Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019: The GRECCO-19 Randomized Clinical Trial.

Importance: Severe acute respiratory syndrome coronavirus 2 infection has evolved into a global pandemic. Low-dose colchicine combines anti-inflammatory action with a favorable safety profile. Objective: To evaluate the effect of treatment with colchicine on cardiac and inflammatory biomarkers and clinical outcomes in patients hospitalized with coronavirus disease 2019 (COVID-19). Design, Setting, and Participants: In this prospective, open-label, randomized clinical trial (the Greek Study in the Effects of Colchicine in COVID-19 Complications Prevention), 105 patients hospitalized with COVID-19 were randomized in a 1:1 allocation from April 3 to April 27, 2020, to either standard medical treatment or colchicine with standard medical treatment. The study took place in 16 tertiary hospitals in Greece. Intervention: Colchicine administration (1.5-mg loading dose followed by 0.5 mg after 60 min and maintenance doses of 0.5 mg twice daily) with standard medical treatment for as long as 3 weeks. Main Outcomes and Measures: Primary end points were (1) maximum high-sensitivity cardiac troponin level; (2) time for C-reactive protein to reach more than 3 times the upper reference limit; and (3) time to deterioration by 2 points on a 7-grade clinical status scale, ranging from able to resume normal activities to death. Secondary end points were (1) the percentage of participants requiring mechanical ventilation, (2) all-cause mortality, and (3) number, type, severity, and seriousness of adverse events. The primary efficacy analysis was performed on an intention-to-treat basis. Results: A total of 105 patients were evaluated (61 [58.1%] men; median [interquartile range] age, 64 [54-76] years) with 50 (47.6%) randomized to the control group and 55 (52.4%) to the colchicine group. Median (interquartile range) peak high-sensitivity cardiac troponin values were 0.0112 (0.0043-0.0093) ng/mL in the control group and 0.008 (0.004-0.0135) ng/mL in the colchicine group (P = .34). Median (interquartile range) maximum C-reactive protein levels were 4.5 (1.4-8.9) mg/dL vs 3.1 (0.8-9.8) mg/dL (P = .73), respectively. The clinical primary end point rate was 14.0% in the control group (7 of 50 patients) and 1.8% in the colchicine group (1 of 55 patients) (odds ratio, 0.11; 95% CI, 0.01-0.96; P = .02). Mean (SD) event-free survival time was 18.6 (0.83) days the in the control group vs 20.7 (0.31) in the colchicine group (log rank P = .03). Adverse events were similar in the 2 groups, except for diarrhea, which was more frequent with colchicine group than the control group (25 patients [45.5%] vs 9 patients [18.0%]; P = .003). Conclusions and Relevance: In this randomized clinical trial, participants who received colchicine had statistically significantly improved time to clinical deterioration. There were no significant differences in high-sensitivity cardiac troponin or C-reactive protein levels. These findings should be interpreted with caution. Trial Registration: ClinicalTrials.gov Identifier: NCT04326790.

Current management and quality of life of patients with acute coronary syndrome undergoing percutaneous coronary intervention in Greece: 12-Month results from antiplatelet therapy observational study II (APTOR II).

INTRODUCTION: We describe the current management of patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) over 12 months in Greece. METHODS: This was a prospective observational study in ACS patients undergoing PCI from September 2008 to April 2009, capturing practices over 12 months at 22 sites that enrolled 558 eligible patients. RESULTS: A total of 351 patients suffered from unstable angina or non-ST elevation myocardial infarction (UA/ NSTEMI), while 207 patients suffered from ST-elevation myocardial infarction (STEMI). For the UA/NSTEMI group, the median age was 64 years (interquartile range: 55-73), while for the STEMI group the median age was 56 years (interquartile range: 49-66). Stents were placed in 96.4% of patients: bare-metal stents alone were placed in 19% of patients, drug-eluting stents alone in 77.5% of patients, and both types of stent in 3.5% of patients. 74% of UA/NSTEMI patients and 87% of STEMI patients received the first antiplatelet loading dose within 1 day of the episode. 76% of UA/NSTEMI patients underwent PCI within 3 days following the initial ACS symptoms, while 67% of STEMI patients underwent PCI within 1 day of the ACS symptoms. Follow-up data were available for 540 (96.8%) patients. The percentages of patients on antiplatelet therapy and on other medications at the time of hospital discharge and at 12 months post-PCI were as follows: aspirin 98%, 97%; clopidogrel 99%, 96%; statins 81%, 79%; beta-blockers 73%, 72%; calcium blockers 11%, 11%; angiotensin II receptor blockers/angiotensin-converting enzyme inhibitors 64%, 62%; proton-pump inhibitors 39%, 35%. CONCLUSIONS: In ACS patients treated with PCI in Greece, dual antiplatelet treatment is maintained in a very high percentage through 1 year post-procedure, and drug-eluting stent use is also high.

Serum levels of ischemia modified albumin in overweight/obese postmenopausal women: a potential biomarker of atherosclerotic burden associated with oxidative stress.

OBJECTIVE: Menopause is associated with weight gain and an increase of cardiovascular risk. The aim of the present study was to estimate serum ischemia-modified albumin (IMA) levels in postmenopausal women and evaluate their association with body mass index (BMI) and coronary artery disease (CAD). METHODS: The study included 130 non-smoker postmenopausal women aged 43-80: 40 with BMI 26-32 kg/m(2) (Group A), 60 with BMI 21-25 kg/m(2) (Group B), and 30 with documented CAD and BMI 23-29 kg/m(2) (Group C). Serum IMA, albumin, hsCRP and NT-proBNP, glucose and insulin were measured. Homeostasis assessment model score (HOMA) and Quantitative insulin sensitivity index (QUICKI) were co-estimated. RESULTS: Serum IMA and IMA to albumin ratio were significantly elevated in Group A as compared to Group B (p<0.001) and similar to those of Group C. hsCRP and NT-proBNP did not differ between Groups A and B while they were lower in comparison to Group C (p<0.001). Glucose, insulin and HOMA were elevated in Group A compared to Group B (p<0.001) while QUICKI was lower (p<0.001). In Group A, IMA was positively correlated with BMI, hsCRP, insulin, HOMA and negatively with QUICKI. In postmenopausal women, multivariable regression analysis revealed that obesity was the strongest significant determinant of circulating IMA levels (p<0.001) contributing, therefore, to the elevated serum IMA concentration. CONCLUSIONS: Postmenopausal obesity is associated with elevated serum IMA possibly due to obesity associated oxidative stress. IMA measurement could provide an assessment of atherosclerotic burden in postmenopausal women. Further clinical evaluation is under investigation.

Relation of ventricular tachycardia/fibrillation to beta-blocker dose maximization guided by pacing mode analysis in nonpacemaker-dependent patients with implantable cardioverter-defibrillator.

We hypothesized that uptitration of ß blockade and adjustment of pacing parameters to achieve a prevalence of single chamber atrial inhibited rate-responsive (AAIR) pacing in patients with dual-chamber implantable cardioverter--defibrillators (ICDs) would result in maximization of ß-blocker dosage and thus decrease appropriate ICD therapies. We included patients with ischemic or dilated cardiomyopathy and implanted ICDs without contraindications to ß blockers and atrioventricular conduction disturbances. Two 6-month periods were compared: clinically guided phase (pacing function set at back-up dual-chamber rate-responsive pacing mode at a lower rate of about 40 beats/min) and pacing-guided phase, during which ß-blocker dosage was titrated with a target of achieving >90% AAIR pacing (lower rate 60 beats/min). Sixty-one patients (64.2 ± 8.3 years old) were included. During the pacing-guided phase the target of ≥90% AAIR pacing was achieved in 80.3% of patients. Mean metoprolol dose during the clinically guided phase was 96.7 ± 29.4 versus 127.0 ± 39.6 mg/day in the pacing-guided phase (p <0.001). Appropriate ICD therapies were recorded in 35 patients (57.4%) during the clinically guided phase versus 20 (32.8%) during the pacing-guided phase (p <0.001; 1.15 and 0.48 appropriate ICD therapies per patient, respectively, p <0.001). In multivariate analysis, AAIR pacing and ß-blocker dose were inversely related to appropriate ICD therapies. In conclusion, a pacing-guided approach for maximizing ß-blocker doses guided by maximizing AAIR pacing in patients with ICDs may be beneficial compared to the conventional strategy. This pacing-guided approach led to higher daily ß-blocker doses, which were correlated to fewer appropriate ICD therapies.

Ischemia modified albumin, high-sensitivity c-reactive protein and natriuretic peptide in patients with coronary atherosclerosis.

BACKGROUND: Ischemia modified albumin (IMA), is a new biomarker of oxidative processes involved with coronary artery disease (CAD). We determined serum IMA, high-sensitivity C-reactive protein (hsCRP), and natriuretic peptide (NT-proBNP), and evaluated their correlation with severity of coronary atherosclerosis in patients undergoing coronary angiography (CA). Cardiac troponin T (cTnT), CK-MB mass, albumin and Total Antioxidant Status (TAS) were also evaluated. METHODS: The study included 114 patients (88 men and 30 women) aged 43-80 years with documented CAD without evidence of acute coronary syndrome undergoing CA and 163 controls (131 men and 32 women) similarly aged. RESULTS: IMA, hsCRP and NT-proBNP were higher (p<0.001 and p=0.008 for NT-proBNP) while TAS was lower (p<0.001) in patients than in controls. IMA and TAS were negatively correlated in all subjects (p<0.01). Among patients, there was no correlation between IMA and the number of diseased vessels. For CAD diagnosis the best cut-off point for IMA was 101.5 KU/L with a sensitivity and a specificity of 87.7% and a negative predictive value of 83.3%. IMA was associated with an increased risk for CAD (OR=1.23, 95% CI: 1.16-1.31; p<0.001). CONCLUSIONS: IMA determination may provide earlier information of CAD presence before hsCRP or NT-proBNP elevation, contributing to early assessment of overall patient risk.

Intracardiac echocardiography-facilitated ablation of a left-lateral bypass tract in a patient with atrial septal aneurysm.

Intracardiac echocardiography (ICE) has been used as an adjunctive tool during electrophysiological procedures, mainly to increase the safety of transseptal puncture. We present the case of a young patient with a left-lateral bypass tract and atrial septal aneurysm, in whom ICE delineated the underlying anatomy, excluded the presence of thrombus and facilitated access to the left atrium through a small atrial septal defect, avoiding the risk of needle puncture for interatrial septal crossing.

Epidemiological characteristics, management and early outcome of acute myocardial infarction in Greece: the HELlenic Infarction Observation Study.

INTRODUCTION: Taking into consideration the need for an updated survey on acute myocardial infarction (AMI) in Greece, we conducted the HELIOS study (HELlenic Infarction Observation Study), aiming to recruit a cohort of AMI patients that would be representative of the total AMI population. METHODS: The HELIOS study is a countrywide registry of AMI, conducted during 2005-2006 by the Prevention Working Group of the Hellenic Cardiological Society. We enrolled 1840 AMI pts from 31 hospitals (mean age 68 +/- 13 years, 75% men, 1096 ST-elevation myocardial infarction [STEMI] patients), with a proportional representation of all types of hospitals and of all geographical areas. The study recruited 10% of the total number of AMI cases that occur per year on a countrywide basis, taking into consideration the seasonal variations of the population in each geographical area. RESULTS: Despite demographic changes, there is still a male predominance among AMI patients and an increasing prevalence of cardiometabolic risk factors, (obesity, diabetes, hypertension) compared to previous AMI studies in the Greek population. Almost 60% of STEMI patients received reperfusion therapy, but the median value of the pain-to-door time was 180 minutes. The rates of administration of evidence-based medications during hospitalisation or upon discharge and the short-term mortality rates were in accordance with those observed in other international AMI registries. CONCLUSIONS: The HELIOS study provided valuable insights into the epidemiology, clinical characteristics, management and outcome of patients with AMI in the Greek population. Although there are notable advances compared to previous reports, there is still considerable room for improvement and we should particularly focus on minimising the time delay between arrival at the emergency department and performance of reperfusion, by either pharmacological or catheter-based approaches.