Applicability of the VOYAGER trial criteria: a cohort study on patients in the nationwide Danish Vascular Registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Soegaard ◽  
P.B Nielsen ◽  
F Skjoeth ◽  
T.B Larsen ◽  
N Eldrup
Keyword(s):  
Myocardial Infarction ◽  
Lower Extremity ◽  
Major Adverse Cardiovascular Events ◽  
Funding Source ◽  
Inclusion Criteria ◽  
Private Company ◽  
Exclusion Criteria ◽  
Dual Pathway ◽  
Event Rates ◽  
Lower Extremity Revascularization

Abstract Introduction Peripheral artery disease (PAD) carries a high risk of debilitating stroke, myocardial infarction, and death. The VOYAGER PAD trial investigates whether rivaroxaban 2.5 mg plus aspirin vs aspirin alone leads to a reduction in major adverse cardiovascular events (MACE) in patients with symptomatic PAD undergoing revascularization. However, it is unclear whether patients enrolled in VOYAGER PAD reflect those undergoing lower extremity revascularization in daily clinical practice. Purpose To describe the proportion of patients eligible for the VOYAGER PAD trial within the nationwide Danish Vascular Registry (DVR), the reasons for ineligibility, and rates of cardiovascular outcomes in VOYAGER-eligible and VOYAGER-ineligible patients. Methods We identified and characterized all patients from 2000–2016 undergoing open surgical or endovascular revascularization for symptomatic PAD in the DVR and applied the VOYAGER inclusion and exclusion criteria. We computed one-year rates per 100 person-years of VOYAGER PAD trial endpoints of MACE, myocardial infarction, ischemic stroke, major amputation, major bleeding, cardiovascular (CV) death, and all cause death. Results In the DVR, 32,911 patients underwent lower extremity revascularization for symptomatic PAD and were evaluated for eligibility. Among these, 32.2% had at least one exclusion criteria and an additional 40.6% without exclusion criteria did not fulfil inclusion criteria. The “VOYAGER-eligible” population therefore comprised 27.2% of the identified patients (Figure 1A). Main reasons for exclusion were atrial fibrillation (30.7%), poorly regulated hypertension (19.6%), PCI or ACS within 12 months before (16.0%), treatment with strong inhibitors or inducers of cytochrome P450 (9.2%), active cancer (8.8%), and severe renal failure (8.3%). Main reasons for non-inclusion were aorto-iliac procedures (79.0%), non-successful revascularization (13.1%), and age<50 years (7.1%). Compared with “VOYAGER-eligible” patients, event rates were slightly lower among patients in the DVR not fulfilling inclusion criteria and markedly higher for “VOYAGER excluded” patients (Figure 1B). Conclusion In this nationwide cohort of symptomatic PAD patients undergoing lower extremity revascularization, 27.2% full filled the inclusion and exclusion criteria for dual pathway therapy in the VOYAGER PAD trial. Non-inclusion predominantly related to aorto-iliac procedures and were associated with lower event rates. Future studies are needed to clarify if these patients could also benefit from dual pathway therapy. Figure 1 Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Bayer AG, Berlin, Germany

Prognosis in patients with prior myocardial infarction and PEGASUS-TIMI 54 criteria in the CLARIFY registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S Biscaglia ◽  
G Campo ◽  
K Fox ◽  
J.C Tardif ◽  
M Tendera ◽  
...  
Keyword(s):  
High Risk ◽  
Major Bleeding ◽  
Artery Bypass ◽  
Real Life ◽  
Prolonged Treatment ◽  
Funding Source ◽  
Inclusion Criteria ◽  
Private Company ◽  
Exclusion Criteria ◽  
Coronary Syndrome

Abstract Background/Introduction The PEGASUS-TIMI 54 trial showed that prolonged treatment with ticagrelor reduces the cumulative occurrence of ischemic adverse events. CLARIFY is the biggest real life registry on chronic coronary syndrome. Purpose - To evaluate the percentage of patients eligible for long-term ticagrelor therapy in the CLARIFY registry. – To compare the outcome of this subgroup of patients with those with PEGASUS exclusion criteria or without PEGASUS inclusion criteria. Methods Within the CLARIFY population, we selected post MI patients and we excluded those with missing info (post MI evaluable population). Then, we divided patients into 3 groups: excluded (meeting PEGASUS exclusion criteria, namely use of P2Y12 receptor antagonists or chronic oral anticoagulant, any stroke, coronary-artery bypass grafting in the past 5 years); eligible (meeting PEGASUS high-risk inclusion criteria, namely age≥65 years; diabetes; multivessel disease; creatinine clearance <60 ml/min) and ineligible (not meeting PEGASUS high-risk inclusion criteria). We therefore compared the ischemic (CV death, MI and stroke) and bleeding (major bleeding) outcome of the 3 groups adjusting for age, sex, smoking and geographical region. Results Among the 11811 post-MI evaluable patients, 4706 (39.8%) were included in the eligible group, 5715 (48.4%) in the excluded group, and 1390 in the ineligible group (11.8%). Both the ischemic and bleeding endpoints were significantly different among the 3 groups with the excluded patients with the worst and ineligible patients with the best outcome (see table). The same trend was shown for CV death, while the occurrence of MI was not significantly different among the 3 groups. In the eligible group, the ratio between ischemic and bleeding events was 6:1, whereas between CV death and major bleeding was 3.5:1. Conclusions Around 40% of CLARIFY post-MI patients could benefit from prolonged ticagrelor therapy. In this group of patients, ischemic risk seems to be higher than the bleeding one. Ischemic & bleeding risk in the 3 groups Funding Acknowledgement Type of funding source: Private company. Main funding source(s): CLARIFY registry was funded by Servier

scholarly journals Outcomes associated with modern treatment paradigms in connective tissue disease (CTD)-associated pulmonary arterial hypertension (PAH): a meta-analysis of randomized controlled trials (RCTs)

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V McLaughlin ◽  
C Zhao ◽  
J.G Coghlan ◽  
L.S Chung ◽  
S.C Mathai ◽  
...  
Keyword(s):  
Drug Treatment ◽  
Treatment Effect ◽  
Meta Analysis ◽  
Response To Treatment ◽  
Funding Source ◽  
Class Iii ◽  
Inclusion Criteria ◽  
Private Company ◽  
Mortality Event

Abstract Background CTD-PAH has historically represented a PAH subtype with poor prognosis. New therapies, as well as combination therapy approaches targeting multiple pathways have been approved for PAH based on RCTs. CTD-PAH patients comprise a subgroup of the RCT populations and efficacy analyses are based on subgroup analyses which can be less reliable than the overall analysis. We conducted a meta-analysis of RCTs of approved PAH therapies to evaluate outcomes of patients with CTD-PAH. Purpose To use meta-analysis to determine response to treatment in patients with CTD-PAH. Methods The PubMed and EMBASE databases were searched for English-only articles published between January 1, 2000 and November 25, 2019. Inclusion criteria were multicenter RCTs that enrolled adults with WHO group 1 pulmonary hypertension (PAH); enrollment in 2000 or later; long-term clinical morbidity and/or mortality event or 6-minute walk distance (6MWD) as an efficacy endpoint reported for ≥30 patients with CTD-PAH; and evaluation of a US Food and Drug Administration-approved PAH therapy. The primary outcomes were treatment effect as measured by the study time to first morbidity or morality event and change in 6MWD from baseline to between 3–6 months, per the data provided in each article. Results from individual studies were combined using a random-effects model for overall study population (PAH patients) and the subgroup of CTD-PAH patients. Results Ten RCTs (N=4329 PAH patients; n=1263 (29%) with CTD-PAH) met inclusion criteria and were included in the meta-analysis. At baseline, PAH patients had a mean age of 50 years, approximately 78% were female, and approximately 58% had functional class III or IV disease. These characteristics were balanced between treatment and control groups. Baseline 6MWD was 356 m for the overall population and 337 m for patients with CTD-PAH. Five RCTs (N=3172; n=941 with CTD-PAH [30%]) reported hazard ratios (HRs) for time to a morbidity or mortality event by drug treatment and PAH etiology: overall population HR=0.63 (95% confidence interval [CI], 0.56–0.72; P<0.001); CTD-PAH population HR=0.64 (95% CI, 0.51–0.80; P<0.001) (Figure). Nine RCTs reported mean change with drug treatment from baseline to 3 to 6 months in 6MWD for PAH and CTD patients: 33.9 m (95% CI, 21.9–45.9; P<0.001) in the overall population; 20.2 m (95% CI, 10.8–29.7; P<0.001) in CTD-PAH patients. Conclusions The improvement in 6MWD in patients with CTD-PAH is smaller than in those with other types of PAH, perhaps reflecting comorbidities and CTD-induced mobility constraints, independent of their cardiopulmonary capacity. Data from long term clinical morbidity/mortality endpoint studies in this large group of patients with CTD-PAH demonstrate that these patients derive significant benefit from currently available PAH therapies which, in many patients, comprised the addition of a drug targeting a second or third pathway involved in the pathophysiology of PAH. Treatment effect on morbidity/mortality Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Actelion Pharmaceuticals US, Inc.

Baseline characteristics and follow-up outcomes in routine clinical practice patients categorised by renal function in the ETNA-AF-Europe registry

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R De Caterina ◽  
M Gwechenberger ◽  
A Bakhai ◽  
P Monteiro ◽  
P Kelly ◽  
...  
Keyword(s):  
Renal Function ◽  
Total Mortality ◽  
Haemorrhagic Stroke ◽  
Risk Scores ◽  
Funding Source ◽  
Private Company ◽  
Group I ◽  
Baseline Characteristics ◽  
Event Rates

Abstract Background Edoxaban is an oral factor Xa inhibitor anticoagulant with 50% renal clearance, and proven efficacy and safety in patients (pts) with atrial fibrillation (AF). The post-authorisation, observational, ETNA-AF-Europe registry (NCT02944019) assessed the risks and benefits of edoxaban in pts with AF from 10 European countries. Purpose Evaluate baseline characteristics and event rates in pts categorised by creatinine clearance (CrCl) at 1-year follow-up of the ETNA-AF-Europe registry. Methods In this analysis, pts were divided into three groups according to CrCl: ≤50 ml/min (I), 50–80 mL/min (II) and ≥80 mL/min (III) (calculated using Cockcroft-Gault). Outcomes were descriptively analysed. Results Pts with the lowest CrCl (Group I) were mostly females, and had a higher mean age, lower body weight, higher stroke and bleeding risk scores and were considered more frail than those with higher CrCl (Groups II and III) (Table). Group I experienced higher rates of stroke or SEE, major or CRNM bleeding, cardiovascular death, and had a higher total mortality (Figure). Rates of intracranial haemorrhage (ICH) and haemorrhagic stroke (intracerebral and subarachnoid haemorrhage) were low and similar in pts across the range of CrCl. Conclusions Those with lower CrCl had more comorbidities and higher event rates than those with higher CrCl, with the exception of ICH and haemorrhagic stroke. A steep rise in the proportion of pts perceived as frail and in overall mortality in the lowest renal function tertile, raises the question whether low renal function is a determinant or a correlate of mortality. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Daiichi Sankyo Europe GmbH, Munich, Germany

Effect of vorapaxar on cardiovascular and limb outcomes in patients with peripheral artery disease with and without coronary artery disease: Analysis from the TRA 2°P-TIMI 50 trial

2020 ◽  
Vol 25 (2) ◽  
pp. 124-132 ◽  
Author(s):  
Arman Qamar ◽  
David A Morrow ◽  
Mark A Creager ◽  
Benjamin M Scirica ◽  
Jeffrey W Olin ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Lower Extremity ◽  
Peripheral Artery Disease ◽  
Absolute Risk ◽  
Major Adverse Cardiovascular Events ◽  
Number Needed To Treat ◽  
Peripheral Artery ◽  
Artery Disease ◽  
Lower Extremity Revascularization

Intensive antithrombotic therapy reduces major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in patients with peripheral artery disease (PAD). Recent studies have suggested heterogeneity in risk and benefit in those with and without concomitant coronary artery disease (CAD) and peripheral revascularization. We evaluated the risk of MACE and MALE in patients with PAD stratified by history of concomitant CAD and prior peripheral revascularization and whether the efficacy and safety of vorapaxar were similar in these subgroups. The TRA 2°P-TIMI 50 trial randomized 26,449 patients with prior MI, ischemic stroke, or PAD to vorapaxar or placebo. This analysis examined the effect of vorapaxar in a broad population of 6136 patients with PAD. Overall, vorapaxar significantly reduced MACE (HR 0.85, 95% CI 0.73, 0.99; p = 0.034) and MALE (HR 0.70, 95% CI 0.53, 0.92; p = 0.011) in patients with PAD. The absolute risk reduction (ARR) for MACE was greater in patients with PAD and CAD versus those with PAD alone (–2.2% vs 0.1%: number needed to treat (NNT) 45 vs 1000). Conversely, the ARR for MALE was higher in those with prior lower extremity revascularization (2.5% vs 0.2%: NNT 40 vs 500). Vorapaxar increased major bleeding (HR 1.39, 95% CI 1.12, 1.71; p = 0.003). The net clinical outcome in all patients with PAD was reduced with vorapaxar (HR 0.82, 95% CI 0.72, 0.94; p = 0.004), with benefits driven by reductions in MACE for those with CAD and by reductions in MALE for those with prior peripheral revascularization. Among patients with PAD, vorapaxar resulted in a net clinical benefit; however, the drivers of benefit were heterogeneous, with greater reductions in MACE in those with concomitant CAD and greater reductions in MALE in those with prior lower extremity revascularization, and unclear benefit in patients with neither. These clinical characteristics may be useful in identifying the subgroups of patients with PAD most likely to benefit from potent antithrombotic therapies. ClinicalTrials.gov Identifier: NCT00526474

Abstract 511: Adverse Outcomes in Patients with Diabetes Mellitus Following Stenting for Lower Extremity Peripheral Arterial Disease

2016 ◽  
Vol 36 (suppl_1) ◽  
Author(s):  
Sarah Kiani ◽  
Usman Salahuddin ◽  
Haekyung Jeon Slaughter ◽  
Atif Mohammad ◽  
Emmanouil S Brilakis ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Myocardial Infarction ◽  
Lower Extremity ◽  
Adverse Outcomes ◽  
Endovascular Intervention ◽  
Major Adverse Cardiovascular Events ◽  
Event Analysis ◽  
Patients With Diabetes ◽  
Baseline Characteristics ◽  
Artery Disease

Introduction: There is limited data on outcomes of percutaneous endovascular intervention for lower extremity peripheral artery disease (PAD) in patients with diabetes mellitus (DM). We assessed the hypothesis that patients with DM, in comparison to patients without DM, have higher rates of major adverse cardiovascular and limb events after lower extremity PAD stenting. Methods: 1,006 patients with primary stent implant procedures between January 2005 and October 2015 enrolled in the observational XLPAD registry (NCT01904851) were analyzed for 12 month major adverse cardiovascular events (MACE; all-cause death, myocardial infarction, and stroke) and major adverse limb events (MALE; target limb repeated endovascular intervention, surgical revascularization, and major amputation). Cochran-Mantel-Haenszel statistics was used for overall association of categorical baseline characteristics; Cox proportional regressions and Kaplan-Meier curves were used for median time to event analysis. Results: At baseline, patients with DM had higher prevalence of coronary artery disease (74.9% vs. 56.2%; p<0.0001), heart failure (22.9% vs. 10.9%; p<0.001), prior myocardial infarction (27.3% vs. 22.5%; p=0.0076) and prior stroke (10.3% vs. 5.8%; p<0.0001) in comparison to patients without DM. Cox proportional regressions after adjusting for baseline characteristics showed significantly higher MACE (8.5% vs. 4.0%; Hazard ratio (HR) 1.99; 95% CI 1.26-3.50; p=0.003, Figure 1A ) as well as MALE (49.0% vs. 40.9%; HR 1.22; 95% CI 1.01-1.48; p=0.043, Figure 1B ) in patients with DM at 12-months. Conclusion: PAD in patients with DM is associated with significantly higher rates of major adverse cardiovascular and limb events.

scholarly journals Trends of sex differences in outcomes of cardiac electronic device implantations in the United States

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Mohamed ◽  
A.S Volgman ◽  
T Contractor ◽  
P.S Sharma ◽  
C.S Kwok ◽  
...  
Keyword(s):  
De Novo ◽  
Electronic Device ◽  
The United States ◽  
Major Adverse Cardiovascular Events ◽  
Cardiac Complications ◽  
Funding Source ◽  
Private Company ◽  
All Cause Mortality ◽  
National Cohort ◽  
Procedural Outcomes

Abstract Background There is limited evidence on the differences in procedural outcomes between sexes after de novo cardiac implantable electronic device implantation (CIED). Furthermore, it is unclear whether any sex-based disparities have changed over the years. Purpose To compare procedural outcomes of de novo CIED implantation between sexes and study the trends of these outcomes over a 11-year period in a nationally representative sample. Methods Using the National Inpatient Sample, all hospitalisations between 2004 and 2014 for de novo CIED implantation were included, stratified by sex. Multivariable logistic regression was performed to 1) examine the association between sex and in-hospital complications of CIED implantation, expressed as odds ratios (OR) with 95% confidence intervals (CI), and 2) analyse trends of in-hospital outcomes by assessing the interaction term between time (years) and sex as covariates. Results Out of 2,815,613 hospitalisations for de novo CIED implantation, 41.9% were performed on women. Women were associated with increased adjusted odds of major adverse cardiovascular events (composite of mortality, thoracic and cardiac complications; OR 1.17 95% CI 1.16, 1.19), procedure-related bleeding (OR 1.13 95% CI 1.12, 1.15), and local complications (thoracic: OR 1.42 95% CI 1.40, 1.44, cardiac: OR 1.44 95% CI 1.38, 1.50). (p&lt;0.001 for all) Notably, there was no difference in odds of all-cause mortality between sexes (OR women: 0.96 95% CI 0.94, 1.00). The odds of adverse complications in the overall CIED cohort were persistently raised in women throughout the study period, whereas similar odds of all-cause mortality across the sexes were observed throughout the study period (see Figure). Conclusion In a national cohort of CIED implantations we demonstrate that women are at a persistently higher risk of procedure-related adverse events other than mortality compared to men. This trend is concerning and warrants further work on procedural techniques to neutralise these sex disparities. Trends of odds of complications in women Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This work constitutes part of a PhD for MOM that is supported by Medtronic Ltd. Medtronic Ltd. was not involved in the conceptualization, design, conduct, analysis, or interpretation of the current study.

scholarly journals Myocardial infarction coincides with increased expression of NO2X2 and the advanced glycation end product N-e-(carboxymethyl) lysine in the microvasculature of the brain

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Korn ◽  
U Baylan ◽  
C.G Schalkwijk ◽  
H.W.M Niessen ◽  
P.A.J Krijnen
Keyword(s):  
Mental Health ◽  
Myocardial Infarction ◽  
Mental Health Disorders ◽  
Inflammatory Factors ◽  
Funding Source ◽  
Phase 2 ◽  
Private Company ◽  
Phase 3 ◽  
Health Disorders ◽  
The Brain

Abstract Background Acute Myocardial Infarction (AMI) is associated with mental health disorders such as cognitive impairment and depression. Neuroinflammation and cerebral microvascular dysfunction may play an important role herein. We previously showed an increased presence of the pro-inflammatory factors N-ε-Carboxymethyllysine (CML) and NADPH oxidase 2 (NOX2) in the microvasculature of the human infarcted heart and diabetic brain. In this study we have quantified the presence of CML and NOX2 in the cerebral microvasculature of patients in time after AMI. Methods Brain tissue was obtained at autopsy from 24 AMI patients and 9 control patients. According to their infarct age, the AMI patients were divided into three groups: 3–6 hours old (phase 1), 6 hours–5 days old (phase 2) and 5–14 days old (phase 3). The presence of CML and NOX2 in the microvasculature was quantified through immunohistochemical analysis. Results We observed a significant approximately 2.5 fold increase in microvascular CML in phase 2 and phase 3 AMI patients in comparison with control patients (p=0.015). NOX2 was present in significantly more microvessels in phase 2 AMI patients compared to control patients (p=0.042). However, no correlation was found between CML and NOX2 (r=0.06, p=0.74). Conclusion AMI coincides with an increased presence of CML and NOX2 in the microvasculature of the brain. These data point to pro-inflammatory alterations in the brain microvasculature that may underlie the mental health disorders associated with AMI. CML and NOX2 in the brain microvessels Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Novo Nordisk BV, European Foundation for the Study of Diabetes

scholarly journals Effect of alirocumab on incidence of atrial fibrillation after acute coronary syndromes: insights from ODYSSEY OUTCOMES

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R Lopes ◽  
P.G Steg ◽  
D.L Bhatt ◽  
V.A Bittner ◽  
A Dauchy ◽  
...  
Keyword(s):  
Heart Failure ◽  
Atrial Fibrillation ◽  
Acute Coronary Syndromes ◽  
Strong Predictor ◽  
Potential Effect ◽  
Major Adverse Cardiovascular Events ◽  
Funding Source ◽  
Private Company ◽  
History Of ◽  
Coronary Syndromes

Abstract Background Atrial fibrillation (AF) is a marker of risk in patients presenting with acute coronary syndromes (ACS). The potential effect of inhibiting proprotein convertase subtilisin/kexin type 9 (PCSK9) on the incidence of AF is unknown. Methods The ODYSSEY OUTCOMES trial compared randomized treatment with the PCSK9 inhibitor alirocumab or placebo in patients with recent ACS and residual dyslipidaemia despite optimal statin therapy. The current analysis determined: 1) whether alirocumab treatment influenced incident AF; 2) whether a history of AF influenced the risk of major adverse cardiovascular events (MACE); and 3) whether there was interaction between AF at baseline and randomized treatment on MACE. AF was determined from the medical history and investigator reports of adverse events. Results Of 18,924 participants, 662 (3.5%) had a history of AF at randomization and 18,262 (96.5%) had no history of AF. Of the latter category, 499 (2.7%) had incident AF. Older age, randomization in South America or Eastern Europe, history of heart failure or myocardial infarction, and higher body mass index were factors associated with incident AF. Treatment with alirocumab or placebo did not influence incident AF (2.2% vs 2.6%, respectively; hazard ratio 0.90, 95% confidence interval 0.75–1.08; Figure). Patients with a history of AF had a greater burden of comorbidities, including cerebrovascular disease, peripheral artery disease, hypertension and heart failure; they also had higher rates of MACE (Table). There was no significant interaction between AF and randomized treatment on risk of MACE (P interaction=0.78) Conclusions Although treatment with alirocumab did not significantly modify the risk of incident AF after ACS in this analysis, future studies with more sensitive and systematic methods of ascertainment may be warranted. History of AF is a strong predictor of risk of recurrent MACE after ACS. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Sanofi, Regeneron Pharmaceuticals, Inc

Ten years of high-sensitivity cardiac troponin testing in the Netherlands: impact on the diagnosis of myocardial infarction

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D.M Kimenai ◽  
Y Appelman ◽  
H.M Den Ruijter ◽  
N.L Mills ◽  
S.J.R Meex
Keyword(s):  
Myocardial Infarction ◽  
The Netherlands ◽  
Cardiac Troponin ◽  
High Sensitivity ◽  
Funding Source ◽  
Private Company ◽  
Absolute Change ◽  
Before And After ◽  
One Year ◽  
The Impact

Abstract Introduction High-sensitivity cardiac troponin (hs-cTn) assays have enhanced sensitivity for myocardial injury and may lead to an increase in the diagnosis of myocardial infarction. Few real-world studies have investigated the transition from conventional cardiac troponin (cTn) to hs-cTn. We evaluated the impact of implementing hs-cTn assays and sex-specific thresholds in the Netherlands on the diagnosis of myocardial infarction in women and men. Methods Twelve Dutch hospitals were included (hs-cTnI assay [sex-specific thresholds], n=4; hs-cTnT assay [uniform threshold], n=8). Data from the health insurance claims of consecutive patients with anginal symptoms were collected before (cTn period) and after (hs-cTn period) implementation from January 2008 to December 2017. The proportion of patients with a diagnosis of myocardial infarction overall, and in men and women separately, and one-year mortality was compared before and after implementation of the hs-cTn assay. Results Across twelve hospitals, a total number of 77,464 patients presenting with anginal symptoms were included (cTn period: 35,409 [36.6% women]; hs-cTn period: 42,055 [34.6% women]). Following implementation of hs-cTn testing the proportion of patients with anginal symptoms diagnosed with myocardial infarction doubled from 24% (3,111/12,970) to 48% (7,014/14,560) in women, and from 25% (5,712/22,439) to 51% (13,912/27,495) in men, with similar increases in sites implementing hs-cTnI and hs-cTnT. The proportion of patients diagnosed with myocardial infarction who were women increased in sites implementing sex-specific thresholds (from 36.4% [1,435/3,941] to 37.5% [1,700/4,532], absolute change 1.1%), but did not increase in sites using a uniform threshold (from 34.3% [1,676/4,882] to 32.4% [5,314/16,394], absolute change −1.9%). In patients with a diagnosis of myocardial infarction, one-year mortality was 15.6% (485/3,111) and 11.6% (814/7,014) in women, and was 11.8% (673/5,712) and 9.4% (1,303/13,912) in men, before and after implementation of hs-cTn. Conclusions In patients presenting with anginal symptoms, the diagnosis of acute myocardial infarction doubled after implementation of hs-cTn testing in both women and men. Use of sex-specific thresholds increased the proportion of patients with myocardial infarction who were women compared to use of a uniform threshold. Implementation was associated with a reduction in one-year mortality, but further research is needed to understand whether this is due to differences in the risk profile of patients with myocardial infarction or improvements in treatment. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This study was supported by a grant from Abbott Laboratories to S.J.R.M.

scholarly journals Recommended and non-recommended edoxaban dosing in patients with atrial fibrillation (AF): one-year clinical events from the Global ETNA-AF non-interventional study (NIS)

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T.F Chao ◽  
P Kirchhof ◽  
Y Koretsune ◽  
T Yamashita ◽  
M Unverdorben ◽  
...  
Keyword(s):  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Event ◽  
Funding Source ◽  
Private Company ◽  
Clinical Events ◽  
History Of ◽  
One Year ◽  
Event Rates

Abstract Background In AF patients on direct oral anticoagulants (DOAC), safety and effectiveness vary with dose. This might impact treatment decisions. Purpose To investigate the effects of dosing of the DOAC edoxaban in AF patients on safety and effectiveness during 1-year observation in a real-world setting. Methods The Global ETNA-AF NIS included 26,823 patients. Baseline data by edoxaban dosing (60mg/30mg) and their influences on the safety (major bleeding [MB], clinically relevant non-major bleeding [CRNMB]), and effectiveness (stroke, systemic embolism, myocardial infarction [MI], death) were investigated (Table). Results Figure shows the breakdown by dose (60mg vs 30mg) and recommended (rec) vs non-recommended (non-rec) dosing. Patients on non-rec 30mg vs on rec 60mg edoxaban were older (mean ± SD: 74±9 vs 70±9 y); had lower creatinine clearance (72.2±20.6 vs 85.8±26.8 mL/min); and had more comorbidities, history of MB (2.1% vs 1.1%), and strokes (11.0% vs 8.6%). Non-rec 60mg vs rec 30mg patients were younger (75±9 vs 78±9 y), had fewer comorbidities, history of MB (1.2% vs 2.6%), and strokes (10.2% vs 16.4%). In non-rec 30mg vs rec 60mg, MB was not lower and ischaemic events were not higher. In non-rec 60mg vs rec 30mg, no increase in MB, CRNMB or ischaemic events was seen. Conclusion Edoxaban was prescribed at the label recommended dose in the vast majority of patients. Non-rec 30mg patients were sicker than rec 60mg patients while non-rec 60mg patients were less sick than rec 30mg patients. Overall event rates were low, and ischaemic event rates of non-rec 30mg and bleeding event rates of non-rec 60mg were not numerically higher than that of corresponding rec dosing groups. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Daiichi Sankyo

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