High versus standard clopidogrel maintenance dose after percutaneous coronary intervention and effects on platelet inhibition, endothelial function, and inflammation: Results of the ARMYDA-150 mg (antiplatelet therapy for reduction of myocardial damage during angioplasty) randomized study
Patti G.,Biomedical University of Rome |
Grieco D.,Biomedical University of Rome |
Dicuonzo G.,Biomedical University of Rome |
Pasceri V.,San Filippo Neri Hospital |
And 2 more authors.
Journal of the American College of Cardiology | Year: 2011
Objectives: This study was done to compare effects of high versus standard clopidogrel maintenance doses on platelet inhibition, inflammation, and endothelial function in patients undergoing percutaneous coronary intervention. Background: Previous data suggested that clopidogrel has various biological actions in addition to antiplatelet effects. Methods: Fifty patients were randomly assigned 1 month after intervention (T-0) to receive standard (75 mg/day; n = 25) or high (150 mg/day; n = 25) clopidogrel maintenance dose for 30 days (until T-1); at this time-point, cross-over was performed, and the assigned clopidogrel maintenance regimen was switched and continued for a further 30 days (until T-2). Platelet reactivity (expressed as P2Y12 reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California]), endothelial function (evaluated by flow-mediated vasodilation), and high-sensitivity C-reactive protein levels were measured at T-0, T-1, and T-2. Results: Patients in the 150-mg/day arm had higher platelet inhibition (50 ± 20% vs. 31 ± 20% in the 75-mg/day group; p < 0.0001), better flow-mediated vasodilation (16.9 ± 12.6% vs. 7.9 ± 7.5%; p = 0.0001), and lower high-sensitivity C-reactive protein levels (3.6 ± 3.0 mg/l vs. 7.0 ± 8.6 mg/l; p = 0.016). Higher clopidogrel dose was associated with decreased proportion of patients with P2Y12 reaction units <240 (12% vs. 32%; p = 0.001), flow-mediated vasodilation <7% (16% vs. 58%; p = 0.0003), and high-sensitivity C-reactive protein levels >3 mg/l (46% vs. 64%; p = 0.07). Conclusions: For patients undergoing percutaneous coronary intervention, the 150-mg/day clopidogrel maintenance dose is associated with stronger platelet inhibition, improvement of endothelial function, and reduction of inflammation, compared with the currently recommended 75-mg/day regimen; those effects might have a role in the clinical benefit observed with clopidogrel and may provide the rationale for using the higher maintenance regimen in selected patients. © 2011 American College of Cardiology Foundation.
Effectiveness of in-laboratory high-dose clopidogrel loading versus routine pre-load in patients undergoing percutaneous coronary intervention: Results of the ARMYDA-5 PRELOAD (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) randomized trial
Di Sciascio G.,Biomedical University of Rome |
Patti G.,Biomedical University of Rome |
Pasceri V.,San Filippo Neri Hospital |
Gatto L.,Biomedical University of Rome |
And 2 more authors.
Journal of the American College of Cardiology | Year: 2010
Objectives: This study sought to evaluate safety and effectiveness of in-laboratory (in-lab) 600-mg clopidogrel loading pre-percutaneous coronary intervention (PCI) versus routine 6-h pre-load. Background: Clopidogrel pre-treatment significantly improves outcome in patients undergoing PCI; however, efficacy of an in-lab loading strategy before PCI after coronary angiography versus routine pre-load has not been fully characterized. Methods: A total of 409 patients (39% with acute coronary syndrome) were randomized to receive a 600-mg clopidogrel loading dose 4 to 8 h before PCI (pre-load group, n = 204) or a 600-mg loading dose given in the catheterization lab after coronary angiography, but prior to PCI (in-lab group, n = 205). Primary end point was 30-day incidence of major adverse cardiac events: cardiac death, myocardial infarction (MI), or unplanned target vessel revascularization. Results: There was no significant difference in primary end point between the 2 randomization arms (8.8% in-lab vs. 10.3% pre-load; p = 0.72); this was mainly driven by periprocedural MI (8.8% vs. 9.3%, p = 0.99). No increased risk of bleeding or vascular complications was observed in the pre-load arm (5.4% vs. 7.8%; p = 0.42). As determined by the VerifyNow assay (Accumetrics, San Diego, California), patients in the in-lab group showed higher platelet reactivity during PCI and 2 h after intervention versus those in the pre-load arm (p ≤ 0.043). Conclusions: ARMYDA-5 PRELOAD (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) trial indicates that a strategy of 600-mg in-lab clopidogrel load pre-PCI may have similar clinical outcomes as routine 4- to 8-h pre-load. Thus, when indicated, in-lab clopidogrel administration can be a safe alternative to routine pre-treatment given before knowing patients' coronary anatomy. © 2010 American College of Cardiology Foundation.
Leto L.,University of Turin |
Aspromonte N.,San Filippo Neri Hospital |
Feola M.,Heart Failure Unit
Heart Failure Reviews | Year: 2014
Intravenous loop diuretics are widely used to treat the symptoms and signs of fluid overload in acute heart failure (AHF). Although diuretic therapy is widely used and strongly recommended by most recent clinical guidelines, prospective studies and randomized clinical trials are lacking and so reliable evidence is missing about the best therapy in terms of doses and methods of administration. In addition, clinical efficacy and safety outcomes are often affected by the presence of contrasting evidence. The efficacy of loop diuretics is impaired by diuretic resistance characterized by a decreased diuretic and natriuretic effect. This review focuses on the current management of AHF with diuretic therapy. Continuous diuretic infusion seems to be a good choice, from a pharmacokinetic point of view, when fluid overload is refractory to conventional therapy. Some available evidence comparing bolus injection to continuous infusion of loop diuretics proved the latter to be an effective and safe method of administration. Continuous infusion seems to produce a constant plasmatic concentration of drug with a more uniform daily diuretic and natriuretic effect and a greater safety profile (fewer adverse events such as worsening renal failure, electrolyte imbalances, ototoxicity). The analyses of the published studies did not provide conclusive data about the effects on clinical outcomes (mortality, rate of hospital readmissions, length of hospital stay and adverse events). Furthermore, recent studies focus their attention on alternative strategies of fluid removal, such as vasopressin antagonists, adenosine antagonists and ultrafiltration but available data are often inconclusive. © 2012 Springer Science+Business Media New York.
Varma N.,Cleveland Clinic |
Ricci R.P.,San Filippo Neri Hospital
Journal of Cardiovascular Electrophysiology | Year: 2015
Impact of RM on Clinical Outcomes Follow-up of patients with cardiac implantable electronic devices is challenging due to both their increasing volume and technical complexity coupled to increasing clinical complexity of recipient patients. Remote monitoring (RM) offers an opportunity to resolve some of these difficulties by improving clinic efficiencies and providing a mechanism for device monitoring and patient management. Several recent randomized clinical trials and registries have demonstrated that RM may reduce in-hospital visit numbers, time required for patient follow-up, physician and nurse time, and hospital and social costs. Furthermore, patient retention and adherence to follow-up schedule are significantly improved by RM. Continuous wireless monitoring of data stored in the device memory with automatic alerts allows early detection of device malfunctions and of events, such as atrial fibrillation, ventricular arrhythmias, and heart failure suitable for clinical intervention. Early reaction may improve patient outcome. RM is easy to use and patients showed a high level of acceptance and satisfaction. Implementing RM in daily practice may require changes in clinic workflow. New organizational models promote significant efficiencies regarding physician and nursing time. Data management techniques are under development. Despite these demonstrable advantages of RM, adoption still remains modest, even in health care systems incentivized to use this follow-up method. © 2015 Wiley Periodicals, Inc.
Scupola A.,San Filippo Neri Hospital
Ophthalmic surgery, lasers & imaging : the official journal of the International Society for Imaging in the Eye | Year: 2012
Spectral-domain optical coherence tomography serial changes in three cases of spontaneous closure of idiopathic macular hole at stages II, III, and IV are described. Initial and serial spectral-domain optical coherence tomography images document the progressive closure. Macular holes apparently resolved spontaneously through two different mechanisms: posterior hyaloid detachment in case 1 and a contraction of epiretinal macular membrane in cases 2 and 3. The spontaneous closure of idiopathic full-thickness macular holes may occur in any stage of idiopathic macular hole; the small size of the hole is a common feature in all cases of spontaneous closure reported. Copyright 2012, SLACK Incorporated.
Santini L.,University of Rome Tor Vergata |
Forleo G.B.,University of Rome Tor Vergata |
Santini M.,San Filippo Neri Hospital
PACE - Pacing and Clinical Electrophysiology | Year: 2013
The worldwide use of both magnetic resonance imaging (MRI) and pacing devices has vastly increased in recent years and an important number of implanted patients likely will need an MRI over the course of the lifetime of their device. Although some studies have demonstrated that, given appropriate precautions, MRI can be safely performed in patients with selected implantable pacemakers, MRI in pacemaker patients is still contraindicated. Recently, new pacing systems have been specifically designed for safe use in the MRI environment and the first experience reported suggests that the technology is safe and may allow patients to undergo MRI. This review will describe the outstanding issues and controversies surrounding the safety of MRI imaging in pacemaker patients and the potential benefits of the new MRI-conditional technology. We will also discuss how to approach the decision whether or not an MRI-conditional system should be implanted and highlight key issues that warrant further studies. © 2012 Wiley Periodicals, Inc.
Gasparini G.,San Filippo Neri Hospital |
Longo R.,San Filippo Neri Hospital
Expert Opinion on Therapeutic Targets | Year: 2012
Introduction: Currently, anticancer therapy is mainly based on histology and on giving the same treatment to presumed homogeneous patients. The switch from histology-driven therapy to molecular clinical oncology is correlated with a better understanding of the 'molecular taxonomy' of each tumor that can provide us with targets for specific drugs. Cancer therapy is moving irreversibly towards personalized therapy that benefits selected patients. Once the potential therapeutic targets are identified, the availability of predictive biomarkers is the key element and their prospective evaluation should be a parallel component of the clinical evaluation of a new drug. Areas covered: The state of the art in clinical results of personalized therapy. The authors discuss the finding that, in patients with advanced disease, a limited number of targeted agents improve overall survival, whilst the majority only have an effect on response rate and/or time to tumor progression, with efficacy limited in time due to acquired resistance. Expert opinion: The mechanisms leading to resistance are related to tumor cell heterogeneity and in part explained by the cancer stem cell model and genetic instability. The steps toward the optimization of tailored therapy need validated predictive biomarkers, pharmacogenetics analysis and a close collaboration between bench and bedside. © 2012 Informa UK, Ltd.
Ricci R.P.,San Filippo Neri Hospital |
Morichelli L.,San Filippo Neri Hospital
Europace | Year: 2013
Remote monitoring of cardiac implantable electronic devices improves device surveillance and patient clinical management. The greatest challenge in implementing remote monitoring in standard practice is the need to develop new organizational models, capable of combining clinical effectiveness, low resource consumption, and patient acceptance. Since 2005, we developed a new model based on 'Primary Nursing' in which each patient is assigned to a nurse responsible for continuity of care. The model is essentially based on a cooperative interaction between the roles of an expert reference nurse and a responsible physician with an agreed list of respective tasks and responsibilities. After a pilot experience, the model was tested in a wide registry, the HomeGuide Registry, in which 1650 patients were enrolled. In this setting, remote monitoring sensitivity in detecting major cardiovascular events was very high (84%) with a positive predictive value of 97%. Overall, 95% of asymptomatic and 73% of actionable events were detected during remote monitoring sessions with a median reaction time of 3 days. Manpower was remarkably low: 55.5 min per health personnel per month every 100 patients. The strongest points of this model include strict definition of workflow, early reaction, traceability, continuity of care, maintaining human relationship with the patient. This model has been tested successfully even in a multicentre setting in the Model Project Monitor Centre study, in which one monitor centre screened daily remote monitoring data from nine satellite clinics. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2013.
Piciche M.,San Filippo Neri Hospital
Open Cardiovascular Medicine Journal | Year: 2015
The “noncoronary collateral circulation” (NCCC) or “noncoronary collateral myocardial blood flow” (NCCMBF), reaches the heart through a micro-vascular network arising from the bronchial, esophageal, pericardial, diaphragmatic, and aortic arteries. The left and right internal thoracic arteries (ITAs) along with their collateral branches also serve as a source of NCCMBF-a feature seen in other mammals. Under certain circumstances the ITAs have a high potential for developing collateral branches. In the case of severe Leriche syndrome or with chronic obstruction of the abdominal aorta, the ITAs can serve as the main or even sole source of blood supply to the lower limbs. It is also possible for the ITAs to develop angiographically visible branches that directly connect with the coronary arteries. In ischemic conditions there is a functional, ischemia-reducing extracardiac coronary artery supply via natural ipsilateral ITA anastomosis. To date we know little about NCCMBF and its potential benefits in clinical applications, which makes this a challenging and intriguing field of research. This paper reviews all available data on noncoronary collateral blood supply to the human heart. © Marco Picichè.
Ricci R.P.,San Filippo Neri Hospital
Europace | Year: 2013
Device-detected atrial fibrillation (AF) episodes predict poor clinical outcome regardless of symptoms. Potential benefits of remote monitoring are early arrhythmia detection and patient continuous monitoring. Several studies of device remote monitoring consistently demonstrated that AF represents the most common clinical alert and that detailed information on arrhythmia onset, duration, and burden as well as on the ventricular rate may be early available for clinical evaluation. Reaction time to AF alerts was very short in all series involving either pacemakers or defibrillators and action ability of AF alerts was very high. In the Home Guide Registry, in which 1650 patients were enrolled, AF was detected in 16.3% of patients and represented 36% of all cardiovascular events during the follow-up. Timely anticoagulation introduction in asymptomatic patients may impact on the stroke rate. According to the results of repeated Monte Carlo simulations based on a real population of 166 patients, daily monitoring may reduce the 2-year stroke risk by 9-18% with an absolute reduction of 0.2-0.6%, compared with conventional inter-visit intervals of 6-12 months. In the COMPAS trial, the incidence of hospitalizations for atrial arrhythmias and related stroke was significantly higher in the control group than in the remote monitoring group. Major questions will be addressed by the ongoing IMPACT trial in which a remote monitoring guided anticoagulation strategy based on AF detection will be compared with a physician-directed standard strategy. In patients with heart failure, AF early detection combined with other indexes may help prevent hospitalizations. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2013.