The Impact of Anxiety and Depression Symptoms on Cardiovascular Risk Factor Control in Patients Without a History of Atherosclerotic Cardiovascular Disease.

Background: Anxiety and depression by affecting lifestyle interfere with preventive actions aimed at eliminating or reducing modifiable risk factors for cardiovascular diseases (CVD). Purpose: The objective of the study was to assess the impact of anxiety and depression on the achievement of therapeutic goals regarding CVD risk factors in patients without a history of atherosclerotic CVD. Patients and Methods: The study included 200 patients (median age 52.0 [IQR 43.0-60.5] years). Control of the basic risk factors was assessed: blood pressure, BMI, waist circumference, physical activity, smoking status, LDL cholesterol, triglycerides, and blood glucose. The data analysis included a comparison of the number of controlled risk factors and the percentage of subjects who achieved the therapeutic goal for each of the cardiovascular risk factors. The risk of CVD was assessed with SCORE2 and SCORE2-OP. Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS). On both subscales (HADS Anxiety and HADS Depression), subjects could achieve normal, borderline, and abnormal scores. Results: The median number of controlled CVD risk factors was 4.0 (IQR 3.0-5.0), and the median CVD risk assessed with SCORE2 and SCORE2-OP was 3.0% (IQR 1.5-7.0%). Median scores for HADS Anxiety were 3.0 (IQR 2.0-6.0) and for HADS Depression 3.0 (1.0-5.0). Patients with symptoms of anxiety and depression had significantly fewer controlled risk factors (HADS Anxiety p=0.0014; HADS Depression p=0.0304). Among subjects with anxiety and depression, there was a significantly lower percentage of those with a normal waist circumference (HADS Anxiety p=0.0464; HADS Depression p=0.0200) and regular physical activity (HADS Anxiety p=0.0431; HADS Depression p=0.0055). Among subjects with anxiety, there was a significantly lower percentage of those with a normal BMI (p=0.0218) and normal triglyceride concentrations (p=0.0278). Conclusion: The presence of anxiety and depression may affect the control of CVD risk factors in individuals without a history of atherosclerotic CVD. Assessment of anxiety and depression symptoms should be part of a comprehensive examination of patients with high CVD risk.

Achieving Cardiovascular Risk Management Goals and Patient Quality of Life.

(1) Background: Eliminating or reducing the severity of modifiable risk factors of cardiovascular disease (CVD) and undertaking health-promoting behaviors is the basis for prevention. (2) Methods: This study included 200 subjects without a history of CVD, aged 18 to 80 years, who had been diagnosed with hypertension, hypercholesterolemia, or diabetes 6 to 24 months before study enrolment. (3) Results: The median 10-year CV risk assessed by the SCORE2 and SCORE2-OP algorithms was 3.0 (IQR 1.5-7.0). An increase in mean cardiovascular risk in the range from low and moderate to very high was associated with a decrease in quality of life both in individual subscales and the overall score. The median number of controlled risk factors was 4.0 (IQR 3.0-5.0). As the mean number of controlled risk factors increased, the quality of life improved in both of HeartQoL questionnaire subscales (emotional p = 0.0018; physical p = 0.0004) and the overall score (global p = 0.0001). The median number of reported health-promoting behaviors undertaken within 3 years before study enrolment was 3.0 (IQR 2.0-4.0). The highest quality of life in each of the studied dimensions was found in people who reported undertaking three health-promoting behaviors. (4) Conclusions: Controlling CVD risk factors and undertaking health-promoting behaviors has a positive impact on the quality of life of patients without a history of atherosclerotic CVD.

Gender-Related Effectiveness of Personalized Post-COVID-19 Rehabilitation.

Background: Post-COVID-19 syndrome (PCS) may affect a substantial proportion of patients who have had COVID-19. The rehabilitation program might improve the physical capacity, functioning of the cardiopulmonary system, and mental conditions of these patients. This study aimed to investigate the effectiveness of personalized rehabilitation in patients with PCS according to gender. Methods: Adults who underwent a 6-week personalized PCS rehabilitation program were enrolled in a prospective post-COVID-19 Rehabilitation (PCR-SIRIO 8) study. The initial visit and the final visit included the hand-grip strength test, the bioimpedance analysis of body composition, and the following scales: modified Borg's scale, Modified Fatigue Impact Scale (MFIS), Functioning in Chronic Illness Scale (FCIS), modified Medical Research Council (mMRC) dyspnea scale, and tests: 30 s chair stand test (30 CST), Six-Minute Walk Test (6MWT), Short Physical Performance Battery test (SPPB)e. Results: A total of 90 patients (54% female) underwent the rehabilitation program. Rehabilitation was associated with an increase in skeletal muscle mass (24.11 kg vs. 24.37 kg, p = 0.001) and phase angle (4.89° vs. 5.01°, p = 0.001) and with a reduction in abdominal fat tissue volume (3.03 L vs. 2.85 L, p = 0.01), waist circumference (0.96 m vs. 0.95 m, p = 0.001), and hydration level (83.54% vs. 82.72%, p = 0.001). A decrease in fat tissue volume and an increase in skeletal muscle mass were observed only in females, while an increase in grip strength was noticed selectively in males. Patients' fatigue (modified Borg's scale, MFIS), physical capacity (30 CST, 6MWT), balance (SPPB), dyspnea (mMRC), and functioning (FICS) were significantly improved after the rehabilitation regardless of gender. Conclusions: Personalized rehabilitation improved the body composition, muscle strength, and functioning of patients diagnosed with PCS. The beneficial effect of rehabilitation on body composition, hydration, and phase angle was observed regardless of gender.

Determinants of Lipid Parameters in Patients without Diagnosed Cardiovascular Disease-Results of the Polish Arm of the EUROASPIRE V Survey.

To assess the determinants of lipid parameters in primary care patients without diagnosed cardiovascular disease (CVD), a cross-sectional study was conducted during 2018-2019 with a total of 200 patients. The following lipid parameters were measured: total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), small, dense LDL (sdLDL-C), and lipoprotein (a) (Lp(a)). Predictors of elevated and adequately controlled lipid parameters were assessed with logistic regression analysis. Older age was related to higher risk of TC ≥ 6.2 mmol/L [OR 1.03 (95% CI 1.0-1.05)], sdLDL-C ≥ 1.0 mmol/L [OR 1.05 (95% CI 1.0-1.1)], and decreased risk of Lp(a) ≥ 50 mg/dL [OR 0.97 (95% CI 0.94-0.99)]. Patients with diabetes mellitus (DM) had increased probability of TG ≥ 2.25 mmol/L [OR 3.77 (95% CI 1.34-10.6)] and Lp(a) ≥ 50 mg/dL [OR 2.97 (1.34-6.10)] as well as adequate control of TG and Lp(a). Higher material status was related to lower risk of TC ≥ 6.2 mmol/L [OR 0.19 (95% CI 0.04-0.82)] and LDL-C ≥ 3.6 mmol/L [OR 0.33 (95% CI 0.12-0.92)]. High BMI was related to increased [OR 1.14 (95% CI 1.02-1.29)], and female gender [OR 0.33 (95% CI 0.12-0.96)] and hypertension [OR 0.29 (95% CI 0.1-0.87)] to decreased risk of TG ≥ 2.25 mmol/L [OR 1.14 (95% CI 1.02-1.29)]. Taking lipid-lowering drugs (LLD) was associated with LDL-C < 2.6 mmol/L [OR 2.1 (95% CI 1.05-4.19)] and Lp(a) < 30 mg/dL [OR 0.48 (95% CI 0.25-0.93)]. Physical activity was related to LDL-C < 2.6 mmol/L [OR 2.02 (95% CI 1.02-3.98)]. Higher abdominal circumference was associated with decreased risk of TG < 1.7 mmol/L [OR 0.96 (95% CI 0.93-0.99)]. Elevated lipid parameters were related to age, gender, material status, BMI, history of DM, and hypertension. Adequate control was associated with age, education, physical activity, LLD, history of DM, and abdominal circumference.

Effects of Multidisciplinary Rehabilitation Program in Patients with Long COVID-19: Post-COVID-19 Rehabilitation (PCR SIRIO 8) Study.

Up to 80% of COVID-19 survivors experience prolonged symptoms known as long COVID-19. The aim of this study was to evaluate the effects of a multidisciplinary rehabilitation program in patients with long COVID-19. The rehabilitation program was composed of physical training (aerobic, resistance, and breathing exercises), education, and group psychotherapy. After 6 weeks of rehabilitation in 97 patients with long COVID-19, body composition analysis revealed a significant decrease of abdominal fatty tissue (from 2.75 kg to 2.5 kg; p = 0.0086) with concomitant increase in skeletal muscle mass (from 23.2 kg to 24.2 kg; p = 0.0104). Almost 80% of participants reported dyspnea improvement assessed with the modified Medical Research Council scale. Patients' physical capacity assessed with the 6 Minute Walking Test increased from 320 to 382.5 m (p < 0.0001), the number of repetitions in the 30 s Chair Stand Test improved from 13 to 16 (p < 0.0001), as well as physical fitness in the Short Physical Performance Battery Test from 14 to 16 (p < 0.0001). The impact of fatigue on everyday functioning was reduced in the Modified Fatigue Impact Scale from 37 to 27 (p < 0.0001). Cardiopulmonary exercise test did not show any change. The multidisciplinary rehabilitation program has improved body composition, dyspnea, fatigue and physical capacity in long COVID-19 patients.

Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs after Vaccination (DANTE-SIRIO 7) Study in a Large Cohort of Healthcare Workers.

The aim of this study was to determine anti-SARS-CoV-2 IgG concentrations and their major determinants in healthcare workers (HCWs) after full vaccination with the BNT162b2 vaccine. We recruited 847 individuals vaccinated with two doses of the BNT162b2 vaccine, who completed the questionnaire, and whose antibody concentrations were tested after 3 and 6 months after full vaccination. Anti-SARS-CoV-2 IgG levels were measured on the routinely employed Siemens Atellica system. The cutoff for positivity was ≥21.8 BAU/mL. Three and 6 months after vaccination, the majority of participants were seropositive. Median concentrations of anti-SARS-CoV-2 IgG significantly decreased from 1145 BAU/mL (IQR: 543-2095) to 225 BAU/mL (IQR: 100-510). Major positive determinants of antibody levels were fever after both doses of vaccine, prior-COVID-19 exposure, and muscle pain after the first dose. Lack of symptoms after the second dose and time since vaccination were significant negative determinants of anti-SARS-CoV-2 IgG concentrations. No other factors, including age and gender, or underlying comorbidities had a significant effect on antibody levels in HCWs. The anti-SARS-CoV-2 response after two doses of BNT162b2 vaccine was independently associated with prior-COVID-19 exposure, time since vaccination, and the occurrence of symptoms after either dose of vaccine. Easily reportable adverse reactions may facilitate the identification of immune response in HCWs.

The occurrence of cardiovascular risk factors and functioning in chronic illness in the Polish population of EUROASPIRE V.

BACKGROUND: The aim of this study was to assess the impact of cardiovascular risk on the functioning of patients without a history of atherosclerotic cardiovascular disease. METHODS: Two hundred patients diagnosed with arterial hypertension, hypercholesterolemia, or diabetes were enrolled in the study. The median age was 52.0 years (interquartile range [IQR] 43.0-60.0). The following risk factors were assessed: blood pressure, body mass index, waist circumference, physical activity, smoking, LDL-cholesterol, triglycerides, and fasting plasma glucose concentration. Total cardiovascular risk was determined as the number of uncontrolled risk factors, and with the Systemic Coronary Risk Evaluation Score (SCORE). The Functioning in the Chronic Illness Scale (FCIS) was applied to assess the physical and mental functioning of patients. RESULTS: The median number of measures of cardiovascular risk factors was 4.0 (IQR 3.0-5.0). The median of SCORE for the whole study population was 2.0 (IQR 1.0-3.0). Patients with lower total cardiovascular risk as defined by SCORE and number of uncontrolled risk factors had better functioning as reflected by higher FCIS (R = -0.315, p < 0.0001; R = -0.336, p < 0.0001, respectively). Multivariate logistic regression analysis identified abnormal blood pressure, abnormal waist circumference, tobacco smoking, and lack of regular physical activity to be negative predictors of functioning. Lack of regular physical activity was the only predictor of low FCIS total score (odds ratio 9.26, 95% confidence interval 1.19-71.77, p = 0.03). CONCLUSIONS: The functioning of patients worsens as the total cardiovascular risk increases. Each of the risk factors affects the functioning of subjects without coronary artery disease with different strength, with physical activity being the strongest determinant of patient functioning.

Ion channel inhibition with amiodarone or verapamil in symptomatic hospitalized nonintensive-care COVID-19 patients: The ReCOVery-SIRIO randomized trial.

BACKGROUND: Ion channel inhibition may offer protection against coronavirus disease 2019 (COVID-19). Inflammation and reduced platelet count occur during COVID-19 but precise quantification of risk thresholds is unclear. The Recov ery-SIRIO study aimed to assess clinical effects of amiodarone and verapamil and to relate patient phenotypes to outcomes. METHODS: RECOVERY-SIRIO is a multicenter open-label 1:1:1 investigator-initiated randomized trial with blinded event adjudication. A sample of 804 symptomatic hospitalized nonintensive-care COVID-19 patients, follow-up for 28 days was initially planned. RESULTS: The trial was stopped when a total of 215 patients had been randomized to amiodarone (n = 71), verapamil (n = 72) or standard care alone (n = 72). At 15 days, the hazard ratio (hazard ratio [HR], 95% confidence interval [CI]) for clinical improvement was 0.77 (0.52-1.14) with amiodarone and 0.97 (0.81-1.17) with verapamil as compared to usual care. Clinically relevant associations were found between mortality or lack of clinical improvement and higher peak C-reactive protein (CRP) levels or nadir platelet count at 7, 10 and 15 days. Mortality rate increased by 73% every 5 mg/dL increment in peak CRP (HR 1.73, 95% CI 1.27-2.37) and was two-fold higher for every decrement of 100 units in nadir platelet count (HR 2.19, 95% CI 1.37-3.51). By cluster analysis, thresholds of 5 mg/dL for peak CRP and 187 × 103/mcL for nadir platelet count identified the phenogroup at greatest risk of dying. CONCLUSIONS: In this randomized trial, neither amiodarone nor verapamil were found to significantly accelerate short-term clinical improvement. Peak CRP and nadir platelet counts were associated with increased mortality both in isolation and by cluster analysis.

The impact of readiness to discharge from hospital on adherence to treatment in patients after myocardial infarction.

BACKGROUND: The healthcare professionals involved in in-hospital treatment of myocardial infarction (MI) are also responsible to patients for their education before leaving the hospital. This education aims to modify patient behaviour in order to reduce relevant risk factors and improve self-control and adherence to medications. The aim of the study was to analyse the relationship between readiness for discharge from hospital and adherence to treatment at follow-up in MI patients. METHODS: An observational, single-center, MI cohort study with 6-month follow-up was conducted between May 2015 and July 2016. The Readiness for Hospital Discharge after Myocardial Infarction Scale (RHD-MIS) and the Adherence in Chronic Diseases Scale (ACDS) were applied. RESULTS: Two hundred and thirteen patients aged 30-91 years (62.91 ± 11.26) were enrolled in the study. The RHD-MIS general score ranged from 29 to 69 points (51.16 ± 9.87). A high level of readiness was found in 66 patients (31%), intermediate in 92 (43.2%), and low in 55 (25.8%) of patients. Adherence level assessed with the ACDS 6-months after discharge from hospital ranged from 7 to 28 points (23.34 ± 4.06). An increase in objective assessment of patient knowledge according to RHD-MIS subscale resulted in significantly higher level of adherence at the follow-up visit (p = 0.0154); R Spearman = 0.16671, p = 0.015; p for trend = 0.005. During the 6-month follow-up 3 (1.41%) patients died and 17 (7.98%) were hospitalized for a subsequent acute coronary syndrome. CONCLUSIONS: This study provided preliminary evidence of a long-term association between the results of assessment of readiness for discharge from hospital and adherence to treatment in patients after MI.

The influence of patient expectations on adherence to treatment regimen after myocardial infarction.

OBJECTIVE: In-hospital patient education is one of the elements affecting patient adherence to treatment regimen after myocardial infarction (MI). Its effectiveness is determined by educator and patient-dependent factors. Previous studies did not identify patient expectations as an independent determinant of successful education. The aim of this study was to assess whether patient knowledge and expectations affect adherence to treatment regimen in a 1-year follow-up. METHODS: This was a single-center, cohort study with a 1-year follow-up. Patient knowledge and expectations were evaluated using the Readiness for Hospital Discharge after Myocardial Infarction Scale (RHD-MIS scale). Medication adherence (including angiotensin converting enzyme inhibitors (ACEI), P2Y12 receptor inhibitors and statins) was verified based on prescription refill data extracted from The National Health Fund database. RESULTS: The study included 225 patients aged 30-91 years (mean age 62.9 ± 11.9 years). In the 4th quarter of follow-up, patients with the highest expectations had lower adherence regarding ACEI (p = 0.01), P2Y12 receptor inhibitors (p = 0.03) and the combination of all three analysed medications (p = 0.003). CONCLUSIONS: The initial results suggest presence of a relationship between patient expectations and long-term adherence to treatment. PRACTICE IMPLICATIONS: Post-MI patient education directed at fulfilling or modification of patient expectations could possibly improve execution of treatment regimen.

A new approach to ticagrelor-based de-escalation of antiplatelet therapy after acute coronary syndrome. A rationale for a randomized, double-blind, placebo-controlled, investigator-initiated, multicenter clinical study.

The risk of ischemic events gradually decreases after acute coronary syndrome (ACS), reaching a stable level after 1 month, while the risk of bleeding remains steady during the whole period of dual antiplatelet treatment (DAPT). Several de-escalation strategies of antiplatelet treatment aiming to enhance safety of DAPT without depriving it of its efficacy have been evaluated so far. We hypothesized that reduction of the ticagrelor maintenance dose 1 month after ACS and its continuation until 12 months after ACS may improve adherence to antiplatelet treatment due to better tolerability compared with the standard dose of ticagrelor. Moreover, improved safety of treatment and preserved anti-ischemic benefit may also be expected with additional acetylsalicylic acid (ASA) withdrawal. To evaluate these hypotheses, we designed the Evaluating Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome - a randomized clinical trial (ELECTRA-SIRIO 2), to assess the influence of ticagrelor dose reduction with or without continuation of ASA versus DAPT with standard dose ticagrelor in reducing clinically relevant bleeding and maintaining anti-ischemic efficacy in ACS patients. The study was designed as a phase III, randomized, multicenter, double-blind, investigator-initiated clinical study with a 12-month follow-up (ClinicalTrials.gov Identifier: NCT04718025; EudraCT number: 2020-005130-15).

Therapy Discontinuation after Myocardial Infarction.

The discontinuation of recommended therapy after myocardial infarction predisposes patients to serious thrombotic complications. The aim of this study was a comprehensive analysis of permanent as well as short- and long-term discontinuation of pharmacotherapy, taking into consideration the basic groups of medications and nonadherence determinants in a one-year follow-up in post-myocardial infarction (MI) patients. MATERIAL AND METHODS: The study was a single center cohort clinical trial with a one-year follow-up including 225 patients (73.3% men, 26.7% women) aged 62.9 ± 11.9 years. In eight cases (3.6%), the follow-up duration was less than one year due to premature death. The following factors were analyzed: lack of post-discharge therapy initiation; short-term therapy discontinuation (<30 days); long-term therapy discontinuation (≥30 days); and permanent cessation of therapy. The analysis of therapy discontinuation was performed based on prescription filling data. RESULTS: Occupational activity (Odds Ratio (OR) 5.15; 95% Confidence interval (CI) 1.42-18.65; p = 0.013) and prior MI (OR 5.02; 95% CI 1.45-16.89; p = 0.009) were found to be independent predictors of a lack of post-discharge therapy initiation with P2Y12 receptor inhibitors. We found no independent predictors of lack of post-discharge therapy initiation with other medications, whether analyzed separately or together. Age above 65 years (Hazard Ratio (HR)-1.59; 95% CI 1.15-2.19; p = 0.0049) and prior revascularization (HR-1.44; 95% CI 1.04-2.19; p = 0.0273) were identified as independent predictors of therapy discontinuation. Multilogistic regression analysis showed no independent predictors of the cessation of any of the medications as well as the permanent or temporary simultaneous discontinuation of all medications. CONCLUSIONS: The vast majority of post-MI patients discontinue, either temporarily or permanently, one of the essential medications within one year following myocardial infarction. The most likely medication class to be discontinued are statins. Older age and prior cardiac revascularization are independent determinants of therapy discontinuation.

Medication adherence and its determinants in patients after myocardial infarction.

Non-adherence to prescribed medication is a serious limitation of long-term treatment in patients after myocardial infarction (MI), which can be associated with medical, social and economical consequences. Improvement of medication adherence has been shown to be a challenge for healthcare providers. The aim of this study was to evaluate changes in medication adherence and variability of adherence determinants during follow-up in patients after MI. A single-center, cohort observational study was conducted in 225 post-MI patients treated with primary coronary intervention (PCI) (27% women and 73% men) aged 30-91 years. Adherence was defined as availability of evaluated drugs within 1-year after discharge from hospital, based on completed prescriptions data obtained from the National Health Fund. The analysis of therapeutic plan realization (adherence to medication prescribed at discharge from hospital) embraced only reimbursed drugs: ACEIs (ramipril, perindopril), P2Y12 receptor inhibitors (clopidogrel) and statins (atorvastatin, simvastatin, rosuvastatin). Sufficient adherence was defined as ≥ 80%. During 1-year follow-up, adherence for all three drug classes was 64 ± 25%, with 67 ± 32% for ACEIs, 62 ± 34% for P2Y12 receptor inhibitor and 64 ± 32% for statins. A gradual decline in adherence was observed from 65% ± 26% in the first quarter of follow-up to 51% ± 34% in the last quarter of follow-up (p < 0.00001). Sufficient adherence for all drugs classes was found only in 29% of patients throughout the whole follow-up period (44% for ACEI, 36% for P2Y12 receptor inhibitor and 41% for statins). According to a multivariate analysis, age, prior CABG, level of education, place of residence, economic status and marital status were independent predictors of drug adherence. Whereas patients > 65 years and having a history of prior CABG more often had an insufficient adherence to drugs, married and hypertensive patients, city inhabitants and patients with higher education tended to have a sufficient drug adherence. Adherence to pharmacotherapy after myocardial infarction decreases over time in a similar manner for all pivotal groups of drugs prescribed after MI. A number of socioeconomic and clinical factors have been identified to affect medication adherence over time.

Adherence to treatment assessed with the Adherence in Chronic Diseases Scale in patients after myocardial infarction.

INTRODUCTION: A substantial subset of patients after myocardial infarction (MI) discontinue pivotal medication early after discharge. In particular, cessation of antiplatelet treatment may lead to catastrophic ischemic events. Thus, adherence to prescribed medication in patients after MI is an issue of medical and social concern. PURPOSE: The aim of the study was to evaluate the level of adherence to treatment using a newly developed scale in patients after MI treated with percutaneous coronary intervention. PATIENTS AND METHODS: A single-center, prospective, observational cohort clinical study with a 6-month follow-up was performed. Patients with physical or cognitive impairment, prisoners, soldiers, and family members and coworkers of the researchers were excluded from the study. The impact of selected sociodemographic and clinical factors on adherence was evaluated in 221 patients (63 women and 158 men) aged 30 to 91 years. RESULTS: The results obtained with the Adherence in Chronic Diseases Scale (ACDS) ranged from 7 to 28 points; with the average and median scored being 23.35 and 24, respectively. The ACDS score reflects the level of adherence to prescribed medication. The high ACDS scores (>26 points) were obtained in 59 (26.7%) patients, intermediate scores (21-26 points) in 110 (49.8%) and low scores (<21 points) in 52 subjects (23.5%). Acute coronary syndrome (re-ACS) occurred in 18 (8.1%) patients during the follow-up period. The high-level adherence (ACDS score >26 points) was found in 11.1% of patients with re-ACS vs 28.4% of the remaining ones (P=0.1). Lower scores (mean ± standard deviation) in re-ACS patients were found for items 2 and 3 of the ACDS: 3.11±0.68 vs 3.45±0.73 (P=0.02) and 3.28±0.89 vs 3.64±0.64 (P=0.04), respectively. CONCLUSION: Age and previous MI were found to be independent factors influencing adherence assessed with the ACDS.