Publications by authors named "Uwe Zeymer"

392 Publications

Comparison of risk prediction models in infarct-related cardiogenic shock.

Eur Heart J Acute Cardiovasc Care 2021 Sep 16. Epub 2021 Sep 16.

Department of Internal Medicine/Cardiology, Heart Center Leipzig at the University of Leipzig, Strümpellstr. 39, D-04289 Leipzig, Germany.

Aims: Several prediction models have been developed to allow accurate risk assessment and provide better treatment guidance in patients with infarct-related cardiogenic shock (CS). However, comparative data between these models are still scarce. The objective of the study is to externally validate different risk prediction models in infarct-related CS and compare their predictive value in the early clinical course.

Methods And Results: The Simplified Acute Physiology Score (SAPS) II Score, the CardShock score, the IABP-SHOCK II score, and the Society for Cardiovascular Angiography and Intervention (SCAI) classification were each externally validated in a total of 1055 patients with infarct-related CS enrolled into the randomized CULPRIT-SHOCK trial or the corresponding registry. The primary outcome was 30-day all-cause mortality. Discriminative power was assessed by comparing the area under the curves (AUC) in case of continuous scores. In direct comparison of the continuous scores in a total of 161 patients, the IABP-SHOCK II score revealed best discrimination [area under the curve (AUC = 0.74)], followed by the CardShock score (AUC = 0.69) and the SAPS II score, giving only moderate discrimination (AUC = 0.63). All of the three scores revealed acceptable calibration by Hosmer-Lemeshow test. The SCAI classification as a categorical predictive model displayed good prognostic assessment for the highest risk group (Stage E) but showed poor discrimination between Stages C and D with respect to short-term-mortality.

Conclusion: Based on the present findings, the IABP-SHOCK II score appears to be the most suitable of the examined models for immediate risk prediction in infarct-related CS. Prospective evaluation of the models, further modification, or even development of new scores might be necessary to reach higher levels of discrimination.
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http://dx.doi.org/10.1093/ehjacc/zuab054DOI Listing
September 2021

Angiography after Out-of-Hospital Cardiac Arrest without ST-Segment Elevation.

N Engl J Med 2021 Aug 29. Epub 2021 Aug 29.

From Heart Center Leipzig at the University of Leipzig, Departments of Internal Medicine-Cardiology (S.D., A.F., J.P., M.A.-W., P.L., A.J., H.T.) and Cardiac Surgery (S.W.-T.), Leipzig Heart Institute (S.D., A.F., A.J., H.T.), and University Clinic Leipzig (K.L.), Leipzig, University Heart Center Lübeck (S.D., T.G., I.E., G.F., A.J.) and the Center for Clinical Trials (D.O., S.B., K.K.) and the Institute for Medical Biometry and Statistics (F.S., I.R.K., M.V.), University of Lübeck, Lübeck, the German Center for Cardiovascular Research (S.D., A.F., I.A., M. Behnes, M.R.P., T.A.Z., C.S., U.L., T.G., I.E., G.F., F.H., S.B.F., S.F., J.L., M.J., C.L., C.J., A.J., D.O., F.S., I.R.K., S.B., M.V., K.K.) and University Clinic Charité, Campus Benjamin Franklin (C.S., U.L.), Berlin, University Clinic Mannheim, Mannheim (I.A., M. Behnes), the Department of Cardiology, Angiology, and Pneumology, University Hospital of Heidelberg, Heidelberg (M.R.P., T.A.Z.), Kliniken Maria Hilf, Mönchengladbach (H.H.), University Clinic Würzburg, Würzburg (P.N.), University Clinic Greifswald, Greifswald (F.H., S.B.F.), University Clinic Frankfurt, Frankfurt (S.F.), Rechts der Isar Hospital, Technical University (J.L.), and the Department of Cardiology, German Heart Center (M.J.), Munich, the Department of Cardiology, Pneumology and Intensive Care, St. Vincenz Hospital, Limburg (S.S.), Kerckhoff Clinic, Bad Nauheim (C.L.), the Departments of Acute and Emergency Medicine and of Cardiology and Angiology, Elisabeth Hospital Essen, Essen (I.V.), Klinikum Ludwigshafen, Ludwigshafen (U.Z.), University Clinic Marien Hospital Herne, Klinikum der Ruhr-Universität Bochum, Herne (M. Brand), the University Heart Center, Bad Krozingen (R.S.), Diakonissenkrankenhaus Flensburg, Flensburg (J.H.), University Medicine Göttingen, Göttingen (C.J.), and Vincentius-Diakonissen Hospital, Karlsruhe (C.J.) - all in Germany; the Division of Cardiology, Medical University of Vienna, Vienna (T.A.Z.); and the Department of Cardiology, Rigshospitalet, and the Department of Clinical Medicine, University of Copenhagen - both in Copenhagen (C.H., T.E.).

Background: Myocardial infarction is a frequent cause of out-of-hospital cardiac arrest. However, the benefits of early coronary angiography and revascularization in resuscitated patients without electrocardiographic evidence of ST-segment elevation are unclear.

Methods: In this multicenter trial, we randomly assigned 554 patients with successfully resuscitated out-of-hospital cardiac arrest of possible coronary origin to undergo either immediate coronary angiography (immediate-angiography group) or initial intensive care assessment with delayed or selective angiography (delayed-angiography group). All the patients had no evidence of ST-segment elevation on postresuscitation electrocardiography. The primary end point was death from any cause at 30 days. Secondary end points included a composite of death from any cause or severe neurologic deficit at 30 days.

Results: A total of 530 of 554 patients (95.7%) were included in the primary analysis. At 30 days, 143 of 265 patients (54.0%) in the immediate-angiography group and 122 of 265 patients (46.0%) in the delayed-angiography group had died (hazard ratio, 1.28; 95% confidence interval [CI], 1.00 to 1.63; P = 0.06). The composite of death or severe neurologic deficit occurred more frequently in the immediate-angiography group (in 164 of 255 patients [64.3%]) than in the delayed-angiography group (in 138 of 248 patients [55.6%]), for a relative risk of 1.16 (95% CI, 1.00 to 1.34). Values for peak troponin release and for the incidence of moderate or severe bleeding, stroke, and renal-replacement therapy were similar in the two groups.

Conclusions: Among patients with resuscitated out-of-hospital cardiac arrest without ST-segment elevation, a strategy of performing immediate angiography provided no benefit over a delayed or selective strategy with respect to the 30-day risk of death from any cause. (Funded by the German Center for Cardiovascular Research; TOMAHAWK ClinicalTrials.gov number, NCT02750462.).
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http://dx.doi.org/10.1056/NEJMoa2101909DOI Listing
August 2021

Impact of HAS-BLED Score on outcome after percutaneous left atrial appendage closure: insights from the German Left Atrial Appendage Occluder Registry LAARGE.

Clin Res Cardiol 2021 Aug 28. Epub 2021 Aug 28.

CardioVascular Center Frankfurt, Seckbacher Landstr. 65, 60389, Frankfurt, Germany.

Aim: Percutaneous left atrial appendage (LAA) closure has been established as alternative stroke prophylaxis in patients with non-valvular atrial fibrillation (AF) and high bleeding risk. However, little is known regarding the outcome after LAA closure depending on the HAS-BLED score.

Methods: A sub-analysis of the prospective, multicenter, Left-Atrium-Appendage Occluder Register-GErmany (LAARGE) registry was performed assessing three different groups with respect to the HAS-BLED score (0-2 [group 1] vs. 3-4 [group 2] vs. 5-7 [group 3]).

Results: A total of 633 patients at 38 centers were enrolled. Of them, 9% (n = 59) were in group 1, 63% (n = 400) in group 2 and 28% (n = 174) in group 3. The Kaplan-Meier estimated 1-year composite of death, stroke and systemic embolism was 3.4% in group 1 vs. 10.4% in group 2 vs. 20.1% in group 3, respectively (p log-rank < 0.001). The difference was driven by death since stroke and systemic embolism did not show a significant difference between the groups. The rate of major bleeding at 1 year was 0% vs. 0% vs. 2.4%, respectively (p = 0.016).

Conclusion: The present data show that patients had similarly low rates of ischemic complications 1 year after LAA closure irrespective of the baseline bleeding risk. Higher HAS-BLED scores were associated with increased mortality due to higher age and more severe comorbidity of these patients.
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http://dx.doi.org/10.1007/s00392-021-01911-1DOI Listing
August 2021

Management of cardiogenic shock.

EuroIntervention 2021 Aug;17(6):451-465

Heart Center Leipzig at University of Leipzig, Leipzig, Germany.

Despite the rapidly evolving evidence base in modern cardiology, progress in the area of cardiogenic shock remains slow, with short-term mortality still reaching 40-50%, relatively unchanged in recent years. Despite advances with an increase in the number of clinical trials taking place in this admittedly difficult-to-study area, the evidence base on which we make day-to-day decisions in clinical practice remains relatively sparse. With only definitive evidence for early revascularisation and the relative ineffectiveness of intra-aortic balloon pumping, most aspects of patient management are based on expert consensus, rather than randomised controlled trials. This updated 2020 review will outline the management of CS mainly after acute myocardial infarction with major focus on state-of-the-art treatment based on randomised clinical trials or matched comparisons if available.
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http://dx.doi.org/10.4244/EIJ-D-20-01296DOI Listing
August 2021

Reperfusion therapies and in-hospital outcomes for ST-elevation myocardial infarction in Europe: the ACVC-EAPCI EORP STEMI Registry of the European Society of Cardiology.

Eur Heart J 2021 Aug 14. Epub 2021 Aug 14.

Spitalul Clinic de Urgenta "Floreasca", Calea Floreasca 8, București 014461, Romania.

Aims : The aim of this study was to determine the contemporary use of reperfusion therapy in the European Society of Cardiology (ESC) member and affiliated countries and adherence to ESC clinical practice guidelines in patients with ST-elevation myocardial infarction (STEMI).

Methods And Results : Prospective cohort (EURObservational Research Programme STEMI Registry) of hospitalized STEMI patients with symptom onset <24 h in 196 centres across 29 countries. A total of 11 462 patients were enrolled, for whom primary percutaneous coronary intervention (PCI) (total cohort frequency: 72.2%, country frequency range 0-100%), fibrinolysis (18.8%; 0-100%), and no reperfusion therapy (9.0%; 0-75%) were performed. Corresponding in-hospital mortality rates from any cause were 3.1%, 4.4%, and 14.1% and overall mortality was 4.4% (country range 2.5-5.9%). Achievement of quality indicators for reperfusion was reported for 92.7% (region range 84.8-97.5%) for the performance of reperfusion therapy of all patients with STEMI <12 h and 54.4% (region range 37.1-70.1%) for timely reperfusion.

Conclusions : The use of reperfusion therapy for STEMI in the ESC member and affiliated countries was high. Primary PCI was the most frequently used treatment and associated total in-hospital mortality was below 5%. However, there was geographic variation in the use of primary PCI, which was associated with differences in in-hospital mortality.
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http://dx.doi.org/10.1093/eurheartj/ehab342DOI Listing
August 2021

Predictors for one-year outcomes of cardiorespiratory fitness and cardiovascular risk factor control after cardiac rehabilitation in elderly patients: The EU-CaRE study.

PLoS One 2021 5;16(8):e0255472. Epub 2021 Aug 5.

Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.

Introduction: Studies on effectiveness of cardiac rehabilitation (CR) in elderly cardiovascular disease patients are rare, and it is unknown, which patients benefit most. We aimed to identify predictors for 1-year outcomes of cardiorespiratory fitness and CV risk factor (CVRF) control in patients after completing CR programs offered across seven European countries.

Methods: Cardiovascular disease patients with minimal age 65 years who participated in comprehensive CR were included in this observational study. Peak oxygen uptake (VO2), body mass index (BMI), resting systolic blood pressure (BPsys), and low-density lipoprotein-cholesterol (LDL-C) were assessed before CR (T0), at termination of CR (T1), and 12 months after start of CR (T2). Predictors for changes were identified by multivariate regression models.

Results: Data was available from 1241 out of 1633 EU-CaRE patients. The strongest predictor for improvement in peak VO2 was open chest surgery, with a nearly four-fold increase in surgery compared to non-surgery patients. In patients after surgery, age, female sex, physical inactivity and time from index event to T0 were negative predictors for improvement in peak VO2. In patients without surgery, previous acute coronary syndrome and higher exercise capacity at T0 were the only negative predictors. Neither number of attended training sessions nor duration of CR were significantly associated with change in peak VO2. Non-surgery patients were more likely to achieve risk factor targets (BPsys, LDL-C, BMI) than surgery patients.

Conclusions: In a previously understudied population of elderly CR patients, time between index event and start of CR in surgery and disease severity in non-surgery patients were the most important predictors for long-term improvement of peak VO2. Non-surgery patients had better CVRF control.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0255472PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8341663PMC
August 2021

Changes and prognostic value of cardiopulmonary exercise testing parameters in elderly patients undergoing cardiac rehabilitation: The EU-CaRE observational study.

PLoS One 2021 3;16(8):e0255477. Epub 2021 Aug 3.

Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.

Objective: We aimed 1) to test the applicability of the previously suggested prognostic value of CPET to elderly cardiac rehabilitation patients and 2) to explore the underlying mechanism of the greater improvement in exercise capacity (peak oxygen consumption, VO2) after CR in surgical compared to non-surgical cardiac patients.

Methods: Elderly patients (≥65 years) commencing CR after coronary artery bypass grafting, surgical valve replacement (surgery-group), percutaneous coronary intervention, percutaneous valve replacement or without revascularisation (non-surgery group) were included in the prospective multi-center EU-CaRE study. CPETs were performed at start of CR, end of CR and 1-year-follow-up. Logistic models and receiver operating characteristics were used to determine prognostic values of CPET parameters for major adverse cardiac events (MACE). Linear models were performed for change in peak VO2 (start to follow-up) and parameters accounting for the difference between surgery and non-surgery patients were sought.

Results: 1421 out of 1633 EU-CaRE patients performed a valid CPET at start of CR (age 73±5.4, 81% male). No CPET parameter further improved the receiver operation characteristics significantly beyond the model with only clinical parameters. The higher improvement in peak VO2 (25% vs. 7%) in the surgical group disappeared when adjusted for changes in peak tidal volume and haemoglobin.

Conclusion: CPET did not improve the prediction of MACE in elderly CR patients. The higher improvement of exercise capacity in surgery patients was mainly driven by restoration of haemoglobin levels and improvement in respiratory function after sternotomy.

Trial Registration: Netherlands Trial Register, Trial NL5166.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0255477PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8330933PMC
August 2021

Interventional occlusion of left atrial appendage in patients with atrial fibrillation. Gender-related outcomes in the German LAARGE Registry.

J Cardiovasc Electrophysiol 2021 Jul 27. Epub 2021 Jul 27.

Department of Cardiology, Klinikum Coburg, Coburg, Germany.

Introduction: Gender-based differences in atrial fibrillation have been identified, but limited data exist for patients undergoing left atrial appendage occluder (LAAO) implantation. This study reports gender-related periprocedural and 1-year outcomes of the prospective, multicenter German left atrial appendage occlusion registry (LAARGE).

Methods: LAARGE enrolled 641 patients who were scheduled for LAAO implantation from July 2014 to January 2016 in 38 hospitals in Germany. The data collected included demographics, clinical characteristics, details of implantation, and outcome. Efficacy and safety at 1-year follow-up were assessed by the occurrence of thrombembolic and bleeding events, as well as mortality.

Results: Of 638 patients undergoing LAAO implantation 38.9% were female and 61.1% male. Females were older (76.4 ± 8.2 [females] vs. 75.6 ± 7.7 [males], p = .042) and had a higher stroke risk (CHA DS -VASc score: 4.9 ± 1.5 vs. 4.3 ± 1.5, p < .001). In contrast, males suffered more often from coronary artery (33.1% vs. 53.8%, p < .001) and vascular disease (18.5% vs. 31.0%, p < .001). Technical success was high and similar for both genders (98.4% vs. 97.2%, p = .33). Severe periprocedural complications (6.9% vs. 3.1%, p = .032) occurred more often in females. At 1-year follow-up the rates of all-cause stroke (0.5% vs. 1.3%, p = .65) and severe bleeding (0.0% and 1.0%, p = .29) were low and comparable between the genders. Also, one-year all-cause mortality (9.2% vs. 13.1%, p = .14) did not differ significantly.

Conclusion: LAARGE documented in this elderly patient population undergoing LAAO implantation a higher rate of severe periprocedural complications in females. At 1-year follow-up similar efficacy and safety outcomes were observed for both genders.
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http://dx.doi.org/10.1111/jce.15189DOI Listing
July 2021

Optimising clinical trials in acute myocardial infarction complicated by cardiogenic shock: a statement from the 2020 Critical Care Clinical Trialists Workshop.

Lancet Respir Med 2021 Jul 7. Epub 2021 Jul 7.

Department of Anesthesia, Burn and Critical Care Medicine, AP-HP, Hôpitaux Universitaires Saint-Louis-Lariboisière, FHU PROMICE, INI-CRCT, and Université de Paris, MASCOT, INSERM, Paris, France. Electronic address:

Acute myocardial infarction complicated by cardiogenic shock (AMICS) is a critical syndrome with a high risk of morbidity and mortality. Current management consists of coronary revascularisation, vasoactive drugs, and circulatory and ventilatory support, which are tailored to patients mainly on the basis of clinicians' experience rather than evidence-based recommendations. For many therapeutic interventions in AMICS, randomised clinical trials have not shown a meaningful survival benefit, and a disproportionately high rate of neutral and negative results has been reported. In this context, an accurate definition of the AMICS syndrome for appropriate patient selection and optimisation of study design are warranted to achieve meaningful results and pave the way for new, evidence-based therapeutic options. In this Position Paper, we provide a statement of priorities and recommendations agreed by a multidisciplinary group of experts at the Critical Care Clinical Trialists Workshop in February, 2020, for the optimisation and harmonisation of clinical trials in AMICS. Implementation of proposed criteria to define the AMICS population-moving beyond a cardio-centric definition to that of a systemic disease-and steps to improve the design of clinical trials could lead to improved outcomes for patients with this life-threatening syndrome.
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http://dx.doi.org/10.1016/S2213-2600(21)00172-7DOI Listing
July 2021

Impact of atrial fibrillation pattern on outcomes after left atrial appendage closure: lessons from the prospective LAARGE registry.

Clin Res Cardiol 2021 May 27. Epub 2021 May 27.

Department of Cardiology, University Heart and Vascular Center Hamburg-Eppendorf, Martinistraße 52, 20251, Hamburg, Germany.

Background: Non-paroxysmal (NPAF) forms of atrial fibrillation (AF) have been reported to be associated with an increased risk for systemic embolism or death.

Methods: Comparison of procedural details and long-term outcomes in patients (pts) with paroxysmal AF (PAF) against controls with NPAF in the prospective, multicentre observational registry of patients undergoing LAAC (LAARGE).

Results: A total of 638 pts (PAF 274 pts, NPAF 364 pts) were enrolled. In both groups, a history of PVI was rare (4.0% vs 1.6%, p = 0.066). The total CHADS-VASc score was lower in the PAF group (4.4 ± 1.5 vs 4.6 ± 1.5, p = 0.033), while HAS-BLED score (3.8 ± 1.1 vs 3.9 ± 1.1, p = 0.40) was comparable. The rate of successful implantation was equally high (97.4% vs 97.8%, p = 0.77). In the three-month echo follow-up, LA thrombi (2.1% vs 7.3%, p = 0.12) and peridevice leak > 5 mm (0.0% vs 7.1%, p = 0.53) were numerically higher in the NPAF group. Overall, in-hospital complications occurred in 15.0% of the PAF cohort and 10.7% of the NPAF cohort (p = 0.12). In the one-year follow-up, unadjusted mortality (8.4% vs 14.0%, p = 0.039) and combined outcome of death, stroke and systemic embolism (8.8% vs 15.1%, p = 0.022) were significantly higher in the NPAF cohort. After adjusting for CHADS-VASc and previous bleeding, NPAF was associated with increased death/stroke/systemic embolism (HR 1.67, 95% CI 1.02-2.72, p = 0.041).

Conclusion: Atrial fibrillation type did not impair periprocedural safety or in-hospital MACE patients undergoing LAAC. However, after one year, NPAF was associated with higher mortality.
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http://dx.doi.org/10.1007/s00392-021-01874-3DOI Listing
May 2021

Clopidogrel vs. prasugrel vs. ticagrelor in patients with acute myocardial infarction complicated by cardiogenic shock: a pooled IABP-SHOCK II and CULPRIT-SHOCK trial sub-analysis.

Clin Res Cardiol 2021 Sep 17;110(9):1493-1503. Epub 2021 May 17.

Department of Medicine I, University Hospital, Ludwig-Maximilians-University, Munich, Germany.

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 = 0.17) or between ticagrelor and clopidogrel treated patients (HR: 0.86, 95% CI 0.65-1.15, p = 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 = 0.002) and not significantly different in patients treated with prasugrel vs. clopidogrel (HR: 0.73, 95% CI 0.43 -1.24, p = 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.
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http://dx.doi.org/10.1007/s00392-021-01866-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8405498PMC
September 2021

Greater burden of risk factors and less effect of cardiac rehabilitation in elderly with low educational attainment: The Eu-CaRE study.

Eur J Prev Cardiol 2021 May;28(5):513-519

Department of Cardiology, Bispebjerg Frederiksberg University Hospital, Copenhagen, Denmark.

Aims: Socioeconomic status is a strong predictor of cardiovascular health. The aim of this study was to describe the immediate and long-term effects of cardiac rehabilitation (CR) across socioeconomic strata in elderly cardiac patients in Europe.

Methods And Results: The observational EU-CaRE study is a prospective study with eight CR sites in seven European countries. Patients ≥65 years with coronary heart disease or heart valve surgery participating in CR were consecutively included. Data were obtained at baseline, end of CR and at one-year follow up. Educational level as a marker for socioeconomic status was divided into basic, intermediate and high. The primary endpoint was exercise capacity (peak oxygen consumption (VO2peak)). Secondary endpoints were cardiovascular risk factors, medical treatment and scores for depression, anxiety and quality of life (QoL). A total of 1626 patients were included; 28% had basic, 48% intermediate and 24% high education. A total of 1515 and 1448 patients were available for follow-up analyses at end of CR and one-year, respectively. Patients with basic education were older and more often female. At baseline we found a socioeconomic gradient in VO2peak, lifestyle-related cardiovascular risk factors, anxiety, depression and QoL. The socioeconomic gap in VO2peak increased following CR (p for interaction <0.001). The socioeconomic gap in secondary outcomes was unaffected by CR. The use of evidence-based medication was good in all socioeconomic groups.

Conclusions: We found a strong socioeconomic gradient in VO2peak and cardiovascular risk factors that was unaffected or worsened after CR. To address inequity in cardiovascular health, the individual adaption of CR according to socioeconomic needs should be considered.
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http://dx.doi.org/10.1177/2047487320921485DOI Listing
May 2021

Evaluation of Dual Versus Triple Therapy by Landmark Analysis in the RE-DUAL PCI Trial.

JACC Cardiovasc Interv 2021 Apr;14(7):768-780

Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, Massachusetts, USA.

Objectives: The aim of this study was to explore the early versus late benefits and risks of dabigatran dual therapy versus warfarin triple therapy in the RE-DUAL PCI (Randomized Evaluation of Dual Antithrombotic Therapy With Dabigatran Versus Triple Therapy With Warfarin in Patients With Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial.

Background: Patients with atrial fibrillation who undergo percutaneous coronary intervention are at increased risk for both bleeding and thrombotic events.

Methods: A total of 2,725 patients with atrial fibrillation underwent percutaneous coronary intervention and were randomized to receive dabigatran 110 mg, or dabigatran 150 mg plus a P2Y inhibitor (and no aspirin), or warfarin plus a P2Y inhibitor plus aspirin. Landmark analysis was performed at 30 and 90 days.

Results: There was a consistent and large reduction in major or clinically relevant nonmajor bleeding in patients randomized to dual therapy during the first 30 days (110 mg: hazard ratio [HR]: 0.45; 95% confidence interval [CI]: 0.31 to 0.66; p < 0.0001; 150 mg: HR: 0.46; 95% CI: 0.30 to 0.72; p = 0.0006) compared with warfarin triple therapy. There was early net clinical benefit in both dabigatran groups versus warfarin (110 mg: HR: 0.65; 95% CI: 0.47 to 0.88; p = 0.0062; 150 mg: HR: 0.54; 95% CI: 0.37 to 0.79; p = 0.0015), due to larger reductions in bleeding than increased thrombotic events for dabigatran 110 mg and bleeding reduction without increased thrombotic risk for dabigatran 150 mg dual therapy versus warfarin triple therapy. After the removal of aspirin in the warfarin group, bleeding remained lower with dabigatran 110 mg and was similar with dabigatran 150 mg versus warfarin.

Conclusions: In RE-DUAL PCI, in which patients in the dual-therapy arms were treated with aspirin for an average of only 1.6 days, there was early net clinical benefit with both doses of dabigatran dual therapy, without an increase in thrombotic events with dabigatran 150 mg. This could be helpful in the subset of patients with elevated risk for both bleeding and thrombotic events.
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http://dx.doi.org/10.1016/j.jcin.2021.02.022DOI Listing
April 2021

The novel cystatin C, lactate, interleukin-6, and N-terminal pro-B-type natriuretic peptide (CLIP)-based mortality risk score in cardiogenic shock after acute myocardial infarction.

Eur Heart J 2021 06;42(24):2344-2352

Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology, Strümpellstr.. 39, 04289 Leipzig, and Leipzig Heart Institute, Leipzig, Germany.

Background: Cardiogenic shock (CS) complicating acute myocardial infarction (AMI) still reaches excessively high mortality rates. This analysis is aimed to develop a new easily applicable biomarker-based risk score.

Methods And Results: A biomarker-based risk score for 30-day mortality was developed from 458 patients with CS complicating AMI included in the randomized CULPRIT-SHOCK trial. The selection of relevant predictors and the coefficient estimation for the prognostic model were performed by a penalized multivariate logistic regression analysis. Validation was performed internally, internally externally as well as externally in 163 patients with CS included in the randomized IABP-SHOCK II trial. Blood samples were obtained at randomization. The two trials are registered with ClinicalTrials.gov (NCT01927549 and NCT00491036), are closed to new participants, and follow-up is completed. Out of 58 candidate variables, the four strongest predictors for 30-day mortality were included in the CLIP score (cystatin C, lactate, interleukin-6, and N-terminal pro-B-type natriuretic peptide). The score was well calibrated and yielded high c-statistics of 0.82 [95% confidence interval (CI) 0.78-0.86] in internal validation, 0.82 (95% CI 0.75-0.89) in internal-external (temporal) validation, and 0.73 (95% CI 0.65-0.81) in external validation. Notably, it outperformed the Simplified Acute Physiology Score II and IABP-SHOCK II risk score in prognostication (0.83 vs 0.62; P < 0.001 and 0.83 vs. 0.76; P = 0.03, respectively).

Conclusions: A biomarker-only score for 30-day mortality risk stratification in infarct-related CS was developed, extensively validated and calibrated in a prospective cohort of contemporary patients with CS after AMI. The CLIP score outperformed other clinical scores and may be useful as an early decision tool in CS.
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http://dx.doi.org/10.1093/eurheartj/ehab110DOI Listing
June 2021

Impact of timing of intraaortic balloon counterpulsation on mortality in cardiogenic shock - a subanalysis of the IABP-SHOCK II trial.

Eur Heart J Acute Cardiovasc Care 2020 Jun 10. Epub 2020 Jun 10.

Department of Internal Medicine/Cardiology, Heart Centre Leipzig at University of Leipzig and Leipzig Heart Institute, Germany.

Background: Conflicting results exist on whether initiation of intraaortic balloon pumping (IABP) before percutaneous coronary intervention (PCI) has an impact on outcome in this setting. Our aim was to assess the outcome of patients undergoing IABP insertion before versus after primary PCI in acute myocardial infarction complicated by cardiogenic shock.

Methods: The IABP-SHOCK II-trial randomized 600 patients with acute myocardial infarction and cardiogenic shock to IABP-support versus control. We analysed the outcome of patients randomized to the intervention group regarding timing of IABP implantation before or after PCI.

Results: Of 600 patients included in the IABP-SHOCK II trial, 301 were randomized to IABP-support. We analysed the 275 (91%) patients of this group undergoing primary PCI as revascularization strategy surviving the initial procedure. IABP insertion was performed before PCI in 33 (12%) and after PCI in 242 (88%) patients. There were no differences in baseline arterial lactate (p = 0.70), Simplified Acute Physiology Score-II-score (p = 0.60) and other relevant baseline characteristics. No differences were observed for short- and long-term mortality (pre vs. post 30-day mortality: 36% vs. 37%, odds ratio 0.99, 95% confidence interval (CI) 0.47-2.12, p = 0.99; one-year mortality: 56% vs. 48%, hazard ratio 1.08, 95% CI 0.65-1.80, p = 0.76; six-year-mortality: 64% vs. 65%, hazard ratio 1.00, 95% CI 0.63-1.60, p = 0.99). In multivariable Cox regression analysis timing of IABP-implantation was no predictor for long-term outcome (hazard ratio 1.08, 95% CI 0.66-1.78, p = 0.75).

Conclusions: Timing of IABP-implantation pre or post primary PCI had no impact on outcome in patients with acute myocardial infarction complicated by cardiogenic shock.
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http://dx.doi.org/10.1177/2048872620930509DOI Listing
June 2020

[COVID-19 pandemic : Effects on clinical care of cardiovascular patients in spring 2020].

Herz 2021 Mar 16;46(2):115-119. Epub 2021 Feb 16.

Herzzentrum Leipzig, Universität Leipzig, Strümpellstr. 39, 04289, Leipzig, Deutschland.

The coronavirus disease 2019 (COVID-19) pandemic has led to a focus of acute medical care on the treatment of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and pneumonia with consequences for all other medical specialties. Between March and May 2020 a decline in the number of admissions for elective cardiac procedures as well as for cardiac emergencies was observed. The number of patients hospitalized for acute myocardial infarction decreased, especially those with non-ST elevation myocardial infarction (NSTEMI), while time intervals between symptom onset and admission sometimes increased. In some studies an increase in infarct-related mortality was reported. There are multiple possible reasons for these findings, which include fear of patients to become infected with SARS-CoV‑2 in hospital, misinterpretation of symptoms and focusing of the healthcare system on the pandemic. In addition, SARS-CoV‑2 can lead to a higher proneness to thrombosis and therefore induce more severe courses of myocardial infarction.
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http://dx.doi.org/10.1007/s00059-020-05015-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7884099PMC
March 2021

Offering, participation and adherence to cardiac rehabilitation programmes in the elderly: a European comparison based on the EU-CaRE multicentre observational study.

Eur J Prev Cardiol 2021 May;28(5):558-568

Department of Cardiology, University Hospital of Santiago de Compostela, SERGAS, IDIS (CIBER-CV), A Choupana s/n, 15706 Santiago de Compostela (A Coruña), Spain.

Aims : Cardiac rehabilitation (CR) is strongly recommended but participation of elderly patients has not been well characterized. This study aims to analyse current rates and determinants of CR referral, participation, adherence, and compliance in a contemporary European cohort of elderly patients.

Methods And Results : The EU-CaRE observational study included data from consecutive patients aged ≥ 65 with acute coronary syndrome, revascularization, stable coronary artery disease, or heart valve replacement, recruited in eight European centres. Rates and factors determining offering, participation, and adherence to CR programmes and compliance with training sessions were studied across centres, under consideration of extensive-outpatient vs. intensive-inpatient programmes. Three thousand, four hundred, and seventy-one patients were included in the offering and participation analysis. Cardiac rehabilitation was offered to 80.8% of eligible patients, formal contraindications being the main reason for not offering CR. Mean participation was 68.0%, with perceived lack of usefulness and transport issues being principal barriers. Mean adherence to CR programmes of participants in the EU-CaRE study (n = 1663) was 90.3%, with hospitalization/physical impairment as principal causes of dropout. Mean compliance with training sessions was 86.1%. Older age was related to lower offering and participation, and comorbidity was associated with lower offering, participation, adherence, and compliance. Intensive-inpatient programmes displayed higher adherence (97.1% vs. 85.9%, P < 0.001) and compliance (full compliance: 66.0% vs. 38.8%, P < 0.001) than extensive-outpatient programmes.

Conclusion : In this European cohort of elderly patients, older age and comorbidity tackled patients' referral and uptake of CR programmes. Intensive-inpatient CR programmes showed higher completion than extensive-outpatient CR programmes, suggesting this formula could suit some elderly patients.
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http://dx.doi.org/10.1093/eurjpc/zwaa104DOI Listing
May 2021

Predictive Value of the Residual SYNTAX Score in Patients With Cardiogenic Shock.

J Am Coll Cardiol 2021 01;77(2):144-155

ACTION Study Group, INSERM UMRS_1166 Cardiology Institute, University of the Sorbonne, Paris, France. Electronic address:

Background: In hemodynamically stable patients, complete revascularization (CR) following percutaneous coronary intervention (PCI) is associated with a better prognosis in chronic and acute coronary syndromes.

Objectives: This study sought to assess the extent, severity, and prognostic value of remaining coronary stenoses following PCI, by using the residual SYNTAX score (rSS), in patients with cardiogenic shock (CS) related to myocardial infarction (MI).

Methods: The CULPRIT-SHOCK (Culprit Lesion Only Percutaneous Coronary Intervention [PCI] Versus Multivessel PCI in Cardiogenic Shock) trial compared a multivessel PCI (MV-PCI) strategy with a culprit lesion-only PCI (CLO-PCI) strategy in patients with multivessel coronary artery disease who presented with MI-related CS. The rSS was assessed by a central core laboratory. The study group was divided in 4 subgroups according to tertiles of rSS of the participants, thereby isolating patients with an rSS of 0 (CR). The predictive value of rSS for the 30-day primary endpoint (mortality or severe renal failure) and for 30-day and 1-year mortality was assessed using multivariate logistic regression.

Results: Among the 587 patients with an rSS available, the median rSS was 9.0 (interquartile range: 3.0 to 17.0); 102 (17.4%), 100 (17.0%), 196 (33.4%), and 189 (32.2%) patients had rSS = 0, 0 < rSS ≤5, 5 < rSS ≤14, and rSS >14, respectively. CR was achieved in 75 (25.2%; 95% confidence interval [CI]: 20.3% to 30.5%) and 27 (9.3%; 95% CI: 6.2% to 13.3%) of patients treated using the MV-PCI and CLO-PCI strategies, respectively. After multiple adjustments, rSS was independently associated with 30-day mortality (adjusted odds ratio per 10 units: 1.49; 95% CI: 1.11 to 2.01) and 1-year mortality (adjusted odds ratio per 10 units: 1.52; 95% CI: 1.11 to 2.07).

Conclusions: Among patients with multivessel disease and MI-related CS, CR is achieved only in one-fourth of the patients treated using an MV-PCI strategy. and the residual SYNTAX score is independently associated with early and late mortality.
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http://dx.doi.org/10.1016/j.jacc.2020.11.025DOI Listing
January 2021

Extracorporeal life support in patients with acute myocardial infarction complicated by cardiogenic shock - Design and rationale of the ECLS-SHOCK trial.

Am Heart J 2021 04 8;234:1-11. Epub 2021 Jan 8.

University Clinic Düsseldorf, Düsseldorf, Germany.

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.
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http://dx.doi.org/10.1016/j.ahj.2021.01.002DOI Listing
April 2021

Health Care Analysis on Myocardial Revascularization in Patients with Chronic Coronary Artery Disease: The Multicenter REVASK Study: Design and Protocol.

Thorac Cardiovasc Surg 2020 Dec 18. Epub 2020 Dec 18.

Institut für Herzinfarktforschung Ludwigshafen, Ludwigshafen, Germany.

Coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are available for revascularization of coronary artery disease (CAD) with the aims to reduce cardiovascular morbidity and mortality and to improve disease-related quality of life in particular. The German National Care Guideline (NVL-cKHK) on chronic CAD recommends the establishment of so-called heart teams for decision making in myocardial revascularization to improve the quality of care. Preferred recommendations for PCI or CABG are given for different patient subgroups depending on patient characteristics, concomitant diseases, and coronary morphology. The myocardial revascularization study (REVASK) is a noninterventional cohort study on care of patients undergoing PCI or CABG based on retrospective statutory health insurance (SHI) routine data, registry data from the German Cardiac Society (DGK) resp., the German Society for Thoracic and Cardiovascular Surgery (DGTHG), combined with prospective primary data collection from health care providers and patients. The primary goal is to investigate whether and to which extent heart teams, consisting of cardiologists and cardiac surgeons, increase guideline adherence in decision making for myocardial revascularization. Ultimately the study project aims to improve patient care in terms of decision making for appropriate myocardial revascularization. Through the consistent implementation of the German National Care Guideline on chronic Coronary Artery Disease (NVL-cKHK) and the European Guidelines on myocardial revascularization, the reduction of morbidity, mortality and the reduced need for subsequent revascularization procedures are also desirable from a health economics perspective.
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http://dx.doi.org/10.1055/s-0040-1721391DOI Listing
December 2020

Use of guideline-recommended drug therapy in patients undergoing percutaneous coronary intervention for stable coronary heart disease in Germany: a multilevel analysis of nationwide routine data.

BMJ Open 2020 12 13;10(12):e042886. Epub 2020 Dec 13.

Chair of Health Economics, Technical University Munich, Munich, Germany.

Objectives: To determine the prescription of guideline recommended drug therapy in patients with stable coronary heart disease (sCHD) prior to percutaneous coronary intervention (PCI) in Germany and to examine the role of patient characteristics and features of regional healthcare supply in a multilevel model.

Design: Secondary data analysis of factors associated with the prescription of guideline recommended drug therapy using a multilevel model to analyse regional-level effects, over and above the effects of patient-level demographic and health status.

Setting: Office-based prescriptions in the year prior to the invasive procedure.

Participants: A linked nationwide dataset from Germany's three largest statutory health insurance funds of all patients receiving PCI in the year 2016.

Main Outcome Measures: Patients' odds of receiving optimal medical therapy and symptom-oriented therapy within 1 year prior to PCI.

Results: 68.6% of patients received at least one lipid-lowering drug and one symptom-oriented therapy prior to PCI. 43.6% received at least two agents to control their symptoms. Patients who received treatment in accordance with the recommendations had a greater number of diagnosed risk factors, a more severe history of cardiac disease and used a higher volume of ambulatory office-based physician services. The prescriptions prevalence for the symptom-oriented therapies differed significantly between eastern and western Germany, with a higher prevalence in the eastern districts.

Conclusions: Guidelines can only provide decision-making corridors, and the applicability of recommendations must always be assessed on a case by case basis. Nevertheless, our analysis indicates that the prevalence of prescriptions in routine practice is subject to substantial variation and that conservative therapy options are not fully exhausted prior to PCI. This suggests that there might be room for improvement in the care of patients with sCHD.
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http://dx.doi.org/10.1136/bmjopen-2020-042886DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7737102PMC
December 2020

Current clinical management of acute myocardial infarction complicated by cardiogenic shock.

Expert Rev Cardiovasc Ther 2021 Jan 19;19(1):41-46. Epub 2021 Jan 19.

Medizinische Klinik B, Klinikum Ludwigshafen , Ludwigshafen, Germany.

Introduction: Cardiogenic shock (CS) remains the leading cause of death among patients admitted with acute myocardial infarction (AMI). Early restoration of blood flow of the infarct-related artery is of paramount importance, either with percutaneous coronary intervention (PCI) or with coronary artery bypass grafting (CABG). In addition, early risk stratification is a critical task and required to guide complex decisions on management and therapy of CS after AMI. The use of short-term mechanical circulatory support (MCS) is increasing, although evidence for their effectiveness is limited.

Areas Covered: We review the evidence for early revascularization of the culprit-lesion and risk stratification in patients with AMI complicated by cardiogenic shock. The current data for the use of MCS will be discussed and put into clinical perspective.

Expert Opinion: The SHOCK trial has introduced an early invasive strategy with subsequent revascularization as standard of care in patients with AMI complicated by CS. In clinical practice PCI is the by far the most often used revascularization therapy in CS. Most important is restoration of normal flow (so called TIMI 3 patency) of the infarct artery to reduce mortality. Therefore, all efforts including intense antithrombotic therapy should be made to achieve TIMI 3 patency. Around three quarters of patients with CS have multivessel coronary artery disease. According to the results of the CULPRIT-SHOCK trial PCI of the culprit lesion only is recommended as the preferred revascularization strategy in these patients, while additional lesions can be revascularized during a staged procedure. Immediate multivessel PCI could be performed in some specific angiographic scenarios, such as subtotal non-culprit lesions with reduced Thrombolysis In Myocardial Infarction (TIMI)-flow, or multiple possible culprit lesions. However, this should be considered on an individual basis. CABG should be performed only in case of failed PCI and coronary anatomies not suitable for PCI. However, small case series report good outcomes in selected patients with CS undergoing CABG. Therefore, a randomized trial comparing PCI and CABG in patients with CS and multivessel disease seems warranted. Hopefully such a trial will take place to determine the optimal revascularization therapy in CS. One problem might be to find a sufficient number of cardiac surgeons who are willing to operate such high-risk surgical patients.
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http://dx.doi.org/10.1080/14779072.2021.1854733DOI Listing
January 2021

Impact of chronic total occlusion and revascularization strategy in patients with infarct-related cardiogenic shock: A subanalysis of the culprit-shock trial.

Am Heart J 2021 02 27;232:185-193. Epub 2020 Nov 27.

First Department of Medicine-Cardiology, University Medical Centre Mannheim (UMM), University of Heidelberg, Mannheim, Germany.

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.
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http://dx.doi.org/10.1016/j.ahj.2020.11.009DOI Listing
February 2021

Clinical Outcomes According to ECG Presentations in Infarct-Related Cardiogenic Shock in the Culprit Lesion Only PCI vs Multivessel PCI in Cardiogenic Shock Trial.

Chest 2021 04 26;159(4):1415-1425. Epub 2020 Nov 26.

ACTION Study Group, Institut de Cardiologie (AP-HP), INSERM UMRS_1166, Sorbonne Université, Paris. Electronic address:

Background: The impact of ECG presentations of acute myocardial infarction (AMI) in cardiogenic shock is unknown.

Research Question: In myocardial infarction with cardiogenic shock, is there a difference in the outcomes and effect of revascularization strategies between non-ST-segment elevation myocardial infarction (NSTEMI) and left bundle branch block myocardial infarction (LBBBMI) vs ST-segment elevation myocardial infarction (STEMI)?

Study Design And Methods: Cardiogenic shock patients from the CULPRIT-SHOCK trial with NSTEMI or LBBBMI were compared with STEMI patients for 30-day and 1-year all-cause mortality. The interaction between ECG presentation and the effect of revascularization strategies on outcomes was evaluated.

Results: Of 665 cardiogenic shock patients analyzed, 55.9% demonstrated STEMI, 29.3% demonstrated NSTEMI, and 14.7% demonstrated LBBBMI. Patients differed in mean age (68.0 years in STEMI patients, 71.0 years in NSTEMI patients, and 73.5 years in LBBBMI patients; P = .015), cardiovascular risk factors, and angiographic severity. No difference was found in the 30-day risk of death between NSTEMI and STEMI patients (48.7% vs 43.0%; adjusted OR [aOR], 1.05; 95% CI, 0.66-1.67; P = .85), nor between LBBBMI and STEMI patients (59.2% vs 43.0%; aOR, 1.31; 95% CI, 0.73-2.34; P = .36). Although the univariate risk of death by 1 year was higher in NSTEMI and LBBBMI patients compared with STEMI patients, ECG presentation was not an independent risk factor of mortality after adjustment (NSTEMI vs STEMI: 56.4% vs 46.8%; aOR, 1.21; 95% CI, 0.76-1.92; P = .42; LBBBMI vs STEMI: 69.4% vs 46.8%; aOR, 1.59; 95% CI, 0.89-2.84; P = .12). ECG presentation did not modify the effect of the revascularization strategy on 30-day and 1-year mortality (P = .91 and P = .97 for interaction).

Interpretation: In patients with cardiogenic shock, NSTEMI and LBBBMI presentations reflect higher-risk profiles than STEMI presentations, but are not independent risk factors of mortality. ECG presentations did not modify the treatment effect, supporting culprit-lesion-only percutaneous coronary intervention as the preferred strategy across the AMI spectrum.
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http://dx.doi.org/10.1016/j.chest.2020.10.089DOI Listing
April 2021

Training intensity and improvements in exercise capacity in elderly patients undergoing European cardiac rehabilitation - the EU-CaRE multicenter cohort study.

PLoS One 2020 13;15(11):e0242503. Epub 2020 Nov 13.

Centre for Preventive Cardiology, Sports Medicine, Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.

Objectives: Guidelines for exercise intensity prescription in Cardiac Rehabilitation (CR) are inconsistent and have recently been discussed controversially. We aimed (1) to compare training intensities between European CR centres and (2) to assess associations between training intensity and improvement in peak oxygen consumption ([Formula: see text]O2) in elderly CR patients.

Methods: Peak [Formula: see text]O2, heart rate and work rate (WR) at the first and second ventilatory thresholds were measured at start of CR. Training heart rate was measured during three sessions spread over the CR. Multivariate models were used to compare training characteristics between centres and to assess the effect of training intensity on change in peak [Formula: see text]O2.

Results: Training intensity was measured in 1011 out of 1633 EU-CaRE patients in 7 of 8 centers and the first and secondary ventilatory threshold were identified in 1166 and 817 patients, respectively. The first and second ventilatory threshold were found at 44% (SD 16%) and 78% (SD 9%) of peak WR and 78% (SD 9%) and 89% (SD 5%) of peak heart rate, respectively. Training intensity and session duration varied significantly between centres but change in peak [Formula: see text]O2 over CR did not. Training above the first individual threshold (β 0.62, 95% confidence interval [0.25-1.02]) and increase in training volume per hour (β 0.06, 95%CI [0.01-0.12]) were associated with a higher change in peak [Formula: see text]O2.

Conclusion: While training intensity and volume varied greatly amongst current European CR programs, changes in peak [Formula: see text]O2 were similar and the effect of training characteristics on these changes were small.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0242503PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7665625PMC
January 2021

Dual antithrombotic therapy with dabigatran in patients with atrial fibrillation after percutaneous coronary intervention for ST-segment elevation myocardial infarction: a post hoc analysis of the randomised RE-DUAL PCI trial.

EuroIntervention 2021 Aug;17(6):474-480

Klinikum Ludwigshafen and Institut für Herzinfarktforschung, Ludwigshafen, Germany.

Background: Little is known about the optimal antithrombotic therapy in patients with atrial fibrillation undergoing PCI for ST-elevation myocardial infarction (STEMI).

Aims: The aim of this study was to investigate the safety and efficacy of dabigatran dual therapy (110 or 150 mg twice daily, plus clopidogrel or ticagrelor) versus warfarin triple therapy in patients with atrial fibrillation and STEMI.

Methods: In the RE-DUAL PCI trial, 305 patients with STEMI were randomised to dabigatran 110 mg (n=113 versus 106 warfarin) or 150 mg (n=86 versus 84 warfarin). The primary endpoint was the time to first major/clinically relevant non-major bleeding event (MBE/CRNMBE). The thrombotic endpoint was a composite of death, thromboembolic events, or unplanned revascularisation.

Results: In STEMI patients, dabigatran 110 mg (HR 0.39, 95% CI: 0.20-0.74) and 150 mg (0.43, 0.21-0.89) dual therapy reduced the risk of MBE/CRNMBE versus warfarin triple therapy (p for interaction vs all other patients=0.31 and 0.16). The risk of thrombotic events for dabigatran 110 mg (HR 1.61, 95% CI: 0.85-3.08) and 150 mg (0.56, 0.20-1.51) had p interactions of 0.20 and 0.33, respectively. For net clinical benefit, the HRs were 0.74 (95% CI: 0.46-1.17) and 0.49 (0.27-0.91) for dabigatran 110 and 150 mg (p for interaction=0.80 and 0.12), respectively.

Conclusions: After PCI for STEMI, patients on dabigatran dual therapy had lower risks of bleeding events versus warfarin triple therapy with similar risks of thromboembolic events, supporting dabigatran dual therapy even in patients with high thrombotic risk.
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http://dx.doi.org/10.4244/EIJ-D-20-00799DOI Listing
August 2021
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