the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent in patients at HBR with abbreviated dual antiplatelet therapy after stenting.</p><p><strong>Methods: </strong>In the investigator-initiated, randomized, open-label COMPARE 60/80 HBR trial (Comparison of the Supraflex Cruz 60 Micron Stent Strut Versus the Ultimaster Tansei 80 Micron Stent Strut in HBR Percutaneous Coronary Intervention Population), 741 patients at HBR according to the Academic Research Consortium HBR criteria were randomized to receive either the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent or thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent. Dual antiplatelet therapy was recommended according to the applicable guidelines and trial data for patients at HBR. The primary outcome was net adverse clinical events, the composite of cardiovascular death, myocardial infarction, target vessel revascularization, stroke, and major bleeding, and was powered for noninferiority with an absolute margin of 4.0% at 1-sided 2.5% alpha.</p><p><strong>Results: </strong>Between September 2020 and August 2022, 371 patients were randomized to the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent and 370 patients to the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent at 11 sites in the Netherlands. At 1 year, the primary outcome was observed in 56 (15.4%) patients in the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent group and 61 (17.1%) in the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent group (risk difference, -1.65%; upper boundary of the 1-sided 95% CI, 3.74; <i>P</i>=0.02 for noninferiority at a 0.025 significance level and <i>P</i>=0.55 for 2-sided superiority at a 0.05 significance level).</p><p><strong>Conclusions: </strong>Among patients at HBR with abbreviated dual antiplatelet therapy post-stenting, the use of an ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent was noninferior compared with the use of a thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT04500912.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e014042"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11472898/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342761","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}
引用次数: 0
Unconscious After Arrest and Primary PCI in STEMI: Hold or Go? STEMI 发生后意识不清和初级 PCI:坚持还是放弃?
IF 6.1 1区 医学
Circulation: Cardiovascular Interventions Pub Date : 2024-10-01 Epub Date: 2024-10-15 DOI: 10.1161/CIRCINTERVENTIONS.124.014689
Anna E Bortnick
{"title":"Unconscious After Arrest and Primary PCI in STEMI: Hold or Go?","authors":"Anna E Bortnick","doi":"10.1161/CIRCINTERVENTIONS.124.014689","DOIUrl":"10.1161/CIRCINTERVENTIONS.124.014689","url":null,"abstract":"","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":"17 10","pages":"e014689"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11542613/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459501","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}
引用次数: 0
Impact of Lipidic Plaque on In-Stent and Stent Edge-Related Events After PCI in Myocardial Infarction: A PROSPECT II Substudy. 心肌梗死 PCI 后脂质斑块对支架内和支架边缘相关事件的影响:PROSPECT II 子研究。
IF 6.1 1区 医学
Circulation: Cardiovascular Interventions Pub Date : 2024-10-01 Epub Date: 2024-09-25 DOI: 10.1161/CIRCINTERVENTIONS.124.014215
Lars Kjøller-Hansen, Akiko Maehara, Henning Kelbæk, Mitsuaki Matsumura, Michael Maeng, Thomas Engstrøm, Ole Fröbert, Jonas Persson, Rune Wiseth, Alf Inge Larsen, Lisette Okkels Jensen, Jan Erik Nordrehaug, Elmir Omerovic, Claes Held, Stefan James, Gary S Mintz, Ziad A Ali, Gregg W Stone, David Erlinge
{"title":"Impact of Lipidic Plaque on In-Stent and Stent Edge-Related Events After PCI in Myocardial Infarction: A PROSPECT II Substudy.","authors":"Lars Kjøller-Hansen, Akiko Maehara, Henning Kelbæk, Mitsuaki Matsumura, Michael Maeng, Thomas Engstrøm, Ole Fröbert, Jonas Persson, Rune Wiseth, Alf Inge Larsen, Lisette Okkels Jensen, Jan Erik Nordrehaug, Elmir Omerovic, Claes Held, Stefan James, Gary S Mintz, Ziad A Ali, Gregg W Stone, David Erlinge","doi":"10.1161/CIRCINTERVENTIONS.124.014215","DOIUrl":"10.1161/CIRCINTERVENTIONS.124.014215","url":null,"abstract":"<p><strong>Background: </strong>Lipid content in untreated nonobstructive coronary artery lesions is associated with adverse clinical outcomes, and residual in-stent or stent edge lipid may worsen outcomes after percutaneous coronary intervention (PCI).</p><p><strong>Methods: </strong>Near-infrared spectroscopy-intravascular ultrasound was performed before and after PCI in patients with myocardial infarction. We evaluated the impact of lipid assessed by near-infrared spectroscopy (maximal lipid core burden index over 4 mm [maxLCBI<sub>4mm</sub>]) along with intravascular ultrasound information including residual plaque burden on in-stent or edge-related major adverse cardiac events (MACE) in de novo PCI-treated culprit coronary artery lesions. The primary end point was culprit lesion-related MACE (CL-MACE), defined as cardiac death, myocardial infarction, or unstable or progressive angina either requiring revascularization or with rapid lesion progression and classified as in-stent or stent edge-related.</p><p><strong>Results: </strong>During a median follow-up of 3.8 years, 25 CL-MACE (11 stent edge-related, 13 in-stent, and 1 in-lesion without a stent) occurred in 1041 PCI-treated lesions in 768 patients. Pre-PCI or post-PCI measures of lipid content were not related to in-stent CL-MACE. However, stent edge-related CL-MACE was increased if both the post-PCI stent edge maxLCBI<sub>4mm</sub> was greater than the upper quartile (108.7) and the stent edge plaque burden was >50% (adjusted odds ratio, 4.11 [95% CI, 1.12-15.2]; <i>P</i>=0.03).</p><p><strong>Conclusions: </strong>In PROSPECT II (Providing Regional Observations to Study Predictors of Events in the Coronary Tree), CL stent implantation leaving behind greater stent edge-related lipid and uncovered plaque burden was associated with an increased risk of stent edge-related CL-MACE during follow-up. In contrast, CL lipid content was not related to in-stent CL-MACE.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT02171065.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e014215"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342762","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}
引用次数: 0
Association Between Neurological Status and Outcomes in Cardiac Arrest Patients Undergoing PCI in Contemporary Practice: Insights From BMC2. 当代实践中接受 PCI 治疗的心脏骤停患者的神经状态与预后之间的关系:BMC2.
IF 6.1 1区 医学
Circulation: Cardiovascular Interventions Pub Date : 2024-10-01 Epub Date: 2024-10-15 DOI: 10.1161/CIRCINTERVENTIONS.124.014189
David E Hamilton, Daniel S Kobe, Milan Seth, Manoj Sharma, Thomas LaLonde, Ibrahim Shah, Hitinder S Gurm, Devraj Sukul
{"title":"Association Between Neurological Status and Outcomes in Cardiac Arrest Patients Undergoing PCI in Contemporary Practice: Insights From BMC2.","authors":"David E Hamilton, Daniel S Kobe, Milan Seth, Manoj Sharma, Thomas LaLonde, Ibrahim Shah, Hitinder S Gurm, Devraj Sukul","doi":"10.1161/CIRCINTERVENTIONS.124.014189","DOIUrl":"https://doi.org/10.1161/CIRCINTERVENTIONS.124.014189","url":null,"abstract":"<p><strong>Background: </strong>Coronary artery disease remains the largest contributor to cardiac arrests worldwide; yet, long-term outcomes are often driven by neurological status after resuscitation. We examined the association between pre-percutaneous coronary intervention (PCI) level of consciousness (LOC) and outcomes among patients with cardiac arrest who underwent PCI.</p><p><strong>Methods: </strong>The study cohort included patients undergoing PCI after cardiac arrest between April 2018 and March 2022 at 48 hospitals in the state of Michigan. Pre-PCI LOC was categorized as mentally alert, partially responsive, unresponsive, and unable to assess. In-hospital outcomes included mortality, bleeding, and acute kidney injury.</p><p><strong>Results: </strong>Among 3021 patients who underwent PCI after cardiac arrest, 1394 (49%) were mentally alert, 132 (5%) were partially responsive, 698 (24%) were unresponsive, and 631 (22%) were unable to assess. The mentally alert cohort had lower mortality (4.59%) compared with the partially responsive (17.42%), unresponsive (50.14%), and unable to assess cohorts (38.03%; <i>P</i><0.001). After adjusting for baseline differences, compared with mentally alert patients, the odds of mortality were markedly elevated in patients who were partially responsive (adjusted odds ratio, 4.63 [95% CI, 2.67-8.04]; <i>P</i><0.001), unable to assess (adjusted odds ratio, 13.95 [95% CI, 9.97-19.51]; <i>P</i><0.001), and unresponsive (adjusted odds ratio, 24.36 [17.34-34.23]; <i>P</i><0.001). After adjustment, patients with impaired LOC also had higher risks of acute kidney injury and bleeding compared with mentally alert patients.</p><p><strong>Conclusions: </strong>Pre-PCI LOC is a strong predictor of in-hospital outcomes after PCI among cardiac arrest patients. A patient's pre-PCI LOC should be considered an important factor when weighing treatment options, designing clinical trials, and counseling patients and their families regarding prognosis after PCI.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":"17 10","pages":"e014189"},"PeriodicalIF":6.1,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459498","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}
引用次数: 0
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