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Background: Hospital mortality after acute myocardial infarction (AMI, ICD-10: I21-I22) is used as OECD indicator of the quality of acute care. The reported AMI hospital mortality in Germany is more than twice as high as in the Netherlands or Scandinavia. Yet, in Europe, Germany ranks high in health spending and availability of cardiac procedures. We provide insights into this contradictory situation., Methods: Information was collected on possible factors causing the reported differences in AMI mortality such as prevalence of risk factors or comorbidities, guideline conform treatment, patient registration, and health system structures of European countries. International experts were interviewed. Data on OECD indicators 'AMI 30-day mortality using unlinked data' and 'average length of stay after AMI' were used to describe the association between these variables graphically and by linear regression., Results: Differences in prevalence of risk factors or comorbidities or in guideline conform acute care account only to a smaller extent for the reported differences in AMI hospital mortality. It is influenced mainly by patient registration rules and organization of health care. Non-reporting of day cases as patients and centralization of AMI care-with more frequent inter-hospital patient transfers-artificially lead to lower calculated hospital mortality. Frequency of patient transfers and national reimbursement policies affect the average length of stay in hospital which is strongly associated with AMI hospital mortality (adj R 2  = 0.56). AMI mortality reported from registries is distorted by different underlying populations., Conclusion: Most of the variation in AMI hospital mortality is explained by differences in patient registration and organization of care instead of differences in quality of care, which hinders cross-country comparisons of AMI mortality. Europe-wide sentinel regions with comparable registries are necessary to compare (acute) care after myocardial infarction., Competing Interests: Declarations. Conflict of interest: None of the authors has a conflict of interest to declare., (© 2023. The Author(s).)

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., Competing Interests: Conflict of interest: none declared., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

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 (79·9%) of 1058 patients with data were male and 213 (20·1%) were female. No significant benefit of early unselected MCS use on 6-month mortality was noted (HR 0·87 [95% CI 0·74-1·03]; p=0·10). No significant differences were observed for left ventricular unloading devices versus control (0·80 [0·62-1·02]; p=0·075), and loading devices also had no effect on mortality (0·93 [0·75-1·17]; p=0·55). Patients with ST-elevation cardiogenic shock without risk of hypoxic brain injury had a reduction in mortality with MCS use (0·77 [0·61-0·97]; p=0·024). Major bleeding (odds ratio 2·64 [95% CI 1·91-3·65]) and vascular complications (4·43 [2·37-8·26]) 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., Funding: The Heart Center Leipzig at Leipzig University and the Foundation Institut für Herzinfarktforschung., Competing Interests: Declaration of interests HT is the current president of the German Cardiac Society. JEM reports lecture fees from Abbott and Boehringer Ingelheim; institutional research grants from Abiomed and Novo Nordisk Foundation; travel support from Abiomed; equipment from Abiomed; and served as a data and safety monitoring board member for DanHeart. JB reports speaker fees from Resuscitec and Getinge. DB reports payment for travel expenses from Abiomed; and institutional support for steering committee membership. MF reports grants paid to their institution from the European Commission. HE reports speaker fees from Novartis; and travel expenses from Abbott paid to their institution. PO reports speaker fees from Getinge, Abiomed, Fresenius, Edwards Lifesciences, and AOP; and is the president of the Czech Society of Cardiology. PCS reports lecture fees from Abiomed and Abbott; and institutional research support from Abiomed. JP reports institutional research grants from the German Cardiac Society, Schwiete Foundation, German Heart Research Foundation, and Maquet. CH reports lecture fees from Abiomed. MH reports research support paid to their institution from the Heart Center Leipzig. AP reports lecture fees and institutional research grants from Abiomed. NM reports lecture fees from Abbott, Abiomed, AstraZeneca, B Braun, Biotronik, the British Society of Cardiovascular Imaging, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, and Sanofi Genzyme; grants paid to their institution from Abiomed; and unrestricted educational grants from Abiomed and BSCI. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Aims: We analysed consecutive patients with acute myocardial infarction complicated by cardiogenic shock (CS) who were enrolled into the CULPRIT-SHOCK randomized controlled trial (RCT) and those with exclusion criteria who were included into the accompanying registry., Methods and Results: In total, 1075 patients with infarct-related CS were screened for CULPRIT-SHOCK in 83 specialized centres in Europe; 369 of them had exclusion criteria for the RCT and were enrolled into the registry. Patients were followed over 1 year. The mean age was 68 years and 260 (25%) were women. 13.5%, 30.9%, and 55.6% had one-vessel, two-vessel, and three-vessel coronary artery disease (CAD), respectively. Significant left main (LM) coronary artery stenosis was present in 8.0%. 54.2% of the patients had cardiac arrest before admission. Thrombolysis in myocardial infarction (TIMI) 3 patency of the infarct vessel after percutaneous coronary intervention was achieved in 83.6% of all patients. Mechanical circulatory support was applied in one-third of patients. Total mortality after 30 days and 1 year was 47.6% and 52.9%. Mortality after 1 year was highest in patients with LM coronary artery stenosis (63.5%), followed by three-vessel (56.6%), two-vessel (49.8%), and one-vessel CAD (38.6%), respectively. Mechanical complications were rare (21/1008; 2.1%) but associated with a high mortality of 66.7% after 1 year., Conclusion: In specialized centres in Europe, short- and long-term mortality of patients with infarct-related CS treated with an invasive strategy is still high and mainly depends on the extent of CAD. Therefore, there is still a need for improvement of care to improve the prognosis of infarct-related CS., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Extracorporeal life support (ECLS) is increasingly used in the treatment of infarct-related cardiogenic shock despite a lack of evidence regarding its effect on mortality., Methods: In this multicenter trial, patients with acute myocardial infarction complicated by cardiogenic shock for whom early revascularization was planned were randomly assigned to receive early ECLS plus usual medical treatment (ECLS group) or usual medical treatment alone (control group). The primary outcome was death from any cause at 30 days. Safety outcomes included bleeding, stroke, and peripheral vascular complications warranting interventional or surgical therapy., Results: A total of 420 patients underwent randomization, and 417 patients were included in final analyses. At 30 days, death from any cause had occurred in 100 of 209 patients (47.8%) in the ECLS group and in 102 of 208 patients (49.0%) in the control group (relative risk, 0.98; 95% confidence interval [CI], 0.80 to 1.19; P = 0.81). The median duration of mechanical ventilation was 7 days (interquartile range, 4 to 12) in the ECLS group and 5 days (interquartile range, 3 to 9) in the control group (median difference, 1 day; 95% CI, 0 to 2). The safety outcome consisting of moderate or severe bleeding occurred in 23.4% of the patients in the ECLS group and in 9.6% of those in the control group (relative risk, 2.44; 95% CI, 1.50 to 3.95); peripheral vascular complications warranting intervention occurred in 11.0% and 3.8%, respectively (relative risk, 2.86; 95% CI, 1.31 to 6.25)., Conclusions: In patients with acute myocardial infarction complicated by cardiogenic shock with planned early revascularization, the risk of death from any cause at the 30-day follow-up was not lower among the patients who received ECLS therapy than among those who received medical therapy alone. (Funded by the Else Kröner Fresenius Foundation and others; ECLS-SHOCK ClinicalTrials.gov number, NCT03637205.)., (Copyright © 2023 Massachusetts Medical Society.)

Background: Cardiac arrest (CA) is common in patients with infarct-related cardiogenic shock (CS)., Objectives: The goal of this study was to identify the characteristics and outcomes of culprit lesion percutaneous coronary intervention (PCI) of patients with infarct-related CS stratified according to CA in the CULPRIT-SHOCK (Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock) randomized trial and registry., Methods: Patients with CS with and without CA from the CULPRIT-SHOCK study were analyzed. All-cause death or severe renal failure leading to renal replacement therapy within 30 days and 1-year death were assessed., Results: Among 1,015 patients, 550 (54.2%) had CA. Patients with CA were younger, more frequently male, had lower rates of peripheral artery disease, a glomerular filtration rate <30 mL/min, and left main disease, and they presented more often with clinical signs of impaired organ perfusion. The composite of all-cause death or severe renal failure within 30 days occurred in 51.2% of patients with CA vs 48.5% in non-CA patients (P = 0.39) and 1-year death in 53.8% vs 50.4% (P = 0.29), respectively. In a multivariate analysis, CA was an independent predictor of 1-year mortality (HR: 1.27; 95% CI: 1.01-1.59). In the randomized trial, culprit lesion-only PCI was superior to immediate multivessel PCI in patients both with and without CA (P for interaction = 0.6)., Conclusions: More than 50% of patients with infarct-related CS had CA. These patients with CA were younger and had fewer comorbidities, but CA was an independent predictor of 1-year mortality. Culprit lesion-only PCI is the preferred strategy, both in patients with and without CA. (Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock [CULPRIT-SHOCK]; NCT01927549)., Competing Interests: Funding Support and Author Disclosures This study was supported by a grant agreement (602202) from the European Union Seventh Framework Program and by the German Heart Research Foundation and the German Cardiac Society. It was also supported by the German Center for Cardiovascular Research (DZHK). Dr Zeymer has received grants from the European Union within the study; has received grants and personal fees from AstraZeneca, Bayer, BMS, Daiichi-Sankyo, and Novartis; and has received personal fees from Boehringer Ingelheim, The Medicines Company, Sanofi, and Ferrer, outside the submitted work. Dr Montalescot has received research grants to the institution or consulting/lecture fees from Abbott, Amgen, Actelion, American College of Cardiology Foundation, AstraZeneca, Axis-Santé, Bayer, Boston Scientific, Boehringer Ingelheim, Bristol Myers Squibb, Beth Israel Deaconess Medical, Brigham Women’s Hospital, China Heart House, Daiichi-Sankyo, Idorsia, Elsevier, Europa, Fédération Française de Cardiologie, ICAN, Lead-Up, Medtronic, Menarini, MSD, Novo Nordisk, Partners, Pfizer, Quantum Genomics, Sanofi, Servier, and WebMD. Dr Desch has received grants from the European Union during the conduct of the study. Dr Thiele has received grants to the institution from the European Union, German Cardiac Society, and German Heart Research Foundation during the conduct of the study. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background Little is known about the impact of center volume on outcomes in acute myocardial infarction complicated by cardiogenic shock. The aim of this study was to investigate the association between center volume, treatment strategies, and subsequent outcome in patients with acute myocardial infarction complicated by cardiogenic shock. Methods and Results In this subanalysis of the randomized CULPRIT-SHOCK (Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock) trial, study sites were categorized based on the annual volume of acute myocardial infarction complicated by cardiogenic shock into low-/intermediate-/high-volume centers (<50; 50-100; and >100 cases/y). Subjects from the study/compulsory registry with available volume data were included. Baseline/procedural characteristics, overall treatment, and 1-year all-cause mortality were compared across categories. n=1032 patients were included in this study (537 treated at low-volume, 240 at intermediate-volume, and 255 at high-volume centers). Baseline risk profile of patients across the volume categories was similar, although high-volume centers included a larger number of older patients. Low-/intermediate-volume centers had more resuscitated patients (57.5%/58.8% versus 42.2%; P <0.01), and more patients on mechanical ventilation in comparison to high-volume centers. There were no differences in reperfusion success despite considerable differences in adjunctive pharmacological/device therapies. There was no difference in 1-year all-cause mortality across volume categories (51.1% versus 56.5% versus 54.4%; P =0.34). Conclusions In this study of patients with acute myocardial infarction complicated by cardiogenic shock, considerable differences in adjunctive medical and mechanical support therapies were observed. However, we could not detect an impact of center volume on reperfusion success or mortality.

Aims: The aim of this pooled sub-analysis of the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) and Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK) trial was to compare the clinical outcome of patients with acute myocardial infarction complicated by cardiogenic shock treated either with clopidogrel or the newer, more potent ADP-receptor antagonists prasugrel or ticagrelor., Methods and Results: For the current analysis the primary endpoint was 1-year mortality and the secondary safety endpoint was moderate or severe bleedings until hospital discharge with respect to three different ADP-receptor antagonists. 856 patients were eligible for analysis. Of these, 507 patients (59.2%) received clopidogrel, 178 patients (20.8%) prasugrel and 171 patients (20.0%) ticagrelor as acute antiplatelet therapy. The adjusted rate of mortality after 1-year did not differ significantly between prasugrel and clopidogrel (hazard ratio [HR]: 0.81, 95% confidence interval [CI] 0.60-1.09, p adj  = 0.17) or between ticagrelor and clopidogrel treated patients (HR: 0.86, 95% CI 0.65-1.15, p adj  = 0.31). In-hospital bleeding events were significantly less frequent in patients treated with ticagrelor vs. clopidogrel (HR: 0.37, 95% CI 0.20 -0.69, p adj  = 0.002) and not significantly different in patients treated with prasugrel vs. clopidogrel (HR: 0.73, 95% CI 0.43 -1.24, p adj  = 0.24)., Conclusion: This pooled sub-analysis is the largest analysis on safety and efficacy of three oral ADP-receptor antagonists and shows that acute therapy with either clopidogrel, prasugrel or ticagrelor is no independent predictor of 1-year mortality. Treatment with ticagrelor seems independently associated with less in-hospital moderate and severe bleeding events compared to clopidogrel. This finding might be due to selection bias and should be interpreted with caution., (© 2021. The Author(s).)

Background: In acute myocardial infarction complicated by cardiogenic shock the use of mechanical circulatory support devices remains controversial and data from randomized clinical trials are very limited. Extracorporeal life support (ECLS) - venoarterial extracorporeal membrane oxygenation - provides the strongest hemodynamic support in addition to oxygenation. However, despite increasing use it has not yet been properly investigated in randomized trials. Therefore, a prospective randomized adequately powered clinical trial is warranted., Study Design: The ECLS-SHOCK trial is a 420-patient controlled, international, multicenter, randomized, open-label trial. It is designed to compare whether treatment with ECLS in addition to early revascularization with percutaneous coronary intervention or alternatively coronary artery bypass grafting and optimal medical treatment is beneficial in comparison to no-ECLS in patients with severe infarct-related cardiogenic shock. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoint of ECLS-SHOCK is 30-day mortality. Secondary outcome measures such as hemodynamic, laboratory, and clinical parameters will serve as surrogate endpoints for prognosis. Furthermore, a longer follow-up at 6 and 12 months will be performed including quality of life assessment. Safety endpoints include peripheral ischemic vascular complications, bleeding and stroke., Conclusions: The ECLS-SHOCK trial will address essential questions of efficacy and safety of ECLS in addition to early revascularization in acute myocardial infarction complicated by cardiogenic shock., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: The impact of coronary artery chronic total occlusion (CTO) and its management with percutaneous coronary intervention (PCI) in the setting of myocardial infarction (MI) related cardiogenic shock (CS) remains unclear., Methods: This is a pre-specified analysis from the culprit-lesion-only PCI vs multivessel PCI in CS (CULPRIT-SHOCK) trial which randomized patients presenting with MI and multivessel disease complicated by CS to a culprit-lesion-only or immediate multivessel PCI strategy. CTO was defined by central core-laboratory evaluation. The independent associations between the presence of CTO and adverse outcomes at 30 days and 1 year were assessed using multivariate logistics models., Results: A noninfarct related CTO was present in 157 of 667 (23.5%) analyzed patients. Patients presenting with CTO had more frequent diabetes mellitus or prior PCI but less frequently presented with ST segment elevation MI as index event. The presence of CTO was associated with higher rate of death at 30 days (adjusted Odds ratio 1.63; 95% confidence interval [CI] 1.01-2.60). Rate of death at 1 year was also increased but did not reach statistical significance (adjusted Odds ratio 1.62; 95%CI 0.99-2.66). Compare to immediate multivessel PCI, a strategy of culprit-lesion-only PCI was associated with lower rates of death or renal replacement therapy at 30 days in patients with and without CTO (Odds ratio 0.79 95%CI 0.42-1.49 and Odds ratio 0.67 95%CI 0.48-0.96, respectively), without significant interaction (P = .68)., Conclusions: In patients with MI-related CS and multivessel disease, the presence of CTO is associated with adverse outcomes while a strategy of culprit-lesion-only PCI seems beneficial regardless of the presence of CTO., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Importance: Myocardial infarction with a culprit lesion located in the left main or proximal left anterior descending artery compared with other coronary segments is associated with more myocardium at risk and worse clinical outcomes., Objective: To evaluate the association of culprit lesion location with outcomes of culprit-lesion-only percutaneous coronary intervention with optional staged revascularization vs immediate multivessel percutaneous coronary intervention in patients with multivessel disease, myocardial infarction, and cardiogenic shock., Design, Setting, and Participants: Post hoc analysis of the Culprit Lesion Only Coronary Intervention vs Multivessel Coronary Intervention in Cardiogenic Shock (CULPRIT-SHOCK), an investigator-initiated randomized, open-label clinical trial. Patients with multivessel disease, acute myocardial infarction, and cardiogenic shock were enrolled at 83 European centers from April 2013 through April 2017., Interventions: Patients were randomized to culprit-lesion-only percutaneous coronary intervention with optional staged revascularization or immediate multivessel percutaneous coronary intervention (1:1). For this analysis, patients were stratified by culprit lesion location in the left main or proximal left anterior descending artery group and other-culprit-lesion location group., Main Outcomes and Measures: End points included a composite of death or kidney replacement therapy at 30 days and death at 1 year., Results: The median age of the study population was 70 (interquartile range, 60-78 years) and 524 of the study participants were men (76.4%). Of the 685 patients, 33.4% constituted the left main or proximal left anterior descending artery group and 66.6% the other-culprit-lesion location group. The left main or proximal left anterior descending artery group had worse outcomes compared with the other-culprit-lesion location group (56.8% vs 47.5%; P = .02 for the composite end point at 30 days and 59.8% vs 50.1%; P = .02 for death at 1 year). In both groups, culprit-lesion-only vs immediate multivessel percutaneous coronary intervention was associated with a reduced risk of the composite end point at 30 days (49.1% vs 64.3% and 44.1% vs 50.9%; P for interaction = .27). At 1 year, culprit-lesion-only vs immediate multivessel percutaneous coronary intervention was associated with a significantly reduced risk of death in the left main or proximal left anterior descending artery but not the other-culprit-lesion location group (50.0% vs 69.6%; P = .003 and 49.8% vs 50.4%; P = .89; P for interaction = 0.02)., Conclusions and Relevance: In patients with multivessel disease with myocardial infarction and cardiogenic shock, a culprit lesion located in the left main or proximal left anterior descending artery vs other coronary segments was associated with worse outcomes. These patients may especially benefit from culprit-lesion-only percutaneous coronary intervention with optional staged revascularization, although further investigation is needed to confirm this finding., Trial Registration: ClinicalTrials.gov Identifier: NCT01927549.

Background: The management of patients with acute myocardial infarction complicated by cardiogenic shock is highly complex, and outcomes may depend on the time of hospital admission and subsequent intervention (ie, ON-hours versus OFF-hours). The CULPRIT-SHOCK trial (Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock) demonstrated superior outcome for culprit-lesion-only versus immediate multivessel percutaneous coronary intervention in patients presenting with acute myocardial infarction, multivessel disease, and cardiogenic shock. However, it is unknown whether the time of hospital admission affects the overall outcome of these high-risk patients., Methods: We analyzed patients from the CULPRIT-SHOCK trial with respect to the time of hospital admission. We divided patients in ON-hours and OFF-hours groups and further stratified them according to their individual revascularization strategy. Outcome measures consisted of a composite end point of death or renal-replacement therapy within 30 days and mortality within 1 year., Results: Out of 686 patients randomized in the CULPRIT-SHOCK trial, 444 patients (64.7%) presented during ON-hours, whereas 242 patients (35.3%) presented during OFF-hours. Death or renal-replacement therapy at 30 days occurred to a similar extent in patients admitted during ON-hours (51.0%) and OFF-hours (50.0%; P =0.80). Similarly, 1-year mortality was not affected by the time of hospital admission (54.4% ON-hours versus 51.7% OFF-hours, P =0.49). Regardless of admission time, patients had a benefit from culprit-lesion-only as compared to immediate multivessel percutaneous coronary intervention. The composite end point at 30 days occurred in 45.1% versus 57.6% of patients admitted ON-hours and in 47.7% versus 51.9% of patients admitted OFF-hours ( P interaction =0.29). Death within 1 year occurred in 49.4% versus 60.0% of patients admitted during ON-hours and in 51.4% versus 51.9% of patients admitted OFF-hours ( P interaction =0.20)., Conclusions: Among patients with myocardial infarction and cardiogenic shock, the risk of death or renal-replacement therapy at 30 days, and mortality at 1 year did not differ significantly according to the time of hospital admission. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01927549.

Objectives: This study sought to determine frequency, associated factors, and impact of bleeding in infarct-related cardiogenic shock., Background: Early revascularization is associated with improved survival in patients with acute myocardial infarction complicated by cardiogenic shock. On the downside, invasive treatment and accompanying antithrombotic therapies are associated with an increased bleeding risk. Prospective data assessing the incidence, severity, risk factors, and prognostic implication of bleeding in patients with cardiogenic shock are scarce., Methods: As a pre-defined subanalysis of the CULPRIT-SHOCK (PCI Strategies in Patients with Acute Myocardial Infarction and Cardiogenic Shock) randomized trial, we examined distribution of bleeding events in 684 patients with infarct-related cardiogenic shock and compared patients with any bleeding to those without., Results: A total of 21.5% patients experienced at least 1 bleeding event until 30 days after randomization. The vast majority of bleeding (57%) occurred within the first 2 days of hospitalization. Patients with bleeding had prolonged catecholamine treatment and mechanical ventilation and there was a significant association with sepsis, peripheral ischemic complications, new atrial fibrillation, and ventricular fibrillation. In multivariable analysis, bleeding was associated with a significantly higher mortality (hazard ratio: 2.11; 95% confidence interval: 1.63 to 2.75; p < 0.0001). Treatment with active mechanical support by extracorporeal membrane oxygenation or Impella emerged as the major risk factor for bleeding., Conclusions: Risk of bleeding in infarct-related cardiogenic shock is high and associated with increased mortality., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Women are more likely to suffer and die from cardiogenic shock (CS) as the most severe complication of acute myocardial infarction. Data concerning optimal management for women with CS are scarce. Aim of this study was to better define characteristics of women experiencing CS and to the influence of sex on different treatment strategies., Methods: In the CULPRIT-SHOCK trial (The Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock), patients with CS complicating acute myocardial infarction and multivessel coronary artery disease were randomly assigned to one of the following revascularization strategies: either percutaneous coronary intervention of the culprit-lesion-only or immediate multivessel percutaneous coronary intervention. Primary end point was composite of death from any cause or severe renal failure leading to renal replacement therapy within 30 days. We investigated sex-specific differences in general and according to the revascularization strategies., Results: Among all 686 randomized patients included in the analysis, 24% were women. Women were older and had more often diabetes mellitus and renal insufficiency, whereas they had less often history of previous acute myocardial infarction and smoking. After 30 days, the primary clinical end point was not significantly different between groups (56% women versus 49% men; odds ratio, 1.29 [95% CI, 0.91-1.84]; P =0.15). There was no interaction between sex and coronary revascularization strategy regarding mortality and renal failure ( P interaction =0.11). The primary end point occurred in 56% of women treated by the culprit-lesion-only strategy versus 42% men, whereas 55% of women and 55% of men in the multivessel percutaneous coronary intervention group., Conclusions: Although women presented with a different risk profile, mortality and renal replacement were similar to men. Sex did not influence mortality and renal failure according to the different coronary revascularization strategies. Based on these data, women and men presenting with CS complicating acute myocardial infarction and multivessel coronary artery disease should not be treated differently. However, further randomized trials powered to address potential sex-specific differences in CS are still necessary. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01927549.

Background It is unclear whether atrial fibrillation (AF) influences prognosis in patients with cardiogenic shock and multivessel disease. We aimed to investigate the prognostic impact of AF in patients with cardiogenic shock complicating acute myocardial infarction. Methods and Results In a subanalysis of the CULPRIT-SHOCK trial (Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock), patients were grouped according to the presence of AF during index hospital stay. The primary end point was all-cause death at 30 days, and the key secondary end point was all-cause death at 1 year. AF was documented in 142 (21%) of 686 patients. AF was not a significant predictor of 30-day (adjusted odds ratio, 1.01; 95% CI 0.67-1.54; P=0.95) and 1-year (adjusted odds ratio, 0.80; 95% CI, 0.52-1.22; P=0.30) all-cause mortality. Patients with AF already on admission showed higher all-cause mortality at 30 days (52 of 90, 58% versus 19 of 52, 37%; P=0.02) and 1 year (57 of 90, 63% versus 20 of 52, 39%; P=0.004) compared with patients with newly detected AF during hospital stay. AF was associated with a longer time to hemodynamic stabilization (4, interquartile range, 1-8 days versus 3, interquartile range, 1-6 days; P=0.04) at 30 days. Conclusions In cardiogenic shock complicating acute myocardial infarction, all-cause mortality is similar in patients with and without AF. Adverse outcome was detected in the subgroup of patients showing AF already on hospital admission. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT01927549.

Background: Percutaneous mechanical circulatory support devices are increasingly used in acute myocardial infarction complicated by cardiogenic shock (AMI-CS), despite limited evidence for their effectiveness. The aim of this study was to evaluate outcomes associated with use of the Impella device compared with intra-aortic balloon pump (IABP) and medical treatment in patients with AMI-CS., Methods: Data of patients with AMI-CS treated with the Impella device at European tertiary care hospitals were collected retrospectively. All patients underwent early revascularization and received optimal medical treatment. Using IABP-SHOCK II (Intraaortic Balloon Pump in Cardiogenic Shock II) trial inclusion and exclusion criteria, 372 patients were identified and included in this analysis. These patients were matched to 600 patients from the IABP-SHOCK II trial. The following baseline criteria were used as matching parameters: age, sex, mechanical ventilation, ejection fraction, prior cardiopulmonary resuscitation, and lactate. Primary end point was 30-day all-cause mortality., Results: In total, 237 patients treated with an Impella could be matched to 237 patients from the IABP-SHOCK II trial. Baseline parameters were similarly distributed after matching. There was no significant difference in 30-day all-cause mortality (48.5% versus 46.4%, P=0.64). Severe or life-threatening bleeding (8.5% versus 3.0%, P<0.01) and peripheral vascular complications (9.8% versus 3.8%, P=0.01) occurred significantly more often in the Impella group. Limiting the analysis to IABP-treated patients as a control group did not change the results., Conclusions: In this retrospective analysis of patients with AMI-CS, the use of an Impella device was not associated with lower 30-day mortality compared with matched patients from the IABP-SHOCK II trial treated with an IABP or medical therapy. To further evaluate this, a large randomized trial is warranted to determine the effect of the Impella device on outcome in patients with AMI-CS., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03313687.

Background: Among patients with acute myocardial infarction, cardiogenic shock, and multivessel coronary artery disease, the risk of a composite of death from any cause or severe renal failure leading to renal-replacement therapy at 30 days was found to be lower with percutaneous coronary intervention (PCI) of the culprit lesion only than with immediate multivessel PCI. We evaluated clinical outcomes at 1 year., Methods: We randomly assigned 706 patients to either culprit-lesion-only PCI or immediate multivessel PCI. The results for the primary end point of death or renal-replacement therapy at 30 days have been reported previously. Prespecified secondary end points at 1 year included death from any cause, recurrent myocardial infarction, repeat revascularization, rehospitalization for congestive heart failure, the composite of death or recurrent infarction, and the composite of death, recurrent infarction, or rehospitalization for heart failure., Results: As reported previously, at 30 days, the primary end point had occurred in 45.9% of the patients in the culprit-lesion-only PCI group and in 55.4% in the multivessel PCI group (P=0.01). At 1 year, death had occurred in 172 of 344 patients (50.0%) in the culprit-lesion-only PCI group and in 194 of 341 patients (56.9%) in the multivessel PCI group (relative risk, 0.88; 95% confidence interval [CI], 0.76 to 1.01). The rate of recurrent infarction was 1.7% with culprit-lesion-only PCI and 2.1% with multivessel PCI (relative risk, 0.85; 95% CI, 0.29 to 2.50), and the rate of a composite of death or recurrent infarction was 50.9% and 58.4%, respectively (relative risk, 0.87; 95% CI, 0.76 to 1.00). Repeat revascularization occurred more frequently with culprit-lesion-only PCI than with multivessel PCI (in 32.3% of the patients vs. 9.4%; relative risk, 3.44; 95% CI, 2.39 to 4.95), as did rehospitalization for heart failure (5.2% vs. 1.2%; relative risk, 4.46; 95% CI, 1.53 to 13.04)., Conclusions: Among patients with acute myocardial infarction and cardiogenic shock, the risk of death or renal-replacement therapy at 30 days was lower with culprit-lesion-only PCI than with immediate multivessel PCI, and mortality did not differ significantly between the two groups at 1 year of follow-up. (Funded by the European Union Seventh Framework Program and others; CULPRIT-SHOCK ClinicalTrials.gov number, NCT01927549 .).

Background: Transmural acute myocardial infarction (AMI) is associated with a high risk for ventricular arrhythmia before, during and after treatment. Consequently, it is recommended that patients diagnosed with transmural AMI be monitored in a cardiac care unit (CCU) so life-threatening arrhythmias can be treated promptly. We examined the incidence and timing of in-hospital malignant ventricular arrhythmias, sudden cardiac or arrhythmic death (SCD/AD) and resuscitation requirements in patients with transmural AMI recovering from percutaneous coronary intervention (PCI) undertaken within 12 h of symptom onset and without antecedent thrombolysis., Methods: This was a retrospective cohort study using the Duisburg Heart Center (Germany) cardiac patient registry. In total, 975 patients met the inclusion criteria. The composite endpoint was post-PCI ventricular fibrillation or tachycardia, SCD/AD or requirement for resuscitation. We compared the demographic and clinical characteristics of patients who met the composite endpoint with those who did not, recorded the timing of endpoint episodes, and used multivariable logistic regression analysis to identify factors associated with the endpoint criteria., Results: There was no significant difference in the length of CCU or hospital stay between the groups. In-hospital mortality was 6.5%, and the composite endpoint was met in 7.4% of cases. Malignant ventricular tachyarrhythmia occurred in 2.8% of the patients, and SCD/AD occurred in 0.3% of the cases. There was a biphasic temporal distribution of endpoint events; specifically, 76.7% occurred < 96 h after symptom onset, and 12.6% occurred 240-360 h after symptom onset. Multivariable regression analysis identified positive associations between an endpoint episode and the following: age (odds ratio [OR] 1.03, 95% confidence interval [CI] 1.01-1.05] per year); left ventricular ejection fraction (LVEF) < 30% (OR 3.66, 95% CI 1.91-6.99); peak serum creatine phosphokinase concentration (OR 1.01, 95% CI 1.00-1.02 per 100 U/dl); leucocytosis (OR 1.86, 95% CI 1.04-3.32), and coronary thrombus (OR 1.85, 95% CI 1.04-3.27)., Conclusions: Most post-PCI malignant ventricular arrhythmias, SCD/AD and resuscitation episodes occurred within 96 h of transmural AMI (76.7%). A substantial minority (12.6%) of these events arose 240-360 h after symptom onset. Further study is needed to establish the influence of age, LVEF < 30%, peak serum creatine phosphokinase concentration, leucocytosis and coronary thrombus on post-PCI outcomes after transmural AMI.

Aims: The aim of the current study was to investigate the impact of a chronic total occlusion (CTO) in a non-infarct-related coronary artery (non-IRA) on one-year mortality and occurrence of cardiac arrhythmia in patients with cardiogenic shock (CS) complicating acute myocardial infarction (AMI)., Methods and Results: In a retrospective sub-analysis of the Intraaortic Balloon Pump in Cardiogenic Shock II trial (IABP-SHOCK II) and its accompanying registry, 201 (26%) of 761 patients had a CTO in a non-IR major coronary artery. Mortality was significantly higher in the CTO group at day of admission (19% vs. 11%; p=0.005), 30 days (53% vs. 41%, p=0.002), and 12 months (63% vs. 51%, p=0.002). In the adjusted multivariate Cox regression analysis, a CTO in a non-IRA was an independent predictor of mortality at 12 months (hazard ratio 1.30, 95% confidence interval [CI]: 1.02-1.67, p=0.03). At 30-day follow-up, ventricular arrhythmias requiring defibrillation occurred more frequently in patients with non-IRA CTO in the univariate analysis (33% vs. 21%, odds ratio 1.83, 95% CI: 1.28-2.62, p=0.002)., Conclusions: In patients with CS complicating AMI, the presence of CTO in a non-IRA is associated with a higher incidence of ventricular arrhythmias and is an independent predictor of mortality at 12-month follow-up.

Background: Aim of the current study was to analyse the impact of atrial fibrillation (AF) on prognosis in patients with cardiogenic shock (CS) complicating acute myocardial infarction (AMI), which has never been investigated yet., Methods: The current analysis is a substudy of the IABP-SHOCK II trial. Patients were grouped according to the presence or absence of AF. The primary endpoint was all-cause mortality at 30-day follow-up. Secondary endpoints included all-cause mortality, recurrent myocardial infarction, repeat revascularisation, and stroke at 12 months., Results: AF was documented in 28.2% (n = 169) of all 600 patients initially enrolled in the IABP-SHOCK II trial. There were no significant differences with respect to mortality at 30 days and 12 months between patients with and without AF (p = 0.81, p = 0.74). Similarly, the rates of recurrent myocardial infarction, repeat revascularisation, and stroke did not differ between groups (all p > 0.05). There was no interaction of intraaortic balloon counterpulsation (IABP) and no IABP in patients with or without AF with respect to clinical outcome at 30 days and 12 months (p > 0.05)., Conclusion: AF is not associated with clinical outcome at 30 days and 12 months in CS complicating AMI.

Background: In patients who have acute myocardial infarction with cardiogenic shock, early revascularization of the culprit artery by means of percutaneous coronary intervention (PCI) improves outcomes. However, the majority of patients with cardiogenic shock have multivessel disease, and whether PCI should be performed immediately for stenoses in nonculprit arteries is controversial., Methods: In this multicenter trial, we randomly assigned 706 patients who had multivessel disease, acute myocardial infarction, and cardiogenic shock to one of two initial revascularization strategies: either PCI of the culprit lesion only, with the option of staged revascularization of nonculprit lesions, or immediate multivessel PCI. The primary end point was a composite of death or severe renal failure leading to renal-replacement therapy within 30 days after randomization. Safety end points included bleeding and stroke., Results: At 30 days, the composite primary end point of death or renal-replacement therapy had occurred in 158 of the 344 patients (45.9%) in the culprit-lesion-only PCI group and in 189 of the 341 patients (55.4%) in the multivessel PCI group (relative risk, 0.83; 95% confidence interval [CI], 0.71 to 0.96; P=0.01). The relative risk of death in the culprit-lesion-only PCI group as compared with the multivessel PCI group was 0.84 (95% CI, 0.72 to 0.98; P=0.03), and the relative risk of renal-replacement therapy was 0.71 (95% CI, 0.49 to 1.03; P=0.07). The time to hemodynamic stabilization, the risk of catecholamine therapy and the duration of such therapy, the levels of troponin T and creatine kinase, and the rates of bleeding and stroke did not differ significantly between the two groups., Conclusions: Among patients who had multivessel coronary artery disease and acute myocardial infarction with cardiogenic shock, the 30-day risk of a composite of death or severe renal failure leading to renal-replacement therapy was lower among those who initially underwent PCI of the culprit lesion only than among those who underwent immediate multivessel PCI. (Funded by the European Union 7th Framework Program and others; CULPRIT-SHOCK ClinicalTrials.gov number, NCT01927549 .).

Background: Current guidelines recommend immediate multivessel percutaneous coronary intervention (PCI) in patients with cardiogenic shock, despite the lack of randomised trials. We sought to investigate the use and impact on outcome of multivessel PCI in comparison to culprit lesion only PCI in a retrospective analysis in patients with cardiogenic shock complicating acute myocardial infarction., Methods and Results: In the randomised IABP-SHOCK II trial, investigating the effect of intra-aortic balloon pump on outcome, 451 (75%) of the total of 600 patients had multivessel coronary artery disease and underwent PCI. Immediate multivessel PCI was performed in 167 (37%) patients. TIMI 3 patency after PCI in all treated vessels was observed in 83.2% versus 79.0% of patients after multivessel versus culprit lesion PCI, respectively. The 30-day (44.9% vs. 42.3%) and 12-month (54.8% vs. 52.7%) mortality rates did not significantly differ between the two groups. In the multivariate analysis multivessel PCI was not associated with an improved mortality after 12 months (odds ratio 0.92, 95% confidence intervals 0.69-1.21)., Conclusion: In this retrospective analysis of the largest randomised study in cardiogenic shock immediate multivessel PCI was used in approximately one third of patients with cardiogenic shock. There was no benefit with immediate multivessel PCI in comparison to culprit lesion only PCI. Therefore a randomised trial is needed to determine the definitive role of multivessel PCI in cardiogenic shock., Clinical Trial Registration: ClinicalTrials.gov , NCT00491036.

Objectives: The aim of the present study was to assess the outcome of patients with acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) receiving drug-eluting stents (DES) compared with bare-metal stents (BMS). Data comparing these two stent technologies in AMI with CS were limited., Methods: A total of 783 patients with AMI and CS undergoing early revascularisation were included in the randomised Intra-aortic Balloon Pump in Cardiogenic Shock II trial (n=600) and the associated registry (n=183). Patients receiving no stent or both, DES and BMS, were excluded. Primary end point was the composite of 1-year mortality or re-AMI., Results: Of the total cohort, 652 (83%) patients received either solely DES or BMS and were included in the present analysis. Of these, 276 (42%) patients received DES and 376 (58%) received BMS. After adjustment for baseline characteristics, there was no significant difference between DES and BMS regarding the primary end point (HR 0.83 (CI 0.64 to 1.06); p=0.14). There was an independent association of BMS use with older age, atrial fibrillation and coronary single-vessel disease. DES use was associated with prior known dyslipidaemia, baseline haemoglobin level, anterior AMI and treatment at frequently enrolling centres., Conclusions: Despite the frequent use of DES nowadays, a substantial number of patients were treated by BMS in AMI complicated by CS. After adjustment for risk factors, the 1-year outcome of patients treated by DES compared with BMS was similar. TRIAL REGISTRATIONNUMBER: www.clinicaltrials.gov: NCT00491036., Competing Interests: Competing Interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Aims: The aim of this post hoc subgroup analysis of the Intraaortic Balloon Pump in Cardiogenic Shock II trial was to compare the clinical outcome of patients treated with either clopidogrel or the newer, more potent P2Y12 receptor inhibitors prasugrel or ticagrelor., Methods and Results: The primary endpoint was one-year mortality with respect to different P2Y12 receptor inhibitors. Secondary safety endpoints were GUSTO bleedings until hospital discharge. After exclusion of 117 patients (patients who died before or during PCI, patients with unavailable information on P2Y12 receptor inhibitor treatment, patients not receiving or receiving a combination of different P2Y12 receptor inhibitors as acute antiplatelet therapy), 483 patients were analysed. Of these, 373 patients (77.2%) received clopidogrel and 110 patients (22.8%) either prasugrel or ticagrelor as acute antiplatelet therapy. The adjusted rate of mortality did not differ between prasugrel/ticagrelor and clopidogrel treated patients (HR: 0.83, 95% CI: 0.59-1.19, padj=0.31). GUSTO bleedings did not differ between groups (14.3% for prasugrel/ticagrelor and 16.4% for clopidogrel, HR: 0.91, 95% CI: 0.55-1.5, padj=0.7)., Conclusions: This IABP-SHOCK II trial subgroup analysis shows that the use of potent P2Y12 receptor inhibitors like prasugrel or ticagrelor is feasible and might not be harmful in selected patients with cardiogenic shock complicating acute myocardial infarction. However, the superiority in comparison to clopidogrel remains to be proven.

Background: In myocardial infarction without cardiogenic shock (CS), the affected coronary vessel has significant influence on the final infarct size and patient prognosis. CS data on this relation are scarce. The objective of this study was to determine the prognostic relevance of the culprit lesion location in patients with CS complicating acute myocardial infarction., Methods: In the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial patients with CS were randomized to therapy with intraaortic balloon pump or control. Additional CS patients not eligible for the randomized trial were included in a registry. We compared the location of the culprit lesions in these patients with regard to the affected coronary vessel [left main (LM), left anterior descending (LAD), left circumflex (LCX) and right coronary artery (RCA)] and location within the vessel (proximal, mid or distal) regarding short- and long-term outcome., Results: Of 758 patients, the majority had the culprit lesion in the LAD (44 %) compared to RCA (27 %), LCX (19 %) or LM (10 %). Proximal lesions were more frequent than mid or distal culprit lesions (60 vs. 27 vs. 13 %, p < 0.001). No differences were observed for mortality with respect to either culprit vessel (log-rank p value = 0.54). In contrast, a higher mortality was observed for patients with distal culprit lesions after 1 year (log-rank p value = 0.04). This difference persisted after multivariable adjustment (hazard ratio for distal lesions 1.40; 95 % confidential interval 1.03-1.90; p = 0.03)., Conclusion: For patients with CS complicating myocardial infarction, the culprit vessel seems to be unrelated with mortality whereas distal culprit lesions may have a worse outcome.

Background: Several studies in patients with acute myocardial infarction (AMI) without cardiogenic shock (CS) indicate a better survival in smokers, the so called "smoker's paradox". For CS, this relationship has not been investigated so far in the primary percutaneous coronary intervention (PCI) era., Methods: In a predefined substudy of the Intraaortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial and its accompanying registry including patients with CS complicating AMI we investigated differences in outcome of smokers compared to non-smokers. All-cause-mortality at 1year was used as primary endpoint., Results: Of 772 patients with available smoking status 263 patients were smokers (34%). Smokers were more often male (79% vs. 65%; p<0.001), of younger age (61 [interquartile range IQR 52-70] vs. 73 [IQR 64-79] years; p<0.001), had less comorbidity including arterial hypertension (62% vs. 71%; p=0.007) and diabetes mellitus (26% vs. 38%; p<0.001) and had lower levels of serum creatinine (13% vs. 25%; p<0.001). There was no significant difference between the 2 groups regarding left ventricular ejection fraction, initial revascularization strategy or use of IABP. Smokers had lower rates of mortality at 12months in univariable analysis (43% vs. 59%; p<0.001) but not after adjustment for important confounders using Cox-regression analysis (hazard ratio 0.77, 95% confidence interval 0.59-1.03; p=0.08)., Conclusion: Smoking is not predictive of outcome in patients with CS complicating AMI. The observed survival benefit in univariable analysis seems to be explained by the younger age and lower risk profile of smokers., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: In acute myocardial infarction complicated by cardiogenic shock (CS), up to 80% of patients present with multivessel coronary artery disease. Currently, the best revascularization strategy is unknown. Therefore, a prospective randomized adequately powered clinical trial is warranted., Study Design: The CULPRIT-SHOCK study is a 706-patient controlled, international, multicenter, randomized, open-label trial. It is designed to compare culprit lesion only percutaneous coronary intervention (PCI) with possible staged non-culprit lesion revascularization versus immediate multivessel PCI in patients with CS complicating acute myocardial infarction. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary efficacy endpoint of CULPRIT-SHOCK is 30-day mortality and severe renal failure requiring renal replacement therapy. Secondary outcome measures such as hemodynamic, laboratory, and clinical parameters will serve as surrogate endpoints for prognosis. Furthermore, an intermediate- and long-term follow-up at 6 and 12 months will be performed. Safety endpoints include the assessment of bleeding and stroke., Conclusions: The CULPRIT-SHOCK trial will address the question of optimal revascularization strategy in patients with multivessel disease and acute myocardial infarction complicated by CS., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Cardiogenic shock (CS) complicating acute myocardial infarction (AMI) is associated with high mortality. Previous studies regarding gender-specific differences in CS are conflicting and there are insufficient data for the presence of gender-associated differences in the contemporary percutaneous coronary intervention era. Aim of this study was therefore to investigate gender-specific differences in a large cohort of AMI patients with CS undergoing contemporary treatment., Methods: In the randomized Intra-aortic Balloon Pump in Cardiogenic Shock II (IABP-SHOCK II) trial, 600 patients with CS complicating AMI undergoing early revascularization were assigned to therapy with or without intra-aortic balloon pump. We compared sex-specific differences in these patients with regard to baseline and procedural characteristics as well as short- and long-term clinical outcome., Results: Of 600 patients 187 (31%) were female. Women were significantly older than men and had a significantly lower systolic and diastolic blood pressure at presentation (p < 0.05 for all). Diabetes mellitus and hypertension were more frequent in women, whereas smoking was more frequent in men (p < 0.05 for all). Women showed a higher mortality within the first day after randomization (p = 0.004). However, after multivariable adjustment this numerical difference was no longer statistically significant. No gender-related differences in clinical outcome were observed after 1, 6 and 12 months of follow-up., Conclusion: In this large-scale multicenter study in patients with CS complicating AMI, women had a worse-risk profile in comparison to men. No significant gender-related differences in treatment as well as short- and long-term outcome were observed.

Background: The prognostic effect of early, comprehensive short-term cardiac rehabilitation on top of current, guideline-adjusted treatment of acute myocardial infarction has not sufficiently been evaluated., Design: Prospective cohort study., Methods: Within the OMEGA study population, the clinical course of 3560 patients still alive 3 months after acute myocardial infarction were evaluated by comparing patients who had attended to cardiac rehabilitation (70.6%) with those who did not. Total mortality and major adverse cerebrovascular and cardiovascular events, as well as non-fatal events, were evaluated within the time period of 4-12 months after hospital admission for acute myocardial infarction. The effect of cardiac rehabilitation on clinical events was estimated by using the propensity score method to adjust for confounding parameters in multivariate analysis., Results: Patients participating in cardiac rehabilitation were younger, more often had acute revascularization, less often experienced non-ST-elevation myocardial infarction, and less often had a history of diabetes or cardiovascular events. Total mortality (OR 0.46, 95% CI 0.27-0.77) and major adverse cerebrovascular and cardiovascular events (OR 0.53, 95% CI 0.38-0.75) were significantly lower in the rehabilitation group. Subgroup analysis including major clinical characteristics also revealed significantly reduced rates of total death and major adverse cerebrovascular and cardiovascular events in the rehabilitation group., Conclusions: Attendance to early, comprehensive short-term cardiac rehabilitation programmes on top of current guideline-adjusted treatment of acute myocardial infarction is associated with a significantly improved 1-year prognosis., (© Authors 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.)

Background: In current international guidelines the recommendation for intra-aortic balloon pump (IABP) use has been downgraded in cardiogenic shock complicating acute myocardial infarction on the basis of registry data. In the largest randomised trial (IABP-SHOCK II), IABP support did not reduce 30 day mortality compared with control. However, previous trials in cardiogenic shock showed a mortality benefit only at extended follow-up. The present analysis therefore reports 6 and 12 month results., Methods: The IABP-SHOCK II trial was a randomised, open-label, multicentre trial. Patients with cardiogenic shock complicating acute myocardial infarction who were undergoing early revascularisation and optimum medical therapy were randomly assigned (1:1) to IABP versus control via a central web-based system. The primary efficacy endpoint was 30 day all-cause mortality, but 6 and 12 month follow-up was done in addition to quality-of-life assessment for all survivors with the Euroqol-5D questionnaire. A masked central committee adjudicated clinical outcomes. Patients and investigators were not masked to treatment allocation. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, NCT00491036., Findings: Between June 16, 2009, and March 3, 2012, 600 patients were assigned to IABP (n=301) or control (n=299). Of 595 patients completing 12 month follow-up, 155 (52%) of 299 patients in the IABP group and 152 (51%) of 296 patients in the control group had died (relative risk [RR] 1·01, 95% CI 0·86-1·18, p=0·91). There were no significant differences in reinfarction (RR 2·60, 95% CI 0·95-7·10, p=0·05), recurrent revascularisation (0·91, 0·58-1·41, p=0·77), or stroke (1·50, 0·25-8·84, p=1·00). For survivors, quality-of-life measures including mobility, self-care, usual activities, pain or discomfort, and anxiety or depression did not differ significantly between study groups., Interpretation: In patients undergoing early revascularisation for myocardial infarction complicated by cardiogenic shock, IABP did not reduce 12 month all-cause mortality., Funding: German Research Foundation; German Heart Research Foundation; German Cardiac Society; Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte; University of Leipzig--Heart Centre; Maquet Cardiopulmonary; Teleflex Medical., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Objective: The effects of supplementation of the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on prevalence and severity of depression were evaluated in patients after a myocardial infarction., Method: A cross-sectional evaluation (posttest-only design) within the prospective, randomized, controlled, multicenter OMEGA trial was performed in patients after myocardial infarction at 12 months' follow-up (N = 2,081; age, mean = 64 years; men, 76.7%; women, 21.8%) from April 2005 to June 2007. Patients received supplementation with ethyl esters 90 (460-mg EPA and 380-mg DHA) or placebo for 12 months. Depression was assessed with the Beck Depression Inventory-II (BDI-II); a BDI-II cutoff score of ≥ 14 was used as diagnosis of depression., Results: When the total population was evaluated, no effects of EPA/DHA supplementation on depressive symptoms according to BDI-II score (mean [SD]) could be demonstrated: EPA/DHA (n = 1,046), 7.1 (6.9); placebo (n = 1,035), 7.1 (7.0); P = .7. The post hoc analyses of depressed patients with and without antidepressants revealed a tendency toward an antidepressant effect in patients with EPA/DHA supplementation as monotherapy: EPA/DHA (n = 125), 19.4 (5.8); placebo (n = 113), 19.9 (5.1); P = .07. However, in depressed patients with EPA/DHA supplementation as adjunctive to conventional antidepressants, a clinically relevant antidepressant effect was demonstrated: EPA/DHA (n = 33), 20.9 (7.1); placebo (n = 29), 24.9 (8.5); P < .05., Conclusions: EPA/DHA supplementation in the total sample of patients after myocardial infarction had no effect on depressive symptoms. The clinically relevant antidepressant effect in the subgroup of depressed patients with EPA/DHA supplementation as adjunctive to conventional antidepressants that was revealed in the post hoc analysis might provide a basis for a controlled, prospective trial of omega-3 augmentation of antidepressants in patients after myocardial infarction., Trial Registration: ClinicalTrials.gov identifier: NCT00251134., (© Copyright 2013 Physicians Postgraduate Press, Inc.)

Background: Predictors of long-term mortality after discharge after acute myocardial infarction (AMI) are well characterized. However, these established risk factors are based on data almost exclusively derived from older studies without consistent use of revascularization therapy and adjunctive therapy with statins, platelet inhibitors, beta-blockers and ACE inhibitors/ARBs. We therefore sought to investigate predictors of 1-year mortality in survivors of AMI treated with contemporary guideline-adherent therapy., Methods and Results: We performed a retrospective analysis of 3,782 patients surviving acute ST-elevation and non ST-elevation myocardial infarction who were enrolled in the prospective, randomized, double-blind, controlled OMEGA trial with 104 German centers. The primary objective of the OMEGA study was to determine the effect of highly purified omega-3 fatty acid ethyl esters-90 on the rate of sudden cardiac death in patients surviving AMI and receiving current guideline-adherent treatment within the 1-year of follow-up. 80.8 % of the patients received early revascularization therapy. At discharge, 94.2 % of the patients received beta-blocker, 90.4 % ACE inhibitor/angiotensin receptor blocker, 94.3 % statin, 95.4 % aspirin and 88.4 % clopidogrel. During the 1-year follow-up 139 patients (3.7 %) died. Multivariate logistic regression analysis revealed the following independent predictors of 1-year mortality in decreasing order of importance: ejection fraction <45 % [odds ratio (OR) 2.28, 95 % confidence interval (CI) 1.53-3.41], age ≥70 years (OR 2.17, 95 % CI 1.42-3.32), no acute revascularization (OR 2.02, 95 % CI 1.33-3.08), prior stroke/transient ischemic attack (OR 1.90, 95 % CI 1.09-3.30), peripheral arterial disease (OR 1.86, 95 % CI 1.12-3.10), heart rate >85/min (OR 1.82, 95 % CI 1.23-2.71), chronic obstructive lung disease (OR 1.77, 95 % CI 1.01-3.10) and HDL cholesterol <40 mg/dl (OR 1.75, 95 % CI 1.15-2.67)., Conclusions: In patients surviving AMI and treated with contemporary guideline-adherent therapy, 1-year mortality was low. Nevertheless, traditional risk factors such as ejection fraction <45 %, older age, no acute revascularization and comorbidities were the strongest predictors of long-term mortality supporting the findings from previous studies.

In the setting of acute myocardial infarction and sinus rhythm, the heart rate (HR) has been demonstrated to correlate closely with mortality. In patients presenting with acute myocardial infarction and atrial fibrillation (AF) on admission, however, the prognostic relevance of the HR has not yet been systematically addressed. A post hoc subgroup analysis of the data from the OMEGA trial was conducted to analyze whether the admission HR determines the 1-year mortality in patients presenting with AF in the setting of acute myocardial infarction. Of 3,851 patients enrolled in the OMEGA study, 211 (6%) presented with AF on admission. This subgroup was dichotomized according to the admission HR (cutoff 95 beats/min). Multiple regression analysis revealed that an admission HR of ≥95 beats/min independently determined the 1-year mortality in patients with AF (odds ratio 4.69, 95% confidence interval 1.47 to 15.01; p = 0.01). In conclusion, this is the first study demonstrating that a high HR (≥95 beats/min) on admission in patients with AF and acute myocardial infarction is associated with an almost fivefold mortality risk., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: In current international guidelines, intraaortic balloon counterpulsation is considered to be a class I treatment for cardiogenic shock complicating acute myocardial infarction. However, evidence is based mainly on registry data, and there is a paucity of randomized clinical trials., Methods: In this randomized, prospective, open-label, multicenter trial, we randomly assigned 600 patients with cardiogenic shock complicating acute myocardial infarction to intraaortic balloon counterpulsation (IABP group, 301 patients) or no intraaortic balloon counterpulsation (control group, 299 patients). All patients were expected to undergo early revascularization (by means of percutaneous coronary intervention or bypass surgery) and to receive the best available medical therapy. The primary efficacy end point was 30-day all-cause mortality. Safety assessments included major bleeding, peripheral ischemic complications, sepsis, and stroke., Results: A total of 300 patients in the IABP group and 298 in the control group were included in the analysis of the primary end point. At 30 days, 119 patients in the IABP group (39.7%) and 123 patients in the control group (41.3%) had died (relative risk with IABP, 0.96; 95% confidence interval, 0.79 to 1.17; P=0.69). There were no significant differences in secondary end points or in process-of-care measures, including the time to hemodynamic stabilization, the length of stay in the intensive care unit, serum lactate levels, the dose and duration of catecholamine therapy, and renal function. The IABP group and the control group did not differ significantly with respect to the rates of major bleeding (3.3% and 4.4%, respectively; P=0.51), peripheral ischemic complications (4.3% and 3.4%, P=0.53), sepsis (15.7% and 20.5%, P=0.15), and stroke (0.7% and 1.7%, P=0.28)., Conclusions: The use of intraaortic balloon counterpulsation did not significantly reduce 30-day mortality in patients with cardiogenic shock complicating acute myocardial infarction for whom an early revascularization strategy was planned. (Funded by the German Research Foundation and others; IABP-SHOCK II ClinicalTrials.gov number, NCT00491036.).

Patients with acute ST-segment elevation myocardial infarction (STEMI) needing prehospital cardiopulmonary resuscitation (CPR) have a very high adverse-event rate. However, little is known about the fate of these patients and predictors of mortality in the era of early reperfusion therapy. From March 2003 through December 2004, 2,317 patients with prehospital diagnosed STEMI were enrolled in the Prehospital Myocardial Infarction Registry. One hundred ninety patients (8.2%) underwent prehospital CPR and were included in our analysis. Overall 90% of patients were treated with early reperfusion therapy, 56.3% received prehospital thrombolysis and 1/2 of these patients received early percutaneous coronary intervention after thrombolysis, 28.4% of patients were treated with primary percutaneous coronary intervention, and 5.3% received in-hospital thrombolysis. Total mortality was 40.0%. The highest mortality was seen in patients with asystole (63%) or pulseless electric activity (64%). Independent predictors of mortality were need for endotracheal intubation and older age, whereas ventricular fibrillation as initial heart rhythm was associated with survival. In conclusion, in this large registry with prehospital diagnosed STEMI, incidence of prehospital CPR was about 8%. Even with a very high rate of early reperfusion therapy, in-hospital mortality was high. Especially in elderly patients with asystole as initial heart rhythm and with need for endotracheal intubation, prognosis is poor despite aggressive reperfusion therapy., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: In current guidelines, intraaortic balloon pumping (IABP) is considered a class 1 indication in cardiogenic shock complicating acute myocardial infarction. However, evidence is mainly based on retrospective or prospective registries with a lack of randomized clinical trials. Therefore, IABP is currently only used in 20% to 40% of cardiogenic shock cases. The hypothesis of this trial is that IABP in addition to early revascularization by either percutaneous coronary intervention or coronary artery bypass grafting will improve clinical outcome of patients in cardiogenic shock., Study Design: The IABP-SHOCK II study is a 600-patient, prospective, multicenter, randomized, open-label, controlled trial. The study is designed to compare the efficacy and safety of IABP versus optimal medical therapy on the background of early revascularization by either percutaneous coronary intervention or coronary artery bypass grafting. Patients will be randomized in a 1:1 fashion to 1 of the 2 treatments. The primary efficacy end point of IABP-SHOCK II is 30-day all-cause mortality. Secondary outcome measures, such as hemodynamic, laboratory, and clinical parameters, will serve as surrogate end points for prognosis. Furthermore, an intermediate and long-term follow-up at 6 and 12 months will be performed. Safety will be assessed, by the GUSTO bleeding definition, peripheral ischemic complications, sepsis, and stroke., Conclusions: The IABP-SHOCK II trial addresses important questions regarding the efficacy and safety of IABP in addition to early revascularization in patients with cardiogenic shock complicating myocardial infarction., (Copyright © 2012 Mosby, Inc. All rights reserved.)

Background: Information about the clinical course of patients with acute myocardial infarction requiring mechanical ventilation is scarce. We sought to evaluate the clinical outcome of a large cohort of such patients in clinical practice., Methods: The German BEAT registry prospectively enrolled consecutive patients requiring mechanical ventilation who were admitted to an internal intensive care unit (ICU) of 45 participating German hospitals between September 2001 and June 2002. For this analysis, we created a subgroup of patients with acute ST-segment-elevation or non-ST-segment-elevation myocardial infarction., Results: During the 9-month study period, 458 consecutive patients fulfilled our inclusion criteria. The mean age was 68 ± 8 years and 71% were men. 40% of the patients were already intubated in the prehospital phase. The initial reason for intubation was in 48% of the cases ventricular fibrillation/tachycardia or sudden cardiac death, in 39% congestive heart failure and in 13% of the cases non-cardiac. The median time of ventilation was 2 days (1-5) among survivors and 1 day (0-5) among non-survivors. Of the 458 patients, 256 (56%) had already or developed cardiogenic shock, 86 (19%) acute renal failure, 76 (17%) coma or brain damage, 64 (14%) severe infection, 46 (10%) sepsis and 28 (6%) multiorgan distress syndrome; 11% were treated with fibrinolysis, 39% with PCI and 6% with coronary artery bypass grafting. The overall hospital mortality rate was 48%. In patients with cardiogenic shock, mortality was even higher with 69%., Conclusions: Patients requiring mechanical ventilation during an acute myocardial infarction constitute a high risk group with a mortality of about 50%. Further research is necessary to improve the outcome of these patients.

Background: There is no randomized, double-blind trial testing the prognostic effect of highly purified omega-3 fatty acids in addition to current guideline-adjusted treatment of acute myocardial infarction., Methods and Results: OMEGA is a randomized, placebo-controlled, double-blind, multicenter trial testing the effects of omega-3-acid ethyl esters-90 (1 g/d for 1 year) on the rate of sudden cardiac death in survivors of acute myocardial infarction, if given in addition to current guideline-adjusted treatment. Secondary end points were total mortality and nonfatal clinical events. Patients (n=3851; female, 25.6%; mean age, 64.0 years) were randomized in 104 German centers 3 to 14 days after acute myocardial infarction from October 2003 until June 2007. Acute coronary angiography was performed in 93.8% and acute percutaneous coronary intervention in 77.8% of all patients. During a follow-up of 365 days, the event rates were (omega and control groups) as follows: sudden cardiac death, 1.5% and 1.5% (P=0.84); total mortality, 4.6% and 3.7% (P=0.18); major adverse cerebrovascular and cardiovascular events, 10.4% and 8.8% (P=0.1); and revascularization in survivors, 27.6% and 29.1% (P=0.34)., Conclusions: Guideline-adjusted treatment of acute myocardial infarction results in a low rate of sudden cardiac death and other clinical events within 1 year of follow-up, which could not be shown to be further reduced by the application of omega-3 fatty acids., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00251134.

Objectives: The aim was to evaluate the effect of short-term cardiac rehabilitation (CR) on clinical events during a 1-year follow-up after acute myocardial infarction., Methods: From the observational, prospective Acute COronary Syndromes (ACOS) registry, 4547 consecutive patients after ST-elevation (STEMI: n = 2432) or non-ST-elevation myocardial infarction (NSTEMI: n = 2115), recruited between June 2000 and December 2002, were characterised and evaluated for clinical outcomes during a 1-year follow-up. From the STEMI group 67.8% and from the NSTEMI group 52.3% participated in cardiac rehabilitation (CR+)., Results: Age > 70 years and previous myocardial infarction were independent predictors not to attend CR in STEMI and NSTEMI patients, whereas early revascularisation (<48 hours after hospital admission) was associated with increased likelihood to undergo CR. Multivariable analysis adjusting for propensity score shows that CR+ was independently associated with a significant reduction of all-cause mortality (STEMI: OR 0.41, 95% CI 0.28-0.60; NSTEMI: OR 0.53, 95% CI 0.38-0.76) and major adverse cardiac and cerebrovascular events (MACCE; STEMI: OR 0.66, 95% CI 0.49-0.89; NSTEMI: OR 0.73, 95% CI 0.55-0.98) during a 1-year follow-up., Conclusion: The study shows an independent and strong association of CR+ with markedly reduced total mortality and MACCE during a 1-year follow-up after STEMI or NSTEMI. The limitation of the study is that it is not a prospective randomised trial. Furthermore, unequal distribution of risk factors relevant for long-term prognosis had to be corrected by multivariable analysis adjusting for propensity score.

Background: Studies continue to identify percutaneous coronary intervention procedural volume both at the institutional level and at the operator level as being strongly correlated with outcome. High-volume centers have been defined as those that perform >400 percutaneous coronary intervention procedures per year. The relationship between drug-eluting stent procedural volume and outcome is unknown. We investigated this relationship in the German Cypher Registry., Methods and Results: The present analysis included 8201 patients treated with sirolimus-eluting stents between April 2002 and September 2005 in 51 centers. Centers that recruited >400 sirolimus-eluting stent patients in this time period were considered high-volume centers; those with 150 to 400 patients were considered intermediate-volume centers; and those with <150 patients were designated as low-volume centers. The primary end point was all death, myocardial infarction, and target-vessel revascularization at 6 months. This end point occurred in 11.3%, 12.1%, and 9.0% of patients in the low-, intermediate-, and high-volume center groups, respectively (P=0.0001). There was no difference between groups in the rate of target-vessel revascularization (P=0.2) or cerebrovascular accidents (P=0.5). The difference in death/myocardial infarction remained significant after adjustment for baseline factors (odds ratio 1.85, 95% confidence interval 1.31 to 2.59, P<0.001 for low-volume centers; odds ratio 1.69, 95% confidence interval 1.29 to 2.21, P<0.001 for intermediate-volume centers). Patient and lesion selection, procedural features, and postprocedural medications differed significantly between groups., Conclusions: The volume of sirolimus-eluting stent procedures performed on an institutional level was inversely related to death and myocardial infarction but not to target-vessel revascularization at 6-month follow-up. Safety issues are better considered in high-volume centers. These findings have important public health policy implications.

Aims: We sought to evaluate the in-hospital fate of patients with ST segment elevation myocardial infarction (STEMI) diagnosed already in the prehospital phase by physican equipped ambulances., Methods: A total of 2326 consecutive STEMI patients were included in PREMIR. For this analysis 218 patients with prehospital cardiopulmonary resuscitation were excluded., Results: The median time between symptom onset and 12-lead ECG was 85 min. The median time intervals between the diagnostic 12-lead ECG and prehospital fibrinolysis were 10 min, until inhospital fibrinolysis 52 min and until primar PCI 86min, respectively. Reperfusion therapy with prehospital fibrinolysis (24%), inhospital fibrinolysis (13%) or primary PCI (45%) was performed in 82% of the patients. Inhospital mortality was 6.0% in patients with prehospital fibrinolysis (n = 504), 5.8% in patients with inhospital fibrinolysis (n = 278), 4.5% in patients with primary percutaneous coronary intervention (n = 962) and 16.2% in patients without early reperfusion therapy (n = 377), respectively. In the multivariate propensity score analysis comparing prehospital fibrinolysis and primary PCI we observed no significant difference in the odds for in-hospital mortality (odds ratio: 1.57, 95% CI: 0.94-2.63). The final discharge diagnosis was STEMI in 90% of the patients, in patients with prehospital fibrinolysis 95%., Conclusions: In patients with STEMI already diagnosed in the prehospital phase the ischemic time is short, accuracy of the diagnosis is high and reperfusion therapy is performed in over 82%. Inhospital mortality was not different between prehospital fibrinolysis and primary PCI.

Background: In the year 2000 a new definition of acute myocardial infarction (AMI) was introduced, now differentiating ST segment elevation AMI (STEMI) from non-ST segment elevation AMI (NSTEMI). The characterization of AMI patients according to this definition is still incomplete., Methods and Results: 888 consecutive AMI patients at a single interventional center were included: 493 (55.5%) STEMI and 395 (44.5%) NSTEMI patients. Median age of STEMI patients was four years lower compared to NSTEMI patients (62.8 versus 66.6 years, P<0.001). STEMI patients more often presented in cardiogenic shock (11.0% versus 2.0%, P<0.001) and after pre-hospital resuscitation (4.9% versus 0.8%, P<0.001). Catheterization was performed in 98.4% of STEMI and in 95.9% of NSTEMI patients (P<0.001). The circumflex artery was more often the culprit lesion in NSTEMI patients compared to STEMI patients (58.3% versus 48%, P=0.003). They also showed significantly more often a 3 vessel disease (41.4% versus 29.9%, P=0.002). Out of STEMI patients 10.1% were treated with medical therapy only compared to 27.2% of NSTEMI patients (P<0.001). Whereas PCI was performed more often in STEMI patients (84.3% versus 57.8%, P<0.001), CABG was used more often in NSTEMI patients (21.6% versus 9.1%, P<0.001). In-hospital death was 8.7% in STEMI compared to 4.8% in NSTEMI patients (P<0.001)., Conclusions: In clinical practice STEMI and NSTEMI seem to occur with similar frequency. Invasive strategies were applied in a high percentage in both groups, however with different therapeutic consequences. In-hospital mortality was twice as high in STEMI compared to NSTEMI patients.

Background: Both left bundle branch block and right bundle branch block (RBBB) have been associated with increased inhospital and long-term mortality in patients with acute ST elevation myocardial infarction (STEMI). However, the prognostic role of RBBB in acute non-ST elevation myocardial infarction (NSTEMI) is not well known. Therefore, the aim of the study was to evaluate the incidence and clinical impact of RBBB in patients with NSTEMI compared to patients with STEMI., Methods: From the German prospective multicenter registry "Maximal Individual Therapy of Acute Myocardial Infarction" (MITRA PLUS), 6,403 consecutive patients with NSTEMI and 20,233 patients with STEMI were analyzed. Patients with left bundle branch block were excluded. The median follow-up time for NSTEMI was 378 days and for STEMI 479 days., Results: A total of 455 (7.1%) patients with NSTEMI and 894 (4.4%) patients with STEMI presented with RBBB on admission. In general, RBBB patients were older, more often had comorbidities, and less often received short-term inhospital treatment according to guidelines. In STEMI, RBBB patients had higher peak enzyme levels and lower left ventricular ejection fraction (LV-EF) than patients without BBB. Right bundle branch block in STEMI was associated with an increased inhospital and long-term mortality. In NSTEMI, however, peak enzyme levels and LV-EF were similar in both groups with and without RBBB. Right bundle branch block in NSTEMI was not independently associated with a worse outcome., Conclusions: Unlike RBBB in STEMI, RBBB in NSTEMI is not an independent predictor of inhospital and long-term mortality.

Background: Drug-eluting coronary stents are the most recent "breakthrough" technology in interventional cardiology. Whereas risk factors influencing restenosis and need for target vessel revascularization are well known, risk factors for dying or developing a myocardial infarction (MI) after drug-eluting coronary stent implantation need to be evaluated yet., Methods: We evaluated data from the German Cypher Stent Registry., Results: From April 2002 to December 2004, 7445 patients at 122 hospitals, who received at least one sirolimus-eluting stent during percutaneous coronary intervention, were included. Complete follow-up at a median of 6.6 months (quartiles 6.1-8.1 months) was available in 6755 patients (91%). Death occurred in 1.8% (120/6755) of patients, nonfatal MI in 2.3% (156/6635), and death or MI in 4.1% (276/6755) of patients. Independent predictors of death or MI were initial presentation with ST-elevation MI or non-ST-elevation MI (OR [odds ratio] 2.21, 95% CI 1.66-2.95, P < .0001), cardiogenic shock (OR 3.05, 95% CI 1.67-5.55, P = .0003), renal insufficiency (OR 1.74, 95% CI 1.24-2.44, P = .0017), reduced left ventricular function (OR 1.74, 95% CI 1.21-2.50, P = .0027), age (per decade) (OR 1.19, 95% CI 1.05-1.36, P = .0058), diabetes mellitus (OR 1.39, 95% CI 1.05-1.84, P = .0183), 3-vessel disease (OR 1.32, 95% CI 0.99-1.77, P = .043), and prior MI (OR 1.35, 95% CI 1.01-1.80, P = .0468), whereas interventional and lesion characteristics showed no significant association., Conclusions: These results demonstrate that the most powerful predictors of death or MI after sirolimus-eluting stent implantation during percutaneous coronary intervention are presentation with an acute coronary syndrome, impaired left ventricular ejection fraction, and conventional risk factors for coronary heart disease. Interventional and lesion characteristics do not play a major role.