Handgrip Strength Weakness and Asymmetry Together are Associated with Cardiovascular Outcomes in Elderly Outpatients: A Prospective Cohort Study

Background: The evaluations of handgrip strength (HGS) weakness and asymmetry have implications for the comprehensive geriatric assessment. The aim of this study was to investigate the association of HGS weakness and asymmetry on cardiovascular outcomes in elderly outpatients. Methods: This was a prospective observational cohort study of 364 geriatrics outpatients aged ≥ 60 years, in which all participants performed HGS tests at baseline. Patients with HGS < 28 kg for men and < 18 kg for women were diagnosed as HGS weakness, and HGS ratio < 0.90 or > 1.10 were diagnosed as HGS asymmetry. Primary outcomes defined as the major adverse cardiovascular event (MACE) and composite endpoints were assessed during 21-month median follow-up.Results: Among 364 participants, 155 (42.6%) demonstrated HGS weakness, and 160 (44.0%) demonstrated HGS asymmetry. HGS weakness was associated with MACE (HR: 2.763, 95%CI: 1.217-6.272) and composite endpoints (HR: 2.842, 95%CI: 1.399-5.774). However, no significant correlation between HGS asymmetry and cardiovascular outcomes was observed. Compared with the normal and symmetric HGS group, older adults with HGS weakness and asymmetry together had a higher risk of MACE (HR: 5.229, 95%CI: 1.559-17.542) and composite endpoints (HR: 4.002, 95%CI: 1.558-10.277). Conclusion: HGS weakness and asymmetry together may increase the risk of cardiovascular outcomes in elderly outpatients. HGS asymmetry offers complementary information to HGS weakness when making a comprehensive assessment of HGS.

Eight-year post-trial follow-up of morbidity and mortality of telephone health coaching

Background Health coaching is a patient-centred approach to supporting self-management for the chronic conditions. However, long-term evidence of effectiveness of health coaching remains scarce. The object of this study was to evaluate the long-term effect of telephone health coaching (THC) on mortality and morbidity among people with type 2 diabetes (T2D), coronary artery disease (CAD) and congestive heart failure (CHF).. Methods 1535 T2D, CAD and CHF patients with unmet treatment targets were randomly allocated into an intervention group (n = 1034) and control group (n = 501). Intervention group received monthly individual strength-based, autonomy supportive THC sessions (average 30 min) for behavior change with a specially trained nurse for 12 months additional to usual health care. Control group received usual health care services. The primary outcome was a composite of death from cardiovascular causes or non-fatal stroke or non-fatal myocardial infarction (AMI) or unstable angina pectoris (UAP) during a follow-up of 8 years Three other composite endpoints with distinct combinations of fatal and non-fatal cardiovascular events and death from any cause were used as secondary outcomes. Other outcomes followed were the most relevant components of the composite endpoints. Randomized controlled trial (RCT) data was linked to Finnish national health and social care registries and electronic health records (EHR). Post-trial eight-year evaluation was conducted using intention-to-treat (ITT) and per-protocol (PP) analysis. Results The composite primary outcome event rate per 100 person years was lower in the intervention group (3.45) than in control group (3.88) in ITT -analysis, but the difference was not statistically significant (hazard ratio in the intervention group 0.87; 95% CI, 0.71 to 1.07; P = 0.19). In the subgroup (T2D, CAD/CHF) analysis, there were no statistically significant effects. The secondary PP-analysis showed statistically significant benefits for those who participated in the study. Conclusions No statistically significant effect of health coaching on mortality and morbidity was found in intention to treat analysis. The per protocol results suggest, however, that the intervention may be effective among patients who are willing and able to participate in health coaching. More research is needed to identify patients most likely to benefit from low-intensity health coaching. Trial registration NCT00552903 (registration date: the 1st of November 2007, updated the 3rd of February 2009).

Benefits of Icosapent Ethyl Across the Range of Kidney Function in Patients with Established Cardiovascular Disease or Diabetes: REDUCE-IT RENAL

Background: Chronic kidney disease is associated with adverse outcomes among patients with established cardiovascular disease (CVD) or diabetes. Commonly used medications to treat CVD are less effective among patients with reduced kidney function. Methods: The Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial (REDUCE-IT) was a multicenter, double-blind, placebo-controlled trial that randomized statin-treated patients with elevated triglycerides (135-499 mg/dL) who had CVD or diabetes and one additional risk factor to treatment with icosapent ethyl (4 grams daily) or placebo. Patients from REDUCE-IT were categorized by prespecified eGFR categories to analyze the effect of icosapent ethyl on the primary endpoint (composite of cardiovascular [CV] death, nonfatal myocardial infarction nonfatal stroke, coronary revascularization, or unstable angina) and key secondary endpoint (a composite of CV death, nonfatal myocardial infarction, or nonfatal stroke). Results: Among the 8179 REDUCE-IT patients, median baseline eGFR was 75 mL/min/1.73m 2 (range: 17 to 123 mL/min/1.73m 2 ). There were no meaningful changes in median eGFR for icosapent ethyl versus placebo across study visits. Treatment with icosapent ethyl led to consistent reduction in both the primary and secondary composite endpoints across baseline eGFR categories. Patients with eGFR<60 mL/min/1.73m 2 treated with icosapent ethyl had the largest absolute and similar relative risk reduction for the primary composite endpoint (icosapent ethyl versus placebo, 21.8% versus 28.9%, hazard ratio [HR] 0.71, 95% confidence interval [CI] 0.59-0.85, P=0.0002) and key secondary composite endpoints (16.8% versus 22.5%, HR 0.71, 95% CI 0.57-0.88, p=0.001). The numerical reduction in CV death was greatest in the eGFR <60 mL/min/1.73m 2 group (icosapent ethyl: 7.6%; placebo: 10.6%; HR 0.70, 95% CI 0.51-0.95, P=0.02). While patients with eGFR <60 mL/min/1.73m 2 treated with icosapent ethyl had the highest numerical rates of atrial fibrillation/flutter (icosapent ethyl: 4.2%; placebo 3.0%; HR 1.42, 95% CI 0.86-2.32, P=0.17) and serious bleeding (icosapent ethyl: 5.4%; placebo 3.6%; HR 1.40, 95% CI 0.90-2.18, P=0.13), hazard ratios for atrial fibrillation/flutter and serious bleeding were similar across eGFR categories (P-interaction for atrial fibrillation/flutter = 0.92; P-interaction for serious bleeding = 0.76). Conclusions: In REDUCE-IT, icosapent ethyl reduced fatal and nonfatal ischemic events across the broad range of baseline eGFR categories. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT01492361

Impact of Renal Function on Effectiveness and Safety Associated With Low Dose Dabigatran in Non-valve Atrial Fibrillation Patients After Catheter Ablation

Aim: The purpose of this study is to compare the effectiveness and safety of 110 mg dabigatran in non-valve atrial fibrillation (NVAF) patients with different eGFRs.Methods: We conducted a single-center retrospective cohort study to investigate the effectiveness and safety of 110 mg dabigatran for NVAF patients between January 2017 and December 2018 based on the eGFR category.Results: A total of 560 NVAF patients who treated with 110 mg dabigatran were included for analysis. In 12 months, the Kaplan-Meier survival curves indicated that the lower eGFR subgroups were more likely to experience thrombosis, bleeding, and cumulative events earlier (P = 0.021 for thrombosis; P = 0.026 for bleeding; P = 0.001 for cumulative events). Gastrointestinal bleeding occurred more frequently in the moderate group than in other groups (6.94% in the moderate group vs. 1.54% in the mild group vs. 1.22% in the normal group, P = 0.028). By multivariate analysis, chronic kidney disease (P = 0.043; OR = 4.273, 95% CI 1.043–17.543) and diabetes mellitus (P = 0.023; OR = 2.194, 95% CI 1.114–4.323) were independent predictors of the composite endpoints. A positive linear relationship was observed between eGFR levels and occurrence rate of thrombosis and bleeding under anticoagulation patients with 110 mg dabigatran (R2 = 0.432 and R2 = 0.784, respectively).Conclusions: Impaired renal function was associated with decreased safety and increased thrombosis risks in NVAF patients taking low dose dabigatran.

A prospective population-based multicentre study on the impact of maternal body mass index on adverse pregnancy outcomes: Focus on normal weight

Background Maternal body mass index (BMI) below or above the reference interval (18.5–24.9 kg/m2) is associated with adverse pregnancy outcomes. Whether BMI exerts an effect within the reference interval is unclear. Therefore, we assessed the association between adverse pregnancy outcomes and BMI, in particular within the reference interval, in a general unselected pregnant population. Methods Data was extracted from a prospective population-based multicentre cohort (Risk Estimation for PrEgnancy Complications to provide Tailored care (RESPECT) study) conducted between December 2012 to January 2014. BMI was studied in categories (I: <18.5, II: 18.5–19.9, III: 20.0–22.9, IV: 23.0–24.9, V: 25.0–27.4, VI: 27.5–29.9, VII: >30.0 kg/m2) and as a continuous variable within the reference interval. Adverse pregnancy outcomes were defined as composite endpoints for maternal, neonatal or any pregnancy complication, and for adverse pregnancy outcomes individually. Linear trends were assessed using linear-by-linear association analysis and (adjusted) relative risks by regression analysis. Results The median BMI of the 3671 included women was 23.2 kg/m2 (IQR 21.1–26.2). Adverse pregnancy outcomes were reported in 1256 (34.2%). Linear associations were observed between BMI categories and all three composite endpoints, and individually for pregnancy-induced hypertension (PIH), preeclampsia, gestational diabetes mellitus (GDM), large-for-gestational-age (LGA) neonates; but not for small-for-gestational-age neonates and preterm birth. Within the reference interval, BMI was associated with the composite maternal endpoint, PIH, GDM and LGA, with adjusted relative risks of 1.15 (95%CI 1.06–1.26), 1.12 (95%CI 1.00–1.26), 1.31 (95%CI 1.11–1.55) and 1.09 (95%CI 1.01–1.17). Conclusions Graded increase in maternal BMI appears to be an indicator of risk for adverse pregnancy outcomes even among women with a BMI within the reference interval. The extent to which BMI directly contributes to the increased risk in this group should be evaluated in order to determine strategies most valuable for promoting safety and long-term health for mothers and their offspring.

Contribution of cardio-ankle vascular index to prediction of cardiovascular events in the adult urban population: data from the ESSE-RF study (Tomsk)

Aim. To determine the role of cardio-ankle vascular index (CAVI) in predicting cardiovascular events (CVEs) in adult Russian population using model of the Epidemiology of Cardiovascular Diseases and their Risk Factors in Regions of Russian Federation (ESSE-RF) study (Tomsk).Material and methods. We analyzed the data of 1342 people aged 25-64 (4,3±11,6) years, in whom arterial stiffness was assessed as part of the ESSE-RF study using the vascular screening system VaSeraVS-1500, followed by phone contacts, on average, 4,7 years later. We studied the prognostic role of CAVI in relation to primary composite (cardiovascular death, nonfatal myocardial infarction (MI) or stroke) and secondary composite (all CVEs) endpoints.Results. We revealed that prior myocardial infarction or stroke (n=52) is associated with an increase in CVE incidence from 2,3 to 11,5% (p=0,0003) and from 5% to 23% (p<0,001) for primary and secondary composite endpoints, respectively. In a group of 1290 people (without prior MI or stroke), CAVI was significantly higher in men than in women: 7,4±1,4 vs 7,1±1,3 (p=0,002), despite more young age: 45,4±11,8 vs 48,0±11,3 years (p<0,001). The risk criterion for CVE was CAVI >7,8 (relative risk (RR): 5,06; 95% confidence interval (CI): 2,32-11,06) (p<0,001) and (RR: 3,95; 95% CI: 2,37-6,58) (p<0,001), which retains its predictive value when adjusted for conventional risk factors (RR: 3,13; 95% CI: 1,26-7,75) (p=0,014) and (RR: 2,16; 95% CI: 1,18-3,98) (p=0,013) — primary and secondary composite endpoints, respectively.Conclusion. CAVI has a significant independent value in predicting CVEs in Tomsk adult urban population aged 25-64 years. To clarify the cardiovascular risk, vascular screening with identifying CAVI should be carried out during preventive and screening examinations for men over 35 and women over 45.

Pilot project to study the association of troponin I with cardiovascular events in the population of Russian region

Aim. As part of a pilot study, to investigate the potential significance of cardiac troponin I (cTnI) in assessing the risk of cardiovascular diseases (CVD) in general population aged 35-64 years of one of the regions from the ESSE-RF study.Material and methods. The study is based on the ESSE-RF observational prospective study using a sample from one Russian region. The analysis included socio-demographic variables, risk factors, history of CVD. The cTnI level was measured from November to December 2021 in serum samples stored at -70° C using high sensitivity chemiluminescent microparticle immunoassay using Architect Stat High Sensitivity Troponin I (Abbott) reagents on an Architect i2000SR immunoassay analyzer (Abbott, Abbot Park IL USA). The endpoints were hard (cardiovascular death and myocardial infarction) and composite endpoints (cardiovascular death, new cases of myocardial infarction, stroke, coronary artery disease and revascularization). The median follow-up was 5,5 years. In total, the analysis included 1120 people aged 35-64 years.Results. Analysis of the associations between Systematic Coronary Risk Evaluation (SCORE) and cTnI showed a significant difference in risk stratification for these two parameters. In women from cTnI-related high-risk category for cardiovascular events (CVE), there were no endpoints at all. In men of moderate and high risk, the proportion of endpoints increases with increasing cTnI-related risk. The survival curves corresponding to first 3 quintiles of cTnI risk distribution did not diverge, and, therefore, the number of CVEs in these groups did not differ. At the same time, the curves corresponding to 4th and 5th quintiles significantly differed from the first 3 quintiles, which indicates a higher CVE risk in subjects from these groups (p<0,001). Considering that there were only 3 endpoints in cTnI-related high-risk group, a survival analysis was performed for low-risk versus moderate-high risk. The curves obtained diverge significantly (p=0.006). Cox proportional hazards models were analyzed to assess the relationship between the cTnI level and endpoints. It was shown that cTnI itself or its logarithm is significantly associated with hard and composite endpoints. The cTnI cut-off point of 12/10 pg/ml (males/females) was associated with hard endpoint, and 6/4 pg/ml — with composite one. It should be noted that the recommended cut-off point of 6/4 pg/ml is close to the upper quartile of cTnI distribution in the European population. For the Russian population, the upper quartile corresponds to cTnI level of 3,5/2,1 pg/ml, which indicates the need to reduce the critical cTnI values in Russia. To assess risk reclassification, Cox models were analyzed using the Net Reclassification Index (NRI), as well as NRIsurvival for survival analysis. For categorical variables, the NRIcategorial was used. Both methods of including cTnI in the model significantly improve the risk classification of severe endpoints in men.Conclusion. The results obtained confirm the need to lower the threshold values for predicting combined endpoints, in particular, in Russian men. cTnl has an independent effect on CVE risk and its addition to SCORE improves the prediction of CVEs among men. However, the data obtained are preliminary and require clarification sing larger sample. At the same time, it is obvious that the determination of cТnI level can play a significant role in cardiovascular risk assessment and be an unfavorable prognosis marker among Russian population.