Publications by authors named "Sigrun Halvorsen"

147 Publications

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

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

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

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

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

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

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

Conclusions: In RE-DUAL PCI, in which patients in the dual-therapy arms were treated with aspirin for an average of only 1.6 days, there was early net clinical benefit with both doses of dabigatran dual therapy, without an increase in thrombotic events with dabigatran 150 mg. This could be helpful in the subset of patients with elevated risk for both bleeding and thrombotic events.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jcin.2021.02.022DOI Listing
April 2021

Comparison of management and outcomes of ST-segment elevation myocardial infarction patients in Estonia, Hungary, Norway and Sweden according to national ongoing registries.

Eur Heart J Qual Care Clin Outcomes 2021 Mar 12. Epub 2021 Mar 12.

Gottsegen National Institute of Cardiology, Hungarian Myocardial Infarction Registry, 29 Haller street, 1096, Budapest, Hungary.

Aim: Describe the characteristics, management and outcomes of hospitalized ST-segment elevation myocardial infarction (STEMI) patients according to national ongoing myocardial infarction registries in Estonia, Hungary, Norway and Sweden.

Methods And Results: Country-level aggregated data was used to study baseline characteristics, use of in-hospital procedures, medications at discharge, in-hospital complications, 30-day and 1-year mortality for all patients admitted with STEMI during 2014-2017 using data from EMIR (Estonia; n = 4584), HUMIR (Hungary; n = 23685), NORMI (Norway; n = 12414, data for 2013-2016) and SWEDEHEART (Sweden; n = 23342). Estonia and Hungary had a higher proportion of women, patients with hypertension, diabetes and peripheral artery disease compared to Norway and Sweden. Rates of reperfusion varied from 75.7% in Estonia to 84.0% in Sweden. Rates of recommendation of discharge medications were generally high and similar. However, Estonia demonstrated the lowest rates of dual antiplatelet therapy (78.1%) and statins (86.5%). Norway had the lowest rates of beta-blockers (80.5%) and angiotensin converting enzyme inhibitors/angiotensin II receptor blockers (61.5%). The 30-day mortality rates ranged between 9.9-13.4% remaining lowest in Sweden. 1-year mortality rates ranged from 14.8% in Sweden and 16.0% in Norway to 20.6% in Hungary and 21.1% in Estonia. Age-adjusted lethality rates were highest for Hungary and lowest for Sweden.

Conclusion: This inter-country comparison of data from four national ongoing European registries provide new insights into the risk factors, management and outcomes of patients with STEMI. There are several possible reasons for the findings, including coverage of the registries and variability of baseline-characteristics' definitions that need to be further explored.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/ehjqcco/qcaa098DOI Listing
March 2021

Comparison of a single high-sensitivity cardiac troponin T measurement with the HEART score for rapid rule-out of acute myocardial infarction in a primary care emergency setting: a cohort study.

BMJ Open 2021 Feb 24;11(2):e046024. Epub 2021 Feb 24.

Department of Cardiolgy, Oslo University Hospital, Ullevaal, Oslo, Norway.

Objective: This study aims to compare the rule-out safety of a single high-sensitivity cardiac troponin T (hs-cTnT) with the History, ECG, Age, Risk factors and Troponin (HEART) score in a low-prevalence primary care setting of acute myocardial infarction (AMI).

Participants: Patients with non-specific symptoms suggestive of AMI were consecutively enroled at a primary care emergency clinic in Oslo, Norway from November 2016 to October 2018.

Methods: After initial assessment by a general practitioner, hs-cTnT samples were drawn. AMI was ruled-out by a single hs-cTnT <5 ng/L measured ≥3 hours after symptom onset. The HEART score was calculated retrospectively; a score ≤3 of 10 points was considered low risk. We also calculated a modified HEART score using more sensitive hs-cTnT thresholds. The primary outcome was the diagnostic performance for the rule-out of AMI at the index event; the secondary the composite of AMI or all-cause death at 90 days.

Results: Among 1711 patients, 61 (3.6%) were diagnosed with AMI, and 569 (33.3%) patients were assigned to single rule-out (<5 ng/L). With no AMIs in this group, the negative predictive value (NPV) and sensitivity were both 100.0% (95% CI 99.4% to 100.0% and 94.1% to 100.0%, respectively), and the specificity 34.5% (32.2% to 36.8%). The original HEART score triaged more patients as low risk (n=871), but missed five AMIs (NPV 99.4% (98.7% to 99.8%); sensitivity 91.8% (81.9% to 97.3%) and specificity 52.5% (50.0% to 54.9%)). The modified HEART score increased the low-risk sensitivity to 98.4% (91.2% to 100.0%), with specificity 38.7% (36.3% to 41.1%). The 90-day incidence of AMI or death in the single rule-out and the original and modified low-risk HEART groups were 0.0%, 0.7%, and 0.2%, respectively.

Conclusion: In a primary care emergency setting, a single hs-cTnT strategy was superior to the HEART score in ruling out AMI. This rapid and safe approach may enhance the assessment of patients with chest pain outside of hospitals.

Trial Registration Number: NCT02983123.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmjopen-2020-046024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7908281PMC
February 2021

The cardiac arrest centre for the treatment of sudden cardiac arrest due to presumed cardiac cause: aims, function, and structure: position paper of the ACVC association of the ESC, EAPCI, EHRA, ERC, EUSEM, and ESICM.

Eur Heart J Acute Cardiovasc Care 2020 Nov 7. Epub 2020 Nov 7.

Department of Intensive Care Medicine, University Hospital of Antwerp, Antwerp, Belgium.

Approximately 10% of patients resuscitated from out-of-hospital cardiac arrest (OHCA) survive to hospital discharge. Improved management to improve outcomes are required, and it is proposed that such patients should be preferentially treated in cardiac arrest centres (CACs). The minimum requirements of therapy modalities for the CAC are 24/7 availability of an on-site coronary angiography laboratory, an emergency department, an intensive care unit, imaging facilities, such as echocardiography, computed tomography, and magnetic resonance imaging, and a protocol outlining transfer of selected patients to CACs with additional resources (OHCA hub hospitals). These hub hospitals are regularly treating a high volume of patients and offer further treatment modalities. This consensus document describes the aims, the minimal requirements for therapeutic modalities and expertise, and the structure, of a CAC. It represents a consensus among the major European medical associations and societies involved in the treatment of OHCA patients.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/ehjacc/zuaa024DOI Listing
November 2020

Biomarkers of coagulation and fibrinolysis in acute myocardial infarction: a joint position paper of the Association for Acute CardioVascular Care and the European Society of Cardiology Working Group on Thrombosis.

Eur Heart J Acute Cardiovasc Care 2020 Nov 7. Epub 2020 Nov 7.

Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Blvd. 161, 8200 Aarhus N, Denmark.

The formation of a thrombus in an epicardial artery may result in an acute myocardial infarction (AMI). Despite major advances in acute treatment using network approaches to allocate patients to timely reperfusion and optimal antithrombotic treatment, patients remain at high risk for thrombotic complications. Ongoing activation of the coagulation system as well as thrombin-mediated platelet activation may both play a crucial role in this context. Whether measurement of circulating biomarkers of coagulation and fibrinolysis could be useful for risk stratification in secondary prevention is currently not fully understood. In addition, measurement of such biomarkers could be helpful to identify thrombus formation as the leading mechanism for AMI. The introduction of biomarkers of myocardial injury such as high-sensitivity cardiac troponins made rule-out of AMI even more precise. However, elevated markers of myocardial injury cannot provide proof of a type 1 AMI, let alone thrombus formation. The combined measurement of markers of myocardial injury with biomarkers reflecting ongoing thrombus formation might be helpful for the fast and correct diagnosis of an atherothrombotic type 1 AMI. This position paper gives an overview of the current knowledge and possible role of biomarkers of coagulation and fibrinolysis for the diagnosis of AMI, risk stratification, and individualized treatment strategies in patients with AMI.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/ehjacc/zuaa025DOI Listing
November 2020

Differences in characteristics, treatments and outcomes in patients with non-ST-elevation myocardial infarction -novel insights from four national European continuous real-world registries.

Eur Heart J Qual Care Clin Outcomes 2021 Feb 19. Epub 2021 Feb 19.

Department of Cardiology, Oslo University Hospital Ulleval, Oslo and University of Oslo, Kirkeveien 166, 0450 Oslo, Norway.

Aims: To study baseline characteristics, in-hospital managements and mortality of non-ST elevation MI (NSTEMI) patients in different European countries.

Methods And Results: NSTEMI patients enrolled in the national MI registries (EMIR; n = 5,817 (Estonia), HUMIR; n = 30,787 (Hungary), NORMI; n = 33,054 (Norway) and SWEDEHEART; n = 49,533 (Sweden)) from 2014 to 2017 were included and presented as aggregated data. The median age at admission ranged from 70 to 75 years. Current smoking status was numerically higher in Norway (24%), Estonia (22%) and Hungary (19%), as compared to Sweden (17%). Patients in Hungary had a high rate of diabetes mellitus (37%) and hypertension (84%). The proportion of performed coronary angiographies (58% versus 75%) and percutaneous coronary interventions (38% versus 56%), differed most between Norway and Hungary. Prescription of dual antiplatelet therapy at hospital discharge ranged from 60% (Estonia) to 81% (Hungary). In-hospital death ranged from 3.5% (Sweden) to 9% (Estonia). The crude mortality rate at 1 month was 12% in Norway and 5% in Sweden (5%), whereas the 1-year mortality rates were similar (20-23%) in Hungary, Estonia and Norway and 15% in Sweden.

Conclusion: Cross-comparisons of four national European MI registries provide important data on differences in risk factors and treatment regiments that may explain some of the observed differences in death rates. A unified European continuous MI registry could be an option to better understand how implementation of guideline recommended therapy can be used to reduce the burden of cardiovascular disease.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/ehjqcco/qcab013DOI Listing
February 2021

2020 Update of the quality indicators for acute myocardial infarction: a position paper of the Association for Acute Cardiovascular Care: the study group for quality indicators from the ACVC and the NSTE-ACS guideline group.

Eur Heart J Acute Cardiovasc Care 2021 Apr;10(2):224-233

Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.

Aims: Quality indicators (QIs) are tools to improve the delivery of evidence-base medicine. In 2017, the European Society of Cardiology (ESC) Association for Acute Cardiovascular Care (ACVC) developed a set of QIs for acute myocardial infarction (AMI), which have been evaluated at national and international levels and across different populations. However, an update of these QIs is needed in light of the accumulated experience and the changes in the supporting evidence.

Methods And Results: The ESC methodology for the QI development was used to update the 2017 ACVC QIs. We identified key domains of AMI care, conducted a literature review, developed a list of candidate QIs, and used a modified Delphi method to select the final set of indicators. The same seven domains of AMI care identified by the 2017 Study Group were retained for this update. For each domain, main and secondary QIs were developed reflecting the essential and complementary aspects of care, respectively. Overall, 26 QIs are proposed in this document, compared to 20 in the 2017 set. New QIs are proposed in this document (e.g. the centre use of high-sensitivity troponin), some were retained or modified (e.g. the in-hospital risk assessment), and others were retired in accordance with the changes in evidence [e.g. the proportion of patients with non-ST segment elevation myocardial infarction (NSTEMI) treated with fondaparinux] and the feasibility assessments (e.g. the proportion of patients with NSTEMI whom risk assessment is performed using the GRACE and CRUSADE risk scores).

Conclusion: Updated QIs for the management of AMI were developed according to contemporary knowledge and accumulated experience. These QIs may be applied to evaluate and improve the quality of AMI care.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/ehjacc/zuaa037DOI Listing
April 2021

Apixaban or Vitamin K Antagonists and Aspirin or Placebo According to Kidney Function in Patients With Atrial Fibrillation After Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial.

Circulation 2021 Mar 19;143(12):1215-1223. Epub 2021 Jan 19.

Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (J.H.A., Z.L., D.M.W., C.B.G., R.D.L.).

Background: In the AUGUSTUS trial (An Open-Label, 2×2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban Versus Vitamin K Antagonist and Aspirin Versus Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention), apixaban resulted in less bleeding and fewer hospitalizations than vitamin K antagonists, and aspirin caused more bleeding than placebo in patients with atrial fibrillation and acute coronary syndrome or percutaneous coronary intervention treated with a P2Y inhibitor. We evaluated the risk-benefit balance of antithrombotic therapy according to kidney function.

Methods: In 4456 patients, the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula was used to calculate baseline estimated glomerular filtration rate (eGFR). The effect of apixaban versus vitamin K antagonists and aspirin versus placebo was assessed across kidney function categories by using Cox models. The primary outcome was International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding. Secondary outcomes included death or hospitalization and ischemic events (death, stroke, myocardial infarction, stent thrombosis [definite or probable], or urgent revascularization). Creatinine clearance <30 mL/min was an exclusion criterion in the AUGUSTUS trial.

Results: Overall, 30%, 52%, and 19% had an eGFR of >80, >50 to 80, and 30 to 50 mL·min·1.73 m, respectively. At the 6-month follow-up, a total of 543 primary outcomes of bleeding, 1125 death or hospitalizations, and 282 ischemic events occurred. Compared with vitamin K antagonists, patients assigned apixaban had lower rates for all 3 outcomes across most eGFR categories without significant interaction. The absolute risk reduction with apixaban was most pronounced in those with an eGFR of 30 to 50 mL·min·1.73 m for bleeding events with rates of 13.1% versus 21.3% (hazard ratio, 0.59; 95% CI, 0.41-0.84). Patients assigned aspirin had a higher risk of bleeding in all eGFR categories with an even greater increase among those with eGFR >80 mL·min·1.73 m: 16.6% versus 5.6% (hazard ratio, 3.22; 95% CI, 2.19-4.74; for interaction=0.007). The risk of death or hospitalization and ischemic events were comparable to aspirin and placebo across eGFR categories with hazard ratios ranging from 0.97 (95% CI, 0.76-1.23) to 1.28 (95% CI, 1.02-1.59) and from 0.75 (95% CI, 0.48-1.17) to 1.34 (95% CI, 0.81-2.22), respectively.

Conclusions: The safety and efficacy of apixaban was consistent irrespective of kidney function, compared with warfarin, and in accordance with the overall trial results. The risk of bleeding with aspirin was consistently higher across all kidney function categories. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02415400.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1161/CIRCULATIONAHA.120.051020DOI Listing
March 2021

The cardiac arrest centre for the treatment of sudden cardiac arrest due to presumed cardiac cause - aims, function and structure: Position paper of the Association for Acute CardioVascular Care of the European Society of Cardiology (AVCV), European Association of Percutaneous Coronary Interventions (EAPCI), European Heart Rhythm Association (EHRA), European Resuscitation Council (ERC), European Society for Emergency Medicine (EUSEM) and European Society of Intensive Care Medicine (ESICM).

Eur Heart J Acute Cardiovasc Care 2020 Nov;9(4_suppl):S193-S202

Department of Cardiology, Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.

Approximately 10% of patients resuscitated from out-of-hospital cardiac arrest survive to hospital discharge. Improved management to improve outcomes is required, and it is proposed that such patients should be preferentially treated in cardiac arrest centres. The minimum requirements of therapy modalities for the cardiac arrest centre are 24/7 availability of an on-site coronary angiography laboratory, an emergency department, an intensive care unit, imaging facilities such as echocardiography, computed tomography and magnetic resonance imaging, and a protocol outlining transfer of selected patients to cardiac arrest centres with additional resources (out-of-hospital cardiac arrest hub hospitals). These hub hospitals are regularly treating a high volume of patients and offer further treatment modalities. This consensus document describes the aims, the minimal requirements for therapeutic modalities and expertise, and the structure, of a cardiac arrest centre. It represents a consensus among the major European medical associations and societies involved in the treatment of out-of-hospital cardiac arrest patients.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/2048872620963492DOI Listing
November 2020

Music therapy as an adjunct in cardiac device lead extraction procedures: A randomized controlled trial.

Appl Nurs Res 2020 12 24;56:151376. Epub 2020 Oct 24.

Department of Cardiology, Oslo University Hospital Ulleval, Kirkeveien 166, 0450 Oslo, Norway; Faculty of Medicine, University of Oslo, Klaus Torgårds vei 3, 0372 Oslo, Norway.

Background: Evidence of music therapy as an effective supportive therapy in invasive cardiac procedures is increasing, but more research is needed.

Aims: To evaluate the impact of music therapy on stress responses during cardiac device lead extraction procedures performed in local anaesthesia.

Methods: Sixty-four patients undergoing cardiac implantable electronic device lead extraction at Oslo University Hospital Ulleval from March 2018 to September 2019 were randomized to music therapy (n = 32) or control (n = 32). Primary endpoints were patient satisfaction with pain management and average pain intensity during the procedure. Secondary endpoints were average anxiety intensity, need for analgesic/anxiolytic drugs, blood pressure, heart and respiration rate.

Results: All patients in the music therapy group completed the intervention. Patient satisfaction with pain management was 10.00 (8.00, 10.00) in the music therapy vs. 10.00 (9.00, 10.00) in the control group (p = 0.85), and average level of pain 0.89 (0.22, 1.13) vs. 0.96 (0.36, 1.58), respectively (p = 0.38). Average anxiety score was 1.00 (0.33, 2.17) in the music therapy vs 1.67 (0.71, 3.35) in the control group (p = 0.056). The use of analgesic/anxiolytic drugs and physiological parameters were similar across groups.

Conclusions: In this study of music therapy during cardiac device lead extractions, no effect was found on patient satisfaction with pain management or average pain level. A decrease in patient anxiety of borderline significance was observed in the music therapy group. More studies with more sensitive measures of pain and anxiety are needed to determine the value of music therapy in invasive cardiac procedures.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.apnr.2020.151376DOI Listing
December 2020

Lipoprotein(a) lowering by alirocumab reduces the total burden of cardiovascular events independent of low-density lipoprotein cholesterol lowering: ODYSSEY OUTCOMES trial.

Eur Heart J 2020 11;41(44):4245-4255

Division of Cardiology, University of Colorado School of Medicine, Box B130, Aurora, CO 80045, USA.

Aims: Lipoprotein(a) concentration is associated with first cardiovascular events in clinical trials. It is unknown if this relationship holds for total (first and subsequent) events. In the ODYSSEY OUTCOMES trial in patients with recent acute coronary syndrome (ACS), the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab reduced lipoprotein(a), low-density lipoprotein cholesterol (LDL-C), and cardiovascular events compared with placebo. This post hoc analysis determined whether baseline levels and alirocumab-induced changes in lipoprotein(a) and LDL-C [corrected for lipoprotein(a) cholesterol] independently predicted total cardiovascular events.

Methods And Results: Cardiovascular events included cardiovascular death, non-fatal myocardial infarction, stroke, hospitalization for unstable angina or heart failure, ischaemia-driven coronary revascularization, peripheral artery disease events, and venous thromboembolism. Proportional hazards models estimated relationships between baseline lipoprotein(a) and total cardiovascular events in the placebo group, effects of alirocumab treatment on total cardiovascular events by baseline lipoprotein(a), and relationships between lipoprotein(a) reduction with alirocumab and subsequent risk of total cardiovascular events. Baseline lipoprotein(a) predicted total cardiovascular events with placebo, while higher baseline lipoprotein(a) levels were associated with greater reduction in total cardiovascular events with alirocumab (hazard ratio Ptrend = 0.045). Alirocumab-induced reductions in lipoprotein(a) (median -5.0 [-13.6, 0] mg/dL) and corrected LDL-C (median -51.3 [-67.1, -34.0] mg/dL) independently predicted lower risk of total cardiovascular events. Each 5-mg/dL reduction in lipoprotein(a) predicted a 2.5% relative reduction in cardiovascular events.

Conclusion: Baseline lipoprotein(a) predicted the risk of total cardiovascular events and risk reduction by alirocumab. Lipoprotein(a) lowering contributed independently to cardiovascular event reduction, supporting the concept of lipoprotein(a) as a treatment target after ACS.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/eurheartj/ehaa649DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7724642PMC
November 2020

Pre-hospital One-Hour Troponin in a Low-Prevalence Population of Acute Coronary Syndrome: OUT-ACS study.

Open Heart 2020 07;7(2)

Department of Cardiology, Oslo University Hospital Ullevaal, Oslo, Norway.

Objective: The European Society of Cardiology 0/1-hour algorithm for high-sensitivity cardiac troponin T (hs-cTnT) has demonstrated high rule-out safety in large hospital validation cohorts. We aimed to validate the algorithm in a primary care setting, where patients have a lower pretest probability for acute coronary syndrome.

Methods: This prospective, observational, diagnostic study included patients with acute non-specific chest pain admitted to a primary care emergency clinic in Oslo, Norway, from November 2016 to October 2018. hs-cTnT was measured after 0, 1 and 4 hours. The primary outcome measure was the diagnostic performance of the 0/1-hour algorithm, the 90-day incidence of AMI or all-cause death the secondary.

Results: Among 1711 included patients, 61 (3.6%) were diagnosed with AMI. By applying the algorithm, 1311 (76.6%) patients were assigned to the rule-out group. The negative predictive value was 99.9% (95% CI 99.5% to 100.0%), the sensitivity and specificity 98.4% (91.2-100.0) and 79.4% (77.4-81.3), respectively. Sixty-six (3.9%) patients were triaged towards rule-in, where 45 were diagnosed with AMI. The corresponding positive predictive value was 68.2% (58.3-76.7), sensitivity 73.8% (60.9-84.2), and specificity 98.7% (98.1-99.2). Among 334 (19.5%) patients assigned to the observation group in need of further tests, 15 patients had an AMI. The following 90 days, five new patients experienced an AMI and nine patients died, with a low incidence in the rule-out group (0.3%).

Conclusion: The 0/1-hour algorithm for hs-cTnT seems safe, efficient and applicable for an accelerated assessment of patients with non-specific chest pain in a primary care emergency setting.

Trial Registration Number: NCT02983123.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/openhrt-2020-001296DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7380862PMC
July 2020

Incidence and prevalence of venous thromboembolism in Norway 2010-2017.

Thromb Res 2020 11 7;195:165-168. Epub 2020 Jul 7.

Department of Haematology, Oslo University Hospital, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Cardiology, Oslo University Hospital Ulleval and University of Oslo, Oslo, Norway. Electronic address:

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.thromres.2020.07.011DOI Listing
November 2020

Worst lead ST deviation and resolution of ST elevation at one hour for prediction of myocardial salvage, infarct size, and microvascular obstruction in patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention.

Ann Noninvasive Electrocardiol 2020 11 27;25(6):e12784. Epub 2020 Jun 27.

Department of Cardiology, Oslo University Hospital Ullevål, Oslo, Norway.

Background: ECG changes after revascularization predicts improved outcome for patients with ST-elevation myocardial infarction (STEMI). Worst lead residual (WLR) ST deviation and resolution of worst lead ST elevation (rST elevation) are simple measures that can be obtained early after PCI. The objective of the current study was to investigate whether simple ECG measures, obtained one hour following PCI, could predict cardiac magnetic resonance (CMR)-derived myocardial salvage index (MSI), infarct size (IS), and microvascular obstruction (MVO) in patients with STEMI included in the MITOCARE trial.

Methods: The MITOCARE trial included 165 patients with a first-time STEMI presenting within six hours of symptom onset. The current analysis included patients that had an ECG recorded at baseline and one hour after PCI and underwent CMR imaging after 3-5 days. Independent core laboratories determined WLR ST deviation, rST elevation, and the CMR variables (MSI, IS, and MVO).

Results: 83 patients with a mean age of 61 years were included. 83.1% were males and 41% had anterior infarctions. In logistic regression models, WLR ST deviation was a statistically significant predictor of IS (OR 2.2, 95% CI 1.3-3.8) and MVO (OR 2.8, 95% CI 1.5-5.2), but not of MSI (OR 0.8, 95% CI 0.5-1.2). rST elevation showed a trend toward a significant association with IS (OR 0.3, 95% CI 0.1-1.0), but not with the other CMR variables.

Conclusion: WLR ST deviation one hour after PCI was a predictor of IS and MVO. WLR ST deviation, a measure easily obtained from ECGs following PCI, may provide important prognostic information in patients with STEMI.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/anec.12784DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7679835PMC
November 2020

Incidence, prevalence, and mortality of heart failure: a nationwide registry study from 2013 to 2016.

ESC Heart Fail 2020 08 12;7(4):1917-1926. Epub 2020 Jun 12.

Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

Aims: Large-scaled population studies of incidence and prevalence of heart failure (HF) are needed for the development of healthcare policies and priorities. The aim of this study was to estimate the incidence, prevalence, and all-cause mortality of HF in Norway from 2013 to 2016 on the basis of a national registry.

Methods And Results: Using data from the nationwide Norwegian Prescription Database, we identified all patients ≥18 years of age in Norway with at least one drug prescription with HF during 2013-2016, defined by 10th revision of the International Classification of Diseases (ICD-10) codes I50, I11, I13, or I42. The individual index date was the date of the first prescription. Patients were followed up until death or end of follow-up (31 October 2017). Annual incidence and prevalence were estimated from 2013 to 2016, using a look-back period starting from 1 March 2008. We calculated standardized estimates by applying direct age and sex standardization to the 2013 European standard population. All-cause mortality from 2013 to 2016 was calculated among the prevalent HF patients. Standardized mortality ratio (SMR) was calculated by indirect standardization using general mortality in the Norwegian population as reference. We identified 54 542 unique patients (58% men) with a first-time diagnosis of HF. The median age was 72 ±14 years, and women were older than men (median age 76 vs. 70 years, respectively). The crude (standardized) incidence of HF was 3.44/1000 (4.23/1000) person-years in 2016 and did not increase over the 4 year period, while the prevalence increased from 2.0% (2.3%) to 2.4% (2.8%). Both incidence and prevalence were higher in men than in women and strongly associated with age. Crude mortality rates in the HF population declined from 94 to 82/1000 person-years from 2013 to 2016, and SMR declined from 2.01 to 1.84. Age-adjusted mortality rates were higher in men than in women.

Conclusions: This nationwide registry study in Norway showed an increase in the prevalence of HF from 2013 to 2016, with stable incidence rates and improved survival.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/ehf2.12773DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7373922PMC
August 2020

Prevalence of genetically verified familial hypercholesterolemia among young (<45 years) Norwegian patients hospitalized with acute myocardial infarction.

J Clin Lipidol 2020 May - Jun;14(3):339-345. Epub 2020 Apr 13.

Norwegian National Advisory Unit on Familial Hypercholesterolemia, Oslo University Hospital, Oslo, Norway; Department of Nutrition, Institute for Basic Medical Sciences, University of Oslo, Oslo, Norway.

Background: Patients with familial hypercholesterolemia (FH) have an increased risk of premature myocardial infarction (MI).

Objectives: The objective of the study is to investigate the prevalence of FH among young patients hospitalized with acute MI.

Methods: Data were collected from medical charts of all patients aged <45 years admitted with acute MI to the Department of Cardiology, Oslo University Hospital Ullevål, in the period 2012 to 2016. Patients who had not already been genetically tested for FH were contacted and offered genetic testing if the pretreatment or the statin-adjusted low-density lipoprotein cholesterol level was >4.0 mmol/L (155 mg/dL).

Results: Of 9332 patients admitted with acute MI, 357 were aged <45 years. Sixteen patients were deceased, and 13 patients did not have MI on an atherosclerotic basis. Of the remaining 328 patients eligible for investigation, 130 had the pretreatment or statin-adjusted low-density lipoprotein cholesterol level >4.0 mmol/L (155 mg/dL). Of these, data from 52 patients genetically tested for FH were available. Eleven patients had genetically verified FH constituting 3.4% of the total eligible population (n = 328), 8.5% of those with indications for genetic testing (n = 130), and 21.2% of those actually tested (n = 52). A Dutch Lipid Clinic Network score for clinical FH diagnosis of "definite FH" identified only 5 of the 11 patients with positive genetic test (45%). Including a score of "probable FH" identified all patients with FH but also 17 of the 41 patients (41%) with a negative genetic test.

Conclusion: The prevalence of FH in young patients with acute MI was higher than in the general population. Routine evaluation of FH diagnosis among these patients could identify more patients with FH, thereby increasing the possibility of initiating early and adequate treatment also among affected relatives.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jacl.2020.04.002DOI Listing
April 2020

EAPCI Position Statement on Invasive Management of Acute Coronary Syndromes during the COVID-19 pandemic.

Eur Heart J 2020 05;41(19):1839-1851

Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, Barts Heart Centre, London, UK and Yale University School of Medicine, New Haven, CT, USA.

The coronavirus disease 2019 (COVID-19) pandemic poses an unprecedented challenge to healthcare worldwide. The infection can be life threatening and require intensive care treatment. The transmission of the disease poses a risk to both patients and healthcare workers. The number of patients requiring hospital admission and intensive care may overwhelm health systems and negatively affect standard care for patients presenting with conditions needing emergency interventions. This position statements aims to assist cardiologists in the invasive management of acute coronary syndrome (ACS) patients in the context of the COVID-19 pandemic. To that end, we assembled a panel of interventional cardiologists and acute cardiac care specialists appointed by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and from the Acute Cardiovascular Care Association (ACVC) and included the experience from the first and worst affected areas in Europe. Modified diagnostic and treatment algorithms are proposed to adapt evidence-based protocols for this unprecedented challenge. Various clinical scenarios, as well as management algorithms for patients with a diagnosed or suspected COVID-19 infection, presenting with ST- and non-ST-segment elevation ACS are described. In addition, we address the need for re-organization of ACS networks, with redistribution of hub and spoke hospitals, as well as for in-hospital reorganization of emergency rooms and cardiac units, with examples coming from multiple European countries. Furthermore, we provide a guidance to reorganization of catheterization laboratories and, importantly, measures for protection of healthcare providers involved with invasive procedures.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/eurheartj/ehaa381DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7239193PMC
May 2020

EAPCI Position Statement on Invasive Management of Acute Coronary Syndromes during the COVID-19 pandemic.

EuroIntervention 2020 Jun;16(3):233-246

Interventional Cardiology Unit, IRCCS San Raffaele Hospital, Milan, Italy.

The coronavirus disease 2019 (COVID-19) pandemic poses an unprecedented challenge to healthcare worldwide. The infection can be life threatening and require intensive care treatment. The transmission of the disease poses a risk to both patients and healthcare workers. The number of patients requiring hospital admission and intensive care may overwhelm health systems and negatively affect standard care for patients presenting with conditions needing emergency interventions. This position statements aims to assist cardiologists in the invasive management of acute coronary syndrome (ACS) patients in the context of the COVID-19 pandemic. To that end, we assembled a panel of interventional cardiologists and acute cardiac care specialists appointed by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and from the Acute Cardiovascular Care Association (ACVC) and included the experience from the first and worst affected areas in Europe. Modified diagnostic and treatment algorithms are proposed to adapt evidence-based protocols for this unprecedented challenge. Various clinical scenarios, as well as management algorithms for patients with a diagnosed or suspected COVID-19 infection, presenting with ST- and non-ST-segment elevation ACS are described. In addition, we address the need for re-organization of ACS networks, with redistribution of hub and spoke hospitals, as well as for in-hospital reorganization of emergency rooms and cardiac units, with examples coming from multiple European countries. Furthermore, we provide a guidance to reorganization of catheterization laboratories and, importantly, measures for protection of healthcare providers involved with invasive procedures.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4244/EIJY20M05_01DOI Listing
June 2020

Eivind Berge, MD, PhD, 1964-2020: Cardiologist Who Was Fighting Stroke.

Stroke 2020 05 23;51(5):1353-1355. Epub 2020 Mar 23.

the Centre for Clinical Brain Sciences, University of Edinburgh, United Kingdom (P.S.).

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1161/STROKEAHA.120.029351DOI Listing
May 2020

Double-Stranded DNA and NETs Components in Relation to Clinical Outcome After ST-Elevation Myocardial Infarction.

Sci Rep 2020 03 19;10(1):5007. Epub 2020 Mar 19.

Center for Clinical Heart Research, Oslo University Hospital Ullevål, PB 4956 Nydalen, 0424, Oslo, Norway.

Neutrophil extracellular traps (NETs) have been implicated in atherothrombosis; however, their potential role as markers of risk is unclear. We investigated whether circulating NETs-related components associated with clinical outcome and hypercoagulability in ST-elevation myocardial infarction (STEMI). In this observational cohort study, STEMI patients admitted for PCI (n = 956) were followed for median 4.6 years, recording 190 events (reinfarction, unscheduled revascularization, stroke, heart failure hospitalization, or death). Serum drawn median 18 hours post-PCI was used to quantify double-stranded DNA (dsDNA) and the more specific NETs markers myeloperoxidase-DNA and citrullinated histone 3. Levels of the NETs markers did not differ significantly between groups with/without a primary composite endpoint. However, patients who died (n = 76) had higher dsDNA compared to survivors (p < 0.001). Above-median dsDNA was associated with an increased number of deaths (54 vs. 22, p < 0.001). dsDNA in the upper quartiles (Q) was associated with increased mortality (Q3 vs. Q1 + 2 adjusted HR: 1.89 [95% CI 1.03 to 3.49], p = 0.041 and Q4 vs. Q1 + 2 adjusted HR: 2.28 [95% CI 1.19 to 4.36], p = 0.013). dsDNA was weakly correlated with D-dimer (r = 0.17, p < 0.001). dsDNA levels associated with increased all-cause mortality, yet weakly with hypercoagulability in STEMI patients. The prognostic significance of potentially NETs-related markers requires further exploration.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1038/s41598-020-61971-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7081350PMC
March 2020

Pharmacy-dispensed drugs for secondary prevention after myocardial infarction.

Tidsskr Nor Laegeforen 2020 Mar 9;140(4). Epub 2020 Mar 9.

Background: Secondary prophylactic drugs are important for avoiding further cardiovascular events after myocardial infarction. We have examined whether patients collect these drugs from pharmacies and whether there are differences in survival between those who collect versus do not collect the drugs.

Material And Method: All patients <80 years registered in the Norwegian Myocardial Infarction Registry in 2013-16 were included in the study. The Norwegian Prescription Database was used to determine whether patients collected their prescriptions from pharmacies.

Results: During the study period, 32 328 patients under the age of 80 were registered in the Norwegian Myocardial Infarction Registry, of whom 96 % were discharged alive. The proportion of patients who were prescribed acetylsalicylic acid was 95 %, two antiplatelet agents, 83 %; a statin, 90 %; beta-blockers, 76 %; and ACE inhibitors/AII receptor blockers, 55 %. The proportions of patients who collected each of these drugs from a pharmacy within six months were 94 %, 90 %, 96 %, 95 % and 94 %, respectively. The combined incidence of death, stroke and myocardial infarction during the follow-up period (median 944 days) was higher among patients who did not collect all of their prescribed drugs (adjusted HR 1.7; 95 % CI 1.6-1.8). Among patients who died, the median time to death was 509 days for those who collected all of their prescribed drugs versus 126 days for those who did not (p <0.001).

Interpretation: Most patients do collect prescribed drugs from a pharmacy after myocardial infarction. A shorter time to death among patients who do not collect the drugs may suggest a high degree of general morbidity in this group.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.4045/tidsskr.19.0416DOI Listing
March 2020

Incidence, risk factors and outcome of young patients with myocardial infarction.

Heart 2020 Sep 28;106(18):1420-1426. Epub 2020 Feb 28.

Department of Cardiology, Oslo University Hospital Ulleval, Oslo, Norway.

Objective: The decline in the incidence and mortality of acute myocardial infarction (AMI) has been less among younger compared with older individuals. The aim of this nationwide study was to assess the current incidence, risk factors and outcome of AMI in patients <45 years of age.

Methods: All patients ≤80 years of age registered in the Norwegian Myocardial Infarction Register in 2013-2016 were included in this observational, nationwide cohort study. Follow-up was conducted through linkage with the Norwegian Patient Registry through 2017.

Results: Among a total of 33 439 patients ≤80 years with AMI, 1468 (4.4%) were <45 years old. The incidence of AMI was 2.1 per 100 000 person-years in people aged 20-29 years, 16.9 in people aged 30-39 years and 97.6 in people aged 40-49 years. Compared with older patients, patients <45 years were more likely to be male (81%), current smokers (56%), obese (30%) and have a family history of premature AMI (44%), and their low-density lipoprotein-cholesterol levels were higher. Patients <45 years were more likely to have non-obstructive coronary artery disease (14% vs 10%, p<0.001) compared with older patients. During a median follow-up time of 2.4 years, 135 (9%) patients <45 years experienced a new AMI, stroke or death, and 58 (4%) patients died.

Conclusions: The rate of AMI was low in people <45 years old in Norway, but almost one in ten patients with AMI <45 years old died or experienced a new cardiovascular event during follow-up. Increased efforts to improve risk factor control in these patients are warranted.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/heartjnl-2019-316067DOI Listing
September 2020

Antithrombotic therapy in patients with acute coronary syndrome complicated by cardiogenic shock or out-of-hospital cardiac arrest: a joint position paper from the European Society of Cardiology (ESC) Working Group on Thrombosis, in association with the Acute Cardiovascular Care Association (ACCA) and European Association of Percutaneous Cardiovascular Interventions (EAPCI).

Eur Heart J Cardiovasc Pharmacother 2021 Mar;7(2):125-140

Department of Pharmacology, Catholic University School of Medicine, Rome, Italy.

Timely and effective antithrombotic therapy is critical to improving outcome, including survival, in patients with acute coronary syndrome (ACS). Achieving effective platelet inhibition and anticoagulation, with minimal risk, is particularly important in high-risk ACS patients, especially those with cardiogenic shock (CS) or those successfully resuscitated following out-of-hospital cardiac arrest (OHCA), who have a 30-50% risk of death or a recurrent ischaemic event over the subsequent 30 days. There are unique challenges to achieving effective and safe antithrombotic treatment in this cohort of patients that are not encountered in most other ACS patients. This position paper focuses on patients presenting with CS or immediately post-OHCA, of presumed ischaemic aetiology, and examines issues related to thrombosis and bleeding risk. Both the physical and pharmacological impacts of CS, namely impaired drug absorption, metabolism, altered distribution and/or excretion, associated multiorgan failure, co-morbidities and co-administered treatments such as opiates, targeted temperature management, renal replacement therapy and circulatory or left ventricular assist devices, can have major impact on the effectiveness and safety of antithrombotic drugs. Careful attention to the choice of antithrombotic agent(s), route of administration, drug-drug interactions, therapeutic drug monitoring and factors that affect drug efficacy and safety, may reduce the risk of sub- or supra-therapeutic dosing and associated adverse events. This paper provides expert opinion, based on best available evidence, and consensus statements on optimising antithrombotic therapy in these very high-risk patients, in whom minimising the risk of thrombosis and bleeding is critical to improving outcome.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/ehjcvp/pvaa009DOI Listing
March 2021

Atrial fibrillation in acute heart failure: A position statement from the Acute Cardiovascular Care Association and European Heart Rhythm Association of the European Society of Cardiology.

Eur Heart J Acute Cardiovasc Care 2020 06 24;9(4):348-357. Epub 2020 Jan 24.

Liverpool Centre for Cardiovascular Science, University of Liverpool, UK.

Atrial fibrillation and acute heart failure frequently co-exist and can exacerbate each other. Their combination leads to increased morbidity and mortality. However, the prevalence and significance, as well as the treatment, of atrial fibrillation in acute heart failure are not well studied. Management of atrial fibrillation in acute heart failure requires a multidisciplinary team approach. Treatment of underlying disease(s), identification and treatment of potentially correctable causes and precipitating factors and anticoagulation are crucial. In this article, current evidence on atrial fibrillation in the setting of acute heart failure is summarised. The recommendations on management of atrial fibrillation in the prehospital stage, the treatment of reversible causes, when and how to use rate or rhythm control, maintenance of sinus rhythm, catheter ablation and pacing, anticoagulation, as well as measures on prevention of atrial fibrillation are provided.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/2048872619894255DOI Listing
June 2020

Diagnosis and risk stratification of chest pain patients in the emergency department: focus on acute coronary syndromes. A position paper of the Acute Cardiovascular Care Association.

Eur Heart J Acute Cardiovasc Care 2020 Feb 20;9(1):76-89. Epub 2020 Jan 20.

Department of Cardiology, Antwerp University Hospital Belgium.

This paper provides an update on the European Society of Cardiology task force report on the management of chest pain. Its main purpose is to provide an update on the decision algorithms and diagnostic pathways to be used in the emergency department for the assessment and triage of patients with chest pain symptoms suggestive of acute coronary syndromes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/2048872619885346DOI Listing
February 2020

Effect of Alirocumab on Lipoprotein(a) and Cardiovascular Risk After Acute Coronary Syndrome.

J Am Coll Cardiol 2020 01;75(2):133-144

Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado.

Background: Lipoprotein(a) concentration is associated with cardiovascular events. Alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, lowers lipoprotein(a) and low-density lipoprotein cholesterol (LDL-C).

Objectives: A pre-specified analysis of the placebo-controlled ODYSSEY Outcomes trial in patients with recent acute coronary syndrome (ACS) determined whether alirocumab-induced changes in lipoprotein(a) and LDL-C independently predicted major adverse cardiovascular events (MACE).

Methods: One to 12 months after ACS, 18,924 patients on high-intensity statin therapy were randomized to alirocumab or placebo and followed for 2.8 years (median). Lipoprotein(a) was measured at randomization and 4 and 12 months thereafter. The primary MACE outcome was coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or hospitalization for unstable angina.

Results: Baseline lipoprotein(a) levels (median: 21.2 mg/dl; interquartile range [IQR]: 6.7 to 59.6 mg/dl) and LDL-C [corrected for cholesterol content in lipoprotein(a)] predicted MACE. Alirocumab reduced lipoprotein(a) by 5.0 mg/dl (IQR: 0 to 13.5 mg/dl), corrected LDL-C by 51.1 mg/dl (IQR: 33.7 to 67.2 mg/dl), and reduced the risk of MACE (hazard ratio [HR]: 0.85; 95% confidence interval [CI]: 0.78 to 0.93). Alirocumab-induced reductions of lipoprotein(a) and corrected LDL-C independently predicted lower risk of MACE, after adjustment for baseline concentrations of both lipoproteins and demographic and clinical characteristics. A 1-mg/dl reduction in lipoprotein(a) with alirocumab was associated with a HR of 0.994 (95% CI: 0.990 to 0.999; p = 0.0081).

Conclusions: Baseline lipoprotein(a) and corrected LDL-C levels and their reductions by alirocumab predicted the risk of MACE after recent ACS. Lipoprotein(a) lowering by alirocumab is an independent contributor to MACE reduction, which suggests that lipoprotein(a) should be an independent treatment target after ACS. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jacc.2019.10.057DOI Listing
January 2020

Comparison of dabigatran, rivaroxaban, and apixaban for effectiveness and safety in atrial fibrillation: a nationwide cohort study.

Eur Heart J Cardiovasc Pharmacother 2020 04;6(2):75-85

Institute of Clinical Medicine, University of Oslo, PO Box 1171 Blindern, 0318 Oslo, Norway.

Aims: The aim of this study was to compare the risk of stroke or systemic embolism (SE) and major bleeding in patients with atrial fibrillation (AF) using dabigatran, rivaroxaban, and apixaban in routine clinical practice.

Methods And Results: Using nationwide registries in Norway from January 2013 to December 2017, we established a cohort of 52 476 new users of non-vitamin K antagonist oral anticoagulants (NOACs) with AF. Users of individual NOACs were matched 1:1 on the propensity score to create three pairwise-matched cohorts: dabigatran vs. rivaroxaban (20 504 patients), dabigatran vs. apixaban (20 826 patients), and rivaroxaban vs. apixaban (27 398 patients). Hazard ratios (HRs) for the risk of stroke or SE and major bleeding were estimated. In the propensity-matched comparisons of the risk of stroke or SE, the HRs were 0.88 [95% confidence interval (CI) 0.76-1.02] for dabigatran vs. rivaroxaban, 0.88 (95% CI 0.75-1.02) for dabigatran vs. apixaban, and 1.00 (95% CI 0.89-1.14) for apixaban vs. rivaroxaban. For the risk of major bleeding, the HRs were 0.75 (95% CI 0.64-0.88) for dabigatran vs. rivaroxaban, 1.03 (95% CI 0.85-1.24) for dabigatran vs. apixaban, and 0.79 (95% CI 0.68-0.91) for apixaban vs. rivaroxaban.

Conclusion: In this nationwide study of patients with AF in Norway, we found no statistically significant differences in risk of stroke or SE in propensity-matched comparisons between dabigatran, rivaroxaban, and apixaban. However, dabigatran and apixaban were both associated with significantly lower risk of major bleeding compared with rivaroxaban.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/ehjcvp/pvz086DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7073510PMC
April 2020

Gastrointestinal bleeding in patients with atrial fibrillation treated with Apixaban or warfarin: Insights from the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial.

Am Heart J 2020 03 31;221:1-8. Epub 2019 Oct 31.

Duke Clinical Research Institute, Durham, NC; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC. Electronic address:

Objectives: A history of gastrointestinal bleeding (GIB) in patients with atrial fibrillation (AF) may impact decisions about anticoagulation treatment. We sought to determine whether prior GIB in patients with AF taking anticoagulants was associated with an increased risk of stroke or major hemorrhage.

Methods: We analyzed key efficacy and safety outcomes in patients with prior GIB in ARISTOTLE. Centrally adjudicated outcomes according to GIB history were analyzed using Cox proportional hazards models adjusted for randomized treatment and established risk factors.

Results: A total of 784 (4.3%) patients had prior GIB events (321 [41%] lower, 463 [59%] upper); 215 (27%) occurred <1 year before study enrollment. Patients with prior GIB were older, had more comorbidities, and higher CHADS and HAS-BLED scores than those with no GIB. Major GIB occurred more frequently in those with prior GIB (lower: aHR 1.72, 95% CI 0.86-3.42; upper: aHR 3.13, 95% CI 1.97-4.96). This association with major GIB was more pronounced in patients with GIB <1 year before randomization versus no recent GIB (recent lower: aHR 2.58, 95% CI 0.95-7.01; recent upper: aHR 5.16, 95% CI 2.66-10.0). There was no association between prior GIB and risk of stroke/systemic embolism or all-cause death. In those with prior GIB, the apixaban versus warfarin relative risks for stroke/systemic embolism, hemorrhagic stroke, death, or major bleeding were consistent with the results of the overall trial.

Conclusions: In patients with AF on oral anticoagulants, prior GIB was associated with an increased risk of subsequent major GIB but not stroke, intracranial bleeding, or all-cause mortality. For the key outcomes of stroke, hemorrhagic stroke, death, and major bleeding, we found no evidence that the treatment effect (apixaban vs. warfarin) was modified by a history of GIB.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ahj.2019.10.013DOI Listing
March 2020

Experiences of informal caregivers after cardiac surgery: a systematic integrated review of qualitative and quantitative studies.

BMJ Open 2019 11 11;9(11):e032751. Epub 2019 Nov 11.

Department of Cardiothoracic Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital Ullevaal, Oslo, Norway.

Objectives: To provide a comprehensive synthesis of informal caregivers' experiences of caring for a significant other following discharge from cardiac surgery.

Design: Systematic integrated review without meta-analysis.

Data Sources: A bibliographic search for publications indexed in six databases (Cochrane Library, CINAHL, MEDLINE, EMBASE, AMED and PsycINFO), including a scan of grey literature sources (GreyNet International, Google Scholar, Web of Science, WorldCat and the Clinical Trials Registry) was conducted in October 2018.

Eligibility Criteria For Selecting Studies: Studies were included if they described views and perspectives of informal caregivers of cardiac surgery patients (non-intervention studies (qualitative and quantitative)), and the effectiveness of interventions to evaluate support programme for informal caregivers of cardiac surgery patients (intervention studies).

Results: Of the 4912 articles identified in searches, 42 primary research studies were included in a narrative synthesis with 5292 participants, including 3231 (62%) caregivers of whom 2557 (79%) were women. The median sample size across studies was 96 (range 6-734). Three major themes emerged from the qualitative study data: (1) caregiver information needs; (2) caregiver work challenges and (3) caregivers adaption to recovery. Across the observational studies (n=22), similar themes were found. The trend across seven intervention studies focused on caregiver information needs related to patient disease management and symptom monitoring, and support for caregivers to reduce symptoms of emotional distress.

Conclusion: Informal caregivers want to assist in the care of their significant others after hospital discharge postcardiac surgery. However, caregivers feel insecure and overwhelmed and they lack clear/concise discharge information and follow-up support during the early at-home recovery period. The burden of caregiving has been recognised and reported since the early 1990s, but there remains a limited number of studies that assesses the effectiveness of caregiver interventions.

Prospero Registration Number: CRD42018096590.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmjopen-2019-032751DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6858143PMC
November 2019

International variation in characteristics and clinical outcomes of patients with type 2 diabetes and heart failure: Insights from TECOS.

Am Heart J 2019 12 28;218:57-65. Epub 2019 Aug 28.

Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. Electronic address:

International differences in management/outcomes among patients with type 2 diabetes and heart failure (HF) are not well characterized. We sought to evaluate geographic variation in treatment and outcomes among these patients. METHODS AND RESULTS: Among 14,671 participants in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), those with HF at baseline and a documented ejection fraction (EF) (N = 1591; 10.8%) were categorized by enrollment region (North America, Latin America, Western Europe, Eastern Europe, and Asia Pacific). Cox models were used to examine the association between geographic region and the primary outcome of all-cause mortality (ACM) or hospitalization for HF (hHF) in addition to ACM alone. Analyses were stratified by those with EF <40% or EF ≥40%. The majority of participants with HF were enrolled in Eastern Europe (53%). Overall, 1,267 (79.6%) had EF ≥40%. β-Blocker (83%) and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (86%) use was high across all regions in patients with EF <40%. During a median follow-up of 2.9 years, Eastern European participants had lower rates of ACM/hHF compared with North Americans (adjusted hazard ratio: 0.45; 95% CI: 0.32-0.64). These differences were seen only in the EF ≥40% subgroup and not the EF <40% subgroup. ACM was similar among Eastern European and North American participants (adjusted hazard ratio: 0.79; 95% CI: 0.44-1.45). CONCLUSIONS: Significant variation exists in the clinical features and outcomes of HF patients across regions in TECOS. Patients from Eastern Europe had lower risk-adjusted ACM/hHF than those in North America, driven by those with EF ≥40%. These data may inform the design of future international trials.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ahj.2019.08.016DOI Listing
December 2019