Importance:Bilateral internal thoracic artery grafting has been proposed to improve survival compared to standard single internal thoracic artery grafting during coronary artery bypass graft (CABG) surgery, but any survival benefit may emerge only with longer-term follow-up. Objective:To report 15-year extended follow-up of a randomized clinical trial of bilateral vs single internal thoracic artery grafting for CABG. Design, Setting, and Participants:This is a secondary analysis of an unblinded randomized clinical trial that took place at 28 cardiac surgery centers in 7 countries between June 2004 and December 2007, with 15-year follow-up reported after 2025. Patients scheduled for CABG on clinical grounds were eligible. Those requiring only single grafts or concomitant valve surgery, as well as those with a history of previous CABG, were excluded. All 3102 patients in the original trial provided data for this analysis, while 3042 completed the full 15-year follow-up. Data were analyzed from January to March 2026. Intervention:If patients fulfilled all the eligibility criteria and provided written informed consent, they were randomly assigned to bilateral or single internal thoracic artery grafts with vein or radial artery grafts used in both groups as clinically indicated. Main Outcomes and Measures:All-cause mortality at 15 years. The composite of all-cause mortality, myocardial infarction, or stroke was a secondary outcome. Results:A total of 1548 patients were randomized to bilateral internal thoracic artery grafts and 1554 to single internal thoracic artery grafts. The mean (SD) age was 64 (9) years and 446 (15%) were female. In the bilateral graft group, 215 (14%) received only a single arterial graft, while in the single graft group, 359 (23%) also received a radial artery graft. At 15 years, vital status was known for 3039 patients (98%). There were 585 deaths (37.8%) in the bilateral graft group and 584 (37.6%) in the single graft group (hazard ratio [HR], 1.00; 95% CI, 0.89-1.12; P = .97). Secondary outcome event rates were 43.9% and 45.8%, respectively (HR, 0.94; 95% CI, 0.85-1.05). Conclusions and Relevance:There was no difference in all-cause mortality at 15 years between patients undergoing CABG who were randomized to bilateral vs single internal thoracic artery grafts in an intention-to-treat analysis. Given the high rate of potential postrandomization confounders (eg, crossovers and use of radial arteries), the multiple arterial graft hypothesis still needs to be tested in randomized clinical trials. Trial Registration:isrctn.org Identifier: ISRCTN46552265.

Percutaneous coronary intervention (PCI) using drug-coated balloons (DCBs) may provide outcomes comparable to drug-eluting stents (DESs) due to the absence of a permanent implant and improved coronary artery remodelling. This study compared clinical outcomes of DCB-only angioplasty with DESs in a real-world setting. All patients undergoing PCI with DCBs or DESs for de novo disease were included in a propensity score-matched analysis using prospective and retrospective collected data from a single centre. The primary outcome was target lesion revascularisation (TLR) at 12 months. The secondary outcomes were major adverse cardiac events (MACEs) defined as a composite of all-cause death, myocardial infarction, or TLR at 12 months. Propensity matching produced 904 DCB lesions (719 patients) matched to 1424 DES lesions (1271 patients). The DCB group had smaller coronary arteries, shorter treated segments, and more bifurcation lesions. The mean age was 65 years, 22% of patients had prior MI, 16% had diabetes, and 58% had acute coronary syndromes. The rate of TLR at 12 months was as follows: 2.3% with DCBs; 2.5% with DESs (OR 0.86, p = 0.726, 95% CI 0.37-2.02). MACE was 8.2% with DCBs and 7.3% for DESs (OR 1.04, 95% CI 0.73-1.47). Results suggest comparable outcomes in patients who received paclitaxel DCBs compared to DESs without excess MACE, highlighting the need for randomised controlled trials.

Importance Bilateral internal thoracic artery grafting has been proposed to improve survival compared to standard single internal thoracic artery grafting during coronary artery bypass graft (CABG) surgery, but any survival benefit may emerge only with longer-term follow-up. Objective To report 15-year extended follow-up of a randomized clinical trial of bilateral vs single internal thoracic artery grafting for CABG. Design, Setting, and Participants This is a secondary analysis of an unblinded randomized clinical trial that took place at 28 cardiac surgery centers in 7 countries between June 2004 and December 2007, with 15-year follow-up reported after 2025. Patients scheduled for CABG on clinical grounds were eligible. Those requiring only single grafts or concomitant valve surgery, as well as those with a history of previous CABG, were excluded. All 3102 patients in the original trial provided data for this analysis, while 3042 completed the full 15-year follow-up. Data were analyzed from January to March 2026. Intervention If patients fulfilled all the eligibility criteria and provided written informed consent, they were randomly assigned to bilateral or single internal thoracic artery grafts with vein or radial artery grafts used in both groups as clinically indicated. Main Outcomes and Measures All-cause mortality at 15 years. The composite of all-cause mortality, myocardial infarction, or stroke was a secondary outcome. Results A total of 1548 patients were randomized to bilateral internal thoracic artery grafts and 1554 to single internal thoracic artery grafts. The mean (SD) age was 64 (9) years and 446 (15%) were female. In the bilateral graft group, 215 (14%) received only a single arterial graft, while in the single graft group, 359 (23%) also received a radial artery graft. At 15 years, vital status was known for 3039 patients (98%). There were 585 deaths (37.8%) in the bilateral graft group and 584 (37.6%) in the single graft group (hazard ratio [HR], 1.00; 95% CI, 0.89-1.12; P = .97). Secondary outcome event rates were 43.9% and 45.8%, respectively (HR, 0.94; 95% CI, 0.85-1.05). Conclusions and Relevance There was no difference in all-cause mortality at 15 years between patients undergoing CABG who were randomized to bilateral vs single internal thoracic artery grafts in an intention-to-treat analysis. Given the high rate of potential postrandomization confounders (eg, crossovers and use of radial arteries), the multiple arterial graft hypothesis still needs to be tested in randomized clinical trials. Trial Registration isrctn.org Identifier: ISRCTN46552265

Extension follow-up trials are essential for understanding the long-term safety and efficacy of cardiovascular interventions. Whereas primary randomized trials primarily capture short-term outcomes, extended observation may reveal delayed benefits or harms that are highly relevant to clinical decision-making. However, methodologic standards for extension trials remain poorly defined, leading to inconsistent design, analysis, and reporting. This scientific statement outlines best practices for cardiovascular trial extensions, addressing outcome selection, duration and completeness of follow-up, and analytic strategies suited to evolving treatment effects. Practical considerations, including strategies for participant retention, reconsent, data continuity, and resource allocation, are also discussed.

Background The Scottish Computed Tomography of the Heart (SCOT-HEART) trial demonstrated that management guided by coronary CT angiography (CCTA) improved the diagnosis, management, and outcome of patients with stable chest pain. We aimed to assess whether CCTA-guided care results in sustained long-term improvements in management and outcomes. Methods SCOT-HEART was an open-label, multicentre, parallel group trial for which patients were recruited from 12 outpatient cardiology chest pain clinics across Scotland. Eligible patients were aged 18-75 years with symptoms of suspected stable angina due to coronary heart disease. Patients were randomly assigned (1:1) to standard of care plus CCTA or standard of care alone. In this prespecified 10-year analysis, prescribing data, coronary procedural interventions, and clinical outcomes were obtained through record linkage from national registries. The primary outcome was coronary heart disease death or non-fatal myocardial infarction on an intention-to-treat basis. This trial is registered at ClinicalTrials.gov (NCT01149590) and is complete. Findings Between Nov 18, 2010, and Sept 24, 2014, 4146 patients were recruited (mean age 57 years [SD 10], 2325 [561%] male, 1821 [439%] female), with 2073 randomly assigned to standard care and CCTA and 2073 to standard care alone. After a median of 100 years (IQR 93-110), coronary heart disease death or non-fatal myocardial infarction was less frequent in the CCTA group compared with the standard care group (137 [66%] vs 171 [82%]; hazard ratio [HR] 079 [95% CI 063-099], p=0044). Rates of all-cause, cardiovascular, and coronary heart disease death, and non-fatal stroke, were similar between the groups (p>005 for all), but non-fatal myocardial infarctions (90 [43%] vs 124 [60%]; HR 072 [055-094], p=0017) and major adverse cardiovascular events (172 [83%] vs 214 [103%]; HR 080 [065-097], p=0026) were less frequent in the CCTA group. Rates of coronary revascularisation procedures were similar (315 [152%] vs 318 [153%]; HR 100 [086-117], p=099) but preventive therapy prescribing remained more frequent in the CCTA group (831 [559%] of 1486 vs 728 [490%] of 1485 patients with available data; odds ratio 117 [95% CI 101-136], p=0034). Interpretation After 10 years, CCTA-guided management of patients with stable chest pain was associated with a sustained reduction in coronary heart disease death or non-fatal myocardial infarction. Identification of coronary atherosclerosis by CCTA improves long-term cardiovascular disease prevention in patients with stable chest pain. Copyright (c) 2025 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license.

The Danish-German Cardiogenic Shock (DanGer-Shock) trial found a 180-day survival benefit with routine mechanical circulatory support (MCS) but notably excluded comatose pre-randomization cardiac arrest patients. Following the publication of DanGer Shock, the high six-month mortality rate of 58.5% among controls has come under scrutiny, as other studies have not reported similar rates. However, cardiac arrest cases are frequent in most MCS studies besides DanGer shock, which makes direct comparison across studies difficult. To assess the 180-day mortality of patients assigned to the control group without cardiac arrest before randomization in available randomized MCS trials. Individual patient data meta-analysis of MCS trials with six-month mortality data comparing routine MCS versus control in infarct-related cardiogenic shock. For this analysis, only patients randomized to the control group were assessed. The cohort was stratified based on whether they had received cardiopulmonary resuscitation before randomization and compared between patients in the DanGer and patients from other MCS trials. All-cause mortality at 180 days was assessed as a time-to-event by Cox regression, including an adjusted analysis. Among 530 patients randomized to standard-of-care, 254 had not been resuscitated within 24 hours prior to randomization. 143 of these originated from the DanGer-Shock and 111 from seven other MCS trials. The control patients without cardiac arrest in the DanGer-shock had lower systolic blood pressure (median 80, (interquartile range (IQR) 70-91 mmHg) vs. 87 (73-107), p=0.005); lower left ventricular ejection fraction (20 % (IQR 15-30) vs. 27 % (IQR 20-35), p=0.003); but lower lactate (4.4 mmol/L (IQR 3.1-6.3) vs. 5.3 mmol/L (IQR 3.6-9.6), p=0.003). Mortality at day 180 in the DanGer-Shock non-arrested population was 60% and 59% in the other MCS trials (hazard ratio (HR) 1.10 (95% CI: 0.79-1.51) and adjusted HR 1.09 (95% CI: 0.74-1.58). In the control population with cardiac arrest (n=261), we found that the mortality at day 180 in DanGer-Shock cardiac arrest population was 52% (17/33) vs. 53% (121/229) in the other trials (hazard ratio (HR) 0.89 (95% CI: 0.53-1.47) and adjusted HR 0.71 (95% CI: 0.40-1.3). The 180-day mortality in the conservatively treated infarct-related cardiogenic shock was similar between the DanGer Shock and previous MCS studies, and 180-day mortality is higher in the LV predominant than the cardiac arrest shock phenotype.

Objective External saphenous vein graft stenting has been shown to reduce intimal hyperplasia, lumen irregularities, and flow disturbances after coronary artery bypass grafting (CABG). The objective of this study is to evaluate the effect of saphenous vein graft external stenting on clinical outcomes up to 5 years. Methods Outcomes for patients who received external vein graft stenting in an international, real-world cohort were compared in a propensity matched analysis with patients from the Arterial Revascularization Trial (ISRCTN46552265). All eligible patients required an internal mammary artery graft to the left anterior descending coronary artery, received at least one vein graft, and survived to discharge. The primary end point was major adverse cardiovascular and cerebrovascular events at 1 year after surgery, consisting of all-cause mortality, myocardial infarction, repeat revascularization, and cerebrovascular accident. Secondary end points included 5-year major adverse cardiovascular and cerebrovascular events with and without stroke and annualized target vessel revascularization. Results In total, 789 treated and 2205 control patients were included. At 1 year after CABG, the weighted hazard ratio comparing outcomes between treated and control patients was 0.60 (90% confidence interval, 0.38-0.94, P = .03). The benefits associated with external stenting for the composite outcome persisted through 5 years’ post-CABG (hazard ratio, 0.70; 95% confidence interval, 0.51-0.98, P = .04). Annual target vessel revascularization rates in vein grafts were significantly lower in the venous external support cohort at 2 to 5 years after surgery (P = .009-.03). Conclusions The current study demonstrates that external vein graft stenting is associated with a significantly lower risk of experiencing adverse clinical outcomes up to 5 years after surgery compared with standard of care.

Cardiac surgery may lead to myocardial damage and release of cardiac biomarkers through various mechanisms such as cardiac manipulation, systemic inflammation, myocardial hypoxia, cardioplegic arrest and ischaemia caused by coronary or graft occlusion. Defining perioperative myocardial infarction (PMI) after cardiac surgery presents challenges, and the association between the current PMI definitions and postoperative outcomes remains uncertain. To address these challenges, the European Association of Cardio-Thoracic Surgery (EACTS) facilitated collaboration among a multidisciplinary group to evaluate the existing evidence on the mechanisms, diagnosis and prognostic implications of PMI after cardiac surgery. The review found that the postoperative troponin value thresholds associated with an increased risk of mortality are markedly higher than those proposed by all the current definitions of PMI. Additionally, it was found that large postoperative increases in cardiac biomarkers are prognostically relevant even in absence of additional supportive signs of ischaemia. A new algorithm for PMI detection after cardiac surgery was also proposed, and a consensus was reached within the group that establishing a prognostically relevant definition of PMI is critically needed in the cardiovascular field and that PMI should be included in the primary composite outcome of coronary intervention trials.

Journal Article The ROMA trial: 7 years of trial activities and the development of the ROMA trial network Get access Mario Gaudino, Mario Gaudino Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, NY, USA Corresponding author. Department of Cardiothoracic Surgery, Weill Cornell Medicine, 525 E 68th St, New York, NY 10065, USA. Tel: +1-212-746-9440; fax. +1-212-746-8080; e-mail: mfg9004@med.cornell.edu (M. Gaudino). https://orcid.org/0000-0003-4680-0815 Search for other works by this author on: Oxford Academic PubMed Google Scholar Massimo Lemma, Massimo Lemma Department of Cardiac Surgery, Jilin Heart Hospital, Changchun, China Search for other works by this author on: Oxford Academic PubMed Google Scholar Sigrid Sandner, Sigrid Sandner Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria https://orcid.org/0000-0003-4669-9841 Search for other works by this author on: Oxford Academic PubMed Google Scholar Andreas Boening, Andreas Boening Department of Cardiovascular Surgery, University Hospital Giessen, Giessen, Germany Search for other works by this author on: Oxford Academic PubMed Google Scholar Lamia Harik, Lamia Harik Department of Cardiothoracic Surgery, Weill Cornell Medicine, New York, NY, USA https://orcid.org/0000-0003-1500-1308 Search for other works by this author on: Oxford Academic PubMed Google Scholar Marc Albert, Marc Albert Department of Cardiovascular Surgery, Robert-Bosch Hospital, Stuttgart, Germany https://orcid.org/0000-0003-2819-2406 Search for other works by this author on: Oxford Academic PubMed Google Scholar Jose Albors Martin, Jose Albors Martin Department of Cardiac Surgery, Hospital Universitario del Vinalopo, Alicante, Spain Search for other works by this author on: Oxford Academic PubMed Google Scholar Jorge Alcocer, Jorge Alcocer Department of Cardiac Surgery, Hospital Clinic de Barcelona, Barcelona, Spain https://orcid.org/0000-0003-3235-3436 Search for other works by this author on: Oxford Academic PubMed Google Scholar John H Alexander, John H Alexander Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC, USA https://orcid.org/0000-0002-1444-2462 Search for other works by this author on: Oxford Academic PubMed Google Scholar Deepak L Bhatt, Deepak L Bhatt Department of Medicine, Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, USA Search for other works by this author on: Oxford Academic PubMed Google Scholar ... Show more Nikolaos Bonaros, Nikolaos Bonaros Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria https://orcid.org/0000-0002-7656-5812 Search for other works by this author on: Oxford Academic PubMed Google Scholar Michael Borger, Michael Borger Department of Cardiac Surgery, Leipzig Heart Center, Leipzig, Germany Search for other works by this author on: Oxford Academic PubMed Google Scholar Bernhard C Danner, Bernhard C Danner Department of Thoracic and Cardiovascular Surgery, University Hospital of Goettingen, Goettingen, Germany Search for other works by this author on: Oxford Academic PubMed Google Scholar Piroze Davierwala, Piroze Davierwala Department of Surgery, Division of Cardiac Surgery, Toronto General Hospital, Toronto, ON, Canada Search for other works by this author on: Oxford Academic PubMed Google Scholar Marek A Deja, Marek A Deja Department of Cardiac Surgery, Medical University of Silesia-Katowice, Katowice, Poland Search for other works by this author on: Oxford Academic PubMed Google Scholar Ruggero De Paulis, Ruggero De Paulis Department of Cardiac Surgery, European Hospital, Unicamillus University, Rome, Italy https://orcid.org/0000-0002-3603-2202 Search for other works by this author on: Oxford Academic PubMed Google Scholar Marcus-Andre Deutsch, Marcus-Andre Deutsch Department of Thoracic and Cardiovascular Surgery, HDZ NRW, University Hospital Ruhr-University Bochum, Bad Oeynhausen, Germany Search for other works by this author on: Oxford Academic PubMed Google Scholar Marcus Flather, Marcus Flather Department of Medicine, Norwich Medical School, University of East Anglia, Norwich, UK https://orcid.org/0000-0001-5644-3116 Search for other works by this author on: Oxford Academic PubMed Google Scholar Pieter Kappetein, Pieter Kappetein Medtronic Bakken Research Center, Maastricht, Netherlands Search for other works by this author on: Oxford Academic PubMed Google Scholar Paul Kurlansky, Paul Kurlansky Department of Surgery, Columbia University College of Physicians and Surgeons, New York, NY, USA https://orcid.org/0000-0003-2681-9885 Search for other works by this author on: Oxford Academic PubMed Google Scholar Andre Lamy, Andre Lamy Department of Surgery, McMaster University, Hamilton, ON, Canada Search for other works by this author on: Oxford Academic PubMed Google Scholar Roberto Lorusso, Roberto Lorusso Department of Cardio-Thoracic Surgery, Maastricht University Medical Center and Cardiovascular Research Maastricht, Maastricht, Netherlands Search for other works by this author on: Oxford Academic PubMed Google Scholar Gopi Chand Mannam, Gopi Chand Mannam Department of Cardiothoracic Surgery, Star Hospitals, Hyderabad, India Search for other works by this author on: Oxford Academic PubMed Google Scholar Mohamed Marzouk, Mohamed Marzouk Department of Cardiovascular Surgery, IUCPQ, Universite Laval, Quebec City, QC, Canada Search for other works by this author on: Oxford Academic PubMed Google Scholar Ruth Masterson Creber, Ruth Masterson Creber Columbia University School of Nursing, New York, NY, USA Search for other works by this author on: Oxford Academic PubMed Google Scholar Milan Milojevic, Milan Milojevic Department of Cardiac Surgery and Cardiovascular Research, Dedinje Cardiovascular Institute, Belgrade, SerbiaDepartment of Cardiothoracic Surgery, Erasmus MC, Rotterdam, Netherlands https://orcid.org/0000-0003-0984-9011 Search for other works by this author on: Oxford Academic PubMed Google Scholar Giuseppe Nasso, Giuseppe Nasso Department of Cardiac Surgery, Anthea Hospital, Bari, Italy Search for other works by this author on: Oxford Academic PubMed Google Scholar Nirav Patel, Nirav Patel Department of Cardiovascular and Thoracic Surgery, Northwell Health, New Hyde Park, NY, USA Search for other works by this author on: Oxford Academic PubMed Google Scholar Ivana Petrovic, Ivana Petrovic Department of Cardiosurgery, Center of Excellence, Dedinje Cardiovascular Institute, Belgrade, Serbia https://orcid.org/0000-0002-4549-2163 Search for other works by this author on: Oxford Academic PubMed Google Scholar Eduard Quintana, Eduard Quintana Department of Cardiac Surgery, Hospital Clinic de Barcelona, Barcelona, Spain Search for other works by this author on: Oxford Academic PubMed Google Scholar Lokeswara Rao Sajja, Lokeswara Rao Sajja Department of Cardiothoracic Surgery, Star Hospitals, Hyderabad, India Search for other works by this author on: Oxford Academic PubMed Google Scholar Mauro Rinaldi, Mauro Rinaldi Department of Cardiac Surgery, University of Turin, Turin, Italy Search for other works by this author on: Oxford Academic PubMed Google Scholar Lisa Rong, Lisa Rong Department of Anesthesia, Weill Cornell Medicine, New York, NY, USA Search for other works by this author on: Oxford Academic PubMed Google Scholar Igor Rudez, Igor Rudez Department of Cardiac and Transplant Surgery, Dubrava University Hospital, Zagreb, Croatia Search for other works by this author on: Oxford Academic PubMed Google Scholar Marc Ruel, Marc Ruel Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, ON, Canada Search for other works by this author on: Oxford Academic PubMed Google Scholar Elfriede Ruttmann-Ulmer, Elfriede Ruttmann-Ulmer Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria Search for other works by this author on: Oxford Academic PubMed Google Scholar Pierre Voisine, Pierre Voisine Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottawa, ON, Canada Search for other works by this author on: Oxford Academic PubMed Google Scholar Qiang Zhao, Qiang Zhao Department of Cardiac Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China https://orcid.org/0000-0002-8930-3854 Search for other works by this author on: Oxford Academic PubMed Google Scholar Zhe Zheng, Zhe Zheng Department of Cardiac Surgery, Fuwai Hospital, Beijing, China https://orcid.org/0000-0002-9162-6492 Search for other works by this author on: Oxford Academic PubMed Google Scholar Stephen E Fremes Stephen E Fremes Division of Cardiac Surgery, Schulich Heart Centre, Department of Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada Search for other works by this author on: Oxford Academic PubMed Google Scholar European Journal of Cardio-Thoracic Surgery, Volume 65, Issue 5, May 2024, ezae188, https://doi.org/10.1093/ejcts/ezae188 Published: 16 May 2024 Article history Received: 27 February 2024 Revision received: 26 April 2024 Accepted: 01 May 2024 Published: 16 May 2024

Background Percutaneous active mechanical circulatory support (MCS) devices are being increasingly used in the treatment of acute myocardial infarction-related cardiogenic shock (AMICS) despite conflicting evidence regarding their effect on mortality. We aimed to ascertain the effect of early routine active percutaneous MCS versus control treatment on 6-month all-cause mortality in patients with AMICS. Methods In this individual patient data meta-analysis, randomised controlled trials of potential interest were identified, without language restriction, by querying the electronic databases MEDLINE via PubMed, Cochrane Central Register of Controlled Trials, and Embase, as well as ClinicalTrials.gov, up to Jan 26, 2024. All randomised trials with 6-month mortality data comparing early routine active MCS (directly in the catheterisation laboratory after randomisation) versus control in patients with AMICS were included. The primary outcome was 6-month all-cause mortality in patients with AMICS treated with early routine active percutaneous MCS versus control, with a focus on device type (loading, such as venoarterial extracorporeal membrane oxygenation [VA-ECMO] vs unloading) and patient selection. Hazard ratios (HRs) of the primary outcome measure were calculated using Cox regression models. This study is registered with PROSPERO, CRD42024504295. Findings Nine reports of randomised controlled trials (n=1114 patients) were evaluated in detail. Overall, four randomised controlled trials (n=611 patients) compared VA-ECMO with a control treatment and five randomised controlled trials (n=503 patients) compared left ventricular unloading devices with a control treatment. Two randomised controlled trials also included patients who did not have AMICS, who were excluded (55 patients [44 who were treated with VA-ECMO and 11 who were treated with a left ventricular unloading device]). The median patient age was 65 years (IQR 57-73); 845 (799%) of 1058 patients with data were male and 213 (201%) were female. No significant benefit of early unselected MCS use on 6-month mortality was noted (HR 087 [95% CI 074-103]; p=010). No significant differences were observed for left ventricular unloading devices versus control (080 [062-102]; p=0075), and loading devices also had no effect on mortality (093 [075-117]; p=055). Patients with ST-elevation cardiogenic shock without risk of hypoxic brain injury had a reduction in mortality with MCS use (077 [061-097]; p=0024). Major bleeding (odds ratio 264 [95% CI 191-365]) and vascular complications (443 [237-826]) were more frequent with MCS use than with control. Interpretation The use of active MCS devices in patients with AMICS did not reduce 6-month mortality (regardless of the device used) and increased major bleeding and vascular complications. However, patients with ST-elevation cardiogenic shock without risk of hypoxic brain injury had a reduction in mortality after MCS use. Therefore, the use of MCS should be restricted to certain patients only.

AIMS:In a recent meta-analysis of randomized controlled trials, routine use of veno-arterial ECMO (VA-ECMO) did not improve outcomes in patients with acute myocardial infarction-related cardiogenic shock (AMI-CS), while a microaxial flow pump reduced mortality in a selected group of patients with AMI-CS in the DanGer-Shock trial. METHODS AND RESULTS:Individual patient data of patients included in four randomized clinical trials investigating the routine use of VA-ECMO in AMI-CS were centrally analysed. For the purpose of this sub-analysis, DanGer-Shock-like patients were analysed (STEMI only, presumed low likelihood of brain injury). The primary endpoint was 180-day all-cause mortality. A total of 202 patients (106 randomized to VA-ECMO and 96 to control) were included. There were no differences in baseline characteristics, angiographic and interventional features between the two groups. Mortality after 6 months was numerically lower with VA-ECMO between the groups [45% in VA-ECMO group vs. 51% in control group; hazard ratio, 0.84; 95% confidence interval (CI), 0.56-1.26], while major bleeding (OR, 2.24; 95% CI, 1.08-4.64) and peripheral vascular complications (OR, 3.65; 95% CI, 1.15-11.56) were increased with the use of VA-ECMO. CONCLUSION:In this exploratory subgroup analysis in patients with CS, STEMI, and a low likelihood of brain injury, there was no mortality benefit with the routine use of VA-ECMO. However, as indicated by the large confidence intervals, the statistical power was limited to draw definite conclusions.