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Drug-coated balloons for coronary bifurcation lesions. 药物包被球囊用于冠状动脉分叉病变。
IF 9.5 1区 医学
Eurointervention Pub Date : 2025-10-10 DOI: 10.4244/EIJ-D-25-00201
Simone Fezzi, Bruno Scheller, Tuomas T Rissanen, Renata Malivojevic, Domenico Tavella, Mattia Lunardi, Bernardo Cortese, Adrian Banning, Gabriele Pesarini, Flavio Ribichini, Roberto Scarsini
{"title":"Drug-coated balloons for coronary bifurcation lesions.","authors":"Simone Fezzi, Bruno Scheller, Tuomas T Rissanen, Renata Malivojevic, Domenico Tavella, Mattia Lunardi, Bernardo Cortese, Adrian Banning, Gabriele Pesarini, Flavio Ribichini, Roberto Scarsini","doi":"10.4244/EIJ-D-25-00201","DOIUrl":"https://doi.org/10.4244/EIJ-D-25-00201","url":null,"abstract":"<p><p>Coronary bifurcation lesions (CBLs) represent a common and challenging subset of coronary artery disease requiring percutaneous coronary intervention (PCI). While drug-eluting stents (DES) remain the cornerstone of treatment, their use is associated with risks such as restenosis, thrombosis, side branch (SB) jailing and the need for prolonged dual antiplatelet therapy. Drug-coated balloons (DCBs) have emerged as a promising alternative, delivering antiproliferative drugs without permanent implants, thereby reducing the risk of late complications and preserving native vessel geometry. This review explores the role of DCBs in CBL management, particularly for SB treatment within the provisional stenting strategy. Evidence from clinical studies indicates that DCBs significantly reduce late lumen loss and restenosis in the SB compared to plain balloon angioplasty, while simplifying PCI procedures and avoiding extensive stenting. Furthermore, hybrid/blended strategies combining DCBs with DES have shown superior clinical and angiographic outcomes in true CBLs compared to DES-only approaches. Despite their potential, the adoption of DCBs faces challenges, including the need for optimal lesion preparation and a lack of standardised procedural techniques. Existing randomised controlled trials are limited by small sample sizes, design heterogeneity, inclusion of bare metal stents either as comparators or as part of the treatment strategy, and inconsistent use of key procedural steps such as proximal optimisation technique and kissing balloon inflation. This manuscript aims to provide interventional cardiologists with practical guidance for managing CBLs, focusing on the effective integration of DCBs into standalone and hybrid strategies. By emphasising procedural optimisation and complication reduction, this review seeks to promote more standardised and reproducible approaches in clinical practice.</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":" ","pages":""},"PeriodicalIF":9.5,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145276677","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
In-depth, patient-level analysis of clinical events in the NOTION-2 trial. 在NOTION-2试验中对临床事件进行深入的、患者层面的分析。
IF 9.5 1区 医学
Eurointervention Pub Date : 2025-10-06 DOI: 10.4244/EIJ-D-25-00139
Arif A Khokhar, Troels Højsgaard Jørgensen, Hans Gustav Hørsted Thyregod, Lars Sondergaard, Bernard Prendergast, Ole De Backer
{"title":"In-depth, patient-level analysis of clinical events in the NOTION-2 trial.","authors":"Arif A Khokhar, Troels Højsgaard Jørgensen, Hans Gustav Hørsted Thyregod, Lars Sondergaard, Bernard Prendergast, Ole De Backer","doi":"10.4244/EIJ-D-25-00139","DOIUrl":"10.4244/EIJ-D-25-00139","url":null,"abstract":"","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 19","pages":"e1169-e1171"},"PeriodicalIF":9.5,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477502/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145234045","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 clinical risk characteristics on the prognostic value of high-risk plaques. 临床风险特征对高危斑块预后价值的影响
IF 9.5 1区 医学
Eurointervention Pub Date : 2025-10-06 DOI: 10.4244/EIJ-D-25-00307
Rick H J A Volleberg, Andi Rroku, Jan-Quinten Mol, Renicus S Hermanides, Maarten van Leeuwen, Balázs Berta, Martijn Meuwissen, Fernando Alfonso, Wojciech Wojakowski, Anouar Belkacemi, Giuseppe De Luca, Laura Rodwell, Tomasz Roleder, Elvin Kedhi, Niels van Royen
{"title":"Impact of clinical risk characteristics on the prognostic value of high-risk plaques.","authors":"Rick H J A Volleberg, Andi Rroku, Jan-Quinten Mol, Renicus S Hermanides, Maarten van Leeuwen, Balázs Berta, Martijn Meuwissen, Fernando Alfonso, Wojciech Wojakowski, Anouar Belkacemi, Giuseppe De Luca, Laura Rodwell, Tomasz Roleder, Elvin Kedhi, Niels van Royen","doi":"10.4244/EIJ-D-25-00307","DOIUrl":"10.4244/EIJ-D-25-00307","url":null,"abstract":"<p><strong>Background: </strong>High-risk coronary plaques (HRPs) are associated with adverse cardiovascular outcomes. However, the clinical practicality of HRP identification is challenged by their modest prevalence and low positive predictive value.</p><p><strong>Aims: </strong>We aimed to evaluate the association between clinical risk factors and HRPs, as well as the clinical impact of HRPs across different clinical risk profiles.</p><p><strong>Methods: </strong>This is a pooled analysis of individual patient data from the prospective observational COMBINE (OCT-FFR) and PECTUS-obs studies. A modified version of the Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS-2P) was used for risk stratification. The composite endpoint of major adverse cardiovascular events (MACE) was evaluated on a patient level, and target lesion failure (TLF), also a composite endpoint, was evaluated on a lesion level.</p><p><strong>Results: </strong>Among 810 patients, 311, 265, and 234 were at low (TRS-2P 0-1), intermediate (TRS-2P 2), and high risk (TRS-2P ≥3), respectively. The modified TRS-2P had no discriminative value for the identification of patients with an HRP (area under the receiver operating characteristic curve 0.51, 95% confidence interval [CI]: 0.47-0.56). A consistent trend towards worse clinical outcome in the presence of an HRP was observed across different clinical risk profiles (p<sub>interaction</sub>=0.539 for MACE and 0.337 for TLF). For TLF, the highest event rate per 100 lesion-years was observed in high-risk patients with HRPs (6.28, 95% CI: 3.52-10.36; 13.6% absolute risk at 2 years).</p><p><strong>Conclusions: </strong>HRPs are associated with a negative clinical outcome, without apparent differences between clinical risk profiles. This highlights the independent value of optical coherence tomography for prognostication beyond clinical risk factors. The high event rates in high-risk patients with HRPs necessitate the search for additional therapeutic strategies to mitigate this risk.</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 19","pages":"e1147-e1158"},"PeriodicalIF":9.5,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477505/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145234074","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
Just tap it in… stent optimisation in TAVI. 只要点击TAVI的支架优化。
IF 9.5 1区 医学
Eurointervention Pub Date : 2025-10-06 DOI: 10.4244/EIJ-E-25-00044
Darren Mylotte, Bing Wei Thaddeus Soh
{"title":"Just tap it in… stent optimisation in TAVI.","authors":"Darren Mylotte, Bing Wei Thaddeus Soh","doi":"10.4244/EIJ-E-25-00044","DOIUrl":"10.4244/EIJ-E-25-00044","url":null,"abstract":"","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 19","pages":"e1113-e1115"},"PeriodicalIF":9.5,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477499/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145234072","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
Transcatheter tricuspid valve-in-ring following bicaval valve degeneration. 双瓣退行性变后经导管三尖瓣入环。
IF 9.5 1区 医学
Eurointervention Pub Date : 2025-10-06 DOI: 10.4244/EIJ-D-24-01165
Lluis Asmarats, Chi-Hion Pedro Li, Dabit Arzamendi
{"title":"Transcatheter tricuspid valve-in-ring following bicaval valve degeneration.","authors":"Lluis Asmarats, Chi-Hion Pedro Li, Dabit Arzamendi","doi":"10.4244/EIJ-D-24-01165","DOIUrl":"10.4244/EIJ-D-24-01165","url":null,"abstract":"","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 19","pages":"e1172-e1173"},"PeriodicalIF":9.5,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477497/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145234186","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
Seeing is believing. 眼见为实。
IF 9.5 1区 医学
Eurointervention Pub Date : 2025-10-06 DOI: 10.4244/EIJ-E-25-00042
Joost Daemen, Karol Sadowski
{"title":"Seeing is believing.","authors":"Joost Daemen, Karol Sadowski","doi":"10.4244/EIJ-E-25-00042","DOIUrl":"10.4244/EIJ-E-25-00042","url":null,"abstract":"","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 19","pages":"e1111-e1112"},"PeriodicalIF":9.5,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477498/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145234169","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
Photon-counting computed tomography for stent assessment. 用于支架评估的光子计数计算机断层扫描。
IF 9.5 1区 医学
Eurointervention Pub Date : 2025-10-06 DOI: 10.4244/EIJ-E-25-00040
Daniele Andreini, Carlo Di Mario
{"title":"Photon-counting computed tomography for stent assessment.","authors":"Daniele Andreini, Carlo Di Mario","doi":"10.4244/EIJ-E-25-00040","DOIUrl":"10.4244/EIJ-E-25-00040","url":null,"abstract":"","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 19","pages":"e1108-e1110"},"PeriodicalIF":9.5,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477501/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145234024","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
Routine post-dilatation at nominal volume to optimise the expansion of balloon-expandable valves: the DOUBLE-TAP study. 以标称容积进行常规后扩张以优化球囊膨胀阀的膨胀:DOUBLE-TAP研究。
IF 9.5 1区 医学
Eurointervention Pub Date : 2025-10-06 DOI: 10.4244/EIJ-D-25-00258
Ali Husain, Julius Jelisejevas, Kevin Millar, Abdulla Alnuwakhtha, Aaisha Ferkh, Julien Delarive, Hacina Gill, Jasem Althekrallah, Sophie Offen, Georgios Tzimas, Jian Ye, Jonathon A Leipsic, Philipp Blanke, Janarthanan Sathananthan, David A Wood, Stephanie L Sellers, David Meier, John G Webb
{"title":"Routine post-dilatation at nominal volume to optimise the expansion of balloon-expandable valves: the DOUBLE-TAP study.","authors":"Ali Husain, Julius Jelisejevas, Kevin Millar, Abdulla Alnuwakhtha, Aaisha Ferkh, Julien Delarive, Hacina Gill, Jasem Althekrallah, Sophie Offen, Georgios Tzimas, Jian Ye, Jonathon A Leipsic, Philipp Blanke, Janarthanan Sathananthan, David A Wood, Stephanie L Sellers, David Meier, John G Webb","doi":"10.4244/EIJ-D-25-00258","DOIUrl":"10.4244/EIJ-D-25-00258","url":null,"abstract":"<p><strong>Background: </strong>Incomplete expansion of balloon-expandable (BE) transcatheter heart valves (THVs) is sometimes treated by ad hoc post-dilatation with an overfilled or larger valvuloplasty balloon. The efficacy of this approach has not been rigorously evaluated, although increased risk for adverse events has been demonstrated. Observational experience suggests that post-dilatation using the original delivery system balloon at the identical filling volume (i.e., double-tap) may routinely improve the degree of THV expansion with low risk.</p><p><strong>Aims: </strong>We sought to assess the safety and efficacy of a strategy of routine double-tap after BE transcatheter aortic valve implantation (TAVI).</p><p><strong>Methods: </strong>Patients undergoing TAVI with the SAPIEN 3 Ultra (S3U) valve were prospectively included. Patients with severe annular or subannular calcification were excluded. A validated method of fluoroscopic analysis was utilised to assess the cross-sectional area at the inflow, midpoint, and outflow of the THV before and after double-tap. Thirty-day clinical outcomes were documented.</p><p><strong>Results: </strong>Routine double-tap was performed in 102 patients. Despite nominal deployment, all patients had some degree of THV underexpansion after the first inflation. Fluoroscopic analysis documented an increase in minimal THV expansion by cross-sectional area of 9.8% for the 20 mm S3U (p=0.151), 9.9% for the 23 mm S3U (p<0.001), 9.2% for the 26 mm S3U (p<0.001), and 8.6% for the 29 mm S3U (p=0.002). There was no stroke or cardiovascular mortality at 30 days.</p><p><strong>Conclusions: </strong>In favourable anatomy, routine double-tap after BE TAVI improved THV expansion with no safety concerns. The impact of this strategy on THV function, haemodynamic profile, and durability remains to be determined.</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 19","pages":"e1159-e1168"},"PeriodicalIF":9.5,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477503/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145234130","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
Photon-counting detector computed tomography for the assessment of coronary stents and in-stent restenosis. 光子计数检测器计算机断层扫描评估冠状动脉支架和支架内再狭窄。
IF 9.5 1区 医学
Eurointervention Pub Date : 2025-10-06 DOI: 10.4244/EIJ-D-25-00257
Doosup Shin, Rick H J A Volleberg, Roosha Parikh, Christopher Chieh Yang Koo, Sarah Malik, Matthew Cannata, Emma Caron, Yasemin Ciftcikal, Koshiro Sakai, J Jane Cao, Lu Chen, Fernando Sosa, Jonathan Weber, Jaffar M Khan, David J Cohen, Jeffrey W Moses, Niels van Royen, Carlos Collet, Richard A Shlofmitz, Evan Shlofmitz, Allen Jeremias, Omar K Khalique, Ziad A Ali
{"title":"Photon-counting detector computed tomography for the assessment of coronary stents and in-stent restenosis.","authors":"Doosup Shin, Rick H J A Volleberg, Roosha Parikh, Christopher Chieh Yang Koo, Sarah Malik, Matthew Cannata, Emma Caron, Yasemin Ciftcikal, Koshiro Sakai, J Jane Cao, Lu Chen, Fernando Sosa, Jonathan Weber, Jaffar M Khan, David J Cohen, Jeffrey W Moses, Niels van Royen, Carlos Collet, Richard A Shlofmitz, Evan Shlofmitz, Allen Jeremias, Omar K Khalique, Ziad A Ali","doi":"10.4244/EIJ-D-25-00257","DOIUrl":"10.4244/EIJ-D-25-00257","url":null,"abstract":"<p><strong>Background: </strong>Photon-counting detector computed tomography (PCD-CT) offers enhanced spatial resolution and reduced blooming artefacts, potentially improving the evaluation of stented coronary vessels.</p><p><strong>Aims: </strong>This study aimed to assess the diagnostic performance of dual-source PCD-CT in detecting obstructive in-stent restenosis (ISR).</p><p><strong>Methods: </strong>We identified consecutive patients with prior coronary stent implantation who underwent clinically indicated coronary computed tomography angiography (CCTA) with PCD-CT and subsequent invasive coronary angiography within 90 days between 2023 and 2024. Obstructive ISR (≥50% diameter stenosis) was determined by visual assessment of CCTA and invasive quantitative coronary angiography (QCA) in a blinded fashion. The diagnostic performance of CCTA for ISR was compared with that of QCA.</p><p><strong>Results: </strong>A total of 283 stented lesions from 171 patients were included. Of these, only 3 lesions (1.1%) were deemed indeterminate by PCD-CT. Using invasive QCA as the reference standard, PCD-CT demonstrated a lesion-level sensitivity of 80.0%, specificity of 90.4%, positive predictive value (PPV) of 58.2%, negative predictive value (NPV) of 96.4%, and an overall diagnostic accuracy of 88.9% for detecting obstructive ISR. In a subgroup analysis according to the stent diameter (<3.00 mm [n=83] vs ≥3.00 mm [n=108]), there were no significant differences in sensitivity (87.5% vs 86.7%; p=1.00), specificity (93.3% vs 92.5%; p=1.00), PPV (58.3% vs 65.0%; p=1.00), NPV (98.6% vs 97.7%; p=1.00), or overall diagnostic accuracy (92.8% vs 91.7%; p=1.00), respectively.</p><p><strong>Conclusions: </strong>PCD-CT demonstrated good diagnostic performance for evaluating obstructive ISR using QCA as the reference standard, regardless of stent diameter.</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":"21 19","pages":"e1137-e1146"},"PeriodicalIF":9.5,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477506/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145234208","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
Mechanical circulatory support in high-risk elective PCI: rationale and design of the PROTECT IV trial. 高危选择性PCI的机械循环支持:PROTECT IV试验的基本原理和设计。
IF 9.5 1区 医学
Eurointervention Pub Date : 2025-09-30 DOI: 10.4244/EIJ-D-25-00486
Norman Mangner, Samin K Sharma, Chris O'Connor, Amir Kaki, George D Dangas, Jeffrey W Moses, Ehtisham Mahmud, Giuseppe Tarantini, Stephan Achenbach, Stuart J Pocock, William W O'Neill, Cindy L Grines, Alexandra J Lansky, Jason R Wollmuth, Jagat Narula, Dimitrios I Karmpaliotis, Haroon A Faraz, Mir B Basir, Aditya S Bharadwaj, Ziad A Ali, Chuck Simonton, Seth D Bilazarian, Navin K Kapur, Roberta C Chapman, Dana Bentley, Jeffrey J Popma, Akiko Maehara, Stephan Windecker, Gregg W Stone
{"title":"Mechanical circulatory support in high-risk elective PCI: rationale and design of the PROTECT IV trial.","authors":"Norman Mangner, Samin K Sharma, Chris O'Connor, Amir Kaki, George D Dangas, Jeffrey W Moses, Ehtisham Mahmud, Giuseppe Tarantini, Stephan Achenbach, Stuart J Pocock, William W O'Neill, Cindy L Grines, Alexandra J Lansky, Jason R Wollmuth, Jagat Narula, Dimitrios I Karmpaliotis, Haroon A Faraz, Mir B Basir, Aditya S Bharadwaj, Ziad A Ali, Chuck Simonton, Seth D Bilazarian, Navin K Kapur, Roberta C Chapman, Dana Bentley, Jeffrey J Popma, Akiko Maehara, Stephan Windecker, Gregg W Stone","doi":"10.4244/EIJ-D-25-00486","DOIUrl":"https://doi.org/10.4244/EIJ-D-25-00486","url":null,"abstract":"<p><p>Coronary artery disease (CAD) is the leading cause of heart failure with reduced ejection fraction (HFrEF). Coronary artery bypass grafting (CABG) improves long-term mortality in HFrEF. Percutaneous coronary intervention (PCI) is often performed as an alternative to CABG in patients at high surgical risk. However, in patients with HFrEF and limited myocardial reserve, PCI may result in haemodynamic instability, increasing risk and precluding optimal revascularisation. Mechanical circulatory support (MCS) during high-risk PCI may enhance haemodynamic stability during the procedure and enable complete revascularisation. We thus performed the PROTECT IV trial to determine whether PCI with routine use of the Impella CP microaxial flow pump improves early and late outcomes in patients with HFrEF and complex CAD compared with PCI with or without use of an intra-aortic balloon pump (IABP). PROTECT IV is a prospective, multicentre, randomised, parallel-controlled, open-label, superiority trial with an adaptive design. Patients with complex CAD and left ventricular ejection fraction ≤40% (n=1,252) deemed at excessive surgical risk for bypass grafting by the Heart Team will be randomised in a 1:1 ratio to PCI with Impella CP versus PCI with or without an IABP. The primary endpoint is the composite of all-cause death, stroke, myocardial infarction, unplanned clinically driven revascularisation, durable left ventricular assist device implant or heart transplant, or other hospitalisation for cardiovascular causes at 3-year follow-up, with at least 1-year follow-up in all patients. Prespecified substudies will evaluate the impact of MCS on renal function, the procedural role of right heart catheterisation, and the utility of myocardial viability assessment. The PROTECT IV trial will determine whether routine MCS with Impella CP during high-risk PCI improves the prognosis of patients with complex CAD and HFrEF.</p>","PeriodicalId":54378,"journal":{"name":"Eurointervention","volume":" ","pages":""},"PeriodicalIF":9.5,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145193579","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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