bluuebunny/crossref_metadata_2025_split huggingface dataset:
Impact of diabetes on outcome with drug-coated balloons versus drug-eluting stents: the BASKET-SMALL 2 trial
Authors: Wohrle J , Scheller B , Seeger J , Farah A , Ohlow A , Mangen N , Moebius-Winkler S , Weilenmann D , Stachel G , Leibundgut G , Rickenbacher P , Cattaneo M , Gilgen N , Kaiser C , Jeger R V ,   BASKET-SMALL 2
Published: October 2021

Abstract

Objectives
To evaluate the impact of diabetes mellitus on 3 year clinical outcome in patients undergoing drug-coated balloon (DCB) or drug-eluting stent (DES) treatment for de-novo lesions.

Background
For the treatment of de-novo coronary small vessel disease DCB are non-inferior to DES regarding clinical outcome up to 3 years.

Methods
In this prespecified analysis of a multicenter, randomized, non-inferiority trial, including 758 patients with de-novo lesions in coronary vessels &lt;3mm who were randomized 1:1 to DCB (n=382) or DES (n=376) and followed over 3 years for major adverse cardiac events (MACE: cardiac death, non-fatal myocardial infarction [MI], and target-vessel revascularization [TVR]), outcome was analyzed regarding the presence or absence of diabetes mellitus.

Results
In non-diabetic patients (n=506) rates of MACE (13.0% vs. 11.5%, hazard ratio [HR] 1.24, 95% confidence interval [CI] 0.73–2.09, p=0.43), cardiac death (2.8% vs. 2.9%, HR 0.97, 95% CI 0.32–2.92, p=0.96), non-fatal MI (5.1% vs. 4.8%, HR 1.00, 95% CI 0.44–2.28, p=0.99), and TVR (8.8% vs. 6.1%, HR 1.64, 95% CI 0.83–3.25, p=0.16) were similar in DCB and DES. In diabetic patients (n=252) rates of MACE (19.3% vs. 22.2%, HR 0.82, 95% CI 0.45–1.48, p=0.51), cardiac death (8.8% vs. 5.9%, HR 2.01, 95% CI 0.76–5.31, p=0.16), non-fatal MI (7.1% vs. 9.8%, HR 0.55, 95% CI 0.21–1.49, p=0.24) were similar in DCB and DES, whereas TVR was significantly lower with DCB compared to DES (9.1% vs. 15.0%, HR 0.40, 95% CI 0.17–0.94, p=0.036). In addition, need for TVR was highest in diabetic patients treated with DES (Picture 1).

Conclusions
The rates of MACE are similar in DCB and DES in de-novo coronary lesions of diabetic and non-diabetic patients. In diabetic patients the need for TVR was significantly lower with DCB compared to DES.

Funding Acknowledgement
Type of funding sources: Foundation. Main funding source(s): Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, Basel Cardiovascular Research Foundation, and B Braun Medical AG. Picture 1
Clinical outcomes with drug-eluting stents, bare-metal stents, and bioresorbable scaffolds implanted in patients with AMI treated with primary PCI. Data from the Prague-18 trial
Authors: Hlinomaz O , Sabbah M , Knot J , Miklik R , Hromadka M , Varvarovsky I , Dusek J , Jarkovsky J , Tousek F , Majtan B , Simek S , Branny M , Svoboda M , Widimsky P , Motovska Z ,   PRAGUE-18 study group
Published: October 2021

Abstract

Background
Drug-eluting stents (DESs) are the recommended choice of stents for primary PCI.

Purpose/Methods
The study aimed to determine why interventional cardiologists used non-DESs and how they had influenced the patient prognosis. The efficacy and safety outcomes of the different stents were also compared in treated with either prasugrel or ticagrelor.

Results
Of the PRAGUE 18 study patients, 749 (67.4%) were treated with DESs, 296 (26.6%) with BMS, and 66 (5.9%) with BVS. Cardiogenic shock at presentation and the left main disease, especially as culprit lesion, and right coronary artery stenosis were the reasons for BMS selection.
The incidence of the primary net-clinical EP (CV death, nonfatal MI, stroke, major bleeding, or revascularization) at 7 days was 2.6% vs. 6.5%, and 3.0% in the DESs, BMSs, and BVSs, respectively (HR 2.7; 95% CI 1.419–5.15, P=0.002 for BMS vs. DES and 1.25 (0.29–5.39) for BVS vs. DES, P=0.76). Patients with BMSs were at higher risk of death at 30 days (HR 2.20; 95% CI 1.01–4.76; for BMS vs. DES, P=0.045), and at one year (HR 2.1; 95% CI 1.19–3.69; P=0.01); they also had higher composite of cardiac death, re-MI and stroke (HR 1.66; 95% CI 1.0–2.74; P=0.047) at one year. BMSs were associated with significantly higher rate of primary EPs either treated with prasugrel or ticagrelor.

Conclusion
Patients with the highest risk profile were preferably treated with BMS the contrary to BVS. BMSs were associated with a significantly higher rate of cardiovascular events either treated with prasugrel or ticagrelor.

Funding Acknowledgement
Type of funding sources: Public Institution(s). Main funding source(s): Charles University Cardiovascular Research Program P-35 and Q-38, Charles University, Czech Republic
Novel pressure-regulated deployment strategy for improving the safety and efficacy of balloon-expandable transcatheter aortic valves
Authors: Snir A , Wilson M K , Ju A L , Wong S , Khor L , Naoum C , Wong K , Keech A , Celermajer D S , Ng M K 
Published: October 2021

Abstract

Background
The optimal method for balloon-expandable transcatheter heart valve (THV) deployment remains unknown. Current implantation protocols are volume-dependent and rely on ad-hoc filling of the deployment apparatus without accounting for annular wall tension during prosthesis expansion, predisposing patients to inconsistent clinical outcomes. During THV deployment, the annular wall tension exerted by the expanding prosthesis is determined by prosthesis diameter and balloon pressure (Laplace's Law).

Objective
We proposed and tested a novel method for balloon-expandable THV deployment, aimed at controlling balloon pressure and the resulting annular wall tension to allow optimal prosthesis-annulus apposition while preventing significant tissue injury.

Methods
330 consecutive patients with severe native aortic stenosis who underwent balloon-expandable THV implantation between 2015–2020 were included. 106 patients were considered high-risk for annular rupture. THVs were deployed until reaching a pre-determined balloon pressure; 4–4.5atm in earlier cases to establish experience and safety, later increasing to 5–6.5atm in most cases. Post-dilatation was performed to reduce &gt;mild angiographic regurgitation (PVR). Using a biomechanical model, annular wall stress (tension) was estimated for each case and assessed against recorded rates of post-dilatation, ≥mild paravalvular regurgitation (PVR) on TTE, new PPM or LBBB and annular rupture.

Results
Patients with wall stress &gt;3MPa (n=184) had reduced post-dilatation rate (p&lt;0.001) and final PVR (≥mild, p=0.014). Annular rupture occurred in 2/3 high-risk cases with wall stress &gt;3.5MPa; no rupture occurred in 102 high-risk cases with wall stress ≤3.5MPa. Based on these results, we defined target deployment wall stress levels (3–3.5MPa) and associated deployment pressure per THV size. Patients within this target range (n=136) had 8.1% new PPM, 12.5% new LBBB, 12.7% mild PVR with no cases of ≥moderate PVR. Importantly, there was an inconsistent relationship between deployment balloon volume and resulting annular wall stress.

Conclusion
Pressure-regulated THV deployment is a simple, easily reproducible, safe and effective method, regardless of high-risk anatomical complexities.

Funding Acknowledgement
Type of funding sources: None. Annular wall stress and PVRModel, stress vs volume and new strategy
Prevalence of atherosclerosis risk factors in Egyptian patients with acute coronary syndromes; final data of the nationwide cross-sectional CardioRisk project
Authors: Reda A , Bendary A , Elbahry A , Farag E , Mostafa T , Khamis H , Wadie M , Bendary M , Abdoul Azeem B , Salah R ,   CardioRisk investigators
Published: October 2021

Abstract

Background
Little are known about the prevalence of atherosclerosis risk factors in Egyptian patients with acute coronary syndromes (ACS). Objective: To describe the prevalence of these risk factors with focus on gender-specific data and patients with premature presentation.

Methods
From November 2015 to August 2018, data were collected from 3224 patients with ACS in 30 coronary care centers covering 11 governorates across Egypt, with focus premature ACS.

Results
The vast majority were males (74%) and the most prevalent age group was (56–65 years) representing 37% of whole study population. Among female patients, 92% were post-menopausal. The prevalence of premature ACS was 51%. Forty five percent of total males and 69.6% of total females with ACS had premature presentation (P&lt;0.001). Abdominal obesity was the most prevalent risk factor (66%). Nearly half of the entire study patients were current smokers (48%). We showed a high prevalence of documented dyslipidemia (48%) as well. Early invasive management strategy was employed in 65% of patients with no significant gender disparity noticed. Vascular access for coronary angiography was most commonly femoral (80% of time). Emergent percutaneous coronary intervention (PCI) was attempted in 53% of patients. Thrombolytic therapy (using Streptokinase) was used in 24% of included participants.

Conclusion
Among Egyptian patients with ACS, premature presentation is common with greater male preponderance. Abdominal obesity is the most prevalent risk factor followed by hypertension. Most traditional risk factors (apart from smoking) were more prevalent in women than men.

Funding Acknowledgement
Type of funding sources: Private company. Main funding source(s): AstraZeneca Table 1. Premature Atherosclerosis subgroupTable 2. Geographic distribution of risk factors
Lifestyle modification based on cluster cardiovascular risk assessment reduced the risk of sleep apnea
Authors: Guo Y , Zhang H , Lip G Y H ,   mAFA investigators
Published: October 2021

Abstract

Background
Sleep apnea is associated with cardiovascular events, nonetheless, the early concern for multi-risk factor management, complied with guideline-based clinical care pathways, is limit.

Objective
The present study aimed to investigate the impact on the burden of sleep apnea with lifestyle and physical activity modification based on cardiovascular cluster risk factors assessment, supported by a mobile health and wearable devices technologies.

Methods
The adult subjects aged over 18 years were enrolled in China between March 2, 2020 and August 4, 2020, who used a smart phone application “IamHealthy”, to assess the CV risk profile, including weight/activity, diet (the quality of diet was assessed using Alternative Healthy Eating Index,AHEI-2010), psychological status, sleep apnea, cardiac rhythm, blood pressure, blood lipid, diabetes. Once the subjects had compatible smart devices (Huawei Technologies Co., Ltd., Shenzhen, China), they achieved photoplethysmography (PPG)-based sleep apnea monitoring. The healthy lifestyle score (five aspects: diet, smoking, physical activity, alcohol consumption, and Body Mass Index) were calculated and a 3-month personalized App-based lifestyle and physical activity package was proposed for those with sleep apnea. The change on risk of sleep apnea monitored were evaluated.

Results
There were 775 subjects (mean age 48 years old, standard deviation, SD, 14, 90.1% male) with the “IamHealthy” App and 487 subjects (mean age 46 years old, standard deviation, SD, 13, 94.4% male) for sleep apnea monitoring with smart devices. Among these subjects, there were 42.3% subjects with overweight, 13.2% with obese; 44.3% with poor quality of healthy diet (AHEI scores &lt;66), 40.0% with inactive physical activity of &lt;1 time/week. The reported depression (Patient Health Questionnaire, PHQ-9 ≥5) and the anxiety (Generalised Anxiety Disorder, GAD-7 scale ≥5) were 41.2% and 62.5%, respectively. Only 22.4% subjects remained healthy lifestyle with over three low risk lifestyle scores.
Dietary Approaches to Control weight (61.6%), to Stop Hypertension (24%), and Mediterranean dietary (5%); Physical activities to control the weight (84.2%), control blood pressure (8.5%), and CV prevention (6.8%) were commonly proposed.
For subjects using IamHealthy to monitor sleep apnea after matching PPG -smart devices on baseline, the proportion of high-risk of sleep apnea decreased over time (baseline, 1 mon, 3 mons, and 6 mons, 60.67%, 47.25%, 44.12%, and 34.19%, p&lt;0.001, Figure).

Conclusions
Lifestyle modification based on cluster cardiovascular risk assessment reduced the high-risk sleep apnea.

Funding Acknowledgement
Type of funding sources: None.
Discriminatory accuracy of the SOFA score for determining clinical decompensation in patients presenting with COVID-19
Authors: Krepostman N , Collins M , Merchant K , De Sirkar S , Chan L , Allen S , Newman J , Patel D , Fareed J , Berg S , Darki A 
Published: October 2021

Abstract

Introduction
While the global dissemination of vaccines targeting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in a decline in the incidence of infections, the case fatality rates have remained relative stable. A major objective of managing hospitalized patients with documented or suspected COVID-19 infection is the rapid identification of features associated with severe illness using readily available laboratory tests and clinical tools. The sequential organ failure assessment (SOFA) score is a validated tool to facilitate the identification of patients at risk of dying from sepsis.

Purpose
The aim of this study was to assess the discriminatory accuracy of the SOFA score in predicting clinical decompensation in patients hospitalized with COVID-19 infection.

Methods
We conducted a retrospective analysis at a three-hospital health system, comprised of one tertiary and two community hospitals, located in the Chicago metropolitan area. All patients had positive SARS-CoV-2 testing and were hospitalized for COVID-19 infection. The primary outcome was clinical decompensation, defined as the composite endpoint of death, ICU admission, or need for intubation. We utilized the most abnormal laboratory values observed during the admission to calculate the SOFA score. Receiver Operating Curves (ROC) were then constructed to determine the sensitivity and specificity of SOFA scores.

Results
Between March 1st and May 31st 2020, 1029 patients were included in our analysis with 367 patients meeting the study endpoint. The median SOFA score was 2.0 IQR (Q1, Q3 1,4) for the entire cohort. Patients who had in-hospital mortality had a median SOFA score of 4.0 (Q1,Q3 3,7). In patients that met the primary composite endpoint, the median SOFA score was 3.0, IQR (Q1, Q3 2,6). The ROC was 0.776 (95% CI 0.746–0.806, p&lt;0.01).

Conclusion
The SOFA score demonstrates strong discriminatory accuracy for prediction of clinical decompensation in patients presenting with COVID-19 at our urban hospital system.

Funding Acknowledgement
Type of funding sources: Public hospital(s). Main funding source(s): Loyola University Medical Center
LDLc reduction with fixed-dose combination rosuvastatin-ezetimibe in patients with coronary heart disease that are not candidates for PCSK9 inhibitors treatment
Authors: Cordero A , Escribano D , Bertomeu-Gonzalez V , Lopez-Ayala J M , Monteagudo M , Quintanilla A M , Moreno-Arribas J , Perez-Berbell P , Zuazola P 
Published: October 2021

Abstract

Background
Statin plus ezetimibe combination has a recommendation class IIa, level of evidence B, for low-density lipoprotein cholesterol (LDLc) reduction. Since LDLc treatment target for patients with coronary heart disease (CHD) has been recently reduced to &lt;55 mg/dl most patients might need lipid-lowering drugs combinations and fixed-dose combinations are known to increase adherence. Current indications for PCSK9 inhibitors accepted for reimbursement in Spain in patients with CHD are LDL &gt;100 mg/dl despite maximal dose tolerated of statins or any of previous patients with statin intolerance and LDL &gt;100 mg/dl.

Methods
Investigator-initiated retrospective analysis of patients with coronary heart disease that received fixed-dose combination with rosuvastatin-ezetimibe between 2019 and 2020 in a specialized unit for patients with CHD. Inclusion criteria were: CHD and LDLc &lt;100 mg/dl despite statin treatment or &gt;100 mg/dl without previous lipid-lowering treatments. We also analysed patients in whom treatment was initiated at discharge from and acute coronary syndrome (ACS) or with chronic coronary syndrome (CCS)

Results
We analyzed 137 patients, 79.4% males, mean age 62. (12.3) and 24.1% with ACS. Statin treatment before initiation fixed-dose combination was higher in patients with CCS (71.2% vs. 8.2%; p&lt;0.01). Mean LDLc before treatment was 103.0 (30.5) mg/dl and it was higher in patients with ACS (121.3 (40.2) vs. 97.4 (24.4); p&lt;0.001). Median time to second blood test was 203 days (IQR 122–300); mean post-treatment LDLc was 60.8 (21.2) mg/dl and no difference (p=0.18) was found in patients with ACS vs CCS: 56.0 (26.1) vs. 62.4 (19.2) mg/dl. Mean LDLc reduction was 38.5% and it was higher in was higher in ACS patients (49.9% vs. 34.7%) (figure). LDLc &lt;55 mg/dl was achieved in 42.1% of the patients, more frequently in patients with ACS: 59.3% vs. 36.3% (p=0.036). No increase in transaminases was detected and a reduction in triglycerides was found (149.1 (100.4) to 124.7 (82.3) mg/dl; p=0.041).

Conclusions
Treatment with a fixed-dose combination with rosuvastatin-ezetimibe in patients with CHD not candidate for PCSK9 inhibitors is effective and safe for LDLc reduction especially in patients discharged after an ACS.

Funding Acknowledgement
Type of funding sources: None.
Association of statin use in older people primary prevention group with risk of cardiovascular events and mortality: a systematic review and meta-analysis of observational studies
Authors: Awad K , Mohammed M , Zaki M M , Abushouk A I , Lip G Y H , Blaha M J , Lavie C J , Toth P P , Jukema J W , Sattar N , Banach M ,   International Lipid Expert Panel (ILEP)
Published: October 2021

Abstract

Background
Current evidence from randomized controlled trials on statins for primary prevention of cardiovascular disease (CVD) in older people, especially those aged &gt;75 years, is still lacking.

Purpose
We conducted a systematic review and meta-analysis of observational studies to extend the current evidence about association of statin use in older people primary prevention group with risk of CVD and mortality.

Methods
PubMed, Scopus, and Embase were searched from inception until March 18, 2021. We included observational studies (cohort or nested case-control) that compared statin use vs non-use for primary prevention of CVD in older people aged ≥65 years; provided that each of them reported the risk estimate on at least one of the following primary outcomes: all cause-mortality, CVD death, myocardial infarction (MI), and stroke. Risk estimates of each relevant outcome were pooled as a hazard ratio (HR) with a 95% confidence interval (CI) using the random-effects meta-analysis model.

Results
Ten observational studies (9 cohort and one case-control study; n=872,845) fulfilled our criteria. The overall combined estimate suggested that statin therapy was associated with a significantly lower risk of all-cause mortality (HR: 0.86 [95% CI: 0.79 to 0.93]), CVD death (HR: 0.80 [95% CI: 0.78 to 0.81]), and stroke (HR: 0.85 [95% CI: 0.76 to 0.94]) and a non-significant association with risk of MI (HR: 0.74 [95% CI: 0.53 to 1.02]). The beneficial association of statins with the risk of all-cause mortality remained significant even at higher ages (&gt;75 years old; HR: 0.88 [95% CI: 0.81 to 0.96]) and in both men (HR: 0.75 [95% CI: 0.74 to 0.76]) and women (HR: 0.85 [95% CI: 0.72 to 0.99]). However, this association with the risk of all-cause mortality remained significant only in those with DM (HR: 0.82 [95% CI: 0.68 to 0.98]) but not in those without DM.

Conclusions
Statin therapy in older people (aged ≥65 years) without CVD was associated with a 14%, 20% and 15% lower risk of all-cause mortality, CVD death and stroke, respectively. The beneficial association with the risk of all-cause mortality remained significant even at higher ages (&gt;75 years old), in both men and women, and in individuals with DM, but not in those without DM. These observational findings support the need for trials to test benefits of statins in those above 75 years of age.

Funding Acknowledgement
Type of funding sources: None. Figure 1. Results of the meta-analysis
Inflammasome activation in epicardial, pericardial and subcutaneous adipose tissue in patients with coronary heart disease
Authors: Aakra S A A , Solheim S S , Tonnessen T T , Braathen B B , Hansen C H H , Arnesen H A , Seljeflot I S ,   Center for Clinical Heart research
Published: October 2021

Abstract

Background
The adipose tissue (AT) compartments surrounding the heart have been claimed to exert different pro-inflammatory properties with different associations with cardiovascular disease states. The epicardial AT (EAT), located close to the coronary arteries between the myocardium and the pericardial layer, seems to be associated with atherosclerosis and metabolic syndrome, whereas the pericardial AT (PAT), separated from the heart by the pericardium, is discussed to have less pro-inflammatory properties.

Purpose
The aim of the present study was to explore any differences in genetic regulation of pro-inflammatory markers included in the inflammasome related pathway in EAT, PAT and in subcutaneous AT (SAT). In addition, any relationship to the corresponding inflammatory markers in the circulation was explored.

Materials and methods
Biopsies from EAT, PAT and SAT, and arterial blood samples were collected from 52 patients with coronary heart disease (CHD) undergoing coronary by-pass surgery (aged 48–82 years, 70% male, median body mass index (BMI) 27.3 kg/m2). RNA was extracted by use of RNeasy Lipid Tissue Mini Kits. Gene expression of Interleukin (IL)-1β, IL-18, NLRP3, Caspase-1, toll-like receptor 4 (TLR4), IL-6, IL-6 receptor and gp130 in the different adipose tissue compartments were analyzed using RT-PCR. Circulating levels where possible, were measured in serum with ELISAs.

Results
We demonstrated that IL-18 and IL-6 were about 4-fold higher expressed in EAT compared to PAT (p&lt;0.01, both) and SAT (p&lt;0.001, both), whereas Caspase-1, IL-6R and gp130 were higher expressed in SAT compared to the other compartments (all p 0.06 - &lt;0.001). TLR4 was significantly higher expressed in PAT compared to EAT (p=0.01) and SAT (p&lt;0.001). No differences in the expression of IL-1β and NLRP3 were found. We could further demonstrate significant correlations between SAT and PAT expression of all the measured genes (r=0.358–0.579, all p≤0.01), except TLR4. No significant correlations between circulating levels and the genetic expression in either AT compartments were observed, and also limited correlations to BMI.

Conclusions
The results shows that only IL-18 and IL-6 were higher expressed in EAT, compared to the two other AT compartments in our non-obese CHD population. The results further show that the inflammasome related genes in pericardial AT associated strongly with subcutaneous AT, suggesting SAT to be more pro-inflammatory than previously expected.

Funding Acknowledgement
Type of funding sources: None.