Baseline triglycerides and non-HDL-C and apoB goal attainment in the ORION-10 and ORION-11 trials

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.K Ray ◽  
D Kallend ◽  
F.J Raal ◽  
R Stoekenbroek ◽  
W Koenig ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Goal Attainment ◽  
Therapeutic Option ◽  
Funding Source ◽  
Private Company ◽  
Atherogenic Dyslipidaemia ◽  
Secondary Endpoints ◽  
Cv Disease ◽  
Total Burden ◽  
The Impact

Abstract Introduction Elevated triglyceride (TG) levels contribute to the total burden of circulating atherogenic lipoprotein levels and are associated with increased cardiovascular (CV) risk. LDL-C underestimates risk in patients with elevated TG. Therefore, 2019 ESC/EAS guidelines recommend apoB or non-HDL-C as secondary lipid goals for patients with TG >150mg/dL. Purpose To assess the impact of inclisiran on apoB and non-HDL-C goal attainment across a range of TG levels among patients with atherosclerotic CV disease (ASCVD). Methods The ORION-10 and ORION-11 trials included 3178 patients with ASCVD and LDL-C >70mg/dl despite maximally tolerated statins randomized to inclisiran or placebo (1:1). Pre-specified secondary endpoints were placebo-corrected changes in lipids at Day 510. For this analysis patients were stratified by TG quartiles at baseline within each trial. The proportion of individuals attaining apoB <55 mg/dL or non-HDL-C <70mg/dl within each trial were assessed across TG strata and the likelihood of goal attainment within TG strata assessed using logistic regression. Results In ORION-10, TG quartiles were ≤94, 94 to ≤128, 128 to ≤181 and >181mg/dl respectively and in ORION-11 corresponding values were ≤101, 101 to ≤135, 135 to ≤183 and >183mg/dl. As compared to placebo a significantly greater proportion of patients randomised to inclisiran attained apoB goals within each TG strata (Table). Similar results were observed for non-HDL-C. Conclusion Among patients with ASCVD on maximally tolerated statin and high TG levels, attainment of apoB and non-HDL-C secondary lipid targets was more likely with inclisiran than placebo. Inclisiran may be a useful therapeutic option for patients with atherogenic dyslipidaemia. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): The Medicines Company

scholarly journals Pooled safety and efficacy of inclisiran in patients with statin intolerance (ORION-10 and ORION-11)

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R.S Wright ◽  
D Kallend ◽  
F.J Raal ◽  
R Stoekenbroek ◽  
W Koenig ◽  
...  
Keyword(s):  
Statin Therapy ◽  
Therapeutic Option ◽  
Lipid Lowering ◽  
Funding Source ◽  
Lipid Lowering Therapy ◽  
Statin Intolerance ◽  
Private Company ◽  
Phase 3 ◽  
Absolute Reduction ◽  
Secondary Endpoints

Abstract Introduction Statin-associated side effects prevent a substantial proportion of patients from being adequately treated with statin therapy and achieving adequate LDL-C reductions. Phase 3 trials showed that inclisiran, a new siRNA, durably lowers LDL-C by ≥50% on top of maximally tolerated statin therapy. Purpose To evaluate inclisiran's tolerability and LDL-C lowering effects among individuals who were not receiving statin therapy mainly because of statin intolerance. Methods The Phase 3 ORION-10 and ORION-11 trials randomized patients with established ASCVD (or risk-equivalents) with LDL-C >70 mg/dl despite maximally tolerated statins to inclisiran or placebo (1:1). Inclisiran sodium 300 mg was administered s.c. at baseline, three months later, then every six months. The primary efficacy endpoints were % change in LDL-C from baseline to Day 510 and time adjusted % change in LDL-C from baseline after Day 90 and up to Day 540. Absolute LDL-C reductions were secondary endpoints. This analysis included individuals who were not on statin therapy at baseline. Results The trials included 252 (7.9% of the pooled trial populations; mean age 68; male 62%; lipid-lowering therapy 28%). AE rates and LDL-C reductions are shown in the Table. Overall, 12 (4.7%) patients had myalgia (4.8% in the inclisiran groups, 4.7% in the placebo groups). There were 8 discontinuations in the inclisiran groups (6.5%) and 3 in the placebo groups (2.3%). The placebo-adjusted mean reduction in LDL-C at Day 510 was 45.8%, an absolute reduction of 68.0 mg/dL (p<0.0001). Conclusion Among statin intolerant individuals in ORION-10 and 11, inclisiran potently and durably lowered LDL-C with an adverse event profile comparable to placebo. Inclisiran may represent a new and potent therapeutic option for patients with elevated LDL-C unable to tolerate statins. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): The Medicines Company

Does Evolocumab use in Europe match 2019 ESC/EAS lipid guidelines? Results from the HEYMANS study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.K Ray ◽  
E Bruckert ◽  
B Van Hout ◽  
M Feudjo Tepie ◽  
I Bridges ◽  
...  
Keyword(s):  
Goal Attainment ◽  
Moderate Intensity ◽  
Funding Source ◽  
Pcsk9 Inhibitors ◽  
Statin Intolerance ◽  
Private Company ◽  
Statin Monotherapy ◽  
Lipid Guidelines ◽  
Cv Disease

Abstract Background 2019 ESC/EAS dyslipidaemia guidelines recommend a 50% lowering in untreated LDL-C and use of PCSK9 inhibitors (PCSK9i) for patients at very-high cardiovascular (CV) risk when LDL-C target goals of <1.4 mmol/L or <1.0 mmol/L (for those with 2 CV events within two-years) are not met despite maximally tolerated statins and ezetimibe. Purpose This observational study describes a cohort of patients initiating evolocumab across 10 EU countries. Methods Patients are followed from evolocumab initiation (baseline). Demographic/clinical characteristics, lipid modifying therapy (LLT) and lipid values were collected from medical records (6 months prior to evolocumab initiation through 30 months post initiation). We report interim data from patients initiating evolocumab from August 2015 with follow-up through October 2019. Results 1896 patients initiated on evolocumab as per local reimbursement criteria were included in this interim analysis (planned sample size: N=2,000). Most (1663 [88%]) had 12 months follow-up, 665 (35%) had 18 months follow-up; mean follow-up, 16.3 months. Mean (SD) age was 60.0 (10.8) years; 85% of patients had a history of CV disease (CVD), 44% had a diagnosis of familial hypercholesterolemia (FH), 19% had type 2 diabetes, 66% were hypertensive, 7% had renal impairment and half (51%) were prior or current smokers. The majority (60%) reported statin intolerance and 42% were not receiving any LLT at evolocumab initiation. Fewer than half (805 [43%]) were receiving a statin (±ezetimibe) at evolocumab initiation; of these, most were on a high/moderate intensity (68%/22%). 12% of patients were receiving statin monotherapy. Median (Q1, Q3) baseline LDL-C was 3.98 (3.16, 5.06) mmol/L. Within 3 months of evolocumab initiation median LDL-C fell by 58% to 1.62 mmol/L. This reduction was maintained over time (Figure). Overall, 58% of patients achieved at least one LDL-C <1.4 mmol/L during follow-up. Among patients receiving background statins and/or ezetimibe at evolocumab initiation, 67% (667/990) achieved at least one LDL-C <1.4 mmol/L, compared with 43% (295/679) of patients not receiving background statins/ezetimibe. During follow-up, 39–46% patients received no background LLT, 40–44% received statin ±ezetimibe, 11–14% received statin monotherapy. Conclusion In Europe, patients initiated on evolocumab had baseline LDL-C levels almost 3 times higher than the present threshold for PCSK9i use, reflecting local reimbursement criteria. Evolocumab resulted in a more than 50% reduction in LDL-C; however, only approximately half of all patients achieved an LDL-C <1.4 mmol/L. LDL-C goal attainment was higher among patients receiving evolocumab with background LLT, suggesting that achievement of EAS/ESC LDL-C goals requires multiple LLTs and a lower threshold for PCSK9i initiation. LDL-C levels after evolocumab initiation Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Amgen

Projecting the long-term benefits of single pill combination therapy for patients with hypertension in five countries

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
C Borghi ◽  
J.G Wang ◽  
A.V Rodionov ◽  
M Rosas ◽  
I.S Sohn ◽  
...  
Keyword(s):  
Combination Therapy ◽  
South Korea ◽  
Health Outcomes ◽  
Clinical Outcomes ◽  
Funding Source ◽  
Combination Therapies ◽  
Private Company ◽  
Treatment Pathways ◽  
Single Pill ◽  
The Impact

Abstract Background It is well established that single pill combination (SPC) therapies have the potential to improve patient adherence versus multi-pill regimens, thereby improving blood pressure control and clinical outcomes in populations with hypertension. Purpose To develop a microsimulation model, capturing different treatment pathways, to project the impact on clinical outcomes of using single pill combination therapies for the management of hypertension in five countries (Italy, Russia, China, South Korea and Mexico). Methods The model was designed to project health outcomes between 2020 and 2030 for populations with hypertension managed according to four different treatment pathways: current treatment practices [CTP], single drug with dosage titration first then sequential addition of other agents [start low and go slow, SLGS], free choice combination with multiple pills [FCC] and combination therapy in the form of a single pill [SPC]. Model inputs were derived from Global Burden of Disease 2017 dataset, including demographics, health status/risk factors, transition probabilities and treatment attributes/healthcare utilization, and the model incorporated real-world challenges to healthcare delivery such as access to care, SBP measurement error, adherence and therapeutic inertia. Simulated outcomes of mortality, incidence of chronic kidney disease (CKD), stroke and ischemic heart disease (IHD), and disability-adjusted life years (DALYs) due to these conditions were estimated for population of 1,000,000 simulated patients for each treatment pathway and country. Results SPC therapy was projected to improve health outcomes over SLGS, FCC and CTP over 10 years in all five countries. SPC was forecast to reduce mortality by 5.4% (Italy), 4.9% (Russia), 4.5% (China), 2.3% (South Korea) and 3.6% (Mexico) versus CTP and showed greater projected reductions in mortality than SLGS and FCC. DALYs were projected to be reduced with SPC therapy by between 5.7% (Italy) and 2.2% (South Korea) compared with CTP and reductions in the incidence of clinical events were also projected with SPC therapy, with decreases in the range of 11.5% (Italy) to 4.9% (South Korea) versus CTP. Conclusions Ten-year projections of clinical outcomes associated with different anti-hypertensive treatment pathways in five countries indicated that both combination therapies (FCC and SPC) are likely to reduce the disease burden of hypertension compared with conventional management approaches, with SPC showing the greatest overall benefits due to improved adherence. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Sanofi, Gentilly, France

Artificial intelligence-guided image acquisition on patients with implanted electrophysiological devices: results from a pivotal prospective multi-center clinical trial

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
S Surette ◽  
A Narang ◽  
R Bae ◽  
H Hong ◽  
Y Thomas ◽  
...  
Keyword(s):  
Qualitative Assessment ◽  
Funding Source ◽  
Software Performance ◽  
Private Company ◽  
Diagnostic Quality ◽  
Icd Leads ◽  
Significant Difference ◽  
Level 3 ◽  
And Function ◽  
The Impact

Abstract Background A novel, recently FDA-authorized software uses deep learning (DL) to provide prescriptive transthoracic echocardiography (TTE) guidance, allowing novices to acquire standard TTE views. The DL model was trained by >5,000,000 observations of the impact of probe motion on image orientation/quality. This study evaluated whether novice-acquired TTE images guided by this software were of diagnostic quality in patients with and without implanted electrophysiological (EP) devices, focusing on RV size and function, which were thought to be sensitive to EP devices. Some aspects of the study have previously been presented. Methods 240 patients (61±16 years old, 58% male, 33% BMI >30 kg/m2, 91% with cardiac pathology) were recruited. 8 nurses without echo experience each acquired 10 view TTEs in 30 patients guided by the software. 235 of the patients were also scanned by a trained sonographer without assistance from the software. 5 Level 3 echocardiographers independently assessed the diagnostic quality of the TTEs acquired by the nurses and sonographers to evaluate the effect of EP devices on DL software performance. Results Nurses using the AI-guided acquisition software acquired TTEs of sufficient quality to make qualitative assessments of right ventricular (RV) size and function in greater than 80% of cases for patients with and without implanted EP devices (Table). There was no significant difference between nurse- and sonographer-acquired scans. Conclusion These results indicate that new DL software can guide novices to obtain TTEs that enable qualitative assessment of RV size even in the presence of implanted EP devices. The results of the comparison to sonographer-acquired exams indicate the software performance is robust to presence of pacemaker/ICD leads visible in the images (Figure). Nurse-acquired TTE with visible ICD lead Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Caption Health, Inc.

scholarly journals First-in-human study to assess the safety, pharmacokinetics and pharmacodynamics of BMS-986177/JNJ-70033093, a direct, reversible, small molecule Factor XIa inhibitor in healthy volunteers

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Perera ◽  
Z Wang ◽  
J Luettgen ◽  
J Wang ◽  
D Li ◽  
...  
Keyword(s):  
Plasma Concentration ◽  
Healthy Volunteers ◽  
Small Molecule ◽  
Healthy Subjects ◽  
Funding Source ◽  
Private Company ◽  
Factor Xia ◽  
Clinically Significant ◽  
Oral Doses ◽  
The Impact

Abstract Background Inhibition of Factor XIa (FXIa) may provide a novel mechanism for systemic anticoagulation without increasing the risk of clinically significant bleeding in many conditions predisposing to a high risk of thrombotic or bleeding events. BMS-986177/JNJ-70033093 (BMS-177/JNJ-3093) is a small molecule that inhibits FXIa with high affinity and selectivity. Depending on the indication, BMS-177/JNJ-3093 may provide benefit to patients as add-on therapy to current standard of care (SOC) antithrombotic agents or potentially as a replacement for current SOC. Purpose To assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple oral doses of BMS-177/JNJ-3093 in healthy subjects. Methods This was a 2-part, randomized, double-blind, placebo-controlled, sequential single- (Part A) and multiple- (Part B) ascending dose study to assess the safety, tolerability, PK, and PD of BMS-177/JNJ-3093 in healthy subjects. In Part A (SAD) of the study, 48 subjects were treated in 6 panels (8 subjects per panel). The 200 mg and 500 mg dose panels investigated the impact of a high fat diet on PK. In Part B (MAD), 56 subjects were treated in 7 panels (8 subjects per panel) on a once daily (QD) or twice daily (BID) regimen for a 14-day period. Within each panel in Parts A and B, subjects were randomized to receive either BMS-177/JNJ-3093 or matched placebo (3:1). Results Administration of single ascending doses of BMS-177/JNJ-3093 up to 500 mg and multiple ascending doses of BMS-177/JNJ-3093 up to 200 mg BID or 500 mg QD for 14 days were safe and well tolerated. No subjects had a clinically significant bleeding event. All treatment-emergent adverse events were mild in severity. After single doses of BMS-177/JNJ-3093 ranging from 4 to 500 mg in fasted status, BMS-177/JNJ-3093 plasma concentration reached Cmax at 3 h postdose in all panels, indicating a similar rate of absorption. The terminal half-life ranged from 8.26 to 13.8 h across SAD panels. Over 20 to 200 mg, a dose proportional increase was observed; however, saturable absorption was seen at higher doses of 300 and 500 mg. Food also increased the bioavailability of BMS-177/JNJ-3093. In the MAD portion of the study, based on visual inspection of trough plasma concentration profiles, BMS-177/JNJ-3093 plasma concentration steady state was reached between 1–3 dosing days (ie, Days 2–4) for the QD panels and 6 dosing days (ie, Day 7) for the 200 mg BID panel. Renal excretion was relatively low, ranging from 8–20%. After single oral dose or multiple oral doses, there is a clear trend that aPTT was prolonged and the magnitude of change was related to drug exposure. Conclusion BMS-177/JNJ-3093 was safe and well tolerated in healthy volunteers. The PK and PD profile demonstrates suitable dosing properties for further clinical studies. Currently, two Phase II studies are ongoing. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): This work was sponsored by Bristol-Myers Squibb and Janssen Research & Development, LLC

scholarly journals Effects of canagliflozin on cardiovascular death and hospitalization for heart failure by baseline estimated glomerular filtration rate: integrated analyses from the CANVAS Program and CREDENCE

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K.W Mahaffey ◽  
G Bakris ◽  
J Blais ◽  
C.P Cannon ◽  
D Cherney ◽  
...  
Keyword(s):  
Heart Failure ◽  
Cox Regression ◽  
Sglt2 Inhibitor ◽  
Cardiovascular Death ◽  
Funding Source ◽  
Private Company ◽  
Interaction Terms ◽  
Hazard Ratios ◽  
Death Event ◽  
Cv Disease

Abstract Background People with type 2 diabetes mellitus (T2DM) have a greater risk of cardiovascular (CV) disease, including hospitalization for heart failure (HHF), a complication that is more common as renal function declines. The sodium glucose co-transporter 2 (SGLT2) inhibitor canagliflozin (CANA) reduced the risk of HHF in patients with T2DM and high CV risk or nephropathy in the CANVAS Program and CREDENCE trials, respectively. Methods This post hoc analysis included integrated, pooled data from the CANVAS Program and the CREDENCE trial. The effects of CANA compared with placebo on CV death or HHF, HHF, and CV death were assessed in subgroups defined by baseline eGFR (<45, 45–60, and >60 mL/min/1.73 m2). Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using Cox regression models, with subgroup by treatment interaction terms added to test for heterogeneity. Interaction P values were calculated by including treatment group and baseline eGFR in the model. Results A total of 14,543 participants from the CANVAS Program (N=10,142) and CREDENCE (N=4,401) were included, with mean age, 65 y; 65% male; 75% white; mean eGFR 70.3 mL/min/1.73 m2. 1919 (13.2%) participants had baseline eGFR <45 mL/min/1.73 m2 (mean, 36.7 mL/min/1.73 m2), 2972 (20.4%) participants had eGFR 45–60 mL/min/1.73 m2 (mean, 53.1 mL/min/1.73 m2), and 9649 (66.3%) participants had eGFR >60 mL/min/1.73 m2 (mean, 82.3 mL/min/1.73 m2). Rates of CV death or HHF, HHF, and CV death increased as eGFR declined (Figure). CANA significantly reduced the risk of CV death or HHF and HHF compared with PBO, with consistent effects observed across subgroups. Conclusions CV death or HHF, HHF, and CV death event rates increased with lower baseline eGFR. CANA significantly reduced the risk of CV death or HHF, jointly and individually, in participants with T2DM and high CV risk or CKD in the CANVAS Program and the CREDENCE trial, with consistent benefits observed regardless of baseline eGFR. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Janssen Scientific Affairs, LLC

scholarly journals Cardiovascular outcomes in patients with type 2 diabetes and reduced eGFR and albuminuria: a REWIND post hoc subgroup analysis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H Colhoun ◽  
R Malik ◽  
F Botros ◽  
C Atisso ◽  
H Gerstein
Keyword(s):  
Risk Factors ◽  
Type 2 Diabetes ◽  
Risk Reduction ◽  
Subgroup Analysis ◽  
Funding Source ◽  
Private Company ◽  
First Occurrence ◽  
Cv Disease ◽  
Post Hoc

Abstract Background/Introduction Diabetic kidney disease affects up to 40% of people with diabetes and is associated with higher cardiovascular (CV) risk. REWIND was a multicentre, randomised, double-blind, placebo-controlled trial with a primary outcome of first occurrence of the composite endpoint of CV death, nonfatal myocardial infarction, or nonfatal stroke (Major Adverse Cardiovascular Event [MACE]-3). Dulaglutide treatment reduced the incidence of MACE-3 in patients with type 2 diabetes (T2D) with or without established CV disease. Purpose This REWIND post hoc subgroup analysis evaluated the effect of dulaglutide on MACE-3 in patients with an eGFR<60 and ≥60 mL/min/1.73m2 and patients with micro-/macro-albuminuria (UACR ≥30 mg/g) or normoalbuminuria (UACR <30 mg/g). Methods Eligible patients were those ≥50 years old with T2D who had either a previous CV event or CV risk factors. Patients were randomised (1:1) to dulaglutide 1.5 mg or placebo, both in addition to standard of care. A Cox proportional hazards model with treatment, eGFR subgroup (<60 and ≥60 mL/min/1.73 m2), and treatment by eGFR subgroup interaction was used to analyse time to the first occurrence of MACE-3. These analyses were also conducted for albuminuria subgroups (micro-/macro-albuminuria or normoalbuminuria). Estimates of hazard ratios (HR) with 95% confidence intervals (CI) were calculated for each subgroup. Results At baseline, 2,199 of 9,901 patients (22.2%) had an eGFR <60 mL/min/1.73 m2, 2,676 (27.0%) had microalbuminuria, and 791 (8.0%) had macroalbuminuria. This post hoc subgroup analysis showed that dulaglutide treatment was consistently associated with MACE-3 risk reduction in patients with eGFR <60 and ≥60 mL/min/1.73 m2 (HR [95% CI]: 0.93 [0.76–1.13] and 0.86 [0.75–0.99], respectively; interaction p=0.545). Similarly, MACE-3 risk reduction was consistent in patients with micro-/macro-albuminuria or normoalbuminuria (HR [95% CI]: 0.84 [0.72–0.99] and 0.93 [0.79–1.10], respectively; interaction p=0.374). Conclusions Regardless of baseline eGFR or albuminuria status, dulaglutide reduces MACE-3 outcomes in patients with T2D and established CV disease or multiple CV risk factors. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Eli Lilly and Company

The impact of age and socioeconomic factors on response to exercise training in patients with ischemic heart disease, heart failure and after valve replacement

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H.K Rasmusen ◽  
N Mikkelsen
Keyword(s):  
Logistic Regression ◽  
Regression Analysis ◽  
Heart Disease ◽  
Exercise Training ◽  
Oxygen Uptake ◽  
Peak Oxygen Uptake ◽  
Funding Source ◽  
Baseline Characteristics ◽  
Response To Exercise ◽  
The Impact

Abstract   The impact of baseline characteristics on response to exercise training in patients with ischemic heart disease. Background Exercise training improves peak oxygen uptake, an important predictor of mortality in patients with coronary artery disease (CAD). Unfortunately, some patients do not response with an increase in peak oxygen uptake after exercise training. If it is possible to identify these patients it would be possible to tailor their exercise training. Purpose To investigate if baseline characteristics can predict response to exercise training in patients with heart disease. Methods A retrospective analysis of 1443 CAD patients (age 64±11 y (mean (±SD)), 74% male, participated and completed an eight-week supervised outpatient exercise intervention with two weekly training sessions of 1.5 hours with high intensity interval- (>80% of VO2peak) and resistance training. Patient characteristics were entered in the local database as the patients entered cardiac rehabilitation (CR). VO2peak was assessed before and after CR using a cardiopulmonary exercise test (CPET) with a maximal symptom limited bicycle ergometer test. Breathing gases were collected and analysed breath-by-breath. Each test aimed at physical exhaustion and a respiratory exchange ratio of more than 1.1 to ensure the validity of the CPET test. Patients were divided into responders defined as an improvement in aerobic capacity (change in VO2peak) after CR and non-responders if no improvement (change in VO2peak of 0.0ml/kg/min or less) post CR. We performed a multivariable logistic regression analysis using responders vs. non-responders as the endpoint. Explanatory variables were identified according to previous literature and comprised the following variables; age, sex, baseline VO2peak, tobacco use, diabetes, COPD, revascularization, working status, educational attainment, ethnicity and hypercholesteremia. Results 1097 patients were responders and 346 (24%) non-responders to the exercise training despite no difference in attendance. Logistic regression analysis of responders vs. non-responders in relation to baseline characteristics are shown in the table. Conclusion In summarize, 24% of these heart patients were exercise non-responders. High baseline VO2peak, older age, having COPD, being on disability pension, low educational attainment and non-western ethnicity were predictors of training non-response. Identification of patients with a large likelihood of non-response is a beginning towards patient tailored exercise programmes. Baseline characteristics in responders. CABG: coronary artery bypass graft; COPD: chronic obstructive pulmonary disease; PCI: percutaneous coronary intervention; SD: standard deviation; VO2peak: change in peak oxygen uptake. P-values of <0.05 are considered significant and shown in bold. 95% confidence intervals are shown in last column. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Helsefonden

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.

Long-term prognostic benefit of beta-blockers use after discharge in patients with Tako-Tsubo syndrome

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
K Jamhour-Chelh ◽  
S Raposeiras-Roubin ◽  
I Nunez-Gil ◽  
E Abu-Assi ◽  
D Aritza Conty ◽  
...  
Keyword(s):  
Large Scale ◽  
Beta Blockers ◽  
Funding Source ◽  
Prognostic Impact ◽  
Private Company ◽  
Cox Analysis ◽  
The Impact ◽  
Long Term Mortality

Abstract Background Tako-tsubo Syndrome (TS) seems to be associated with a catecholamine-mediated mechanism. However, the impact of beta-blockers (BB) in-hospital and after discharge still remain uncertain. Objectives: The purpose of the study was to examine whether BB use after discharge in patients with TS, was associated with lower long-term mortality and recurrence. Methods Using a national multicentre large-scale inpatient database (RETAKO Registry), we analysed patients with a definitive TS diagnosis. Results A total of 970 patients were analysed (568 with BB therapy and 402 no-BB therapy). After discharge and over a median of follow-up of 1.1 years, treatment with BB have no shown prognostic effectiveness in terms of mortality and TS recurrence in unadjusted and adjusted Cox analysis (HR 0.86; 95% CI: 0.59 to 1.27; and 0.95; 95% CI: 0.57–1.13, respectively). Conclusions This data suggests that use of beta-blockers after hospital discharge has not shown long-term prognostic benefit in patients with Tako-tsubo Syndrome. Prognostic impact of BB in TS. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Retako webpage was funded by a non-conditioned Astrazeneca scholarship.

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