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1.
Heliyon ; 10(4): e26076, 2024 Feb 29.
Article in English | MEDLINE | ID: mdl-38404762

ABSTRACT

The evaluation of airborne pathogens diffusion is a crucial practice in preventing airborne diseases like COVID-19, especially in indoor environments. Through this transmission route, pathogens can be carried by droplets, droplet nuclei and aerosols and be conveyed over long distances. Therefore, understanding their diffusion is vital for prevention and curbing disease transmission. There are different techniques used for this purpose, and one of the most common is the utilization of tracer gas, however, it has limitations such as the difference in size between the gas molecules and the respiratory droplets, as well as its incapability to take into account evaporation. For this reason, a new method for evaluating the diffusion of respiratory droplets has been developed. This approach involves the use of an ultrasonic emitter to release and disperse pigmented aerosols, and a colorimeter for the following quantitative evaluation. A comparison with the tracer gas technique has been carried out, showing for the pigmented aerosols methodology a response that is dependent on different relative humidity conditions, while there is no clear difference in the dispersion of tracer gas at high or low humidity.

2.
Catheter Cardiovasc Interv ; 101(6): 1074-1080, 2023 05.
Article in English | MEDLINE | ID: mdl-36994869

ABSTRACT

A 76-year-old male with severe comorbidities and multiple cardiovascular risk factors including stage IV chronic kidney disease presents with non-ST-elevation myocardial infarction. An ultra-low contrast invasive coronary angiography using the DyeVert system and iso-osmolar contrast agent revealed a multivessel disease with heavy calcifications involving the left main stem and its bifurcation requiring a complex percutaneous coronary intervention. Because of the high risk of contrast-induced acute kidney injury, a zero-contrast intervention was performed using intravascular ultrasound guidance and dedicated stenting techniques with optimal imaging, clinical, and renal outcomes. Zero-contrast policies can be safely implemented even in complex clinical scenarios but at least two orthogonal angiographic projections should always be acquired to rule out distal complications.


Subject(s)
Coronary Artery Disease , Percutaneous Coronary Intervention , Male , Humans , Aged , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Coronary Artery Disease/complications , Treatment Outcome , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Coronary Angiography/adverse effects , Coronary Angiography/methods , Ultrasonography, Interventional/methods
3.
J Environ Manage ; 331: 117257, 2023 Apr 01.
Article in English | MEDLINE | ID: mdl-36634419

ABSTRACT

This work is aimed at investigating the effects derived from the application of minimum amounts of two different sized biochars, obtained through biomass gasification, on the greenhouse gases and ammonia emissions from a co-composting process of the organic fraction of municipal solid waste. The chosen biochar-to-organic waste share is set to 3% w/w dry, and the results obtained are compared with a conventional composting process without biochar. Nine aerated static pilot-scale bins with a volume of 1.3 m3 were prototyped and run, three per thesis and three for the control. The trial lasted 63 days, following the same approach used in full-scale composting facilities. The testing period was divided into a forced aeration phase followed by a static phase. In terms of global warming potential, the use of fine biochar and coarse biochar resulted in 13 and 11 kg CO2eq ton-1 emitted respectively. These values are 36% and 45% lower than the 20 kg of CO2eq ton-1 emitted by the control theses. Specifically, the chosen minimum amounts of biochar produced a reduction of CH4 and N2O, while a significant reduction in NH3 emissions was not detected. Carbon dioxide showed a slight increase in biochar theses. This work has proven that fine and coarse gasification-derived biochars improve the bio-oxidative phenomena and reduce greenhouse gases emissions of the composters, regardless of the biochar particle size and regardless of the modest 3% w/w biochar-to-organic waste share used.


Subject(s)
Composting , Greenhouse Gases , Greenhouse Gases/analysis , Ammonia/analysis , Charcoal , Carbon Dioxide/analysis , Soil , Methane/analysis
4.
G Ital Cardiol (Rome) ; 23(12): 932-937, 2022 Dec.
Article in Italian | MEDLINE | ID: mdl-36504211

ABSTRACT

Given the lack of adequately sized randomized clinical trials (RCTs) testing the value of maintenance beta-blockers for post-myocardial infarction (MI) patients without reduced left ventricular ejection fraction and treated according to current standards, several observational studies have tried to address this highly relevant issue. However, results from observational studies have yielded opposite conclusions, with some suggesting that beta-blockers are associated with clinical benefit and others suggesting that they have no benefit. Due to the observational nature of these studies, the risk of bias is very high. In particular the existence of a confounding by indication factor is present when the prescription of the therapy is not random and is instead based on patients' clinical characteristics. Some randomness is needed to ensure that individuals with identical characteristics can be observed in both states (with or without beta-blockers). The only chance, therefore, to solve the question of benefits of beta-blockers is the execution of adequately sized RCTs. Currently, four large RCTs are ongoing in Europe, and, among them, the REBOOT-CNIC trial is already beyond three quarters of the expected cohort to be enrolled (6000/8648 revascularized MI patients without left ventricular dysfunction). An Italian cohort (1800 patients) will be included, enrolled by the Italian REBOOT Network. Enrollment is expected to be complete by the end of 2022, and the first results will become available by the end of 2025.


Subject(s)
Myocardial Infarction , Ventricular Dysfunction, Left , Humans , Adrenergic beta-Antagonists/therapeutic use , Myocardial Infarction/drug therapy , Stroke Volume , Systole , Ventricular Dysfunction, Left/drug therapy , Randomized Controlled Trials as Topic , Observational Studies as Topic
5.
Eur Heart J Acute Cardiovasc Care ; 11(11): 797-805, 2022 11 30.
Article in English | MEDLINE | ID: mdl-36124872

ABSTRACT

AIMS: Using the principles of clinical governance, a patient-centred approach intended to promote holistic quality improvement, we designed a prospective, multicentre study in patients with acute coronary syndrome (ACS). We aimed to verify and quantify consecutive inclusion and describe relative and absolute effects of indicators of quality for diagnosis and therapy. METHODS AND RESULTS: Administrative codes for invasive coronary angiography and acute myocardial infarction were used to estimate the ACS universe. The ratio between the number of patients included and the estimated ACS universe was the consecutive index. Co-primary quality indicators were timely reperfusion in patients admitted with ST-elevation ACS and optimal medical therapy at discharge. Cox-proportional hazard models for 1-year death with admission and discharge-specific covariates quantified relative risk reductions and adjusted number needed to treat (NNT) absolute risk reductions. Hospital codes tested had a 99.5% sensitivity to identify ACS universe. We estimated that 7344 (95% CI: 6852-7867) ACS patients were admitted and 5107 were enrolled-i.e. a consecutive index of 69.6% (95% CI 64.9-74.5%), which varied from 30.7 to 79.2% across sites. Timely reperfusion was achieved in 22.4% (95% CI: 20.7-24.1%) of patients, was associated with an adjusted hazard ratio (HR) for 1-year death of 0.60 (95% CI: 0.40-0.89) and an adjusted NNT of 65 (95% CI: 44-250). Corresponding values for optimal medical therapy were 70.1% (95% CI: 68.7-71.4%), HR of 0.50 (95% CI: 0.38-0.66), and NNT of 98 (95% CI: 79-145). CONCLUSION: A comprehensive approach to quality for patients with ACS may promote equitable access of care and inform implementation of health care delivery. REGISTRATION: ClinicalTrials.Gov ID NCT04255537.


Subject(s)
Acute Coronary Syndrome , Humans , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/epidemiology , Acute Coronary Syndrome/therapy , Prospective Studies , Clinical Governance , Time Factors , Coronary Angiography/methods
6.
Int J Cardiol ; 369: 5-11, 2022 12 15.
Article in English | MEDLINE | ID: mdl-35907504

ABSTRACT

Hemoglobin (Hb) levels have emerged as a useful tool for risk stratification and the prediction of outcome after myocardial infarction. We aimed at evaluating the prognostic impact of this parameter among patients in advanced age, where the larger prevalence of anemia and the higher rate of comorbidities could directly impact on the cardiovascular risk. METHODS: All the patients in the ELDERLY-2 trial, were included in this analysis and stratified according to the values of hemoglobin at admission. The primary endpoint of this study was cardiovascular mortality within one year. The secondary endpoints were all-cause mortality, MI, Bleeding Academic Research Consortium (BARC) type 2-3 or 5 bleeding, any stroke, re-hospitalization for cardiovascular event or stent thrombosis (probable or definite) within 12 months after index admission. RESULTS: We included in our analysis 1364 patients, divided in quartiles of Hb values (<12.2; 12.2-13.39; 13.44-14.49; ≥ 4.5 g/dl). At a mean follow- up of 330.4 ± 99.9 days cardiovascular mortality was increased in patients with lower Hb (HR[95%CI] = 0.76 [0.59-0.97], p = 0.03). Results were no more significant after correction for baseline differences (adjusted HR[95%CI] = 1.22 [0.41-3.6], p = 0.16). Similar results were observed for overall mortality. At subgroup analysis, (according to Hb median values) a significant interaction was observed only with the type of antiplatelet therapy, but not with major high-risk subsets of patients. CONCLUSIONS: Among elderly patients with acute coronary syndrome managed invasively, lower hemoglobin at admission is associated with higher cardiovascular and all-cause mortality and major ischemic events, mainly explained by the higher risk profile.


Subject(s)
Acute Coronary Syndrome , Percutaneous Coronary Intervention , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/drug therapy , Aged , Clopidogrel , Hemorrhage/epidemiology , Hospitalization , Humans , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors , Prasugrel Hydrochloride , Treatment Outcome
7.
Intern Emerg Med ; 17(7): 2083-2092, 2022 10.
Article in English | MEDLINE | ID: mdl-35708821

ABSTRACT

Rapid and systematic access to coronary angiography (CAG) and target temperature management (TTM) might improve outcome in comatose patients who survive cardiac arrest (CA). However, there is controversy around indicating immediate CAG in the absence of transmural ischemia on the electrocardiogram after return of spontaneous circulation (ROSC). We evaluated the short- and long-term outcome of patients undergoing systematic CAG and TTM, based on whether culprit lesion percutaneous coronary intervention (PCI) was performed. All consecutive comatose CA survivors without obvious extra-cardiac causes undergoing TTM were included. Analysis involved the entire population and subgroups, namely patients with initial unshockable rhythm, no ST elevation on electrocardiogram, and good neurological recovery. We enrolled 107 patients with a median age of 64.9 (57.7-73.6) years. The initial rhythm was shockable in 83 (77.6%). Sixty-six (61.7%) patients underwent PCI. In-hospital survival was 71%. It was 78.8% and 58.5% in those undergoing or not PCI (p = 0.022), respectively. Age, time from CA to ROSC and culprit lesion PCI were independent predictors of in-hospital survival. Long-term survival was significantly higher in patients who underwent PCI (respectively 61.5% vs 34.1%; Log-rank: p = 0.002). Revascularization was associated with better outcomes regardless of initial rhythm (shockable vs non-shockable) and ST deviation (elevation vs no-elevation), and improved the long-term survival of patients discharged with good neurological recovery. Systematic CAG and revascularization, when indicated, were associated with higher survival in comatose patients undergoing TTM, regardless of initial rhythm and ST deviation in the post-ROSC electrocardiogram. The benefit was sustained at long-term particularly in those with neurological recovery.


Subject(s)
Cardiopulmonary Resuscitation , Hypothermia, Induced , Out-of-Hospital Cardiac Arrest , Percutaneous Coronary Intervention , Aged , Coma/etiology , Coma/therapy , Coronary Angiography , Humans , Middle Aged , Out-of-Hospital Cardiac Arrest/complications , Out-of-Hospital Cardiac Arrest/therapy , Survivors
8.
Sci Total Environ ; 817: 153022, 2022 Apr 15.
Article in English | MEDLINE | ID: mdl-35031371

ABSTRACT

This work investigates the effects of gasification biochar on the thermal behavior of organic municipal waste composting. Two different biochar granulometries were mixed in a 3% w/w share with the organic fraction of municipal waste and tested in nine (three per thesis and three as control) reactors of 1 m3 of volume, designed to simulate full-scale aerated static piles. The temperatures of each composter were monitored for 31 days of the active composting phase and used as key parameters for air flow tuning. After the active phase was completed, the air was turned off and the temperatures were monitored for an additional 31 days during compost maturation. Results show that biochar-aided composters run 4 °C hotter and are more stable in temperature compared to the control thesis. Experimental data were used as a basis for thermal energy modeling: the addition of fine biochar to composting material increased the thermal energy production by 0.5 MJ kg-1 compared to the control thesis; coarse biochar increased the thermal energy production by 0.4 MJ kg-1. The standard composting process, without biochar, produced 2.5 MJ kg-1. Results might serve as a starting point for further considerations in terms of composting time reduction, improvement of the final product and reduction of process related issues, such as undesired anaerobic decomposition, leachate production and temperature instability.


Subject(s)
Composting , Charcoal , Nitrogen/analysis , Particle Size , Soil
9.
Eur Heart J Cardiovasc Pharmacother ; 8(3): 291-301, 2022 05 05.
Article in English | MEDLINE | ID: mdl-34351426

ABSTRACT

AIMS: There is a lack of evidence regarding the benefits of ß-blocker treatment after invasively managed acute myocardial infarction (MI) without reduced left ventricular ejection fraction (LVEF). METHODS AND RESULTS: The tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT) trial is a pragmatic, controlled, prospective, randomized, open-label blinded endpoint (PROBE design) clinical trial testing the benefits of ß-blocker maintenance therapy in patients discharged after MI with or without ST-segment elevation. Patients eligible for participation are those managed invasively during index hospitalization (coronary angiography), with LVEF >40%, and no history of heart failure (HF). At discharge, patients will be randomized 1:1 to ß-blocker therapy (agent and dose according to treating physician) or no ß-blocker therapy. The primary endpoint is a composite of all-cause death, non-fatal reinfarction, or HF hospitalization over a median follow-up period of 2.75 years (minimum 2 years, maximum 3 years). Key secondary endpoints include the incidence of the individual components of the primary composite endpoint, the incidence of cardiac death, and incidence of malignant ventricular arrhythmias or resuscitated cardiac arrest. The primary endpoint will be analysed according to the intention-to-treat principle. CONCLUSION: The REBOOT trial will provide robust evidence to guide the prescription of ß-blockers to patients discharged after MI without reduced LVEF.


Subject(s)
Myocardial Infarction , Ventricular Dysfunction, Left , Adrenergic beta-Antagonists/adverse effects , Humans , Myocardial Infarction/complications , Myocardial Infarction/diagnosis , Myocardial Infarction/drug therapy , Prospective Studies , Stroke Volume , Ventricular Dysfunction, Left/drug therapy , Ventricular Function, Left
10.
Open Heart ; 7(2)2020 12.
Article in English | MEDLINE | ID: mdl-33372102

ABSTRACT

INTRODUCTION: Despite the availability of diverse evidence-based diagnostic and treatment options, many patients with acute coronary syndrome (ACS) still fail to receive effective, safe and timely diagnoses and therapies. The Association of Acute CardioVascular Care of the European Society of Cardiology has proposed and retrospectively validated a set of ACS-specific quality indicators. Combining these indicators with the principles of clinical governance-a holistic, patient-centred approach intended to promote continuous quality improvement-we designed the clinical governance programme in patients with ACS. METHODS AND ANALYSIS: This is a multicentre quality improvement initiative exploring multiple dimensions of care, including diagnosis, therapy, patient satisfaction, centre organisation and efficiency in all comers patients with ACS.The study will enrol ≈ 5000 patients prospectively (ie, at the time of the first objective qualifying ACS criterion) with a 1-year follow-up. Consecutive inclusion will be promoted by a simplified informed consent process and quantified by the concordance with corresponding hospital administrative records using diagnosis-related group codes of ACS.Coprimary outcome measures are (1) timely reperfusion in patients with ST-elevation ACS and (2) optimal medical therapy at discharge in patients with confirmed acute myocardial infarction. Secondary outcomes broadly include multiple indicators of the process of care. Clinical endpoints (ie, death, myocardial infarction, stroke and bleeding) will be adjudicated by a clinical event committee according to predefined criteria. ETHICS AND DISSEMINATION: The study has been approved by local ethics committee of all study sites. As a quality improvement initiative and to promote consecutive inclusion of the population of interest, a written informed consent will be requested only to patients who are discharged alive. Dissemination will be actively promoted by (1) the registration site (ClinicalTrials.Gov ID NCT04255537), (2) collaborations with investigators through open data access and sharing.


Subject(s)
Acute Coronary Syndrome/therapy , Clinical Governance/standards , Practice Guidelines as Topic , Quality Improvement , Risk Assessment/methods , Acute Coronary Syndrome/diagnosis , Follow-Up Studies , Humans , Prospective Studies
11.
G Ital Cardiol (Rome) ; 21(3): 195-208, 2020 Mar.
Article in Italian | MEDLINE | ID: mdl-32100732

ABSTRACT

Cardiomyopathies are a heterogeneous group of cardiac diseases for which diagnosis and treatment are not always simple. The diagnosis of cardiomyopathy, in particular the etiology, comes from an integration between symptoms and results collected by several instrumental exams. The brain storming for the diagnosis includes also the identification of the "red flags", i.e. the pathognomonic features for each etiology that can drive the choice of appropriate diagnostic tests and therapy. In this review, we provide a step by step approach in order to help cardiologists, not specifically dedicated to cardiomyopathies, to draw the diagnosis, therapy and follow-up. This approach will be accompanied by the consultation of other specialists to discuss together the results of the exams performed and to deepen extracardiac signs and symptoms.


Subject(s)
Cardiomyopathies/diagnosis , Cardiomyopathies/genetics , Phenotype , Symptom Assessment , Arrhythmogenic Right Ventricular Dysplasia/diagnosis , Arrhythmogenic Right Ventricular Dysplasia/genetics , Arrhythmogenic Right Ventricular Dysplasia/therapy , Cardiomyopathies/therapy , Cardiomyopathy, Dilated/diagnosis , Cardiomyopathy, Dilated/genetics , Cardiomyopathy, Dilated/therapy , Cardiomyopathy, Hypertrophic/diagnosis , Cardiomyopathy, Hypertrophic/genetics , Cardiomyopathy, Hypertrophic/therapy , Cardiomyopathy, Restrictive/diagnosis , Cardiomyopathy, Restrictive/etiology , Cardiomyopathy, Restrictive/therapy , Diagnosis, Differential , Echocardiography , Electrocardiography , Humans , Magnetic Resonance Imaging, Cine , Positron-Emission Tomography , Referral and Consultation , Sarcoidosis/diagnosis
12.
J Invasive Cardiol ; 31(2): E40, 2019 02.
Article in English | MEDLINE | ID: mdl-30700630

ABSTRACT

A 31-year-old man with Noonan syndrome who suffered an out-of-hospital cardiac arrest presented at our institution with severe postanoxic coma (Glasgow coma scale 3), but normalized electrocardiogram and stable hemodynamics. Coronary angiography documented a giant right coronary artery supplying collateral flow to the left coronary artery, which presented a left main functional occlusion.


Subject(s)
Coronary Occlusion/complications , Coronary Vessels/diagnostic imaging , Heart Arrest/etiology , Hypertension, Pulmonary/complications , Noonan Syndrome/complications , Adult , Coronary Angiography , Coronary Occlusion/diagnosis , Electrocardiography , Fatal Outcome , Heart Arrest/diagnosis , Humans , Hypertension, Pulmonary/diagnosis , Male , Tomography, X-Ray Computed
13.
Intern Emerg Med ; 14(3): 403-410, 2019 04.
Article in English | MEDLINE | ID: mdl-30499074

ABSTRACT

The reliability of initial high-sensitivity cardiac troponin T (hs-cTnT) under limit-of-detection in ruling-out short- and long-term acute coronary events in subjects for suspected non-ST-segment elevation acute coronary syndrome (NSTE-ACS) is not definitely settled. In a retrospective chart review analysis, 1001 subjects with hs-cTnT ≤ 14 ng/L out of 4053 subjects with hs-cTnT measured at Emergency Department (ED) presentation were recruited. The main outcome measure is fatal or non-fatal myocardial infarction (MI) within 30 days; secondary outcomes are MI or major acute coronary events (MACE) as a combination of MI or re-hospitalization for unstable angina within 1 year. In subjects with hs-cTnT < 5 ng/L [32.6% of cases, mean age 63 years (interquartile range 23)], no cases (0%, NPV 100%) had MI within 30 days, 2 cases (0.6%, NPV 99.4%) MI at 1-year, and 11 cases (3.4%, NPV 96.6%) MACE at 1-year. Patients with hs-cTnT < 5 ng/L would have benefited from a shortened decision (9.30 h and 53% overnight ED stay saved). Hs-cTnT < 5 ng/L is confirmed as safe for patients and comfortable for physicians in ruling out MI or MACE both at short and long term, suggesting that a sizable number of patients can be rapidly discharged without unnecessary diagnostic tests and ED observation.


Subject(s)
Acute Coronary Syndrome/diagnosis , Predictive Value of Tests , Troponin T/analysis , Acute Coronary Syndrome/epidemiology , Adult , Aged , Aged, 80 and over , Biomarkers/analysis , Biomarkers/blood , Emergency Service, Hospital/organization & administration , Emergency Service, Hospital/statistics & numerical data , Female , Humans , Male , Middle Aged , Reproducibility of Results , Retrospective Studies , Troponin T/blood
16.
G Ital Cardiol (Rome) ; 19(9): 514-518, 2018 Sep.
Article in Italian | MEDLINE | ID: mdl-30087513

ABSTRACT

The recommended treatment for ST-segment elevation myocardial infarction (STEMI) is primary percutaneous coronary intervention (pPCI). However, in a non-negligible proportion of patients, pPCI is ineffective and the cardiologist must face the decision of how to achieve optimal myocardial reperfusion. Although the possibility of a rescue fibrinolytic strategy has not been evaluated yet in this clinical setting, it is a viable alternative to emergency cardiac surgery. We here report the case of a 60-year-old STEMI patient presenting with a coronary anatomy unsuitable for percutaneous mechanical revascularization, characterized by marked dilation and tortuosity of the proximal and middle epicardial segments. After pPCI failure, the administration of recombinant tissue-type plasminogen activator allowed us to obtain reperfusion as shown by clinical outcome, ST-segment resolution and subsequent angiographic study. No indication was given to further percutaneous or surgical revascularization. The long-term pharmacological management of these patients represents a challenge for the clinician, also considering the available data on the use of new antiplatelet and anticoagulant molecules and their possible associations.


Subject(s)
Coronary Aneurysm/therapy , Percutaneous Coronary Intervention/methods , ST Elevation Myocardial Infarction/therapy , Thrombolytic Therapy/methods , Coronary Angiography/methods , Humans , Male , Middle Aged , Myocardial Reperfusion/methods , ST Elevation Myocardial Infarction/physiopathology , Tissue Plasminogen Activator/administration & dosage , Treatment Outcome
17.
Minerva Cardioangiol ; 66(4): 452-463, 2018 Aug.
Article in English | MEDLINE | ID: mdl-29589674

ABSTRACT

Ischemic heart disease remains a leading cause of death worldwide, responsible for an estimated 17.5 million deaths in 2012. Mortality from ST-elevation myocardial infarction STEMI have decreased over the last 3 decades. However, despite the success of reperfusion therapy by primary percutaneous coronary intervention (PPCI) or thrombolysis, STEMI is still of significant concern. A recent patient-level meta-analysis emphasized the pivotal importance of infarct size within 1 month after PPCI as a determinant of all-cause mortality and hospitalization for heart failure at 1 year. Although timely and complete reperfusion is the most effective way of limiting infarct size (IS) and subsequent ventricular remodeling, reperfusion per se adds an additional component of irreversible injury to the myocardium (known as ischemia/reperfusion injury, IRI), and the coronary circulation and it contributes to final infarct size. The prevention and treatment of lethal IRI and coronary microvascular dysfunction pose a continued and formidable barrier to successful myocardial perfusion as opposed to establishing patency of the epicardial infarct-related artery (IRA), and in this context the need for additional cardioprotective strategies to reduce IS and coronary microvascular dysfunction remains the 'last frontier' of reperfusion therapy.


Subject(s)
Cardiotonic Agents/therapeutic use , Myocardial Reperfusion Injury/prevention & control , Myocardial Reperfusion/methods , Percutaneous Coronary Intervention/methods , ST Elevation Myocardial Infarction/therapy , Humans , Percutaneous Coronary Intervention/adverse effects , Postoperative Complications/prevention & control , ST Elevation Myocardial Infarction/surgery
18.
Circulation ; 137(23): 2435-2445, 2018 06 05.
Article in English | MEDLINE | ID: mdl-29459361

ABSTRACT

BACKGROUND: Elderly patients are at elevated risk of both ischemic and bleeding complications after an acute coronary syndrome and display higher on-clopidogrel platelet reactivity compared with younger patients. Prasugrel 5 mg provides more predictable platelet inhibition compared with clopidogrel in the elderly, suggesting the possibility of reducing ischemic events without increasing bleeding. METHODS: In a multicenter, randomized, open-label, blinded end point trial, we compared a once-daily maintenance dose of prasugrel 5 mg with the standard clopidogrel 75 mg in patients >74 years of age with acute coronary syndrome undergoing percutaneous coronary intervention. The primary end point was the composite of mortality, myocardial infarction, disabling stroke, and rehospitalization for cardiovascular causes or bleeding within 1 year. The study was designed to demonstrate superiority of prasugrel 5 mg over clopidogrel 75 mg. RESULTS: Enrollment was interrupted, according to prespecified criteria, after a planned interim analysis, when 1443 patients (40% women; mean age, 80 years) had been enrolled with a median follow-up of 12 months, because of futility for efficacy. The primary end point occurred in 121 patients (17%) with prasugrel and 121 (16.6%) with clopidogrel (hazard ratio, 1.007; 95% confidence interval, 0.78-1.30; P=0.955). Definite/probable stent thrombosis rates were 0.7% with prasugrel versus 1.9% with clopidogrel (odds ratio, 0.36; 95% confidence interval, 0.13-1.00; P=0.06). Bleeding Academic Research Consortium types 2 and greater rates were 4.1% with prasugrel versus 2.7% with clopidogrel (odds ratio, 1.52; 95% confidence interval, 0.85-3.16; P=0.18). CONCLUSIONS: The present study in elderly patients with acute coronary syndromes showed no difference in the primary end point between reduced-dose prasugrel and standard-dose clopidogrel. However, the study should be interpreted in light of the premature termination of the trial. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01777503.


Subject(s)
Acute Coronary Syndrome/mortality , Acute Coronary Syndrome/therapy , Clopidogrel/administration & dosage , Myocardial Infarction/mortality , Myocardial Infarction/therapy , Prasugrel Hydrochloride/administration & dosage , Aged , Aged, 80 and over , Clopidogrel/adverse effects , Disease-Free Survival , Female , Hemorrhage/chemically induced , Hemorrhage/mortality , Humans , Male , Percutaneous Coronary Intervention , Prasugrel Hydrochloride/adverse effects , Survival Rate
19.
Int J Cardiol ; 255: 8-14, 2018 Mar 15.
Article in English | MEDLINE | ID: mdl-29336914

ABSTRACT

BACKGROUND: Clopidogrel is used to pretreat patients with non-ST elevation acute coronary syndromes (NSTE-ACS), but prasugrel provides better platelet inhibition with improved outcome. However, switching from clopidogrel at the time of percutaneous coronary intervention (PCI) remains incompletely defined. Our aim was to compare the pharmacodynamic (PD) effects of 3 prasugrel loading doses (LDs; G1:10mg, G2: 30mg, and G3: 60mg) before PCI. A fourth group, continuing clopidogrel, served as control (G4). METHODS: 100 clopidogrel-pretreated patients were enrolled and blood collected before PCI, 30min, 1, 2, 4, 6, 24 and 48h thereafter. Platelet inhibition was measured by vasodilator-stimulated phosphoprotein phosphorylation (VASP) and Verify-Now assays. The end-points (EP) was the difference of PD effect at 4h between G3 and G4 (primary EP) with hierarchic evaluation between G2 and G1 versus G4 (secondary EP). A mixed-design ANOVA statistic was used to compare the four group scores over time. RESULTS: Baseline characteristics were balanced across the groups. Only patients receiving 60 and 30mg prasugrel LDs showed a rapid (<1h) and significant (p<0.001) platelet inhibition up to 48h after PCI·The primary EP was met by G3 (p<0.0001), but also G2 scored different (p<0-001) from G4 at 4h after PCI. Similar findings were observed with Verify-Now. No differences in 30-day clinical outcomes were observed across groups. CONCLUSIONS: Switching NSTE-ACS patients before PCI to prasugrel 60 or 30mg LDs determined a better and faster platelet inhibition than continuing clopidogrel, while PCI it is still underway.


Subject(s)
Acute Coronary Syndrome/blood , Acute Coronary Syndrome/drug therapy , Drug Substitution/trends , Platelet Aggregation Inhibitors/therapeutic use , Prasugrel Hydrochloride/therapeutic use , Ticlopidine/analogs & derivatives , Acute Coronary Syndrome/diagnostic imaging , Aged , Clopidogrel , Female , Humans , Male , Middle Aged , Platelet Activation/drug effects , Platelet Activation/physiology , Platelet Aggregation Inhibitors/pharmacology , Prasugrel Hydrochloride/pharmacology , Prospective Studies , Ticlopidine/pharmacology , Ticlopidine/therapeutic use
20.
Data Brief ; 14: 197-205, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28795098

ABSTRACT

Mortality and morbidity in patients with ST elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) are still high [1]. A huge amount of the myocardial damage is related to the mitochondrial events happening during reperfusion [2]. Several drugs directly and indirectly targeting mitochondria have been administered at the time of the PCI and their effect on fatal (all-cause mortality, cardiovascular (CV) death) and non fatal (hospital readmission for heart failure (HF)) outcomes have been tested showing conflicting results [3], [4], [5], [6], [7], [8], [9], [10], [11], [12], [13], [14], [15], [16]. Data from 15 trials have been pooled with the aim to analyze the effect of drug administration versus placebo on outcome [17]. Subgroup analysis are here analyzed: considering only randomized clinical trial (RCT) on cyclosporine or nicorandil [3], [4], [5], [9], [10], [11], excluding a trial on metoprolol [12] and comparing trial with follow-up length <12 months versus those with longer follow-up [3], [4], [5], [6], [7], [8], [9], [10], [11], [12], [13], [14], [15], [16]. This article describes data related article titled "Clinical Benefit of Drugs Targeting Mitochondrial Function as an Adjunct to Reperfusion in ST-segment Elevation Myocardial Infarction: a Meta-Analysis of Randomized Clinical Trials" [17].

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