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Effect of a lifestyle-focused electronic patient support application for improving risk factor management, self-rated health, and prognosis in post-myocardial infarction patients: study protocol for a multi-center randomized controlled trial.
Gonzalez, M, Sjölin, I, Bäck, M, Ögmundsdottir Michelsen, H, Tanha, T, Sandberg, C, Schiopu, A, Leosdottir, M
Trials. 2019;(1):76
Abstract
BACKGROUND Cardiac rehabilitation (CR) programs addressing risk factor management, educational interventions, and exercise contribute to reduce mortality after myocardial infarction (MI). However, the fulfillment of guideline-recommended CR targets is currently unsatisfactory. eHealth, i.e., the use of electronic communication for healthcare, including the use of mobile smartphone applications combined with different sensors and interactive computerized programs, offers a new array of possibilities to provide clinical care. The present study aims to assess the efficacy of a web-based application (app) designed to support persons in adhering to lifestyle advice and medication as a complement to traditional CR programs for improvement of risk factors and clinical outcomes in patients with MI compared with usual care. METHODS/DESIGN An open-label multi-center randomized controlled trial is being conducted at different CR centers from three Swedish University Hospitals. The aim is to include 150 patients with MI < 75 years of age who are confident smartphone and/or Internet users. In addition to participation in CR programs according to the usual routine at each center, patients randomized to the intervention arm will receive access to the web-based app. A CR nurse reviews the patients' self-reported data twice weekly through a medical interface at the clinic. The primary outcome of the study will be change in submaximal exercise capacity (in watts) between 2 and 4 weeks after discharge and when the patient has completed his/her exercise program at the CR center, usually around 3-6 months post-discharge. Secondary outcomes include changes in self-reported physical activity, objectively assessed physical activity by accelerometry, self-rated health, dietary, and smoking habits, body mass index, blood pressure, blood lipids, and glucose/HbA1c levels between inclusion and follow-up visits during the first year post-MI. Additionally, we will assess uptake and adherence to the application, the number of CR staff contacts, and the incidence of cardiovascular events at 1 and 3 years after the MI. Patient recruitment started in 2016, and the first study results are expected in the beginning of 2019. DISCUSSION The present study will add evidence to whether electronic communication can be used to improve traditional CR programs for patients after MI. TRIAL REGISTRATION ClinicalTrials.gov, NCT03260582 . Retrospectively registered on 24 August 2017.
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Evaluating the effect of lifestyle education based on peer model on anxiety in patients with acute myocardial infarction.
Mohammadpourhodki, R, Bagheri, H, Basirinezhad, MH, Ramzani, H, Keramati, M
Journal of complementary & integrative medicine. 2019;(3)
Abstract
Background Anxiety in patients with myocardial infarction (MI) which has a very negative effect on the prognosis of their disease and their physical and mental health. We performed this study in order to find the impact of a peer based education (PE) on anxiety in patients with MI. Methods This was a randomized clinical trial study. The study participants included 60 patient with MI, who were randomly divided into two groups. The first group received routine education and the other one received PE. We assessed anxiety before and 30 days after the intervention through a valid questionnaires. Data were analyzed by independent sample t-test, two-way ANOVA and the Bonferroni test. Results The majority of samples were male, married, self-employer, and living in city. After 30 days intervention the anxiety score was significantly lower in the PE group compare to the control group. Conclusion Our findings indicated that the implication of PE as an educational element in decreasing anxiety score and can be considered as a method for continuing of care, and could as well as be a good approach for other patients.
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Applying contemporary antithrombotic therapy in the secondary prevention of chronic atherosclerotic cardiovascular disease.
Welsh, RC, Peterson, ED, De Caterina, R, Bode, C, Gersh, B, Eikelboom, JW
American heart journal. 2019;:100-109
Abstract
For 4 decades, antithrombotic therapy with aspirin has been a cornerstone of secondary prevention for patients with chronic atherosclerotic cardiovascular disease (ASCVD). Unfortunately, despite the use of evidence-based therapies, patients with ASCVD continue to have recurrent major adverse cardiovascular events including death, myocardial infarction, and stroke-at a rate of approximately 2%-4% per year. To combat this continuing risk, several recent trials have evaluated the efficacy and safety of more intensive antithrombotic strategies through prolonged dual antiplatelet therapy (DAPT), combining a P2Y12 receptor antagonists and low-dose aspirin, or alternatively applying a dual pathway inhibition approach, combining low-dose non-vitamin K antagonist anticoagulant and low-dose aspirin. Both combination strategies have been shown to reduce recurrent ischemic events but at the cost of increased bleeding events. The clinical application of these antithrombotic strategies requires clinicians to assess and balance the risk of recurrent ischemic and bleeding events in an individual patient. Furthermore, clinicians may also need to adapt their antithrombotic strategies to achieve best patient outcomes, as ASCVD is a progressive disease and the risks of cardiovascular ischemic and bleeding events may shift over time. This state-of-the-art article reviews evidence from the trials and provides a practical approach to the application of DAPT and dual pathway antithrombotic therapy in the long-term management of patients with chronic ASCVD.
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Contribution of the polymorphism rs1800469 of transforming growth factor β in the development of myocardial infarction: meta-analysis of 5460 cases and 8413 controls (MOOSE-compliant article).
Du, L, Gong, T, Yao, M, Dai, H, Ren, HG, Wang, H
Medicine. 2019;(26):e15946
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Abstract
Studies investigating the association between transforming growth factor (TGF-β-509C/T, rs1800469) promoter polymorphism and myocardial infarction (MI) risk reported inconsistent results. The aim of our study was to assess the association between the 509C/T polymorphism of the TGF-β gene (rs1800469) and MI risk.A total of 5460 cases and 8413 controls in 7 case-control studies were incorporated in our current meta-analysis. The original studies were selected through searching the databases of the PubMed and EMBASE. The odds ratio (OR) and 95% confidence interval (95% CI) of TGF-β 509C/T (rs1800469) for MI risk were applied to estimate the strength of the association.Our results showed that T allele carriers had a 13% increased risk of MI, when compared with the C allele carriers (OR = 1.13, 95% CI: 1.00-1.27). In the subset analysis by the type of MI, significantly elevated risk of MI was associated with the homozygote TT and heterozygote C/T in no-AMI subjects, when compared with the CC homozygote carriers (OR = 1.12, 95% CI:1.02-1.23).Our meta-analysis shows that the polymorphism with homozygote TT and heterozygote C/T of TGF-β 509C/T (rs1800469) is significantly associated with the increased risk of MI.
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Assessment of Vascular Event Prevention and Cognitive Function Among Older Adults With Preexisting Vascular Disease or Diabetes: A Secondary Analysis of 3 Randomized Clinical Trials.
Offer, A, Arnold, M, Clarke, R, Bennett, D, Bowman, L, Bulbulia, R, Haynes, R, Li, J, Hopewell, JC, Landray, M, et al
JAMA network open. 2019;(3):e190223
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IMPORTANCE Acquisition of reliable randomized clinical trial evidence of the effects of cardiovascular interventions on cognitive decline is a priority. OBJECTIVES To estimate the association of cognitive aging with the avoidance of vascular events in cardiovascular intervention trials and understand whether reports of nonsignificant results exclude worthwhile benefit. DESIGN, SETTING, AND PARTICIPANTS This secondary analysis of 3 randomized clinical trials in participants with preexisting occlusive vascular disease or diabetes included survivors to final in-trial follow-up in the Heart Protection Study (HPS), Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH), and Treatment of HDL (High-Density Lipoprotein) to Reduce the Incidence of Vascular Events (HPS2-THRIVE) trials of lipid modification for prevention of cardiovascular events. Data were collected from February 1994 through January 2013 and analyzed from January 2015 through December 2018. EXPOSURES Incident vascular events and diabetes and statin therapy. MAIN OUTCOMES AND MEASURES Cognitive function was assessed at the end of a mean (SD) of 4.9 (1.5) years of follow-up using a 14-item verbal test. Associations of the incidence of vascular events and new-onset diabetes during the trials, with cognitive function at final in-trial follow-up were estimated and expressed as years of cognitive aging (using the association of the score with age >60 years). The benefit on cognitive aging mediated through the effects of lowering low-density lipoprotein cholesterol levels on events was estimated by applying these findings to nonfatal event differences observed with statin therapy in the HPS trial. RESULTS Among 45 029 participants undergoing cognitive assessment, mean (SD) age was 67.9 (8.0) years; 80.7% were men. Incident stroke (n = 1197) was associated with 7.1 (95% CI, 5.7-8.5) years of cognitive aging; incident transient ischemic attack, myocardial infarction, heart failure, and new-onset diabetes were associated with 1 to 2 years of cognitive aging. In HPS, randomization to statin therapy for 5 years resulted in 2.0% of survivors avoiding a nonfatal stroke or transient ischemic attack and 2.4% avoiding a nonfatal cardiac event, which yielded an expected reduction in cognitive aging of 0.15 (95% CI, 0.11-0.19) years. With 15 926 participants undergoing cognitive assessment, HPS had 80% power to detect a 1-year (ie, 20% during the 5 years) difference in cognitive aging. CONCLUSIONS AND RELEVANCE The expected cognitive benefits of the effects of preventive therapies on cardiovascular events during even the largest randomized clinical trials may have been too small to be detectable. Hence, nonsignificant findings may not provide good evidence of a lack of worthwhile benefit on cognitive function with prolonged use of such therapies. TRIAL REGISTRATION isrctn.com and ClinicalTrials.gov Identifiers: ISRCTN48489393, ISRCTN74348595, and NCT00461630.
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PCSK9 inhibition in patients with and without prior myocardial infarction or ischemic stroke: A pooled analysis of nine randomized-controlled studies of alirocumab.
Bruckert, E, Kereiakes, DJ, Koren, MJ, Louie, MJ, Letierce, A, Miller, K, Cannon, CP
Journal of clinical lipidology. 2019;(3):443-454
Abstract
BACKGROUND Patients with prior cardiovascular events are at very high risk of recurrent events and may benefit from low-density lipoprotein cholesterol (LDL-C) lowering beyond that achieved with maximally tolerated statins. OBJECTIVE To assess potential differences between the efficacy and safety of the proprotein convertase subtilisin/kexin type 9 inhibitor, alirocumab, in patients with vs without prior myocardial infarction (MI)/ischemic stroke. METHODS Data (n = 4880) were pooled from nine ODYSSEY phase 3 trials of alirocumab 75/150 mg or 150 mg every 2 weeks, mostly on background statins ± other lipid-lowering therapies. Analyses were performed according to statin status, alirocumab dose, and control (placebo or ezetimibe). RESULTS Baseline LDL-C, non-high-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and apolipoprotein B levels were lower and lipoprotein(a) higher in patients with than without prior MI/ischemic stroke. LDL-C levels were reduced from baseline to week 24 in patients with (51.1%-62.9%) and without (43.6%-58.3%) prior MI/ischemic stroke, with no significant interaction between prior MI/ischemic stroke status and LDL-C-lowering efficacy of alirocumab vs controls. Alirocumab significantly reduced other lipid/lipoproteins (including lipoprotein[a]) similarly in patients with/without MI/ischemic stroke. Week 24 LDL-C goal attainment rates for subgroups with/without prior MI/ischemic stroke on background statins were 74.1%-84.8% and 63.7%-74.7%, respectively. The safety profile of alirocumab was generally similar regardless of prior MI/ischemic stroke status. CONCLUSIONS Alirocumab significantly reduced LDL-C and other atherogenic lipids/lipoproteins in patients with prior MI/ischemic stroke, and the majority of this very high cardiovascular risk population achieved LDL-C goals; efficacy and safety results were similar in patients without prior MI/ischemic stroke.
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Myocardial infarction after acute ischaemic stroke: Incidence, mortality and risk factors.
Pana, TA, Wood, AD, Mamas, MA, Clark, AB, Bettencourt-Silva, JH, McLernon, DJ, Potter, JF, Myint, PK, ,
Acta neurologica Scandinavica. 2019;(3):219-228
Abstract
OBJECTIVES To determine the risk factor profiles associated with post-acute ischaemic stroke (AIS) myocardial infarction (MI) over long-term follow-up. METHODS This observational study includes prospectively identified AIS patients (n = 9840) admitted to a UK regional centre between January 2003 and December 2016 (median follow-up: 4.72 years). Predictors of post-stroke MI during follow-up were examined using logistic and Cox regression models for in-hospital and post-discharge events, respectively. MI incidence was determined using a competing risk non-parametric estimator. The influence of post-stroke MI on mortality was examined using Cox regressions. RESULTS Mean age (SD) of study participants was 77.3 (12.2) years (48% males). Factors associated with in-hospital MI (OR [95% CI]) were increasing blood glucose (1.80 [1.17-2.77] per 10 mmol/L), total leucocyte count (1.25 [1.01-1.54] per 10 × 109 /L) and CRP (1.05 [1.02-1.08] per 10 mg/L increase). Age (HR [95% CI] = 1.03 [1.01-1.06]), coronary heart disease (1.59 [1.01-2.50]), chronic kidney disease (2.58 [1.44-4.63]) and cancers (1.76 [1.08-2.89]) were associated with incident MI between discharge and one-year follow-up. Age (1.02 [1.00-1.03]), diabetes (1.96 [1.38-2.65]), congestive heart failure (2.07 [1.44-2.99]), coronary heart disease (1.81 [1.31-2.50]), hypertension [1.86 (1.24-2.79)] and peripheral vascular disease (2.25 [1.40-3.63]) were associated with incident MI between 1 and 5 years after discharge. Diabetes (2.01 [1.09-3.72]), hypertension (3.69 [1.44-9.45]) and peripheral vascular disease (2.46 [1.02-5.98]) were associated with incident MI between 5 and 10 years after discharge. Cumulative MI incidence over 10 years was 5.4%. MI during all follow-up periods (discharge-1, 1-5, 5-10 years) was associated with increased risk of death (respective HR [95% CI] = 3.26 [2.51-4.15], 1.96 [1.58-2.42] and 1.92 [1.26-2.93]). CONCLUSIONS In conclusion, prognosis is poor in post-stroke MI. We highlight a range of potential areas to focus preventative efforts.
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Relative Prognostic Importance and Optimal Levels of Risk Factors for Mortality and Cardiovascular Outcomes in Type 1 Diabetes Mellitus.
Rawshani, A, Rawshani, A, Sattar, N, Franzén, S, McGuire, DK, Eliasson, B, Svensson, AM, Zethelius, B, Miftaraj, M, Rosengren, A, et al
Circulation. 2019;(16):1900-1912
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BACKGROUND The strength of association and optimal levels for risk factors related to excess risk of death and cardiovascular outcomes in type 1 diabetes mellitus have been sparsely studied. METHODS In a national observational cohort study from the Swedish National Diabetes Register from 1998 to 2014, we assessed relative prognostic importance of 17 risk factors for death and cardiovascular outcomes in individuals with type 1 diabetes mellitus. We used Cox regression and machine learning analyses. In addition, we examined optimal cut point levels for glycohemoglobin, systolic blood pressure, and low-density lipoprotein cholesterol. Patients with type 1 diabetes mellitus were followed up until death or study end on December 31, 2013. The primary outcomes were death resulting from all causes, fatal/nonfatal acute myocardial infarction, fatal/nonfatal stroke, and hospitalization for heart failure. RESULTS Of 32 611 patients with type 1 diabetes mellitus, 1809 (5.5%) died during follow-up over 10.4 years. The strongest predictors for death and cardiovascular outcomes were glycohemoglobin, albuminuria, duration of diabetes mellitus, systolic blood pressure, and low-density lipoprotein cholesterol. Glycohemoglobin displayed ≈2% higher risk for each 1-mmol/mol increase (equating to ≈22% per 1% glycohemoglobin difference), whereas low-density lipoprotein cholesterol was associated with 35% to 50% greater risk for each 1-mmol/L increase. Microalbuminuria or macroalbuminuria was associated with 2 to 4 times greater risk for cardiovascular complications and death. Glycohemoglobin <53 mmol/mol (7.0%), systolic blood pressure <140 mm Hg, and low-density lipoprotein cholesterol <2.5 mmol/L were associated with significantly lower risk for outcomes observed. CONCLUSIONS Glycohemoglobin, albuminuria, duration of diabetes mellitus, systolic blood pressure, and low-density lipoprotein cholesterol appear to be the most important predictors for mortality and cardiovascular outcomes in patients with type 1 diabetes mellitus. Lower levels for glycohemoglobin, systolic blood pressure, and low-density lipoprotein cholesterol than contemporary guideline target levels appear to be associated with significantly lower risk for outcomes.
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eHealth to improve patient outcome in rehabilitating myocardial infarction patients.
Verburg, A, Selder, JL, Schalij, MJ, Schuuring, MJ, Treskes, RW
Expert review of cardiovascular therapy. 2019;(3):185-192
Abstract
Cardiac rehabilitation is aimed at risk factor modification and improving quality of life. eHealth has a couple of potential benefits to improve this aim. The primary purpose of this review is to summarize available literature for eHealth strategies that have been investigated in randomized controlled trials in post-myocardial infarction (MI) patients. The second purpose of this review is to investigate the clinical effectiveness in post-MI patients. Areas covered: The literature was searched using PubMed. Randomized controlled trials (RCTs) describing interventions in patients that had experienced an ST-elevation myocardial infarction or non-ST acute coronary syndrome were eligible for inclusion. Fifteen full-texts were included and their results are described in this review. These RCTs described interventions that used remote coaching or remote monitoring in post-MI patients. Most interventions resulted in an improved cardiovascular risk profile. Remote coaching had a positive effect on activity and dietary intake. Expert opinion: eHealth might be clinically beneficial in post-MI patients, particularly for risk estimation. Moreover, eHealth as a tool for remote coaching on activity is a good addition to traditional cardiac rehabilitation programs. Further research needs to corroborate these findings.
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PCSK9 inhibitor therapy: A systematic review and meta-analysis of metabolic and cardiovascular outcomes in patients with diabetes.
Monami, M, Sesti, G, Mannucci, E
Diabetes, obesity & metabolism. 2019;(4):903-908
Abstract
AIMS: Pro-protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors bring about a wide reduction in low-density lipoprotein (LDL) cholesterol, greater than that of other lipid-lowering agents. The aim of this metanalysis was assessment of the effects of PCSK9 inhibitors on glucose metabolism, LDL cholesterol, cardiovascular morbidity and mortality in individuals with and without diabetes. MATERIALS AND METHODS A Medline and Clinicaltrials.gov search for eligible studies published before 1 December 2017 was performed. All randomized trials comparing PCSK-9 inhibitors with placebo or active drugs were included. Primary endpoints included (a) incident diabetes, fasting glucose and HbA1c, (b) LDL cholesterol at endpoint in patients with diabetes and in the total sample, and (c) major cardiovascular events (MACE) and mortality in individuals with and without diabetes. RESULTS A total of 38 trials was identified. The risk of incident diabetes was not increased by PCSK-9 inhibitors, vs placebo or any comparator. The reduction in LDL cholesterol vs placebo in patients with diabetes was 52.6 [41.3;63.8] mg/dL; the corresponding figure for all patients was 66.9 [62.4;71.3] mg/dL. Meta-regression analysis showed an inverse correlation between proportion of patients with diabetes and drug effect on LDL cholesterol in trials vs ezetimibe, but not in those vs placebo. In studies reporting data on MACE and mortality separately for individuals with and without diabetes, the effect of PCSK-9 did not appear to be affected by diabetes. CONCLUSION PCSK-9 inhibitors do not affect glucose metabolism. Their efficacy on LDL cholesterol and MACE in patients with diabetes does not seem to be very dissimilar to that observed in non-diabetic participants.