Publications by authors named "Lisette Okkels Jensen"

166 Publications

Coronary Artery Healing Process after Bioresorbable Scaffold in Patients with Non-ST-Segment Elevation Myocardial Infarction: Rationale, Design, and Methodology of the HONEST Study.

Cardiology 2021 Feb 1:1-11. Epub 2021 Feb 1.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Background: Bioresorbable scaffolds (BRSs) is a relatively new approach in treating coronary artery stenosis. The initial results of the first commercially available scaffolds consisting of a backbone of poly-L-lactide raised safety concerns related to delayed resorption and healing. The magnesium alloy-based scaffold degrades via bio-corrosion within months, whereas it often takes several years for polymer scaffolds to degrade. The aim of the study was to assess the healing stage by optical coherence tomography (OCT) after 6 months in patients with non-ST-segment elevation myocardial infarct (NSTEMI) randomized to OCT or angiography-guided percutaneous coronary intervention with implantation of a magnesium sirolimus-eluting Magmaris scaffold (Magmaris; Biotronik, Bülach, Switzerland).

Methods: We analyzed the healing process by comparing OCT at baseline and after 6 months. Five stages of healing were defined with stage 1 being the least healed and stage 5 demonstrating complete resorption and healing with no visible scaffold/remnant. The primary end point is a calculated healing score that is based on 5 subtypes of healing stage: (1) malapposed, (2) uncovered with no detection of smooth surface tissue on top of struts or remnants, (3) covered protruding, (4) covered embedded, and (5) complete healing with a smooth neointimal surface and no sign of struts or visible remnants assessed by OCT 6 months after the index procedure.

Results: The impact of OCT-guided compared to angiography-guided scaffold implantation will be illuminated.

Conclusion: The present study will provide new information on midterm healing properties of the magnesium BRS in patients with NSTEMI.
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http://dx.doi.org/10.1159/000512417DOI Listing
February 2021

Ten-year cardiovascular risk in diabetes patients without obstructive coronary artery disease: a retrospective Western Denmark cohort study.

Cardiovasc Diabetol 2021 Jan 21;20(1):23. Epub 2021 Jan 21.

Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.

Background: Diabetes patients without obstructive coronary artery disease as assessed by coronary angiography have a low risk of myocardial infarction, but their myocardial infarction risk may still be higher than the general population. We examined the 10-year risks of myocardial infarction, ischemic stroke, and death in diabetes patients without obstructive coronary artery disease according to coronary angiography, compared to risks in a matched general population cohort.

Methods: We included all diabetes patients without obstructive coronary artery disease examined by coronary angiography from 2003 to 2016 in Western Denmark. Patients were matched by age and sex with a cohort from the Western Denmark general population without a previous myocardial infarction or coronary revascularization. Outcomes were myocardial infarction, ischemic stroke, and death. Ten-year cumulative incidences were computed. Adjusted hazard ratios (HR) then were computed using stratified Cox regression with the general population as reference.

Results: We identified 5734 diabetes patients without obstructive coronary artery disease and 28,670 matched individuals from the general population. Median follow-up was 7 years. Diabetes patients without obstructive coronary artery disease had an almost similar 10-year risk of myocardial infarction (3.2% vs 2.9%, adjusted HR 0.93, 95% CI 0.72-1.20) compared to the general population, but had an increased risk of ischemic stroke (5.2% vs 2.2%, adjusted HR 1.87, 95% CI 1.47-2.38) and death (29.6% vs 17.8%, adjusted HR 1.24, 95% CI 1.13-1.36).

Conclusions: Patients with diabetes and no obstructive coronary artery disease have a 10-year risk of myocardial infarction that is similar to that found in the general population. However, they still remain at increased risk of ischemic stroke and death.
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http://dx.doi.org/10.1186/s12933-021-01212-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7819163PMC
January 2021

Efficacy of Thin- Versus Thick-Strut Polymer-Free Biolimus-Eluting Stents: the Biofreedom QCA Randomized Trial.

EuroIntervention 2021 Jan 12. Epub 2021 Jan 12.

Department of Interventional Cardiology, Cardiovascular Institute, Hospital Clinic IDIBAPS, Barcelona, Spain.

Aims: To evaluate the efficacy of the new BioFreedom Ultra™ drug-coated stent with a thin-strut cobalt-chromium platform (BF-CoCr) compared to the BioFreedom™ drug-coated stent with a stainless-steel platform (BF-SS) in an all-comers population undergoing percutaneous coronary interventions (PCI).

Methods And Results: This was a prospective, multi-center, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) as determined by quantitative coronary angiographic at 9-month follow-up. Clinical evaluation was performed at 1 year. A total of 200 patients were randomized (1:1) to either the BF-CoCr or the BF-SS stent at 8 centers in Spain and Denmark. Baseline clinical and lesion characteristics were similar among the groups. Mean age was 66 years and 23% were females. The mean number of stents implanted per patient was 1.5. At 9-month follow-up, mean in-stent LLL was 0.34±0.49mm in BF-CoCr versus 0.29±0.37mm in the BF-SS, p=0.005 for non-inferiority. At 1-year, target lesion failure was similar between groups (7.3% in Bf-CoCr vs 9.3% in the BF-SS group; p=0.60).

Conclusions: The BF-CoCr was non-inferior to the BF-SS in terms of in-stent LLL at 9 months. Larger studies powered for clinical endpoints are warranted to compare the efficacy of this new platform with currently available DES.
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http://dx.doi.org/10.4244/EIJ-D-20-01162DOI Listing
January 2021

Hemodynamic and metabolic recovery in acute myocardial infarction-related cardiogenic shock is more rapid among patients presenting with out-of-hospital cardiac arrest.

PLoS One 2020 23;15(12):e0244294. Epub 2020 Dec 23.

Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

Background: Most studies in acute myocardial infarction complicated by cardiogenic shock (AMICS) include patients presenting with and without out-of-hospital cardiac arrest (OHCA). The aim was to compare OHCA and non-OHCA AMICS patients in terms of hemodynamics, management in the intensive care unit (ICU) and outcome.

Methods: From a cohort corresponding to two thirds of the Danish population, all patients with AMICS admitted from 2010-2017 were individually identified through patient records.

Results: A total of 1716 AMICS patients were identified of which 723 (42%) presented with OHCA. A total of 1532 patients survived to ICU admission. At the time of ICU arrival, there were no differences between OHCA and non-OHCA AMICS patients in variables commonly used in the AMICS definition (mean arterial pressure (MAP) (72mmHg vs 70mmHg, p = 0.12), lactate (4.3mmol/L vs 4.0mmol/L, p = 0.09) and cardiac output (CO) (4.6L/min vs 4.4L/min, p = 0.30)) were observed. However, during the initial days of ICU treatment OHCA patients had a higher MAP despite a lower need for vasoactive drugs, higher CO, SVO2 and lactate clearance compared to non-OHCA patients (p<0.05 for all). In multivariable analysis outcome was similar but cause of death differed significantly with hypoxic brain injury being leading cause in OHCA and cardiac failure in non-OHCA AMICS patients.

Conclusion: OHCA and non-OHCA AMICS patients initially have comparable metabolic and hemodynamic profiles, but marked differences develop between the groups during the first days of ICU treatment. Thus, pooling of OHCA and non-OHCA patients as one clinical entity in studies should be done with caution.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0244294PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7757873PMC
December 2020

Impact of COVID-19 pandemic and diabetes on mechanical reperfusion in patients with STEMI: insights from the ISACS STEMI COVID 19 Registry.

Cardiovasc Diabetol 2020 12 18;19(1):215. Epub 2020 Dec 18.

Division of Cardiology, Azienda Ospedaliero-Universitaria Maggiore della Carità, Università del Piemonte Orientale, Novara, Italy.

Background: It has been suggested the COVID pandemic may have indirectly affected the treatment and outcome of STEMI patients, by avoidance or significant delays in contacting the emergency system. No data have been reported on the impact of diabetes on treatment and outcome of STEMI patients, that was therefore the aim of the current subanalysis conducted in patients included in the International Study on Acute Coronary Syndromes-ST Elevation Myocardial Infarction (ISACS-STEMI) COVID-19.

Methods: The ISACS-STEMI COVID-19 is a retrospective registry performed in European centers with an annual volume of > 120 primary percutaneous coronary intervention (PCI) and assessed STEMI patients, treated with primary PCI during the same periods of the years 2019 versus 2020 (March and April). Main outcomes are the incidences of primary PCI, delayed treatment, and in-hospital mortality.

Results: A total of 6609 patients underwent primary PCI in 77 centers, located in 18 countries. Diabetes was observed in a total of 1356 patients (20.5%), with similar proportion between 2019 and 2020. During the pandemic, there was a significant reduction in primary PCI as compared to 2019, similar in both patients with (Incidence rate ratio (IRR) 0.79 (95% CI: 0.73-0.85, p < 0.0001) and without diabetes (IRR 0.81 (95% CI: 0.78-0.85, p < 0.0001) (p int = 0.40). We observed a significant heterogeneity among centers in the population with and without diabetes (p < 0.001, respectively). The heterogeneity among centers was not related to the incidence of death due to COVID-19 in both groups of patients. Interaction was observed for Hypertension (p = 0.024) only in absence of diabetes. Furthermore, the pandemic was independently associated with a significant increase in door-to-balloon and total ischemia times only among patients without diabetes, which may have contributed to the higher mortality, during the pandemic, observed in this group of patients.

Conclusions: The COVID-19 pandemic had a significant impact on the treatment of patients with STEMI, with a similar reduction in primary PCI procedures in both patients with and without diabetes. Hypertension had a significant impact on PCI reduction only among patients without diabetes. We observed a significant increase in ischemia time and door-to-balloon time mainly in absence of diabetes, that contributed to explain the increased mortality observed in this group of patients during the pandemic.

Trial Registration Number: NCT04412655.
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http://dx.doi.org/10.1186/s12933-020-01196-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7747477PMC
December 2020

Invasive aortic pulse pressure is not superior to cuff pulse pressure in cardiovascular risk prediction.

J Hypertens 2021 Apr;39(4):607-613

Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus N.

Objective: Aortic pulse pressure (PP) represents the hemodynamic cardiac and cerebral burden more directly than cuff PP. The objective of this study was to investigate whether invasively measured aortic PP confers additional prognostic value beyond cuff PP for cardiovascular events and death. With increasing age, cuff PP progressively underestimates aortic PP. Whether the prognostic association between cuff PP and outcomes is age-dependent remains to be elucidated.

Methods: Cuff PP and invasively measured aortic PP were recorded in 21 908 patients (mean age 63 years, 58% men, 14% with diabetes) with stable angina pectoris undergoing elective coronary angiography during January 2001--December 2012. Multivariate Cox models were used to assess the association with incident myocardial infarction, stroke, and death. Discrimination was assessed using Harrell's C-index.

Results: During a median follow-up period of 3.7 years (range 0.1-10.8 years), 422 strokes, 511 myocardial infarctions, and 1530 deaths occurred. Both cuff and aortic PP were associated with stroke, myocardial infarction, and death in crude analyses. However, only cuff PP remained associated with stroke (hazard ratio per 10 mmHg, 1.06 (95% confidence interval (CI) 1.01--1.12)] and myocardial infarction [hazard ratio per 10 mmHg 1.05 (95% CI 1.01--1.11)] in multivariate Cox models. Both cuff and aortic PP lost significance as predictors of death in multivariate models. Age did not modify the prognostic association between cuff PP and stroke, myocardial infarction, and death.

Conclusion: Invasively measured aortic PP did not add prognostic information about cardiovascular outcomes and death beyond cuff PP in patients with stable angina pectoris.
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http://dx.doi.org/10.1097/HJH.0000000000002694DOI Listing
April 2021

Impact of COVID-19 Pandemic on Mechanical Reperfusion for Patients With STEMI.

J Am Coll Cardiol 2020 11;76(20):2321-2330

Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland.

Background: The fear of contagion during the coronavirus disease-2019 (COVID-19) pandemic may have potentially refrained patients with ST-segment elevation myocardial infarction (STEMI) from accessing the emergency system, with subsequent impact on mortality.

Objectives: The ISACS-STEMI COVID-19 registry aims to estimate the true impact of the COVID-19 pandemic on the treatment and outcome of patients with STEMI treated by primary percutaneous coronary intervention (PPCI), with identification of "at-risk" patient cohorts for failure to present or delays to treatment.

Methods: This retrospective registry was performed in European high-volume PPCI centers and assessed patients with STEMI treated with PPPCI in March/April 2019 and 2020. Main outcomes are the incidences of PPCI, delayed treatment, and in-hospital mortality.

Results: A total of 6,609 patients underwent PPCI in 77 centers, located in 18 countries. In 2020, during the pandemic, there was a significant reduction in PPCI as compared with 2019 (incidence rate ratio: 0.811; 95% confidence interval: 0.78 to 0.84; p < 0.0001). The heterogeneity among centers was not related to the incidence of death due to COVID-19. A significant interaction was observed for patients with arterial hypertension, who were less frequently admitted in 2020 than in 2019. Furthermore, the pandemic was associated with a significant increase in door-to-balloon and total ischemia times, which may have contributed to the higher mortality during the pandemic.

Conclusions: The COVID-19 pandemic had significant impact on the treatment of patients with STEMI, with a 19% reduction in PPCI procedures, especially among patients suffering from hypertension, and a longer delay to treatment, which may have contributed to the increased mortality during the pandemic. (Primary Angioplasty for STEMI During COVID-19 Pandemic [ISACS-STEMI COVID-19] Registry; NCT04412655).
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http://dx.doi.org/10.1016/j.jacc.2020.09.546DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7834750PMC
November 2020

Culprit lesion morphology in patients with ST-segment elevation myocardial infarction assessed by optical coherence tomography.

Coron Artery Dis 2020 12;31(8):671-677

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Aims: This study sought to evaluate the incidence of ruptured plaques and nonruptured plaques (NRP) and to compare patient characteristics and detailed plaque morphology features between the two culprit types in ST-segment elevation myocardial infarction (STEMI) patients, using optical coherence tomography (OCT).

Methods And Results: Using OCT, the culprit lesions in patients with STEMI were assessed prior to stent implantation. The culprit lesion was categorized as ruptured plaques or NRP, and the plaque components were evaluated. Fifty-two patients (69.3%) presented with ruptured plaques and 23 (30.7%) with NRP. Patients with NRP were younger (58.0 ± 10.4 vs 64.7 ± 9.9 years, P = 0.01) and more often smokers (72.7% vs 37.1%, P = 0.001), compared to ruptured plaques. NRP contained significantly more fibrotic plaque (20.0% [interquartile range (IQR) 13.7-29.8] vs 11.3% [IQR 6.9-18.1], P = 0.005), but less lipidic plaque (44.0% ± 13.7 vs 59.3% ± 13.6, P < 0.001), less superficial [5.0% (IQR 2.8-7.5) vs 8.1% (IQR 5.7-11.0), P = 0.005] and profound macrophages [0.9% (IQR 0.0-1.7) vs 2.2% (IQR 0.9-4.7), P = 0.003]. The prevalence, numbers and lengths of thin-cap fibroatheroma (TCFA) were significantly lower in NRP, compared to ruptured plaques [47.8% vs 88.5%, 0 (IQR 0-1) vs 1 (IQR 1-2) and 0 mm (IQR 0-2.7) vs 4.5 mm (IQR 2.3-7.7), P < 0.001].

Conclusions: One-third of STEMI patients had culprit lesions without an OCT-detectable ruptured plaque. Culprit lesions with NRP contained less vulnerable plaque components, such as lipid plaque, TCFAs and macrophages compared to ruptured plaques.
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http://dx.doi.org/10.1097/MCA.0000000000000957DOI Listing
December 2020

The association between self-reported health status and adverse events: a comparison among coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI).

Qual Life Res 2020 Nov 28;29(11):3017-3029. Epub 2020 Aug 28.

Department of Cardiology, Odense University Hospital, J.B. Winsløws Vej 4, 5000, Odense C, Denmark.

Purpose: While several studies have investigated clinical outcomes following coronary artery bypass grafting (CABG) vs. percutaneous coronary intervention (PCI), studies investigating self-reported health and the association with adverse outcomes are limited. Thus, the aim was to investigate differences in health-related quality of life (HRQoL), anxiety and depression at discharge and the association with a composite endpoint of the first event of acute cardiac readmission, revascularisation or 1-year mortality among patients undergoing CABG vs. PCI.

Methods: Data from the national cohort study, DenHeart, were used, including measures of HRQoL; EuroQoL-5D-5L (EQ-5D Index Score and VAS) and HeartQoL (Global, Physical and Emotional), anxiety and depression (Hospital Anxiety and Depression Scale, HADS) and register-based follow-up. A total of 7000 patients were included (CABG n = 652, PCI n = 6348) (median age 65, 75% men). Cox Proportional Hazard models were performed among a propensity-matched population of responders (n = 520).

Results: HRQoL was significantly better among patients undergoing PCI vs. CABG, but with no differences in time to readmission or revascularisation. HRQoL, anxiety and depression were significantly associated with the risk of the composite endpoint among the PCI group (Hazard Ratio, HR (95% confidence intervals, CI) [EQ-5D index score 3.07 (1.67-5.67), EQ-5D VAS 0.97 (0.96-0.99), HeartQol Global 0.61 (0.38-0.95), HeartQol Emotional 0.56 (0.39-0.80), HADS-D ≥ 8 3.12 (1.61-6.01), HADS-A ≥ 8 2.08 (1.14-3.80)].

Conclusion: Patients undergoing PCI reported better HRQoL at discharge compared with patients undergoing CABG, whereas readmission rates were similar. Self-reported health was associated with the risk of adverse events among patients undergoing PCI, but not among patients undergoing CABG.

Clinical Trial Registration: NCT01926145.
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http://dx.doi.org/10.1007/s11136-020-02573-8DOI Listing
November 2020

Unloading using Impella CP during profound cardiogenic shock caused by left ventricular failure in a large animal model: impact on the right ventricle.

Intensive Care Med Exp 2020 Aug 12;8(1):41. Epub 2020 Aug 12.

Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

Background And Aim: This study aimed to assess right ventricular (RV) function during cardiogenic shock due to acute left ventricular (LV) failure, including during LV unloading with Impella CP and an added moderate dose of norepinephrine.

Methods: Cardiogenic shock was induced by injecting microspheres in the left main coronary artery in 18 adult Danish Landrace pigs. Conductance catheters were placed in both ventricles and pressure-volume loops were recorded simultaneously.

Results: Cardiogenic shock due to LV failure also impaired RV performance, which was partially restored during haemodynamic support with Impella CP, as demonstrated by changes in the ventriculo-arterial coupling (Ea/Ees ratio) (baseline (median [Q1;Q3]) 1.2 [1.1;1.6]), cardiogenic shock (3.0 [2.4;4.5]), Impella CP (2.1 [1.3;2.7]) (p < 0.0001, p = 0.001)). Impella CP support also improved RV stroke work (SW) (cardiogenic shock 333 [263;530] vs Impella CP (830 [717;1121]) (p < 0.001). Moderate norepinephrine infusion concomitant with Impella CP further improved RV SW (Impella CP (818 [751;1065]) vs Impella CP+moderate norepinephrine (1231 [1142;1335]) (p = 0.01)) but at the expense of an increase in LV SW (Impella CP (858 [555;1392]) vs Impella CP+moderate norepinephrine (2101 [1024;2613]) (p = 0.04)).

Conclusions: The Impella CP provided efficient LV unloading, improved RV function, and end-organ perfusion. Moderate doses of norepinephrine during Impella support further improved RV function, but at the expense of an increase in SW of the failing LV.
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http://dx.doi.org/10.1186/s40635-020-00326-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7423825PMC
August 2020

A Novel Model for Prediction of Thromboembolic and Cardiovascular Events in Patients Without Atrial Fibrillation.

Am J Cardiol 2020 09 28;131:40-48. Epub 2020 Jun 28.

Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. Electronic address:

Patients without atrial fibrillation (AF) constitute approximately 75% of patients suffering thromboembolism and major adverse cardiovascular events (MACE), but evidence supporting risk stratification in these patients is sparse. We aimed to develop a risk prediction model for identification of patients without AF at high risk of first-time thromboembolic events. We included 72,381 coronary angiography patients without AF and without previous ischemic stroke or transient ischemic attack. The cohort was randomly divided into a derivation cohort (80%, n = 57,680) and a validation cohort (20%, n = 14,701). The primary thromboembolic end point was a composite of ischemic stroke, transient ischemic attack, and systemic embolism. MACE was defined as a composite of cardiac death, myocardial infarction, and ischemic stroke. The final model was compared with 2 validated clinical risk models (CHADS and CHADS-VASc). The risk prediction model assigned 1 point to heart failure, hypertension, diabetes mellitus, renal disease, age 65 to 74 years, active smoking, and multivessel obstructive coronary artery disease, and 2 points to age ≥75 years and peripheral artery disease. A C-index of 0.66 (95% CI 0.64 to 0.69) for prediction of the composite thromboembolic end point was found in the validation cohort, which was higher than for CHADS (C-index 0.63 [95% CI 0.60 to 0.67]; p < 0.001) and CHADS-VASc (C-index 0.64 [95% CI 0.62 to 0.67]; p = 0.034). The model also predicted MACE (C-index 0.71 [95% CI 0.69 to 0.73]). In conclusion it is possible to identify patients without AF at high risk of first-time thromboembolic events and MACE by use of a simple clinical prediction model.
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http://dx.doi.org/10.1016/j.amjcard.2020.06.031DOI Listing
September 2020

Mortality in cardiogenic shock is stronger associated to clinical factors than contemporary biomarkers reflecting neurohormonal stress and inflammatory activation.

Biomarkers 2020 Sep 20;25(6):506-512. Epub 2020 Jul 20.

Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

Purpose: To validate the IABP-SHOCK II risk score in a Danish cohort and assess the association between the IABP-SHOCK II risk score and admission concentration of biomarkers reflecting neurohormonal - (Copeptin, Pro-atrial natriuretic peptide (proANP), Mid-regional pro-adrenomedullin (MRproADM)) and inflammatory (ST2) activation in patients with CS complicating ST segment elevation myocardial infarction (STEMI).

Methods: A total of 137 consecutive patients admitted with STEMI and CS at two tertiary heart centres were stratified according to the IABP-SHOCK II risk score (0-2; 3/4; 5-9), and had blood sampled upon admission.

Results: Plasma concentrations of Copeptin (median (pmol/L) score 0-2: 313; score 3/4: 682; score 5-9: 632  < 0.0001), proANP (pmol/L) (1459; 2225; 2876  = 0.0009) and MRproADM (nmol/L) (0.86; 1.2; 1.4  = 0.04) were significantly associated with the risk score, whereas ST2 (ng/mL) was not (44; 60; 45  = 0.23). The IABP-SHOCK II risk score predicted 30-day mortality (score 0-2: 22%; score 4/3: 51%; score 5-9: 72%, area under the curve (AUC): 0.73, logrank < 0.0001), while the tested biomarkers did not (AUC: 0.51
Conclusion: Plasma concentrations of Copeptin, MRproADM and proANP were associated with the IABP-SHOCK II risk score in STEMI patients admitted with CS. The risk score predicted 30-day mortality, with no improvement in prediction when concentrations of the assessed biomarkers were added.
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http://dx.doi.org/10.1080/1354750X.2020.1795265DOI Listing
September 2020

The association of diabetes and admission blood glucose with 30-day mortality in patients with acute myocardial infarction complicated by cardiogenic shock.

Eur Heart J Acute Cardiovasc Care 2020 Sep 26;9(6):626-635. Epub 2020 May 26.

Department of Cardiology, Rigshospitalet - Copenhagen University Hospital, Denmark.

Background: Cardiogenic shock is the leading cause of death in patients with acute myocardial infarction, with short-term mortality of approximately 50%. Whether diabetes mellitus and high blood glucose levels are associated with mortality in contemporary patients with acute myocardial infarction complicated by cardiogenic shock is inadequately described.

Purpose: To investigate if diabetes mellitus and high admission blood glucose were associated with 30-day mortality in a large, contemporary population with acute myocardial infarction complicated by cardiogenic shock.

Methods: Patients with acute myocardial infarction complicated by cardiogenic shock admitted at two tertiary centres in Denmark from 2010 to 2017 were individually identified through patient charts, resulting in the inclusion of 1716 cardiogenic shock patients. Glucose level at admission to the intensive care unit was available in 1302 patients.

Results: There was no significant difference in 30-day mortality between diabetes mellitus types I and II (63% vs. 62%, NS). Thirty-day mortality was significantly higher in diabetes patients compared to non-diabetes patients (62% vs. 50%,  < 0.001). Increasing admission glucose was associated with increasing 30-day mortality in a dose-dependent manner in diabetes mellitus (4-8 mmol/L, 41%; 8-12 mmol/L, 49%; 12-16 mmol/L, 63%; >16 mmol/L, 67%;  = 0.028) and non-diabetes patients (4-8 mmol/L, 32%; 8-12 mmol/L, 43%; 12-16 mmol/L, 57%; >16 mmol/l; 68%;  < 0.001).

Conclusion: Patients with acute myocardial infarction complicated by cardiogenic shock and concomitant diabetes mellitus type I or II had a significantly higher 30-day mortality in comparison to patients without diabetes mellitus, whereas no difference was found between diabetes mellitus types I and II. High glucose levels on admission to the intensive care unit were associated with increased 30-day mortality in diabetes mellitus and non-diabetes mellitus patients.
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http://dx.doi.org/10.1177/2048872620925265DOI Listing
September 2020

Randomized Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent With the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent in an All-Comers Population Treated With Percutaneous Coronary Intervention: The SORT OUT IX Trial.

Circulation 2020 06 21;141(25):2052-2063. Epub 2020 May 21.

Department of Cardiology, Aarhus University Hospital, Skejby Hospital, Denmark (M.M., L.J., S.D.K., S.C., C.J.T., H.E.B., T.T., A.E., E.H.C.).

Background: In patients with increased bleeding risk, the biolimus A9-coated BioFreedom stent, a stainless steel drug-coated stent free from polymer, has shown superiority compared with a bare-metal stent. The aim of this study was to investigate whether the BioFreedom stent is noninferior to a modern ultrathin strut biodegradable polymer cobalt-chromium sirolimus-eluting Orsiro stent in an all-comers patient population treated with percutaneous coronary intervention.

Methods: The SORT OUT IX trial (Scandinavian Organization for Randomized Trials With Clinical Outcome IX), was a large-scale, registry-based, randomized, multicenter, single-blind, 2-arm, noninferiority trial. The primary end point, major adverse cardiovascular events, was defined as the composite of cardiac death, myocardial infarction not related to any segment other than the target lesion, or target lesion revascularization within 1 year, analyzed by intention-to-treat. The trial was powered to assess noninferiority for major adverse cardiovascular events of the BioFreedom stent compared with the Orsiro stent with a predetermined noninferiority margin of 0.021.

Results: Between December 14, 2015 and April 21, 2017, 3151 patients were assigned to treatment with the BioFreedom stent (1572 patients, 1966 lesions) or to the Orsiro stent (1579 patients, 1985 lesions). Five patients were lost to follow-up because of emigration (99.9% follow-up rate). Mean age was 66.3±10.9, diabetes mellitus was seen in 19.3% of patients, and 53% of the patients had acute coronary syndromes. At 1 year, intention-to-treat analysis showed that 79 (5.0%) patients, who were assigned the BioFreedom stent, and 59 (3.7%), who were assigned the Orsiro stent, met the primary end point (absolute risk difference 1.29% [upper limit of one-sided 95% CI 2.50%]; =0.14). Significantly more patients in the BioFreedom stent group had target lesion revascularization than those in the Orsiro stent group (55 [3.5%] vs 20 [1.3%], rate ratio 2.77 [95% CI, 1.66-4.62]; <0.0001).

Conclusions: The biolimus A9-coated BioFreedom polymer-free stent did not meet criteria for noninferiority for major adverse cardiovascular events at 12 months when compared with the ultrathin strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02623140.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.119.040241DOI Listing
June 2020

Clinical outcomes three-year after revascularization with biodegradable polymer stents: ultrathin-strut sirolimus-eluting stent versus biolimus-eluting stent: from the Scandinavian organization for randomized trials with clinical outcome VII trial.

Coron Artery Dis 2020 09;31(6):485-492

Department of Cardiology, Odense University Hospital, Odense.

Background: Drug-eluting stents with biodegradable polymers have been designed to improve safety and efficacy. However, drug-eluting stents with biodegradable polymers may not be a class effect, as stent strut thickness, polymer coating, and drug resorption differ between these groups of stents. Twelve months results of Scandinavian Organization for Randomized Trials With Clinical Outcome VII showed that ultrathin-strut sirolimus-eluting Orsiro stent was noninferior to the biolimus-eluting Nobori stent. The sirolimus-eluting Orsiro stent was associated with a reduced risk of definite stent thrombosis.

Methods: The Scandinavian Organization for Randomized Trials With Clinical Outcome VII trial is a prospective multicenter randomized clinical trial comparing sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent in all-comers patients. The endpoint target lesion failure was a composite of cardiac death, myocardial infarction (not related to other than index lesion) and target lesion revascularization.

Results: A total of 1261 patients were randomized to treatment with sirolimus-eluting Orsiro stent and 1264 patients to biolimus-eluting Nobori stent and followed for 3 years. At 3-year the target lesion failure was comparable for sirolimus-eluting Orsiro stent (9.0%) and the biolimus-eluting Nobori stent (9.1%), (rate ratio, 0.99; 95% confidence interval, 0.77-1.29). Cardiac death (sirolimus-eluting Orsiro stent 3.0% vs. biolimus-eluting Nobori stent 2.6% [rate ratio, 1.16; 95% confidence interval, 0.73-1.86]), target lesion revascularization (sirolimus-eluting Orsiro stent 5.2% vs. biolimus-eluting Nobori stent 5.9% [rate ratio, 0.90; 95% confidence interval, 0.64-1.25]), myocardial infarction (sirolimus-eluting Orsiro stent 4.7% vs. biolimus-eluting Nobori stent 4.5% [rate ratio, 1.04; 95% confidence interval, 0.72-1.50]), and definite stent thrombosis (sirolimus-eluting Orsiro stent 1.0% vs. biolimus-eluting Nobori stent 1.7% [rate ratio, 0.59; 95% confidence interval, 0.30-1.18]) did not differ significantly between the two groups.

Conclusion: At 3-year follow-up, target lesion failure did not differ among ultrathin-strut sirolimus-eluting Orsiro stent and biolimus-eluting Nobori stent with biodegradable polymers.
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http://dx.doi.org/10.1097/MCA.0000000000000875DOI Listing
September 2020

O-Water Positron Emission Tomography of Myocardial Ischemia in Patients Referred for Percutaneous Coronary Intervention.

Cardiovasc Revasc Med 2020 Oct 7;21(10):1237-1243. Epub 2020 Mar 7.

Department of Cardiology, Odense University Hospital, Odense, Denmark. Electronic address:

The diagnostic accuracy of non-invasive diagnostic methods for detecting coronary artery disease has increased in recent years. This study aimed to assess the diagnostic performance of O-water positron emission tomography (PET) in terms of stress myocardial blood flow (MBF) and myocardial flow reserve (MFR) in patients with single-vessel disease referred for percutaneous coronary intervention (PCI), using fractional flow reserve (FFR) value of ≤0.80 as the reference for a significant stenosis. We also assessed the influence of the index of microcirculatory resistance (IMR) on the diagnostic performance of PET. O-water PET FFR and IMR were measured before PCI in 26 patients with single-vessel disease. Stress MBF < 2.5 ml/min/g (95% confidence interval [CI]) had sensitivity 78% (95% CI: 52%-94%), specificity 50% (95% CI: 16%-84%), positive predictive value (PPV) 78% (95% CI: 63%-88%), negative predictive value (NPV) 50% (95% CI: 25%-75%), and accuracy 69% (95% CI: 48%-86%). MFR < 2.5 had sensitivity 72% (95% CI: 47%-90%), specificity 75% (95% CI: 35%-97%), PPV 87% (95% CI: 65%-96%), NPV 55% (95% CI: 34%-74%), and accuracy 73% (95% CI: 52%-88%). In patients with IMR > 24, stress MBF correlated with FFR (r = 0.651; p = 0.016) whereas stress MBF did not correlate with FFR in patients with IMR < 24. In conclusion, stress MBF and MFR had modest diagnostic performance compared to invasive FFR measurements in patients with single-vessel disease.
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http://dx.doi.org/10.1016/j.carrev.2020.03.010DOI Listing
October 2020

Contemporary trends in use of mechanical circulatory support in patients with acute MI and cardiogenic shock.

Open Heart 2020 4;7(1):e001214. Epub 2020 Mar 4.

Department of Cardiology, Odense Universitetshospital, Odense, Denmark.

Objectives: To describe the contemporary trends in the use of mechanical circulatory support (MCS) in patients with acute myocardial infarction and cardiogenic shock (AMICS). To evaluate survival benefit with early application of intra-aortic balloon pump (IABP) or Impella CP.

Methods: A cohort study of all consecutive patients with AMICS undergoing percutaneous coronary intervention (PCI) <24 hours of symptom onset (early PCI) in southeastern Denmark from 2010 to 2017. A matched case-control study comparing 30-day mortality between patients receiving early-IABP or early-Impella CP and their respective control group. Controls were matched on age, left ventricular ejection fraction, arterial lactate, estimated glomerular filtration rate and cardiac arrest before PCI. Early-IABP/Impella CP was defined as applied before PCI if shock developed pre-PCI, or immediately after PCI if shock developed during PCI.

Results: 903 patients with AMICS undergoing early PCI were identified. Use of MCS decreased from 50% in 2010 to 25% in 2017, p for trend of <0.001. The IABP was abandoned in 2012 and replaced mostly by Impella CP. Patients receiving MCS in 2013-2017 had more compromised haemodynamics compared with patients receiving MCS in 2010-2012. 40 patients received early IABP, and 40 patients received early Impella CP. Only the group receiving early Impella CP was associated with lower 30-day mortality compared with their matched control group (30-day mortality 40% vs 77.5%, of<0.001).

Conclusion: Use of MCS decreased by 50% from 2010 to 2017. Patients receiving MCS had more compromised haemodynamics in recent years. Early application of Impella CP was associated with reduced 30-day mortality compared with a matched control group.
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http://dx.doi.org/10.1136/openhrt-2019-001214DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7059524PMC
June 2020

Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch: the Nordic-Baltic Bifurcation Study IV.

Open Heart 2020 19;7(1):e000947. Epub 2020 Jan 19.

Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.

Background: It is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple) or by routine two-stent techniques (complex). We aimed to compare clinical outcome after treatment of lesions in large bifurcations by simple or complex stent implantation.

Methods: The study was a randomised, superiority trial. Enrolment required a SB≥2.75 mm, ≥50% diameter stenosis in both vessels, and allowed SB lesion length up to 15 mm. The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months. Two-year clinical follow-up was included in this primary reporting due to lower than expected event rates.

Results: A total of 450 patients were assigned to simple stenting (n=221) or complex stenting (n=229) in 14 Nordic and Baltic centres. Two-year follow-up was available in 218 (98.6%) and 228 (99.5%) patients, respectively. The primary endpoint of major adverse cardiac events (MACE) at 6 months was 5.5% vs 2.2% (risk differences 3.2%, 95% CI -0.2 to 6.8, p=0.07) and at 2 years 12.9% vs 8.4% (HR 0.63, 95% CI 0.35 to 1.13, p=0.12) after simple versus complex treatment. In the subgroup treated by newer generation drug-eluting stents, MACE was 12.0% vs 5.6% (HR 0.45, 95% CI 0.17 to 1.17, p=0.10) after simple versus complex treatment.

Conclusion: In the treatment of bifurcation lesions involving a large SB with ostial stenosis, routine two-stent techniques did not improve outcome significantly compared with treatment by the simpler main vessel stenting technique after 2 years.

Trial Registration Number: NCT01496638.
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http://dx.doi.org/10.1136/openhrt-2018-000947DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6999681PMC
June 2020

Effect of remote ischaemic conditioning on clinical outcomes in patients with acute myocardial infarction (CONDI-2/ERIC-PPCI): a single-blind randomised controlled trial.

Lancet 2019 10 6;394(10207):1415-1424. Epub 2019 Sep 6.

The Hatter Cardiovascular Institute, University College London, London, UK. Electronic address:

Background: Remote ischaemic conditioning with transient ischaemia and reperfusion applied to the arm has been shown to reduce myocardial infarct size in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). We investigated whether remote ischaemic conditioning could reduce the incidence of cardiac death and hospitalisation for heart failure at 12 months.

Methods: We did an international investigator-initiated, prospective, single-blind, randomised controlled trial (CONDI-2/ERIC-PPCI) at 33 centres across the UK, Denmark, Spain, and Serbia. Patients (age >18 years) with suspected STEMI and who were eligible for PPCI were randomly allocated (1:1, stratified by centre with a permuted block method) to receive standard treatment (including a sham simulated remote ischaemic conditioning intervention at UK sites only) or remote ischaemic conditioning treatment (intermittent ischaemia and reperfusion applied to the arm through four cycles of 5-min inflation and 5-min deflation of an automated cuff device) before PPCI. Investigators responsible for data collection and outcome assessment were masked to treatment allocation. The primary combined endpoint was cardiac death or hospitalisation for heart failure at 12 months in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02342522) and is completed.

Findings: Between Nov 6, 2013, and March 31, 2018, 5401 patients were randomly allocated to either the control group (n=2701) or the remote ischaemic conditioning group (n=2700). After exclusion of patients upon hospital arrival or loss to follow-up, 2569 patients in the control group and 2546 in the intervention group were included in the intention-to-treat analysis. At 12 months post-PPCI, the Kaplan-Meier-estimated frequencies of cardiac death or hospitalisation for heart failure (the primary endpoint) were 220 (8·6%) patients in the control group and 239 (9·4%) in the remote ischaemic conditioning group (hazard ratio 1·10 [95% CI 0·91-1·32], p=0·32 for intervention versus control). No important unexpected adverse events or side effects of remote ischaemic conditioning were observed.

Interpretation: Remote ischaemic conditioning does not improve clinical outcomes (cardiac death or hospitalisation for heart failure) at 12 months in patients with STEMI undergoing PPCI.

Funding: British Heart Foundation, University College London Hospitals/University College London Biomedical Research Centre, Danish Innovation Foundation, Novo Nordisk Foundation, TrygFonden.
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http://dx.doi.org/10.1016/S0140-6736(19)32039-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6891239PMC
October 2019

Interaction of ischaemic postconditioning and thrombectomy in patients with ST-elevation myocardial infarction.

Heart 2020 01 17;106(1):24-32. Epub 2019 Jul 17.

Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

Objective: The Third Danish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction - Ischaemic Postconditioning (DANAMI-3-iPOST) did not show improved clinical outcome in patients with ST-segment elevation myocardial infarction (STEMI) treated with ischaemic postconditioning. However, the use of thrombectomy was frequent and thrombectomy may in itself diminish the effect of ischaemic postconditioning. We evaluated the effect of ischaemic postconditioning in patients included in DANAMI-3-iPOST stratified by the use of thrombectomy.

Methods: Patients with STEMI were randomised to conventional primary percutaneous coronary intervention (PCI) or ischaemic postconditioning plus primary PCI. The primary endpoint was a combination of all-cause mortality and hospitalisation for heart failure.

Results: From March 2011 until February 2014, 1234 patients were included with a median follow-up period of 35 (interquartile range 28 to 42) months. There was a significant interaction between ischaemic postconditioning and thrombectomy on the primary endpoint (p=0.004). In patients not treated with thrombectomy (n=520), the primary endpoint occurred in 33 patients (10%) who underwent ischaemic postconditioning (n=326) and in 35 patients (18%) who underwent conventional treatment (n=194) (adjusted hazard ratio (HR) 0.55 (95%confidence interval (CI) 0.34 to 0.89), p=0.016). In patients treated with thrombectomy (n=714), there was no significant difference between patients treated with ischaemic postconditioning (n=291) and conventional PCI (n=423) on the primary endpoint (adjusted HR 1.18 (95% CI 0.62 to 2.28), p=0.62).

Conclusions: In this post-hoc study of DANAMI-3-iPOST, ischaemic postconditioning, in addition to primary PCI, was associated with reduced risk of all-cause mortality and hospitalisation for heart failure in patients with STEMI not treated with thrombectomy.

Trial Registration Number: NCT01435408.
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http://dx.doi.org/10.1136/heartjnl-2019-314952DOI Listing
January 2020

Extent of coronary artery disease is associated with myocardial infarction and mortality in patients with diabetes mellitus.

Clin Epidemiol 2019 23;11:419-428. Epub 2019 May 23.

Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.

We examined risk of myocardial infarction and all-cause death associated with the extent of coronary artery disease ascertained by coronary angiography in patients with diabetes mellitus. We hypothesized that risks of myocardial infarction and death were associated with extent of coronary artery disease in diabetes patients. We conducted a cohort study of patients with type 1 and type 2 diabetes, who underwent coronary angiography from 2004 to 2012. Patients were stratified according to extent of coronary artery disease: 0-, 1-, 2- or 3-vessel disease or diffuse vessel disease. Endpoints were myocardial infarction, all-cause death, and major adverse cardiovascular events (MACE), defined as the composite of myocardial infarction, cardiac death, or ischemic stroke. Adjusted incidence and mortality rate ratios (IRRs) were calculated using patients with 0-vessel disease as the reference group. Median follow-up was 3 years for a total of 45,164 person-years. The study included 12,594 diabetes patients. Of these, 3,147 (25.0%) had 0-vessel disease, 1,195 (9.5%) had diffuse vessel disease, 3,001 (23.8%) had 1-vessel disease, 2,220 (17.6%) had 2-vessel disease, and 3,031 (24.1%) had 3-vessel disease. The myocardial infarction rate was 0.4 per 100 person-years (95% CI: 0.3-0.5) in patients with 0-vessel disease. Using patients with 0-vessel disease as reference, the risk of myocardial infarction increased according to the number of diseased vessels (diffuse vessel disease: 1.4 per 100 person-years, IRR 3.87, 95% CI: 2.41-6.23; 1-vessel disease: 1.9 per 100 person-years, IRR 4.99, 95% CI: 3.33-7.46; 2-vessel disease: 2.7 per 100 person-years, IRR 7.14, 95% CI: 4.78-10.65; and 3-vessel disease: 4.3 per 100 person-years, IRR 11.42, 95% CI: 7.76-16.82; p<0.001). Similar associations were observed for all-cause death and MACE. The extent of coronary artery disease is a major risk factor for myocardial infarction and death in patients with diabetes mellitus.
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http://dx.doi.org/10.2147/CLEP.S200173DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6536131PMC
May 2019

Rationale and design of DanGer shock: Danish-German cardiogenic shock trial.

Am Heart J 2019 08 6;214:60-68. Epub 2019 May 6.

Heart Center, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.

Objective: The DanGer Shock trial test the hypothesis that left ventricular (LV) mechanical circulatory support with Impella CP transvalvular microaxial flow pump improves survival in patients with ST segment elevation acute myocardial infarction complicated by cardiogenic shock (AMICS) compared to conventional guideline-driven treatment. This paper describes the rationale and design of the randomized trial, in addition to the baseline characteristics of the population screened and enrolled so far.

Methods: The DanGer Shock study is a prospective, multicenter, open-label trial in patients with AMICS randomized 1:1 to Impella CP or current guideline-driven therapy with planned enrollment of 360 patients. Patients comatose after out of hospital cardiac arrest are excluded. Eligible patients are randomized immediately following shock diagnosis. Among patients randomized to receive Impella CP, the device is placed prior to angioplasty. The primary endpoint is all-cause mortality at 180 days. Baseline characteristics of patients screened and randomized in the DanGer Shock as of June 2018 are compared with 2 contemporary AMICS studies.

Results: As of end of June 2018, 314 patients were screened and 100 patients were randomized. Patients had median arterial lactate of 5.5 mmol/L (interquartile range 3.7-8.8 mmol/L), median systolic blood pressure of 76 mmHg (interquartile range 70-88 mmHg), and median LV ejection fraction of 20% (interquartile range 10%-30%).

Conclusion: The DanGer Shock trial will be the first adequately powered randomized trial to address whether mechanical circulatory LV support with Impella CP can improve survival in AMICS. Baseline characteristics of the first 100 randomized patients indicate a population in profound cardiogenic shock.
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http://dx.doi.org/10.1016/j.ahj.2019.04.019DOI Listing
August 2019

Influence of Ezetimibe on Plaque Morphology in Patients with ST Elevation Myocardial Infarction Assessed by Optical Coherence Tomography: An OCTIVUS Sub-Study.

Cardiovasc Revasc Med 2020 Nov 24;21(11):1417-1424. Epub 2019 Apr 24.

Department of Cardiology, Odense University Hospital, Odense, Denmark.

Aims: The aim of the trial was to examine the influence of ezetimibe on plaque morphology in patients with ST-segment Elevation Myocardial Infarction (STEMI) with respect to fibrous cap thickness (FCT) and arcs of lipid plaque, calcific plaque, and macrophages using Optical Coherence Tomography (OCT).

Methods And Results: In 87 statin naïve patients with STEMI treated with primary percutaneous intervention, a non-culprit study plaque in a non-infarct related coronary artery was assessed with OCT at baseline and after 12 months. Patients were treated with atorvastatin 80 mg and randomized (1:1) to ezetimibe 10 mg (n = 43) or placebo (n = 44). An increase in median FCT (ezetimibe 200 (140-260) μm to 240 (190-305) μm (p = 0.002) vs. placebo 205 (135-260) μm to 230 (180-270) μm (p < 0.001), between groups p = ns), a reduction in lipid arc (ezetimibe 1728.5 (1022.5-3904.7)° to 1164.5 (736.6-2580.1)° (p = 0.001) vs. placebo 1671.6 (978.3-2868.7)° to 1373.7 (791.2-2267.3)° (p = 0.019), between groups p = ns), and macrophage arc (ezetimibe 1730.3 (965.7-2984.4)° to 1324.8 (819.0-2819.7)° (p < 0.05) vs. placebo 1570.5 (794.7-3016.8)° to 1418.9 (584.1-2501.1)° (p < 0.01), between groups p = ns) were observed.

Conclusion: Aggressive LDL-lowering resulted in changes in OCT assessed plaque composition by increased FCT thickness and a reduction in lipid content and macrophage infiltration. Addition of ezetimibe 10 mg to atorvastatin 80 mg resulted in further LDL reduction, but no additional change in plaque composition was found.
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http://dx.doi.org/10.1016/j.carrev.2019.04.021DOI Listing
November 2020

Unreported exclusion and sampling bias in interpretation of randomized controlled trials in patients with STEMI.

Int J Cardiol 2019 08 1;289:1-5. Epub 2019 May 1.

Department of Cardiology, The Heart Centre, Copenhagen University Hospital, Rigshospitalet, Denmark; University of Lund, Sweden.

Aims: To assess the impact of sampling bias due to reported as well as unreported exclusion of the target population in a multi-center randomized controlled trial (RCT) of ST-elevation myocardial infarction (STEMI).

Methods And Results: We compared clinical characteristics and mortality between participants in the DANAMI-3 trial to contemporary non-participants with STEMI using unselected registries. A total of 179 DANAMI-3 participants (8%) and 617 contemporary non-participants (22%) had died (Log-Rank: P < 0.001) after a median follow-up of 1333 days (range: 1-2021 days). In an unadjusted Cox regression model all groups of non-participants had a higher hazard ratio to predict mortality compared to participants: eligible excluded (n = 144) (hazard ratio: 3.41 (95% CI: (2.69-4.32)), ineligible excluded (n = 472) (hazard ratio: 3.42 (95% CI: (2.44-4.80), eligible non-screened (n = 154) (hazard ratio: 3.37 (95% CI: (2.36-4.82)), ineligible non-screened (n = 154) (hazard ratio: 6.48 (95% CI: (4.77-8.80).

Conclusion: Sampling bias had occurred due to both reported and unreported exclusion of eligible patients and the difference in mortality between participants and non-participants could not be explained only by the trial exclusion criteria. Thus, screening logs may not be suited to address the risks of sampling bias.
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http://dx.doi.org/10.1016/j.ijcard.2019.04.064DOI Listing
August 2019

Admission Leukocyte Count is Associated with Late Cardiogenic Shock Development and All-Cause 30-Day Mortality in Patients with St-Elevation Myocardial Infarction.

Shock 2020 03;53(3):299-306

Department of Cardiology, The Heart Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.

Background: Thirty-day mortality in ST-elevation myocardial infarction (STEMI) patients is primarily driven by cardiogenic shock (CS). High neutrophil counts and high neutrophil/lymphocyte ratios (NLR) have previously been associated with mortality in STEMI patients; however, there is only sparse knowledge regarding their association with CS.

Purpose: We sought to assess the associations between neutrophil count and NLR with the development of CS as well as 30-day mortality in STEMI patients.

Methods: Patients admitted with STEMI at two tertiary Heart Centres throughout 1 year were included in the study and stratified into quartiles according to the level of leukocyte count upon admission. The primary endpoint was development of CS both before (early CS) and after leaving the catheterization laboratory (late CS). The secondary endpoint was all-cause 30-day mortality.

Results: A total of 1,892 STEMI patients were included, whereof 194 (10%) developed CS while 122 (6.4%) died within 30 days. Patients in the highest quartile of neutrophils (OR: 2.54; 95% CI: 1.40-4.60; P = 0.002) and NLR (OR: 3.64; 95% CI: 2.02-6.54; P<0.0001) were at increased risk of developing late CS compared with patients in the lower quartiles, whereas there was no risk difference across quartiles regarding development of early CS. Both biomarkers correlated strongly to an increased 30-day mortality (plogrank<0.0001) and, moreover, a high level of neutrophils was independently associated with 30-day mortality (HR: 1.95; 95% CI: 1.25-3.03; P = 0.003).

Conclusion: High levels of neutrophils and a high NLR upon admission for STEMI were independently associated with an increased risk of developing late CS and, additionally, both biomarkers showed association to 30-day mortality.
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http://dx.doi.org/10.1097/SHK.0000000000001369DOI Listing
March 2020

Are drug-eluting stents safer than bare-metal stents?

Lancet 2019 06 2;393(10190):2472-2474. Epub 2019 May 2.

Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.

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http://dx.doi.org/10.1016/S0140-6736(19)31000-1DOI Listing
June 2019