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1.
  • Venetsanos, D, et al. (author)
  • Correction
  • 2021
  • In: JACC. Cardiovascular interventions. - : Elsevier BV. - 1876-7605 .- 1936-8798. ; 14:17, s. 1964-1964
  • Journal article (other academic/artistic)
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  • Bohlooly-Yeganeh, Mohammad, 1966, et al. (author)
  • Selective cerebral overexpression of growth hormone alters cardiac function, morphology, energy metabolism and catecholamines in transgenic mice
  • 2005
  • In: Growth hormone & IGF research. - : Elsevier BV. - 1096-6374. ; 15:2, s. 148-55
  • Journal article (peer-reviewed)abstract
    • BACKGROUND: Growth hormone (GH) has important regulatory effects on cardiac morphology and function both during normal development as well as in pathophysiological settings such as myocardial infarction (MI) and congestive heart failure (CHF). In order to investigate in more detail the interaction between GH and sympathetic nervous system (SNS) system we studied the effects of selective cerebral GH overexpression on myocardial content of catecholamines, myocardial and brain energy metabolism as well as on cardiac function during resting and stress conditions in a transgenic mouse model. METHODS: Transgenic mice with selective bovine GH overexpression under control of glial fibrillary acidic protein promoter in the brain (GFAP-bGH, n=15) were created and compared to genetically matched non-transgenic mates (Control, n=15). Cardiac morphology and function were evaluated in vivo using transthoracic echocardiography during resting and stress conditions induced pharmacologically by dopamine (D) and isoprotenolol (ISO). Myocardial and brain energy metabolism were evaluated non-invasively using in vivo volume-selective phosphorus magnetic resonance spectroscopy ((31)P MRS). Myocardial content of catecholamines was analyzed by means of HPLC. RESULTS: Compared to the C animals, the GFAP-bGH mice have showed several differences in the cardiac phenotype. Systolic (fractional shortening) and diastolic function (E/A wave ratio of mitral flow) was disturbed in the GFAP-bGH mice (both p<0.05). During the dopamine stress, there was chronotropic insufficiency in the GFAP-bGH group (p<0.01) while no difference was observed in response to isoprotenolol. Left ventricular dimensions were increased in GFAP-bGH mice (p<0.05). There was a tendency for higher body weight in GFAP-bGH compared to the control group (p=0.06) while no difference was observed in heart weight and brain weight when normalized for body weight. Myocardial content of noradrenaline was lower in the GFAP-bGH group (p<0.05). PCr/ATP ratio was higher (p<0.05) in the brain and lower in the heart (p<0.05) in the GFAP-bGH mice. CONCLUSIONS: Selective cerebral overexpression of GH results in alterations of cardiac function, morphology and metabolism in transgenic mice. Decreased myocardial content of catecholamines in the GFAP-bGH mice suggests central interaction between GH and sympathetic nervous system.
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  • Christiansen, Evald H, et al. (author)
  • Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI.
  • 2017
  • In: The New England journal of medicine. - : Massachussetts Medical Society. - 1533-4406 .- 0028-4793. ; 376:19, s. 1813-1823
  • Journal article (peer-reviewed)abstract
    • The instantaneous wave-free ratio (iFR) is an index used to assess the severity of coronary-artery stenosis. The index has been tested against fractional flow reserve (FFR) in small trials, and the two measures have been found to have similar diagnostic accuracy. However, studies of clinical outcomes associated with the use of iFR are lacking. We aimed to evaluate whether iFR is noninferior to FFR with respect to the rate of subsequent major adverse cardiac events.We conducted a multicenter, randomized, controlled, open-label clinical trial using the Swedish Coronary Angiography and Angioplasty Registry for enrollment. A total of 2037 participants with stable angina or an acute coronary syndrome who had an indication for physiologically guided assessment of coronary-artery stenosis were randomly assigned to undergo revascularization guided by either iFR or FFR. The primary end point was the rate of a composite of death from any cause, nonfatal myocardial infarction, or unplanned revascularization within 12 months after the procedure.A primary end-point event occurred in 68 of 1012 patients (6.7%) in the iFR group and in 61 of 1007 (6.1%) in the FFR group (difference in event rates, 0.7 percentage points; 95% confidence interval [CI], -1.5 to 2.8; P=0.007 for noninferiority; hazard ratio, 1.12; 95% CI, 0.79 to 1.58; P=0.53); the upper limit of the 95% confidence interval for the difference in event rates fell within the prespecified noninferiority margin of 3.2 percentage points. The results were similar among major subgroups. The rates of myocardial infarction, target-lesion revascularization, restenosis, and stent thrombosis did not differ significantly between the two groups. A significantly higher proportion of patients in the FFR group than in the iFR group reported chest discomfort during the procedure.Among patients with stable angina or an acute coronary syndrome, an iFR-guided revascularization strategy was noninferior to an FFR-guided revascularization strategy with respect to the rate of major adverse cardiac events at 12 months. (Funded by Philips Volcano; iFR SWEDEHEART ClinicalTrials.gov number, NCT02166736 .).
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  • Drevinge, Christina, 1983, et al. (author)
  • Perilipin 5 is protective in the ischemic heart
  • 2016
  • In: International Journal of Cardiology. - : Elsevier BV. - 0167-5273 .- 1874-1754. ; 219, s. 446-454
  • Journal article (peer-reviewed)abstract
    • Background: Myocardial ischemia is associated with alterations in cardiac metabolism, resulting in decreased fatty acid oxidation and increased lipid accumulation. Here we investigate how myocardial lipid content and dynamics affect the function of the ischemic heart, and focus on the role of the lipid droplet protein perilipin 5 (Plin5) in the pathophysiology of myocardial ischemia. Methods and results: We generated Plin5(-/-) mice and found that Plin5 deficiency dramatically reduced the triglyceride content in the heart. Under normal conditions, Plin5(-/-) mice maintained a close to normal heart function by decreasing fatty acid uptake and increasing glucose uptake, thus preserving the energy balance. However, during stress or myocardial ischemia, Plin5 deficiency resulted in myocardial reduced substrate availability, severely reduced heart function and increased mortality. Importantly, analysis of a human cohort with suspected coronary artery disease showed that a common noncoding polymorphism, rs884164, decreases the cardiac expression of PLIN5 and is associated with reduced heart function following myocardial ischemia, indicating a role for Plin5 in cardiac dysfunction. Conclusion: Our findings indicate that Plin5 deficiency alters cardiac lipid metabolism and associates with reduced survival following myocardial ischemia, suggesting that Plin5 plays a beneficial role in the heart following ischemia. (C) 2016 The Authors. Published by Elsevier Ireland Ltd.
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  • Erlinge, David, et al. (author)
  • Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II) : a prospective natural history study
  • 2021
  • In: The Lancet. - : Elsevier. - 0140-6736 .- 1474-547X. ; 397:10278, s. 985-995
  • Journal article (peer-reviewed)abstract
    • Background: Near-infrared spectroscopy (NIRS) and intravascular ultrasound are promising imaging modalities to identify non-obstructive plaques likely to cause coronary-related events. We aimed to assess whether combined NIRS and intravascular ultrasound can identify high-risk plaques and patients that are at risk for future major adverse cardiac events (MACEs).Methods: PROSPECT II is an investigator-sponsored, multicentre, prospective natural history study done at 14 university hospitals and two community hospitals in Denmark, Norway, and Sweden. We recruited patients of any age with recent (within past 4 weeks) myocardial infarction. After treatment of all flow-limiting coronary lesions, three-vessel imaging was done with a combined NIRS and intravascular ultrasound catheter. Untreated lesions (also known as non-culprit lesions) were identified by intravascular ultrasound and their lipid content was assessed by NIRS. The primary outcome was the covariate-adjusted rate of MACEs (the composite of cardiac death, myocardial infarction, unstable angina, or progressive angina) arising from untreated non-culprit lesions during follow-up. The relations between plaques with high lipid content, large plaque burden, and small lumen areas and patient-level and lesion-level events were determined. This trial is registered with ClinicalTrials.gov, NCT02171065.Findings: Between June 10, 2014, and Dec 20, 2017, 3629 non-culprit lesions were characterised in 898 patients (153 [17%] women, 745 [83%] men; median age 63 [IQR 55-70] years). Median follow-up was 3.7 (IQR 3.0-4.4) years. Adverse events within 4 years occurred in 112 (13.2%, 95% CI 11.0-15.6) of 898 patients, with 66 (8.0%, 95% CI 6.2-10.0) arising from 78 untreated non-culprit lesions (mean baseline angiographic diameter stenosis 46.9% [SD 15.9]). Highly lipidic lesions (851 [24%] of 3500 lesions, present in 520 [59%] of 884 patients) were an independent predictor of patient-level non-culprit lesion-related MACEs (adjusted odds ratio 2.27, 95% CI 1.25-4.13) and nonculprit lesion-specific MACEs (7.83, 4.12-14.89). Large plaque burden (787 [22%] of 3629 lesions, present in 530 [59%] of 898 patients) was also an independent predictor of non-culprit lesion-related MACEs. Lesions with both large plaque burden by intravascular ultrasound and large lipid-rich cores by NIRS had a 4-year non-culprit lesion-related MACE rate of 7.0% (95% CI 4.0-10.0). Patients in whom one or more such lesions were identified had a 4-year non-culprit lesion-related MACE rate of 13.2% (95% CI 9.4-17.6).Interpretation: Combined NIRS and intravascular ultrasound detects angiographically non-obstructive lesions with a high lipid content and large plaque burden that are at increased risk for future adverse cardiac outcomes.
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  • Escaned, Javier, et al. (author)
  • Safety of the Deferral of Coronary Revascularization on the Basis of Instantaneous Wave-Free Ratio and Fractional Flow Reserve Measurements in Stable Coronary Artery Disease and Acute Coronary Syndromes
  • 2018
  • In: JACC. - : Elsevier. - 1936-8798 .- 1876-7605. ; 11:15, s. 1437-1449
  • Journal article (peer-reviewed)abstract
    • OBJECTIVES The aim of this study was to investigate the clinical outcomes of patients deferred from coronary revascularization on the basis of instantaneous wave-free ratio (iFR) or fractional flow reserve (FFR) measurements in stable angina pectoris (SAP) and acute coronary syndromes (ACS). BACKGROUND Assessment of coronary stenosis severity with pressure guidewires is recommended to determine the need for myocardial revascularization. METHODS The safety of deferral of coronary revascularization in the pooled per-protocol population (n = 4,486) of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation) and iFR-SWEDEHEART (Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve in Patients With Stable Angina Pectoris or Acute Coronary Syndrome) randomized clinical trials was investigated. Patients were stratified according to revascularization decision making on the basis of iFR or FFR and to clinical presentation (SAP or ACS). The primary endpoint was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. RESULTS Coronary revascularization was deferred in 2,130 patients. Deferral was performed in 1,117 patients (50%) in the iFR group and 1,013 patients (45%) in the FFR group (p < 0.01). At 1 year, the MACE rate in the deferred population was similar between the iFR and FFR groups (4.12% vs. 4.05%; fully adjusted hazard ratio: 1.13; 95% confidence interval: 0.72 to 1.79; p = 0.60). A clinical presentation with ACS was associated with a higher MACE rate compared with SAP in deferred patients (5.91% vs. 3.64% in ACS and SAP, respectively; fully adjusted hazard ratio: 0.61 in favor of SAP; 95% confidence interval: 0.38 to 0.99; p = 0.04). CONCLUSIONS Overall, deferral of revascularization is equally safe with both iFR and FFR, with a low MACE rate of about 4%. Lesions were more frequently deferred when iFR was used to assess physiological significance. In deferred patients presenting with ACS, the event rate was significantly increased compared with SAP at 1 year. (C) 2018 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.
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  • Fröbert, Ole, 1964-, et al. (author)
  • Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial. A registry-based randomized clinical trial
  • 2017
  • In: American Heart Journal. - : MOSBY-ELSEVIER. - 0002-8703 .- 1097-6744. ; 189, s. 94-102
  • Journal article (peer-reviewed)abstract
    • Background: Registry studies and case-control studies have demonstrated that the risk of acute myocardial infarction (AMI) is increased following influenza infection. Small randomized trials, underpowered for clinical end points, indicate that future cardiovascular events can be reduced following influenza vaccination in patients with established cardiovascular disease. Influenza vaccination is recommended by international guidelines for patients with cardiovascular disease, but uptake is varying and vaccination is rarely prioritized during hospitalization for AMI.Methods/design: The Influenza vaccination After Myocardial Infarction (IAMI) trial is a double-blind, multicenter, prospective, registry-based, randomized, placebo-controlled, clinical trial. A total of 4,400 patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI undergoing coronary angiography will randomly be assigned either to in-hospital influenza vaccination or to placebo. Baseline information is collected from national heart disease registries, and follow-up will be performed using both registries and a structured telephone interview. The primary end point is a composite of time to all cause death, a new AMI, or stent thrombosis at 1 year.Implications: The IAMI trial is the largest randomized trial to date to evaluate the effect of in-hospital influenza vaccination on death and cardiovascular outcomes in patients with STEMI or non-STEMI. The trial is expected to provide highly relevant clinical data on the efficacy of influenza vaccine as secondary prevention after AMI.
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  • Ghadri, J. R., et al. (author)
  • International Expert Consensus Document on Takotsubo Syndrome (Part I): Clinical Characteristics, Diagnostic Criteria, and Pathophysiology
  • 2018
  • In: European Heart Journal. - : Oxford University Press (OUP). - 0195-668X .- 1522-9645. ; 39:22, s. 2032-2046
  • Journal article (peer-reviewed)abstract
    • Takotsubo syndrome (TTS) is a poorly recognized heart disease that was initially regarded as a benign condition. Recently, it has been shown that TTS may be associated with severe clinical complications including death and that its prevalence is probably underestimated. Since current guidelines on TTS are lacking, it appears timely and important to provide an expert consensus statement on TTS. The clinical expert consensus document part I summarizes the current state of knowledge on clinical presentation and characteristics of TTS and agrees on controversies surrounding TTS such as nomenclature, different TTS types, role of coronary artery disease, and etiology. This consensus also proposes new diagnostic criteria based on current knowledge to improve diagnostic accuracy.
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  • Ghadri, J. R., et al. (author)
  • International Expert Consensus Document on Takotsubo Syndrome (Part II): Diagnostic Workup, Outcome, and Management
  • 2018
  • In: European Heart Journal. - : Oxford University Press (OUP). - 0195-668X .- 1522-9645. ; 39:22, s. 2047-2062
  • Journal article (peer-reviewed)abstract
    • The clinical expert consensus statement on takotsubo syndrome (TTS) part II focuses on the diagnostic workup, outcome, and management. The recommendations are based on interpretation of the limited clinical trial data currently available and experience of international TTS experts. It summarizes the diagnostic approach, which may facilitate correct and timely diagnosis. Furthermore, the document covers areas where controversies still exist in risk stratification and management of TTS. Based on available data the document provides recommendations on optimal care of such patients for practising physicians.
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  • Gudmundsson, T., et al. (author)
  • Does the quality index of adherence to the evidence-based guidelines predict mortality in patients with myocardial infarction?
  • 2022
  • In: European Heart Journal. - : Oxford University Press. - 0195-668X .- 1522-9645. ; 43:Suppl. 2, s. 2282-2282
  • Journal article (other academic/artistic)abstract
    • Background: The SWEDEHEART quality index of hospitals’ adherence to the evidence-based (EB) guidelines for myocardial infarction (MI) patients has been continuously used for several decades in Sweden. The grading protocol is based on the consensus among hospitals. The hospitals are awarded points (0, 0.5, 1) for each of the 11 indicators depending on the proportion of patients who received EB treatment and achieved treatment goals. The 11 indicators at present are reperfusion treatment in STEMI (yes/no), time to-reperfusion treatment in STEMI, time to revascularisation in NSTEMI, P2Y12 antagonists at discharge, ACE-inhibitor/ARB at discharge, the proportion of patients at follow-up, smoking cessation at one-year, participation in a physical exercise program, target LDL-cholesteroland target blood pressure at one year.Purpose: To evaluate whether the SWEDEHEART quality index predicts mortality in patients with MI.Methods: We used data for all MI patients reported to the SWEDEHEAR Tregistry from 72 hospitals in Sweden between 2015–2021. We calculated the difference in quality index between 2021 and 2015. The hospitals were divided into quintiles based on the difference in the score. Logistic regression with log-time offset was used to adjust for confounders (age, gender, diabetes, hypertension, hyperlipidemia, STEMI/NSTEMI, cardiac arrest before admission, occupation status, history of heart failure, prior MI, prior PCI, prior CABG, cardiogenic shock).Results: We identified 98,635 patients with MI, 32,608 (33.1%) were women and 34,198 (34.7%) had STEMI. The average age was 70.8±12.2 years. The median follow-up time was 2.7 years (IQR 1.06–4.63). The crude all-cause mortality rate was 5.5% at 30-days and 22.3% after long-term follow-up. Most hospitals (72.1%) improved their quality index on average by 3.4% per year (P<0.001). The increase in the quality index continued during COVID-19 pandemic (2020–2021) with average increase of 8.6%, 95% CI, 0.97–1.02; P<0.001. The median change in SWEDE-HEART quality index score among the quintiles were −1.5 (Q1), 0,5 (Q2), 2,5 (Q3), 3 (Q4), and 4 (Q5). We found no difference in mortality between the quintiles at 30-days (OR 0.99; 95% CI 0.97–1.02; p=1.02) and long-term (OR 1.01; 95% CI 0,99–1.02; p=0.850).Conclusion: The SWEDEHEART quality index provides valuable descriptive information about hospitals’ adherence to the guidelines. However, the index, in its current form, does not predict mortality in patients with MI.
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  • Gudmundsson, T., et al. (author)
  • Importance of hospital and clinical factors in predicting of 30-day mortality in Takotsubo syndrome : data from the Swedish Coronary Angiography and Angioplasty Registry
  • 2023
  • In: European Heart Journal. - : Oxford University Press. - 0195-668X .- 1522-9645. ; 44:Suppl. 2
  • Journal article (other academic/artistic)abstract
    • Background: Takotsubo syndrome (TS) is an acute heart failure condition that presents with symptoms similar to acute myocardial infarction. TS is often triggered by emotional or physical stress and is an important cause of morbidity and mortality but predictors of mortality in TS patients are not well understood. There is a need to identify high-risk patients and tailor treatment accordingly.Purpose: The purpose of this study was to assess the importance of various clinical factors in predicting 30-day mortality in TS patients using a machine-learning algorithm capable of identifying complex relationships between variables.Methods: We analyzed data from the nationwide Swedish Coronary Angiography and Angioplasty Registry for all TS patients between 2015-2022. Gradient boosting was used to assess the relative importance of variables in predicting 30-day mortality in TS patients.Results: Of the 3,180 hospitalized TS patients, 76% were women. The average age was 68.3 ± 11.2 years. The crude all-cause mortality rate was 2.57% at 30 days. The most important variable in predicting 30-day mortality was the hospital where the patient was treated, with a relative importance of 35.5%. This was followed by the clinical presentation for angiography (21.1%), creatinine level (11.9%), Killip class (8.9%), and age at angioplasty (6.5%). Other less important factors included weight, height, and certain medical conditions such as hyperlipidemia, smoking status, and hypertension. Gender and previous stroke history had a low impact on 30-day mortality in TS patients.Conclusions: The treating hospital was the most important factor in predicting 30-day mortality in TS. Since the level of evidence for recommended treatments of TS is low, our findings highlight the importance of conducting randomized studies in this patient group to improve care.
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  • Gyldenkerne, Christine, et al. (author)
  • Coronary Artery Lesion Lipid Content and Plaque Burden in Diabetic and Nondiabetic Patients : PROSPECT II
  • 2023
  • In: Circulation. - : Lippincott Williams & Wilkins. - 0009-7322 .- 1524-4539. ; 147:6, s. 469-481
  • Journal article (peer-reviewed)abstract
    • BACKGROUND: Patients with diabetes have increased rates of major adverse cardiac events (MACEs). We hypothesized that this is explained by diabetes-associated differences in coronary plaque morphology and lipid content.METHODS: In PROSPECT II (Providing Regional Observations to Study Predictors of Events in the Coronary Tree), 898 patients with acute myocardial infarction with or without ST-segment elevation underwent 3-vessel quantitative coronary angiography and coregistered near-infrared spectroscopy and intravascular ultrasound imaging after successful percutaneous coronary intervention. Subsequent MACEs were adjudicated to either treated culprit lesions or untreated nonculprit lesions. This substudy stratified patients by diabetes status and assessed baseline culprit and nonculprit prevalence of high-risk plaque characteristics defined as maximum plaque burden ≥70% and maximum lipid core burden index ≥324.7. Separate covariate-adjusted multivariable models were performed to identify whether diabetes was associated with nonculprit lesion-related MACEs and high-risk plaque characteristics.RESULTS: Diabetes was present in 109 of 898 patients (12.1%). During a median 3.7-year follow-up, MACEs occurred more frequently in patients with versus without diabetes (20.1% versus 13.5% [odds ratio (OR), 1.94 (95% CI, 1.14-3.30)]), primarily attributable to increased risk of myocardial infarction related to culprit lesion restenosis (4.3% versus 1.1% [OR, 3.78 (95% CI, 1.12-12.77)]) and nonculprit lesion-related spontaneous myocardial infarction (9.3% versus 3.8% [OR, 2.74 (95% CI, 1.25-6.04)]). However, baseline prevalence of high-risk plaque characteristics was similar for patients with versus without diabetes concerning culprit (maximum plaque burden ≥70%: 90% versus 93%, P=0.34; maximum lipid core burden index ≥324.7: 66% versus 70%, P=0.49) and nonculprit lesions (maximum plaque burden ≥70%: 23% versus 22%, P=0.37; maximum lipid core burden index ≥324.7: 26% versus 24%, P=0.47). In multivariable models, diabetes was associated with MACEs in nonculprit lesions (adjusted OR, 2.47 [95% CI, 1.21-5.04]) but not with prevalence of high-risk plaque characteristics (adjusted OR, 1.21 [95% CI, 0.86-1.69]).CONCLUSIONS: Among patients with recent myocardial infarction, both treated and untreated lesions contributed to the diabetes-associated ≈2-fold increased MACE rate during the 3.7-year follow-up. Diabetes-related plaque characteristics that might underlie this increased risk were not identified by multimodality imaging.
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  • Haeck, Joost D. E., et al. (author)
  • Percutaneous Coronary Intervention vs Medical Therapy for Coronary Lesions With Positive Fractional Flow Reserve (FFR) but Preserved Pressure-Bounded Coronary Flow Reserve (CFR): A Substudy of the Randomized Compare-Acute Trial
  • 2021
  • In: JOURNAL OF INVASIVE CARDIOLOGY. - 1042-3931 .- 1557-2501. ; 33:7
  • Journal article (peer-reviewed)abstract
    • Objectives. Performing percutaneous coronary intervention (PCI) for fractional flow reserve (FFR) positive coronary lesions improves clinical outcomes and is recommended by international guidelines. It has been hypothesized that lesions with a positive FFR but a preserved coronary flow reserve (CFR) are less likely to be flow limiting and might best be treated medically. We investigated the association of CFR in FFR-positive lesions with clinical outcomes when treated medically, as well as the treatment effect of PCI vs medical therapy in FFR-positive lesions and a preserved CFR. Methods. We performed a substudy of the randomized, multicenter Compare-Acute trial, in which stabilized ST-segment elevation myocardial infarction (STEMI) patients with non-culprit lesions were randomized to either FFR-guided PCI or medical therapy. Based on baseline and hyperemic pressure gradients, we computed physiologic limits of CFR, the so-called pressure-bounded CFR (pb-CFR), and classified lesions as low (<2) or preserved (>= 2). The primary endpoint was 12-month major adverse cardiac and cerebrovascular event (MACCE) rate, defined as a composite of death from any cause, non-fatal myocardial infarction, revascularization, or cerebrovascular events. Results. A total of 980 lesions from 885 patients were included in this substudy. In lesions with FFR <= 0.80, a total of 249 patients had a pb-CFR<2 and 29 patients had a preserved CFR (pb-CFR >= 2). The rate of MACCE at 1 year was not significantly different between patients with FFR <= 0.80 and pb-CFR <2 vs patients with FFR <= 0.80 and pb-CFR >= 2 (25% vs 17%, respectively; P=.39). Because of randomization, baseline characteristics were well balanced between patients with FFR <= 0.80 and pb-CFR >= 2 treated by either by PCI or medical therapy. Importantly, in patients with FFR <= 0.80 and pb-CFR >= 2, MACCE occurred more frequently in patients treated medically vs patients treated by PCI (44% vs 0%, respectively; P=.01). Conclusions. Preserved or low pb-CFR did not alter clinical outcomes in patients with a positive FFR. Patients with FFR-positive coronary lesions but a preserved CFR had more clinical events when treated medically vs those treated with PCI.
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  • Herlitz, Johan, et al. (author)
  • Is pre-hospital treatment of chest pain optimal in acute coronary syndrome? Both relief of pain and anxiety are needed
  • 2011
  • In: International Journal of Cardiology. - : Elsevier Ireland Ltd. - 0167-5273 .- 1874-1754. ; 149:2, s. 147-151
  • Journal article (peer-reviewed)abstract
    • Background Many patients who suffer from acute chest pain are transported by ambulance. It is not known how often treatment prior to hospital admission is optimal and how optimal pain-relieving treatment is defined. It is often difficult to delineate pain from anxiety. Aim To describe various aspects of chest pain in the pre-hospital setting with the emphasis on a) treatment and b) presumed acute coronary syndrome. Methods In the literature search, we used PubMed and the appropriate key words. We included randomised clinical trials and observational studies. Results Four types of drug appear to be preferred: 1) narcotic analgesics, 2) nitrates, 3) beta-blockers and 4) benzodiazepines. Among narcotic analgesics, morphine has been associated with the relief of pain at the expense of side-effects. Alfentanil was reported to produce more rapid pain relief. Nitrates have been associated with the relief of pain with few side-effects. Beta-blockers have been reported to increase the relief of pain when added to morphine. The combination of beta-blockers and morphine has been reported to be as effective as beta-blockers alone in pain relief, but this combination therapy was associated with more side-effects. Experience from anxiety-relieving drugs such as benzodiazepines is limited. It is not known how these 4 drugs should be combined. The results indicate that various pain-relieving treatments might modify the disease. Conclusion Our knowledge of the optimal treatment of chest pain and associated anxiety in the pre-hospital setting is insufficient. Recommendations from existing guidelines are limited. Large randomised clinical trials are warranted.
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  • Jernberg, T., et al. (author)
  • Long-Term Effects of Oxygen Therapy on Death or Hospitalization for Heart Failure in Patients With Suspected Acute Myocardial Infarction
  • 2018
  • In: Circulation. - : Ovid Technologies (Wolters Kluwer Health). - 0009-7322 .- 1524-4539. ; 138:24, s. 2754-2762
  • Journal article (peer-reviewed)abstract
    • BACKGROUND: In the DETO2X-AMI trial (Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction), we compared supplemental oxygen with ambient air in normoxemic patients presenting with suspected myocardial infarction and found no significant survival benefit at 1 year. However, important secondary end points were not yet available. We now report the prespecified secondary end points cardiovascular death and the composite of all-cause death and hospitalization for heart failure. METHODS: In this pragmatic, registry-based randomized clinical trial, we used a nationwide quality registry for coronary care for trial procedures and evaluated end points through the Swedish population registry (mortality), the Swedish inpatient registry (heart failure), and cause of death registry (cardiovascular death). Patients with suspected acute myocardial infarction and oxygen saturation of >= 90% were randomly assigned to receive either supplemental oxygen at 6 L/min for 6 to 12 hours delivered by open face mask or ambient air. RESULTS: A total of 6629 patients were enrolled. Acute heart failure treatment, left ventricular systolic function assessed by echocardiography, and infarct size measured by high-sensitive cardiac troponin T were similar in the 2 groups during the hospitalization period. All-cause death or hospitalization for heart failure within 1 year after randomization occurred in 8.0% of patients assigned to oxygen and in 7.9% of patients assigned to ambient air (hazard ratio, 0.99; 95% CI, 0.84-1.18; P=0.92). During long-term follow-up (median [range], 2.1 [1.0-3.7] years), the composite end point occurred in 11.2% of patients assigned to oxygen and in 10.8% of patients assigned to ambient air (hazard ratio, 1.02; 95% CI, 0.88-1.17; P=0.84), and cardiovascular death occurred in 5.2% of patients assigned to oxygen and in 4.8% assigned to ambient air (hazard ratio, 1.07; 95% CI, 0.87-1.33; P=0.52). The results were consistent across all predefined subgroups. CONCLUSIONS: Routine use of supplemental oxygen in normoxemic patients with suspected myocardial infarction was not found to reduce the composite of all-cause mortality and hospitalization for heart failure, or cardiovascular death within 1 year or during long-term follow-up.
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  • Kedhi, Elvin, et al. (author)
  • Clinical Impact of Second-Generation Everolimus-Eluting Stent Compared With First-Generation Drug-Eluting Stents in Diabetes Mellitus Patients Insights From a Nationwide Coronary Intervention Register
  • 2012
  • In: JACC: Cardiovascular Interventions. - : Elsevier BV. - 1876-7605 .- 1936-8798. ; 5:11, s. 1141-1149
  • Journal article (peer-reviewed)abstract
    • Objectives This study sought to study the second-generation everolimus-eluting stent (EES) as compared with first-generation sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) in diabetes mellitus (DM) patients. Background There are limited data available comparing clinical outcomes in this setting with EES and SES, whereas studies comparing EES with PES are not powered for low-frequency endpoints. Methods All DM patients treated with EES, PES, or SES from January 18, 2007, to July 29, 2011, from the SCAAR (Swedish Coronary Angiography and Angioplasty Registery) were included. The EES was compared with SES or PES for the primary composite endpoint of clinically driven detected restenosis, definite stent thrombosis (ST), and all-cause mortality. Results In 4,751 percutaneous coronary intervention-treated DM patients, 8,134 stents were implanted (EES = 3,928, PES = 2,836, SES = 1,370). The EES was associated with significantly lower event rates compared with SES (SES vs. EES hazard ratio [HR]: 1.99; 95% confidence interval (CI): 1.19 to 3.08). The same was observed when compared with PES (PES vs. EES HR: 1.33; 95% CI: 0.93 to 1.91) but did not reach statistical significance. These results were mainly driven by lower incidence of ST (SES vs. EES HR: 2.87; 95% CI: 1.08 to 7.61; PES vs. EES HR: 1.74, 95% CI: 0.82 to 3.71) and mortality (SES vs. EES HR: 2.02; 95% CI: 1.03 to 3.98; PES vs. EES HR: 1.69; 95% CI: 1.06 to 2.72). No significant differences in restenosis rates were observed between EES and SES or PES (SES vs. EES HR: 1.26; 95% CI: 0.77 to 2.08; PES vs. EES HR: 1.05; 95% CI: 0.71 to 1.55). Conclusions In all-comer DM patients the use of EES was associated with improved outcomes compared with SES and PES mainly driven by lower rates of ST and mortality. These results suggest better safety rather than efficacy with EES when compared with SES or PES. (J Am Coll Cardiol Intv 2012;5:1141-9) (C) 2012 by the American College of DM
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30.
  • Omerovic, E., et al. (author)
  • Impact of COVID-19 pandemics on the incidence and mortality in Takotsubo syndrome : a report from Swedish Coronary Angiography and Angioplasty Registry
  • 2023
  • In: European Heart Journal. - : Oxford University Press. - 0195-668X .- 1522-9645. ; 44:Suppl. 2
  • Journal article (other academic/artistic)abstract
    • Background: The COVID-19 pandemic resulted in severe psychological, social, and economic stress. Countries applied different anti-pandemic strategies that substantially impacted citizens' psychosocial stress and health. Takotsubo syndrome (TS) is frequently triggered by emotional stress. Previous studies from the USA have reported a severalfold increase in TS incidence during pandemics.Purpose: To determine the incidence and outcomes of TS in Sweden before (2015-March 2020) and during (April 2020-December 2022) the pandemic.Methods: We assessed the incidence rate ratio (IRR) for all patients with TS referred for coronary angiography in Sweden using the nationwide Swedish Coronary Angiography and Angioplasty Registry. Incidence rate ratios (IRRs) before and during the pandemic were calculated with Poisson regression adjusted for age and sex. We evaluated mortality with multivariable Cox proportional hazards regression, which accounted for clustering of patients within hospitals. The following variables were used for adjustment: age, sex, diabetes, smoking status, hypertension, hyperlipidemia, previous myocardial infarction, and Killip class.Results: We identified 3,180 patients (2,128 [76.0%] women) hospitalized with TS during the study period; 2,189 (69%) pre-pandemic and 991 (31%) during the pandemic. The average age was 68.3 ± 11.2 years. The median follow-up time was 1250 days (IQR 562-1995). The crude all-cause mortality rate was 2.57% at 30 days and 15.5% after long-term follow-up. The incidence of TS was 11% lower during the pandemic compared with the pre-pandemic period (IRR 0.90, 95% CI 0.83-0.98, P=0.009, Fig. 1). We found no difference in 30-day mortality (adjusted HR 1.12, 95% CI 0.69-1.78, P= 0.642) or long-term mortality (adjusted HR 0.96, 95% CI 0.73-1.28, P= 0.816) among patients with TS between the pre-pandemic and pandemic periods. When only data after 2016 are used, we found no difference in TS incidence (IRR 1.00, 95% CI 0.92-1.08, P=1.00).Conclusions: In this observational study, the incidence of TS was lower during than before the pandemic but mortality was unchanged. The lower incidence of TS could be related to the specific anti-pandemic strategies applied at the national level in Sweden.
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33.
  • Redfors, B. Björn, et al. (author)
  • Incidence and prognosis of the takotsubo syndrome compared to acute myocardial infarction
  • 2019
  • In: European Journal of Heart Failure. - : John Wiley & Sons. - 1388-9842 .- 1879-0844. ; 21, s. 267-267
  • Journal article (other academic/artistic)abstract
    • Background: Takotsubo syndrome (TS) is a potentially life-threatening acute cardiac syndrome with a clinical presentation very similar to myocardial infarction (MI) and for which the natural history, management and outcome remain incompletely understood.Purpose: The aims of this study were to assess the relative short- and long-term mortality risk of TS , ST-elevation MI (STEMI) and non STEMI (NSTEMI) and to identify predictors of in-hospital complications and poor prognosis in patients with TS.Methods: Using the nationwide Swedish Angiography and Angioplasty Registry (SCAAR) we identified almost all (n=117,720) patients who underwent coronary angiography due to TS (N=2,898 [2.5%]), STEMI (N=48,493 [41.2%]) or NSTEMI (N=66,329 [56.3%]) in Sweden between January 2009 and February 2018.Results: Patients with TS were more often women as compared with patients with STEMI or NSTEMI. TS was associated with unadjusted and adjusted 30-day mortality risks lower than STEMI (adjusted hazard ratio [adjHR] 0.60, 95% confidence interval [CI]0.48-0.76, p<0.001), but higher than NSTEMI (adjHR 2.70, 95% CI 2.14-3.41, p<0.001). Compared to STEMI, TS was associated with similar risk of acute heart failure (adjHR 1.26, 95% CI 0.91–1.76, p=0.16) but lower risk of cardio-genic shock (adjHR 0.55, 95% CI 0.34–0.89, p=0.02). The relative 30-day mortality risk for TS versus STEMI and NSTEMI was higher for smokers than non-smokers (adjusted pinteractionSTEMI=0.01 and pinteractionNSTEMI=0.01).Conclusion: Thirty-day mortality in TS was higher than in NSTEMI but lower than STEMI, despite a similar risk of acute heart failure in TS and STEMI. Among patients with TS, smoking was an independent predictor of mortality
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  • Siddiqui, AJ, et al. (author)
  • Association of coronary angiographic lesions and mortality in patients over 80 years with NSTEMI
  • 2022
  • In: Open heart. - : BMJ. - 2053-3624. ; 9:1
  • Journal article (peer-reviewed)abstract
    • Coronary angiography (CA) and percutaneous coronary intervention (PCI) is of great importance during non-ST-segment elevation myocardial infarction (NSTEMI) management. Coronary artery lesions and their association to mortality in elderly patients with NSTEMI was investigated.MethodsPatients >80 years of age who underwent CA at index NSTEMI during 2011–2014 were included. Data were collected from the Swedish Coronary Angiography and Angioplasty Registry and Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies registries. Coronary lesions were categorised into; one vessel disease (1VD), multi-vessel disease (MVD) and left main disease (LMD) and 0%–49% stenosis grade were considered as controls.Cox regression was used to estimate HRs for all-cause mortality associated with coronary lesions. Survival benefit was determined after PCI and in relation to if revascularisation was complete or incomplete and any complications in the Cath lab was assessed.ResultsFive thousand seven hundred and seventy patients with history of CA and PCI were included, 10% had normal coronary arteries, 26% had 1VD, 50% MVD and 14% LMD. Mortality was higher in patients with 1VD, MVD and LMD: HR 1.8 (1.3–2.5), HR 2.2 (1.6–3.0) and HR 2.8 (2.1–3.9), respectively. PCI were treated in 84% of 1VD, 73% MVD, and 54% in LMD. Survival was higher with PCI HR 0.85 (0.73–0.99). MVD had lower adjusted mortality HR 0.71 (0.58–0.87) compared with patients with MVD who did not undergo PCI. Complications and mortality were higher in patients with LMD both during CA and PCI, HR 2.9 (1.1–7.6) and HR 4.5 (1.6–12.5).ConclusionCoronary lesions (>50% stenosis) are strong predictors of mortality in elderly patients with NSTEMI. MVD is common and PCI treatment is associated with increased survival.
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40.
  • Smits, Pieter C, et al. (author)
  • Fractional Flow Reserve-Guided Multivessel Angioplasty in Myocardial Infarction.
  • 2017
  • In: The New England journal of medicine. - 1533-4406. ; 376:13, s. 1234-1244
  • Journal article (peer-reviewed)abstract
    • Background In patients with ST-segment elevation myocardial infarction (STEMI), the use of percutaneous coronary intervention (PCI) to restore blood flow in an infarct-related coronary artery improves outcomes. The use of PCI in non-infarct-related coronary arteries remains controversial. Methods We randomly assigned 885 patients with STEMI and multivessel disease who had undergone primary PCI of an infarct-related coronary artery in a 1:2 ratio to undergo complete revascularization of non-infarct-related coronary arteries guided by fractional flow reserve (FFR) (295 patients) or to undergo no revascularization of non-infarct-related coronary arteries (590 patients). The FFR procedure was performed in both groups, but in the latter group, both the patients and their cardiologist were unaware of the findings on FFR. The primary end point was a composite of death from any cause, nonfatal myocardial infarction, revascularization, and cerebrovascular events at 12 months. Clinically indicated elective revascularizations performed within 45 days after primary PCI were not counted as events in the group receiving PCI for an infarct-related coronary artery only. Results The primary outcome occurred in 23 patients in the complete-revascularization group and in 121 patients in the infarct-artery-only group that did not receive complete revascularization, a finding that translates to 8 and 21 events per 100 patients, respectively (hazard ratio, 0.35; 95% confidence interval [CI], 0.22 to 0.55; P<0.001). Death occurred in 4 patients in the complete-revascularization group and in 10 patients in the infarct-artery-only group (1.4% vs. 1.7%) (hazard ratio, 0.80; 95% CI, 0.25 to 2.56), myocardial infarction in 7 and 28 patients, respectively (2.4% vs. 4.7%) (hazard ratio, 0.50; 95% CI, 0.22 to 1.13), revascularization in 18 and 103 patients (6.1% vs. 17.5%) (hazard ratio, 0.32; 95% CI, 0.20 to 0.54), and cerebrovascular events in 0 and 4 patients (0 vs. 0.7%). An FFR-related serious adverse event occurred in 2 patients (both in the group receiving infarct-related treatment only). Conclusions In patients with STEMI and multivessel disease who underwent primary PCI of an infarct-related artery, the addition of FFR-guided complete revascularization of non-infarct-related arteries in the acute setting resulted in a risk of a composite cardiovascular outcome that was lower than the risk among those who were treated for the infarct-related artery only. This finding was mainly supported by a reduction in subsequent revascularizations. (Funded by Maasstad Cardiovascular Research and others; Compare-Acute ClinicalTrials.gov number, NCT01399736 .).
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41.
  • Smits, P. C., et al. (author)
  • Fractional flow reserve-guided multivessel angioplasty in myocardial infarction: three-year follow-up with cost benefit analysis of the Compare-Acute trial
  • 2020
  • In: Eurointervention. - : Europa Digital & Publishing. - 1774-024X. ; 16:3, s. 225-232
  • Journal article (peer-reviewed)abstract
    • Aims: The Compare-Acute trial showed superiority of fractional flow reserve (FFR)-guided acute complete revascularisation compared to culprit-only treatment in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD) at one year. The aim of this study was to investigate the outcome at three years, together with cost analysis of this strategy. Methods and results: After primary percutaneous coronary intervention (PCI), 885 patients with STEMI and MVD were randomised (1:2 ratio) to FFR-guided complete revascularisation (295 patients) or infarct-related artery (IRA)-only treatment (590 patients). After 36 months, the primary endpoint (composite of death, myocardial infarction, revascularisation, stroke) occurred significantly less frequently in the FFR-guided complete revascularisation group: 46/295 patients (15.6%) versus 178/590 patients (30.2%) (HR 0.46, 95% CI: 0.33-0.64; p<0.001). This benefit was driven mainly by the reduction of revascularisations in the follow-up (12.5% vs 25.2%; HR 0.45, 95% CI: 0.31-0.64; p<0.001). Cost analysis shows benefit of the FFR-guided complete revascularisation strategy, which can reduce the cost per patient by up to 21% at one year (8,150(sic) vs 10,319(sic)) and by 22% at three years (8,653(sic) vs 11,100(sic)). Conclusions: In patients with STEMI and MVD, FFR-guided complete revascularisation is more beneficial in terms of outcome and healthcare costs compared to IRA-only revascularisation at 36 months.
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42.
  • Tallheden, Tommi, 1972, et al. (author)
  • In vivo MR imaging of magnetically labeled human embryonic stem cells
  • 2006
  • In: Life sciences. - : Elsevier BV. - 0024-3205. ; 79:10, s. 999-1006
  • Journal article (peer-reviewed)abstract
    • INTRODUCTION: Human embryonic stem cells (hES) have emerged as a potentially new therapeutic approach for treatment of heart and other diseases applying the concept of regenerative medicine. A method for in vivo visualization and tracking of transplanted hES would increase our understanding of in vivo hES behavior in both experimental and clinical settings. The aim of this study was to evaluate the feasibility of magnetic labeling and visualization of hES with magnetic resonance imaging (MRI). METHODS: hES were established and expanded according to standard procedures. After expansion, the cells were cultured under feeder free conditions and magnetically labeled by addition of dextran-coated Ferrum-oxide particles (Endorem) to the medium. Accumulation of small particles of iron-oxide (SPIO) in hES was assessed by Prussian blue staining and electron microscopy. For in vitro MRI, the labeled and unlabeled hES were examined in cell solution and after transplantation into explanted mouse heart ( approximately 100,000 cells) on a Bruker Avance DMX 500 vertical magnet at 11.75 T. A multi-slice, multi spin-echo T(2)-weighted images were obtained. For in vivo imaging, the experiments were performed on male Sprague-Dawley using Bruker Biospec 2.35 T magnet. The hES were directly injected ( approximately 500,000 cells) after surgical procedure (thoracotomy) into anterior left ventricular (LV) wall. Multi-slice T(2)-weighted gradient echo images were obtained using cardiac gating. RESULTS: hES appeared to be unaffected by magnetic labeling and maintained their ability to proliferate and differentiate. No additive agent for membrane permeabilisation was needed for facilitation of intracellular SPIO accumulation. Prussian blue and electron microscopy have revealed numerous iron particles in the cytoplasm of hES. On T(2)-weighted images, the labeled cells have shown well-defined hyopintense areas at the site of injection in anterior LV wall both in vitro and in vivo. CONCLUSIONS: It is feasible to magnetically label and visualize hES both in vitro and in vivo. MR visualization of magnetically labeled hES may be a valuable tool for in vivo tracking of hES.
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46.
  • Tranter, Matthew H, et al. (author)
  • Hyperthermia as a trigger for Takotsubo syndrome in a rat model.
  • 2022
  • In: Frontiers in cardiovascular medicine. - : Frontiers Media SA. - 2297-055X. ; 9
  • Journal article (peer-reviewed)abstract
    • Takotsubo syndrome is a well-characterized cause of acute yet reversible heart failure associated with periods of intense emotional stress, often mimicking on presentation an acute coronary syndrome. Animal models of Takotsubo syndrome have been developed, either through the application of a stressor, or administration of exogenous catecholamine. We found that in a model of isoproterenol-induced Takotsubo syndrome in anesthetized rats hyperthermia (40-41°C) would occur after the administration of isoproterenol. Maintenance of this hyperthermia would result in an apical hypocontractility typical of the syndrome, whereas prevention of hyperthermia with active cooling to maintain a euthermic core body temperature prevented (but did not subsequently reverse) apical hypocontractility. In vitro experimentation with isolated cardiomyocytes showed no effect of hyperthermia on either baseline contractility or contractility change after beta-adrenoceptor stimulation. We suggest that the rise in body temperature that is characteristic of catecholamine storm may be a component in the development of Takotsubo syndrome.
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48.
  • Venetsanos, Dimitrios, et al. (author)
  • Sex-related response to bivalirudin and unfractionated heparin in patients with acute myocardial infarction undergoing percutaneous coronary intervention : A subgroup analysis of the VALIDATE-SWEDEHEART trial
  • 2019
  • In: European Heart Journal. - : Sage Publications. - 2048-8726 .- 2048-8734. ; 8:6, s. 502-509
  • Journal article (peer-reviewed)abstract
    • AIMS: Our aim was to study the impact of sex on anticoagulant treatment outcomes during percutaneous coronary intervention in acute myocardial infarction patients.METHODS: This study was a prespecified analysis of the Bivalirudin versus Heparin in ST-Segment and Non ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease Evaluated according to Recommended Therapies Registry Trial (VALIDATE-SWEDEHEART) trial, in which patients with myocardial infarction were randomised to bivalirudin or unfractionated heparin during percutaneous coronary intervention. The primary outcome was the composite of death, myocardial infarction or major bleeding at 180 days.RESULTS: There was a lower risk of the primary outcome in women assigned to bivalirudin than to unfractionated heparin (13.6% vs 17.1%, hazard ratio 0.78, 95% confidence interval (0.60-1.00)) with no significant difference in men (11.8% vs 11.2%, hazard ratio 1.06 (0.89-1.26), p for interaction 0.05). The observed difference was primarily due to lower risk of major bleeding (Bleeding Academic Research Consortium definition 2, 3 or 5) associated with bivalirudin in women (8.9% vs 11.8%, hazard ratio 0.74 (0.54-1.01)) but not in men (8.5% vs 7.3%, hazard ratio 1.16 (0.94-1.43) in men, p for interaction 0.02). Conversely, no significant difference in the risk of Bleeding Academic Research Consortium 3 or 5 bleeding, associated with bivalirudin, was found in women 4.5% vs 5.4% (hazard ratio 0.84 (0.54-1.31)) or men 2.9% vs 2.1% (hazard ratio 1.36 (0.93-1.99)). Bleeding Academic Research Consortium 2 bleeding occurred significantly less often in women assigned to bivalirudin than to unfractionated heparin. The risk of death or myocardial infarction did not significantly differ between randomised treatments in men or women.CONCLUSION: In women, bivalirudin was associated with a lower risk of adverse outcomes, compared to unfractionated heparin, primarily due to a significant reduction in Bleeding Academic Research Consortium 2 bleeds.
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50.
  • Venetsanos, D., et al. (author)
  • Utilization and outcomes of rotational atherectomy in Sweden
  • 2020
  • In: European Heart Journal. - : Oxford University Press. - 0195-668X .- 1522-9645. ; 41:Suppl. 2, s. 2528-2528
  • Journal article (other academic/artistic)abstract
    • Aim: To evaluate utilization and outcomes of rotational atherectomy (RA) using data from the Swedish Coronary and Angioplasty Registry (SCAAR).Methods: We included 1476 patients with 2218 lesions who underwent RA from 2005 to 2016. To study temporal changes, the study period was divided into three equal time-periods, period A, B and C.Results: Although the number of RA procedures increased 3-fold from 2005 to 2016, the rate of RA (of all PCI procedures) remained low (0.5% vs 1.2% in 2005 vs 2016). RA patients consisted a high-risk group, with advanced age and clustering of comorbidities. Over time, included patients were older and had a higher risk profile. Trans-radial access, drug eluting stent (DES) use and use of intravascular imaging significantly increased from period A to C whereas positioning of a temporary pacemaker or intra-aortic balloon pump declined. Unfractionated heparin became the main anticoagulant (52 vs 87%) and use of glycoprotein IIb/IIIa inhibitors declined (31 vs 12%, in period A vs C). Following RA, 11% of lesions were treated without stent (15 vs 15 vs 8%, in period A, B and C) (Rota-only). In lesions treated with a stent, a bare metal stent (BMS) was implanted in 39% vs 12% vs 2% and a new generation DES (N-DES) in 5 vs 75 vs 97% (period A vs B vs C) of lesions.The 3-year cumulative rate of restenosis was 6.7% (122 events), (11.1 vs 7.1 vs 4.1% in period A vs B vs C). As compared to DES, rota-only (adjusted HR 2.71; 95% CI 1.69- 4.36) and BMS (adjusted HR 3.63; 95% CI 2.27- 5.81) were associated with significantly higher risk for restenosis. First generation DES were associated with numerically higher but not significantly different risk for restenosis as compared to N-DES (adjusted HR 1.31; 95% CI 0.74- 2.31).The 3 year cumulative rate of major adverse cardiac events (MACE), including death, myocardial infarction (MI) or any restenosis was 30.6% (34.2 vs 31.4 vs 28.2%, in period A vs B vs C) and the corresponding numbers for all-cause mortality were 18.1% (18.9 vs 18.4 vs 17.0%). After adjustment for baseline characteristics and angiographic findings, RA in period A was associated with higher risk for MACE as compared to period C (adjusted HR 1.40; 95% CI 1.09- 1.79), due to higher risk for MI and restenosis. The difference disappeared when procedural characteristics, including DES use, were added to the model.The rate of major in-hospital complications was 7.0%, including in-hospital death 1.3%, periprocedural MI 2.8%, perforation 1.1%, cardiac tamponade 0.7%, stroke 0.2% and major bleedings 2.1%. We found no significant differences over time.Conclusion: During the studied period, RA remained a rare procedure, utilised in a highly selected population. Over time a declining rate of restenosis and MI after RA was observed, a finding that appeared to be mainly driven by an increased use of DES. The rate of major in-hospital complication remained low.
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