Multinational Registry Research Articles

Early predictors of disability in paediatric multiple sclerosis: evidence from a multi-national registry

BackgroundEarly recognition of markers of faster disability worsening in paediatric-onset multiple sclerosis (MS) is a key requisite of personalised therapy for children with MS at the earliest possible time.ObjectiveTo identify...

The impact of UEFA Euro 2020 football championship on Takotsubo Syndrome: Results of a multicenter national registry.

ObjectivesThe UEFA 2020 European Football Championship held in multiple cities across Europe from June 11 to July 11, 2021, was won by Italy, providing an opportunity to examine the relationship between emotional stress and the incidence of acute cardiovascular events (ACE).Methods and resultsCardiovascular hospitalizations in the Cardiac Care Units of 49 hospital networks in Italy were assessed by emergency physicians during the UEFA Euro 2020 Football Championship. We compared the events that occurred during matches involving Italy with events that occurred during the remaining days of the championship as the control period. ACE was assessed in 1,235 patients. ACE during the UEFA Euro 2020 Football Championship semifinal and final, the most stressful matches ended with penalties and victory of the Italian team, were assessed. A significant increase in the incidence of Takotsubo Syndrome (TTS) by a factor of 11.41 (1.6–495.1, P < 0.003), as compared with the control period, was demonstrated during the semifinal and final, whereas no differences were found in the incidence of ACS [IRR 0.93(0.74–1.18), P = 0.57]. No differences in the incidence of ACS [IRR 0.98 (0.87–1.11; P = 0.80)] or TTS [IRR 1.66(0.80–3.4), P = 0.14] were found in the entire period including all matches of the UEFA Euro 2020 compared to the control period.ConclusionsThe data of this national registry demonstrated an association between the semifinal and final of UEFA Euro 2020 and TTS suggesting that it can be triggered by also positive emotions such as the victory in the European Football Championship finals.

Hemoglobin A1c trajectories in the first 18 months after diabetes diagnosis in the SWEET diabetes registry

Brief Summary: Analysis of the multi-national SWEET diabetes registry showed that mean HbA1c in youth is highest at diagnosis and lowest at 4 to 5 months post-diagnosis. The HbA1c trajectory was lower in countries with nationalized health insurance. High gross domestic product (GDP) and high use of technology did not seem to protect from a higher trajectory.

Inner branched complex aortic repair outcomes from a national multicenter registry using the E-xtra design platform

BackgroundComplex aortic pathology still represents an open issue in contemporary endovascular management, with continuous technological advancement being introduced in practice over time aiming to improve outcomes. Thus far, the dualism between the fenestrated and branched configuration for visceral artery revascularization is yet unsolved, with each approach having its own pros and cons. The inner branched technology for endovascular aneurysm repair (iBEVAR) aims to take the best out of both strategies, offering wide applicability and stable bridging stent sealing. The objective of this study was to evaluate the early outcomes obtained with a single manufacturer custom-made inner-branched endograft in a multicenter Italian experience. MethodsAll patients consecutively treated with E-xtra design devices in three Italian facilities were enrolled. Anatomic characteristics and perioperative data were analyzed. The main objective was to asses technical and clinical success after iBEVAR. Secondary end points were overall survival, aortic-related mortality, target visceral vessel (TVV) patency, and freedom from target vessel instability during follow-up. ResultsFrom 2016 to 2021, 45 patients were treated with an E-xtra design device revascularizing at least one visceral vessel through an inner branch. The mean age at the time of the procedure was 71.1 ± 9.3 years and 77.8% were males. The total number of target visceral arteries to be bridged with an inner branch was 159. The extent of aortic repair was thoracoabdominal in 91.1% of the cases. Technical success was achieved in 93.3% of the procedures (42/45) with all failures owing to a type I endoleak at final angiography. Each TVV was successfully connected to the graft’s main body as planned without complications. Following their intervention, five patients developed spinal cord ischemia and in three of these cases symptoms persisted after discharge (6.7%). At 30 days clinical success was 93.3% (42/45). No death as well as no TVV thrombosis occurred within 30 days from the primary procedures. The mean follow-up was 22.8 ± 14.2 months. The Kaplan-Meier estimate of overall survival and TVV patency at 36 months were 83.9% and 95.9%, respectively. ConclusionsInner branches seem to be a promising technology in the complex aortic repair landscape, with an applicability ranging from type II thoracoabdominal aneurysm to type I endoleak repair after infrarenal endografting. Whether iBEVAR could offer results comparable with those provided by fenestrated/branched endovascular aneurysm repair in terms of target vessel patency and stent stability is yet to be established and further studies are, therefore, needed.

TCT-512 Differential Prognostic Impact of Conventional Surgical Risk Score on One-Year Mortality After Transcatheter Aortic Valve Replacement Among Asian and Non-Asian Populations: Insights From the Multinational Multicenter TP-TAVR Registry

TCT-512 Differential Prognostic Impact of Conventional Surgical Risk Score on One-Year Mortality After Transcatheter Aortic Valve Replacement Among Asian and Non-Asian Populations: Insights From the Multinational Multicenter TP-TAVR Registry

Survival and lung function decline in patients with definite, probable and possible idiopathic pulmonary fibrosis treated with pirfenidone.

There is no clear evidence whether pirfenidone has a benefit in patients with probable or possible UIP, i.e. when idiopathic pulmonary fibrosis (IPF) is diagnosed with a lower degree of diagnostic certainty. We report on outcomes of treatment with pirfenidone in IPF patients diagnosed with various degrees of certainty. We followed patients in the multi-national European MultiPartner IPF Registry (EMPIRE) first seen between 2015 and 2018. Patients were assessed with HRCT, histopathology and received a multi-disciplinary team (MDT) IPF diagnosis. Endpoints of interest were overall survival (OS), progression-free survival (PFS) and lung function decline. A total of 1626 patients were analysed, treated with either pirfenidone (N = 808) or receiving no antifibrotic treatment (N = 818). When patients treated with pirfenidone were compared to patients not receiving antifibrotic treatment, OS (one-, two- and three-year probability of survival 0.871 vs 0.798; 0.728 vs 0.632; 0.579 vs 0.556, P = 0.002), and PFS (one-, two- and three-year probability of survival 0.597 vs 0.536; 0.309 vs 0.281; 0.158 vs 0.148, P = 0.043) was higher, and FVC decline smaller (-0.073 l/yr vs -0.169 l/yr, P = 0.017). The benefit of pirfenidone on OS and PFS was also seen in patients with probable or possible IPF. This EMPIRE analysis confirms the favourable outcomes observed for pirfenidone treatment in patients with definitive IPF and indicates benefits also for patients with probable or possible IPF.

455 The Changing Trends of Image Guided Biopsy of Small Renal Masses Before Intervention- an Analysis of European Multinational Prospective EuRECA Registry

Abstract Aim To evaluate the use of pre-cryoablation biopsy for small renal masses (SRMs) and the effects of increasing up take on histological results of treated SMRs. Method From 2015 to 2019, patients with sporadic T1N0M0 SRMs undergoing percutaneous, laparoscopic or open cryoablation from 14 European institutions within the European Registry For Renal Cryoablation (EuRECA) were included for the retrospective analysis. Univariate and multivariate logistic models were used to evaluate the trends, histological results and the factors influencing use of pre-cryoablation biopsy. Results 871 patients (Median [IQR] age, 69[14], 298 women) undergoing cryoablation were evaluated. The use of pre-cryoablation biopsy has significantly increased from 42% (65/156) in 2015 to 72% (88/122) in 2019 (p&amp;lt;0.001). Patients treated for a benign histology are significantly more likely to have presented later in the trend, where pre-cryoablation biopsy is more prevalent (OR: 0.64, 95% CI 0.51–0.81, p&amp;lt;0.001). Patients treated for undiagnosed histology are also significantly less likely to have presented in 2018 compared to 2016 (OR 0.31, 95% CI 0.10–0.97, p=0.044). Patients aged 70+ are less likely to be biopsies pre-cryoablation (p&amp;lt;0.05). R.E.N.A.L. nephrometry score of 10+ and a Charlson Comorbidity Index &amp;gt;1 are factors associated with lower likelihood to not have received a pre-cryoablation biopsy (p&amp;lt;0.05). Conclusion An increased use of pre-cryoablation biopsy was observed and cryoablation patients treated with a benign histology is more likely to have presented in periods where pre-cryoablation biopsy is not as prevalent. Comparative studies are needed to draw definitive conclusions on the effect of pre-cryoablation biopsy on SRM treatments.

Revascularization in patients with ST‑segment elevation myocardial infarction and multivessel coronary artery disease: preliminary results from a large multicenter national registry.

Revascularization in patients with ST‑segment elevation myocardial infarction and multivessel coronary artery disease: preliminary results from a large multicenter national registry.

A new framework for advancing in drug-induced liver injury research. The Prospective European DILI Registry.

No multi-national prospective study of drug-induced liver injury (DILI) has originated in Europe. The design of a prospective European DILI registry, clinical features and short-term outcomes of the cases and controls is reported. Patients with suspected DILI were prospectively enrolled in the United Kingdom, Spain, Germany, Switzerland, Portugal and Iceland, 2016-2021. DILI cases or non-DILI acute liver injury controls following causality assessment were enrolled. Of 446 adjudicated patients, 246 DILI patients and 100 had acute liver injury due to other aetiologies, mostly autoimmune hepatitis (n=42) and viral hepatitis (n=34). DILI patients (mean age 56 years), 57% women, 60% with jaundice and 3.6% had pre-existing liver disease. DILI cases and non-DILI acute liver injury controls had similar demographics, clinical features and outcomes. A single agent was implicated in 199 (81%) DILI cases. Amoxicillin-clavulanate, flucloxacillin, atorvastatin, nivolumab/ipilimumab, infliximab and nitrofurantoin were the most commonly implicated drugs. Multiple conventional medications were implicated in 37 (15%) and 18 cases were caused by herbal and dietary supplements. The most common single causative drug classes were antibacterials (40%) and antineoplastic/immunomodulating agents (27%). Overall, 13 (5.3%) had drug-induced autoimmune-like hepatitis due to nitrofurantoin, methyldopa, infliximab, methylprednisolone and minocycline. Only six (2.4%) DILI patients died (50% had liver-related death), and another six received liver transplantation. In this first multi-national European prospective DILI Registry study, antibacterials were the most commonly implicated medications, whereas antineoplastic and immunomodulating agents accounted for higher proportion of DILI than previously described. This European initiative provides an important opportunity to advance the study on DILI.

Design and Rationale of the National Tunisian Registry of Percutaneous Coronary Intervention: Protocol for a Prospective Multicenter Observational Study.

BackgroundCoronary artery diseases remain the leading cause of death in the world. The management of this condition has improved remarkably in the recent years owing to the development of new technical tools and multicentric registries.ObjectiveThe aim of this study is to investigate the in-hospital and 1-year clinical outcomes of patients treated with percutaneous coronary intervention (PCI) in Tunisia.MethodsWe will conduct a prospective multicentric observational study with patients older than 18 years who underwent PCI between January 31, 2020 and June 30, 2020. The primary end point is the occurrence of a major adverse cardiovascular event, defined as cardiovascular death, myocardial infarction, cerebrovascular accident, or target vessel revascularization with either repeat PCI or coronary artery bypass grafting (CABG). The secondary end points are procedural success rate, stent thrombosis, and the rate of redo PCI/CABG for in-stent restenosis.ResultsIn this study, the demographic profile and the general risk profile of Tunisian patients who underwent PCI and their end points will be analyzed. The complexity level of the procedures and the left main occlusion, bifurcation occlusion, and chronic total occlusion PCI will be analyzed, and immediate as well as long-term results will be determined. The National Tunisian Registry of PCI (NATURE-PCI) will be the first national multicentric registry of angioplasty in Africa. For this study, the institutional ethical committee approval was obtained (0223/2020). This trial consists of 97 cardiologists and 2498 patients who have undergone PCI with a 1-year follow-up period. Twenty-eight catheterization laboratories from both public (15 laboratories) and private (13 laboratories) sectors will enroll patients after receiving informed consent. Of the 2498 patients, 1897 (75.9%) are managed in the public sector and 601 (24.1%) are managed in the private sector. The COVID-19 pandemic started in Tunisia in March 2020; 719 patients (31.9%) were included before the COVID-19 pandemic and 1779 (60.1%) during the pandemic. The inclusion of patients has been finished, and we expect to publish the results by the end of 2022.ConclusionsThis study would add data and provide a valuable opportunity for real-world clinical epidemiology and practice in the field of interventional cardiology in Tunisia with insights into the uptake of PCI in this limited-income region.Trial RegistrationClinicaltrials.gov NCT04219761; https://clinicaltrials.gov/ct2/show/NCT04219761International Registered Report Identifier (IRRID)RR1-10.2196/24595

Blueprint for harmonising unstandardised disease registries to allow federated data analysis: prepare for the future.

Real-world evidence from multinational disease registries is becoming increasingly important not only for confirming the results of randomised controlled trials, but also for identifying phenotypes, monitoring disease progression, predicting response to new drugs and early detection of rare side-effects. With new open-access technologies, it has become feasible to harmonise patient data from different disease registries and use it for data analysis without compromising privacy rules. Here, we provide a blueprint for how a clinical research collaboration can successfully use real-world data from existing disease registries to perform federated analyses. We describe how the European severe asthma clinical research collaboration SHARP (Severe Heterogeneous Asthma Research collaboration, Patient-centred) fulfilled the harmonisation process from nonstandardised clinical registry data to the Observational Medical Outcomes Partnership Common Data Model and built a strong network of collaborators from multiple disciplines and countries. The blueprint covers organisational, financial, conceptual, technical, analytical and research aspects, and discusses both the challenges and the lessons learned. All in all, setting up a federated data network is a complex process that requires thorough preparation, but above all, it is a worthwhile investment for all clinical research collaborations, especially in view of the emerging applications of artificial intelligence and federated learning.

Clinical Characteristics and Surgical Outcomes of Carotid Body Tumors: Data from the Carotid Paraganglioma Cooperative International Registry (CAPACITY) Group

This study's objective was to conduct a multinational registry of patients with carotid body tumors (CBTs) and to analyze patients' clinical characteristics, treatments, and outcomes. Retrospective study from the Carotid Paraganglioma Cooperative International Registry involving eleven medical centers in Bolivia, Ecuador, Mexico, and Spain, of all patients with a CBT who underwent resection between 2009 and 2019. A total of 1432 patients with a CBT surgically treated were included. Median patient age was 54years (range: 45-63years), and 82.9% (1184) of the study cohort were female. While at low altitude, the proportion of female-to-male cases was 2:1, at high altitude, this proportion increased to 8:1, with statistically significant differences (p = .022). Median operative time was 139min (range: 110-180min), while median operative blood loss was 250ml (range: 100-500ml), with statistically significant difference in increased blood loss (p = .001) and operative time (p = .001) with a higher Shamblin classification. Eight (0.6%) patients suffered stroke. Univariate analysis analyzing for possible factors associated with increased odds of stroke revealed intraoperative vascular lesion to present an OR of 2.37 [CI 95%; 1.19-4.75] (p = 0.001). In 245 (17.1%), a cranial nerve injury was reported. Seven (0.5%) deaths were recorded. The most common CBT type on this cohort was hyperplasic, which might be partially explained by the high altitudes where these patients lived. Increased blood loss and operative time were associated with a higher Shamblin classification, and the risk of stroke was associated with patients presenting transoperative vascular lesions.

THU493 - COVID-19 in patients with cirrhosis: insights from the multinational LEOSS registry

THU493 - COVID-19 in patients with cirrhosis: insights from the multinational LEOSS registry

Right Temporal Lobe Variant of Frontotemporal Dementia: Systematic Review.

Frontotemporal dementia corresponds to a heterogenous group of syndromes characterized by progressive changes in behavior and/or language. Approximately 30% of patients with primary progressive aphasia, semantic variant (semantic dementia), present with atrophy in the right cerebral hemisphere, in a rare clinical condition called right temporal variant of frontotemporal dementia (rtvFTD). The objective of the study is to present the main demographic, clinical, neuropsychological, neuroimaging, and pathologic characteristics of rtvFTD patients. A systematic review of the literature was carried out in the PubMed, LILACS, and SCIELO databases between January and March 2022. After the evaluation process, 41 articles were selected, published between 1993 and 2021. We found that rtvFTD presents with severe and progressive prosopagnosia (related to anterior temporal lobe injury) associated with behavioral symptoms-desinibition (51%), apathy (39%), obsessive-compulsive symptoms (37%), changes in eating habits (33%), and depression (28%), which is different from semantic dementia. The most common pathologic pattern is TDP-43, type C. This field of knowledge has few studies (mainly reports and case series) and heterogenous nomenclature, which is a limitation. A multinational longitudinal registry of people with rtvFTD, with standardized assessment and description of symptoms, is necessary to elucidate the characteristics of this entity.

The GermAn Laser Lead Extraction RegistrY: GALLERY.

The GermAn Laser Lead Extraction RegistrY: GALLERY is a retrospective, national multicentre registry, investigating the safety and efficacy of laser lead extraction procedures in Germany. Twenty-four German centres that are performing laser lead extraction have participated in the registry. All patients, treated with a laser lead extraction procedure between January 2013 and March 2017, were consecutively enrolled. Safety and efficacy of laser lead extraction were investigated. A total number of 2524 consecutive patients with 6117 leads were included into the registry. 5499 leads with a median lead dwell time of 96 (62-141) months were treated. The mean number of treated leads per patient was 2.18 ± 1.02. The clinical procedural success rate was 97.86% and the complete lead removal was observed in 94.85%. Additional extraction tools were used in 6.65% of cases. The rate of procedural failure was 2.14% with lead age ≥10 years being its only predictor. The overall complication rate was 4.32%, including 2.06% major and 2.26% minor complications. Procedure-related mortality was 0.55%. Female sex and the presence of abandoned leads were predictors for procedure-related complications. The all-cause in-hospital mortality was 3.56% with systemic infection being the strongest predictor, followed by age ≥75 years and chronic kidney disease. In the GALLERY, a high success- and low procedure-related complication rates have been demonstrated. In multivariate analysis, female sex and the presence of abandoned leads were predictors for procedure-related complications, while the presence of systemic infection, age ≥75 years, and chronic kidney disease were independent predictors for all-cause mortality.

Skills Capacity Building For Health Care Services and Research Through the Sickle Pan African Research Consortium.

Skills development, the building of human capacity, is key to any sustainable capacity building effort, however, such undertakings require adaptable and tailored strategies. The Sickle Pan-African Research Consortium (SPARCo) is building capacity in sickle cell disease (SCD) management and research in sub-Saharan Africa, including a multi-national SCD patient registry, this is underpinned by skills development activities in data, research, and SCD management. Method: The SPARCo Skills Working Group was set up with the mandate of coordinating skills development activities across the three SPARCo sites in Ghana, Nigeria and Tanzania. To tailor activities to the requirements of the consortium, a needs assessment was conducted at the start of the project which identified skills required for SCD management and research and catalogued existing external and internal training programmes. The needs assessment highlighted differences in skill levels between the sites and different organisational structures which required tailored skills development activities at individual, site and consortium levels. Strategy: Based on the needs and the resources available, different types of training activities were implemented: these included online, blended and face to face activities. In order to create a sustainable skills development programme, existing short, medium, long-term, on-job training activities were used wherever possible. World Sickle Cell Day (19th June) was leveraged for training and health education activities. Results: SPARCo has recorded 1,726 participants in skills development activities across the three sites. Skills have been enhanced in data management, SCD and research to underpin the core deliverables of SPARCo. Conclusion and Lessons Learned: The baseline needs assessments and continual review and adjustment were critical for development of an effective skill development strategy for the consortium. This adaptability was particularly valuable during the COVID-19 pandemic. The sustainability plan leveraged existing programmes and activities and has created a pool of people with required skills for health care and research in SCD. To be effective, skills development programmes need to take into account existing capacity, training opportunities and local conditions. The model was applied to SCD and is adaptable to other skills development in healthcare and research in low and middle- income countries.

Association Between Changes in Perivascular Adipose Tissue Density and Plaque Progression

BackgroundThe association between the change in vessel inflammation, as quantified by perivascular adipose tissue (PVAT) density, and the progression of coronary atherosclerosis remains to be determined. ObjectivesThe purpose of this study was to explore the association between the change in PVAT density and the progression of total and compositional plaque volume (PV). MethodsPatients were selected from a prospective multinational registry. Patients who underwent serial coronary computed tomography angiography studies with ≥2-year intervals and were scanned with the same tube voltage at baseline and follow-up were included. Total and compositional PV and PVAT density at baseline and follow-up were quantitatively analyzed for every lesion. Multivariate linear regression models using cluster analyses were constructed. ResultsA total of 1,476 lesions were identified from 474 enrolled patients (mean age 61.2 ± 9.3 years; 65.0% men). The mean PVAT density was −74.1 ± 11.5 HU, and total PV was 48.1 ± 83.5 mm3 (19.2 ± 44.8 mm3 of calcified PV and 28.9 ± 51.0 mm3 of noncalcified PV). On multivariate analysis (adjusted for clinical risk factors, medication use, change in lipid levels, total PV at baseline, luminal HU attenuation, location of lesions, and tube voltage), the increase in PVAT density was positively associated with the progression of total PV (estimate = 0.275 [95% CI: 0.004-0.545]; P = 0.047), driven by the association with fibrous PV (estimate = 0.245 [95% CI: 0.070-0.420]; P = 0.006). Calcified PV progression was not associated with the increase in PVAT density (P > 0.050). ConclusionsIncrease in vessel inflammation represented by PVAT density is independently associated with the progression of the lipid component of coronary atherosclerotic plaques. (Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography Imaging [PARADIGM]; NCT02803411)

Latin American Registry of Idiopathic Pulmonary Fibrosis (REFIPI): Clinical Characteristics, Evolution and Treatment

IntroductionIdiopathic pulmonary fibrosis (IPF) is a progressive, irreversible and frequently fatal disease. Currently there are national and multinational registries in Europe, United States, Australia and China to better understand the magnitude of the problem and the characteristics of the IPF patients. However, there are no national or regional registries in Latin America, so the objective of this study was to carry out a Latin American registry that would allow the identification of IPF patients in our region. MethodologyA system consisting of 3 levels of control was designed, ensuring that patients met the diagnostic criteria for IPF according to international guidelines ATS/ERS/ALAT/JRS 2011. Demographic, clinical, serological, functional, tomographic, histological and treatment variables were recorded through a digital platform. Results761 IPF patients from 14 Latin American countries were included for analysis, 74.7% were male, with a mean age of 71.9+8.3 years. In general there was a long period of symptoms before definitive diagnosis (median 1 year). In functional tests, an average reduction of FVC (70.9%) and DLCO (53.7%) was detected. 72% received at least one antifibrotic drug (pirfenidone or nintedanib) and 11.2% of the patients had an acute exacerbation, of which 38 (45.2%) died from this cause. ConclusionsLike other registries, we found that there is difficulty in the recognition and excessive delay in the diagnosis of IPF in Latin America. Most of the patients in REFIPI received antifibrotics; these were well tolerated and associated with fewer adverse events than those reported in clinical trials.

Review of Corneal Graft Registries.

Corneal graft registries are organized systems that collect and analyze outcome data (such as long-term graft survival and visual outcomes) after keratoplasty procedures. The aim of this review was to identify existing corneal graft registries and to describe their characteristics. A search of the PubMed database was performed on June 1, 2021, for articles pertaining to corneal graft registries. The PubMed literature search yielded 958 publications, of which 116 met all the inclusion and exclusion criteria. Among these articles, 15 corneal graft registries were identified, including 6 regional registries, 8 national registries, and 1 multinational registry. This article provides an overview of their characteristics and discusses the main advantages and pitfalls of clinical registries. Clinical registry data are increasingly recognized as a valuable tool to monitor corneal transplant outcomes to improve health care services and optimize resource management.

Reperfusion therapy for ST-elevation myocardial infarction complicated by cardiogenic shock: the European Society of Cardiology EurObservational programme acute cardiovascular care-European association of PCI ST-elevation myocardial infarction registry.

To determine the current state of the use of reperfusion and adjunctive therapies and in-hospital outcomes in European Society of Cardiology (ESC) member and affiliated countries for patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock (CS). ESC EurObservational Research Programme prospective international cohort study of admissions with STEMI within 24 h of symptom onset (196 centres; 26 ESC member and 3 affiliated countries). Of 11 462 patients enrolled, 448 (3.9%) had CS. Patients with compared to patients without CS, less frequently received primary percutaneous coronary intervention (PCI) (65.5% vs. 72.2%) and fibrinolysis (15.9% vs. 19.0), and more often had no reperfusion therapy (19.0% vs. 8.5%). Mechanical support devices (intraaortic ballon pump 11.2%, extracoporeal membrane oxygenation 0.7%, other 1.1%) were used infrequently in CS. Bleeding definition academic research consortium 2-5 bleeding complications (10.1% vs. 3.0%, P < 0.01) and stroke (4.2% vs. 0.9%, P < 0.01) occurred more frequently in patients with CS. In-hospital mortality was 10-fold higher (35.5% vs. 3.1%) in patients with CS. Mortality in patients with CS in the groups with PCI, fibrinolysis, and no reperfusion therapy were 27.4%, 36.6%, and 62.4%, respectively. In this multi-national registry, patients with STEMI complicated by CS less frequently receive reperfusion therapy than patients with STEMI without CS. Early mortality in patients with CS not treated with primary PCI is very high. Therefore, strategies to improve clinical outcome in STEMI with CS are needed.