Bossi Dott.ssa Irene
Pubblicazioni su PubMed
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Safety and efficacy of single antiplatelet therapy in a large cohort of patients treated with sirolimus-coated balloon: Post hoc analysis from the prospective EASTBOURNE registry.
Cardiovasc Revasc Med2024 Jul;():. doi: S1553-8389(24)00610-9.
Mangier Antonio, Testa Luca, Heang Tay M, Bossi Irene, Lee Chuey Y, Perez Ignacio S, Milazzo Diego, Nuruddin Amin A, Seresini Giuseppe, Singh Ramesh, Cacucci Michele, Sciahbasi Alessandro, Torres Alfonso, Sengottvelu Gunasekaran, Colombo Antonio, Cortese Bernardo,
Abstract
BACKGROUND:
Drug coated balloons (DCB) are potentially less thrombogenic than drug eluting stents (DES).
AIMS:
To explore the safety and the feasibility of single antiplatelet therapy in percutaneous coronary intervention with sirolimus-coated balloons.
METHODS:
The All-comers Sirolimus-coated Balloon European Registry (EASTBOURNE) is a prospective investigator-driven registry assessing the performance of a novel sirolimus-coated balloon (SCB) in a real-world population. This prespecified post hoc analysis aimed at comparing the outcome in patients prescribed either single antiplatelet therapy (SAPT) or dual antiplatelet therapy (DAPT); choice of antiplatelet agent and duration of the regimen were at operator's discretion in both groups. Primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints were bleeding grade 3-5 according to The Bleeding Academic Research Consortium (BARC) criteria and major adverse cardiovascular events (MACE) at 12 months follow-up.
RESULTS:
Among 2123 patients enrolled in the study between September 2016 and November 2020, 113 patients (5.8 %) received SAPT while 1826 patients (94.1 %) received DAPT after SCB. The majority of the patients underwent DCB PCI for de novo lesions (n = 1091, 56.3 %) while 848 patients (47.7 %) had DCB revascularization for in-stent restenosis. No cases of TLR occurred in the SAPT group within one month after the index procedure, and no acute occlusive events were recorded during follow up in patients taking a single antiplatelet agent. Moreover, no differences in terms of TLR were observed between SAPT vs DAPT regimens nor in case of de novo treatment with an overall rate of TLR at 12 months of 7.7 % for SAPT and 5.6 % for DAPT (p = 0.6). The cumulative rate of MACE at 12 months was not different between SAPT and DAPT regimens (n = 12 [11.2 %] vs. n = 162 [8.9 %], p = 0.4), and results were consistent in the de novo and in-stent restenosis groups.
CONCLUSIONS:
Our post hoc analysis of the EASTBOURNE registry suggests that the use of single antiplatelet agent after sirolimus-DCB PCI for both de novo or in-stent restenosis lesions is safe and effective and can help to contain the risk of bleeding in a selected population.
CONDENSED ABSTRACT:
The manuscript aims to explore the feasibility of a single antiplatelet regimen following angioplasty using drug coated balloon with sirolimus. Among 2123 patients treated with sirolimus coated balloon (SCB), 113 patients (5.8 %) received a single antiplatelet therapy (SAPT) while 1826 patients (94.1 %) received dual antiplatelet therapy DAPT. No cases of target lesion revascularization occurred in the SAPT group within one month after the index procedure, and no acute occlusive events were recorded during follow up in patients taking a single antiplatelet agent. The cumulative rate of major adverse cardiovascular events at 12 months was not different between SAPT and DAPT regimens and results were consistent in the de novo and in-stent restenosis groups.
Copyright © 2024 Elsevier Inc. All rights reserved.
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Sirolimus-coated balloon in acute and chronic coronary syndromes: the PEACE study, a subanalysis of the EASTBOURNE registry.
Rev Esp Cardiol (Engl Ed)2024 Jul;77(7):527-536. doi: 10.1016/j.rec.2023.11.010.
Laricchia Alessandra, Bossi Irene, Latini Roberto A, Lee Chuey Y, Pérez Ignacio S, Tomai Fabrizio, Nuruddin Amin A, Buccheri Dario, Seresini Giuseppe, Ocaranza Raymundo, Sengottvelu Gunasekaran, Pesenti Nicola, Mangieri Antonio, Cortese Bernardo,
Abstract
INTRODUCTION AND OBJECTIVES:
The PEACE study (Performance of a sirolimus-eluting balloon strategy in acute and chronic coronary syndromes) investigated for the first time whether a sirolimus-coated balloon (SCB) (Magic Touch, Concept Medical, India) is associated with different outcomes depending on whether it is used in acute coronary syndromes (ACS) or chronic coronary syndromes (CCS).
METHODS:
This was a post-hoc analysis from the all-comers EASTBOURNE Registry (NCT03085823). Out of 2083 patients enrolled, an SCB was used to treat 968 (46.5%) ACS and 1115 (53.5%) CCS patients. The primary endpoint was target lesion revascularization at 12 months, while secondary endpoints were angiographic success and major adverse cardiovascular events.
RESULTS:
Baseline demographics, mean reference vessel diameter and mean lesion length were comparable between ACS and CCS. Predilatation was more commonly performed in ACS (P=.007). SCB was inflated at a standard pressure in both groups with a slight trend toward longer inflation time in ACS. Angiographic success was high in both groups (ACS 97.4% vs CCS 97.7%, P=.820) with limited bailout stenting. Similarly, at 12 months the cumulative incidence of target lesion revascularization (ACS 6.6% vs CCS 5.2%, P=.258) was comparable between ACS and CCS. Conversely, a higher rate of major adverse cardiovascular events in acute presenters was mainly driven by myocardial infarction recurrencies (ACS 10.4% vs CCS 8.3%, P=.009). In-stent restenosis showed a higher proportion of target lesion revascularization and major adverse cardiovascular events than de novo lesions, independently of the type of presentation at the index procedure.
CONCLUSIONS:
This SCB shows good performance in terms of acute and 1-year outcomes independently of the clinical presentation.
Copyright © 2023 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.
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Sirolimus-Coated Balloon in an All-Comer Population of Coronary Artery Disease Patients: The EASTBOURNE Prospective Registry.
JACC Cardiovasc Interv2023 Jul;16(14):1794-1803. doi: 10.1016/j.jcin.2023.05.005.
Cortese Bernardo, Testa Luca, Heang Tay M, Ielasi Alfonso, Bossi Irene, Latini Roberto A, Lee Chuey Y, Perez Ignacio S, Milazzo Diego, Caiazzo Gianluca, Tomai Fabrizio, Benincasa Susanna, Nuruddin Amin A, Stefanini Giulio, Buccheri Dario, Seresini Giuseppe, Singh Ramesh, Karavolias George, Cacucci Michele, Sciahbasi Alessandro, Ocaranza Raymundo, Menown Ian B A, Torres Alfonso, Sengottvelu Gunasekaran, Zanetti Anna, Pesenti Nicola, Colombo Antonio,
Abstract
BACKGROUND:
Drug-coated balloons (DCB) represent 1 of the most promising innovations in interventional cardiology and may represent a valid alternative to drug-eluting stents. Currently, some sirolimus-coated balloons (SCB) are being investigated for several coronary artery disease applications.
OBJECTIVES:
This study sought to understand the role of a novel SCB for the treatment of coronary artery disease.
METHODS:
EASTBOURNE (All-Comers Sirolimus-Coated Balloon European Registry) is a prospective, multicenter, investigator-driven clinical study that enrolled real-world patients treated with SCB. Primary endpoint was target lesion revascularization (TLR) at 12 months. Secondary endpoints were procedural success, myocardial infarction (MI), all-cause death, and major adverse clinical events (a composite of death, MI, and TLR). All adverse events were censored and adjudicated by an independent clinical events committee.
RESULTS:
A total population of 2,123 patients (2,440 lesions) was enrolled at 38 study centers in Europe and Asia. The average age was 66.6 ± 11.3 years, and diabetic patients were 41.5%. De novo lesions (small vessels) were 56%, in-stent restenosis (ISR) 44%, and bailout stenting occurred in 7.7% of the patients. After 12 months, TLR occurred in 5.9% of the lesions, major adverse clinical events in 9.9%, and spontaneous MI in 2.4% of the patients. The rates of cardiac/all-cause death were 1.5% and 2.5%, respectively. The primary outcome occurred more frequently in the ISR cohort (10.5% vs 2.0%; risk ratio: 1.90; 95% CI: 1.13-3.19). After multivariate Cox regression model, the main determinant for occurrence of the primary endpoint was ISR (OR: 5.5; 95% CI: 3.382-8.881).
CONCLUSIONS:
EASTBOURNE, the largest DCB study in the coronary field, shows the safety and efficacy of a novel SCB in a broad population of coronary artery disease including small vessels and ISR patients at mid-term follow-up. (The All-Comers Sirolimus-Coated Balloon European Registry [EASTBOURNE]; NCT03085823).
Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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Natural history and clinical burden of moderate aortic stenosis: a systematic review and explorative meta-analysis.
J Cardiovasc Med (Hagerstown)2023 Sep;24(9):659-665. doi: 10.2459/JCM.0000000000001490.
Morelli Martina, Galasso Michele, Esposito Giuseppe, Soriano Francesco Stefano, Nava Stefano, Da Pozzo Caterina, Bossi Irene, Piccaluga Emanuela, Bruschi Giuseppe, Maloberti Alessandro, Oliva Fabrizio, Oreglia Jacopo Andrea, Giannattasio Cristina, Montalto Claudio
Abstract
AIMS:
The mortality risk of patients with moderate aortic stenosis is not well known, but recent studies suggested that it might negatively affect prognosis. We aimed to assess the natural history and clinical burden of moderate aortic stenosis and to investigate the interaction of patients' baseline characteristics with prognosis.
METHODS:
Systematic research was conducted on PubMed. The inclusion criteria were inclusion of patients with moderate aortic stenosis; and report of the survival at 1-year follow-up (minimum). Incidence ratios related to all-cause mortality in patients and controls of each study were estimated and then pooled using a fixed effects model. All patients with mild aortic stenosis or without aortic stenosis were considered controls. Meta-regression analysis was performed to assess the impact of left ventricular ejection fraction and age on the prognosis of patients with moderate aortic stenosis.
RESULTS:
Fifteen studies and 11?596 patients with moderate aortic stenosis were included. All-cause mortality was significantly higher among patients with moderate aortic stenosis than in controls in all timeframes analysed (all P ?0.0001). Left ventricular ejection fraction and sex did not significantly impact on the prognosis of patients with moderate aortic stenosis ( P ?=?0.4584 and P ?=?0.5792), while increasing age showed a significant interaction with mortality (estimate = 0.0067; 95% confidence interval: 0.0007-0.0127; P ?=?0.0323).
CONCLUSION:
Moderate aortic stenosis is associated with reduced survival. Further studies are necessary to confirm the prognostic impact of this valvulopathy and the possible benefit of aortic valve replacement.
Copyright © 2023 Italian Federation of Cardiology - I.F.C. All rights reserved.
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CMV seroprevalence and coronary CMV-DNA detection in immunocompetent patients with heart diseases.
Minerva Med2023 Jun;114(3):289-299. doi: 10.23736/S0026-4806.22.07778-3.
Cento Valeria, Colagrossi Luna, Bossi Irene, Armenia Daniele, Nava Alice, Piccinelli Enrico, Maloberti Alessandro, Inglese Elvira, Matarazzo Elisa, DI Ruscio Federica, Paba Pierpaolo, Marcuccilli Fabbio, Perrone Marco, Chiricolo Gaetano, Alteri Claudia, Scaglione Francesco, Vismara Chiara, Campisi Daniela A, Fanti Diana, Romeo Francesco, Andreoni Massimo, Oliva Fabrizio, Ceccherini-Silberstein Francesca, Giannattasio Cristina, Perno Carlo F
Abstract
BACKGROUND:
Acute coronary syndromes (ACS) are a major cause of morbidity and mortality. As cytomegalovirus (CMV) may contribute to cardio-vascular (CV) manifestations, we sought to provide a proof-of-concept for the involvement of coronary and/or systemic CMV-reactivation as a possible ACS trigger.
METHODS:
We prospectively enrolled consecutive patients undergoing a coronary angiography for ACS (acute-cases, N.=136), or non-ACS reasons (chronic-cases, N.=57). Matched coronary and peripheral blood-samples were processed for quantification of CMV-DNAemia (RT-PCR), CMV-IgG/IgM, and CMV-IgG avidity (ELISA). Peripheral-blood samples from 17 healthy subjects were included as controls.
RESULTS:
Out of the 193 cases included, 18.1% were aged ?55 years, 92.5% were Central-European, and 100% immunocompetent. CMV-IgG seroprevalence was 91.7% (95%CI: 87.8-95.6), significantly higher than in healthy-controls (52.9% [95%CI: 29.2-76.5]; P
CONCLUSIONS:
CMV-IgG seroprevalence was high in patients with heart diseases. CMV-DNAemia can be found, although uncommonly, in coronary circulation during an ACS, with increased prevalence in older subjects and in absence of CV risk-factors, identifying possible areas for novel interventions.
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Multivessel vs. culprit-only percutaneous coronary intervention strategy in older adults with acute myocardial infarction.
Eur J Intern Med2022 Nov;105():82-88. doi: 10.1016/j.ejim.2022.09.006.
Montalto Claudio, Morici Nuccia, Myat Aung, Crimi Gabriele, De Luca Giuseppe, Bossi Irene, de Belder Adam, Savonitto Stefano, De Servi Stefano
Abstract
BACKGROUND:
The optima revascularization strategy for senior patients admitted with acute myocardial infarction (AMI) in the context of multivessel coronary artery disease (MVCAD) remains unclear. We aimed to compare a strategy of culprit-vessel (CV) vs. multi-vessel percutaneous coronary intervention (MV-PCI) in older adults (?75 years) with AMI.
METHODS:
We analyzed four randomized controlled trials designed to include older adults with AMI. The primary endpoint was all-cause death. The secondary endpoint was the composite of all-cause death, myocardial infarction, stroke and major bleeding (Net Adverse Clinical Events, NACE). A non-parsimonious propensity score and nearest-neighbor matching was performed to account for bias.
RESULTS:
A total of 1,334 trial participants were included; of them, 770 (57.7%) underwent CV-PCI and 564 (42.3%) a MV-PCI strategy. After a median follow-up of 365 days, patients treated with MV-PCI experienced a lower rate of death (6.0% vs. 9.9%; p = 0.01) and of NACE (11.2% vs. 15.5%; p = 0.016). After multivariable analysis, MV-PCI was independently associated with a lower hazard of death (hazard ratio [HR]: 0.65; 95% confidence interval [CI]: 0.42-0.96; p = 0.03) and NACE (NACE 0.72[0.53-0.98]; p = 0.04). These results were confirmed in a matched propensity analysis, were consistent throughout the spectrum of older age and when analyzed by subgroups and when immortal-time bias was considered.
CONCLUSIONS:
In the setting of older adults with MVCAD who were managed invasively for AMI, a MV-PCI strategy to pursue complete revascularization was associated with better survival and lower risk of NACE compared to a CV-PCI. Adequately sized RCTs are required to confirm these findings.
Copyright © 2022. Published by Elsevier B.V.
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Impact of hemoglobin levels at admission on outcomes among elderly patients with acute coronary syndrome treated with low-dose Prasugrel or clopidogrel: A sub-study of the ELDERLY ACS 2 trial.
Int J Cardiol2022 Dec;369():5-11. doi: 10.1016/j.ijcard.2022.07.033.
De Luca Giuseppe, Verdoia Monica, Morici Nuccia, Ferri Luca A, Piatti Luigi, Grosseto Daniele, Bossi Irene, Sganzerla Paolo, Tortorella Giovanni, Cacucci Michele, Ferrario Maurizio, Murena Ernesto, Tondi Stefano, Toso Anna, Bongioanni Sergio, Ravera Amelia, Corrada Elena, Mariani Matteo, Di Ascenzo Leonardo, Petronio A Sonia, Cavallini Claudio, Vitrella Giancarlo, Antonicelli Roberto, Cesana Bruno M, De Luca Leonardo, Ottani Filippo, Moffa Nadia, Savonitto Stefano, De Servi Stefano,
Abstract
UNLABELLED:
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.
Copyright © 2022 Elsevier B.V. All rights reserved.
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Association of statin pretreatment with presentation characteristics, infarct size and outcome in older patients with acute coronary syndrome: the Elderly ACS-2 trial.
Age Ageing2022 Jun;51(6):. doi: afac121.
Toso Anna, Morici Nuccia, Leoncini Mario, Villani Simona, Ferri Luca A, Piatti Luigi, Grosseto Daniele, Bossi Irene, Sganzerla Paolo, Tortorella Giovanni, Cacucci Michele, Ferrario Maurizio, Tondi Stefano, Ravera Amelia, Bellandi Francesco, Cavallini Claudio, Antonicelli Roberto, De Servi Stefano, Savonitto Stefano
Abstract
BACKGROUND:
prior statin treatment has been shown to have favourable effects on short- and long-term prognosis in patients with acute coronary syndrome (ACS). There are limited data in older patients. The aim of this study was to investigate the association of previous statin therapy and presentation characteristics, infarct size and clinical outcome in older patients, with or without atherosclerotic cardiovascular disease (ASCVD), included in the Elderly-ACS 2 trial.
METHODS:
data on statin use pre-admission were available for 1,192 of the 1,443 patients enrolled in the original trial. Of these, 531 (44.5%) were already taking statins. Patients were stratified based on established ASCVD and statin therapy. ACS was classified as non-ST elevation or ST elevation myocardial infarction (STEMI). Infarct size was measured by peak creatine kinase MB (CK-MB). All-cause death in-hospital and within 1 year were the major end points.
RESULTS:
there was a significantly lower frequency of STEMI in statin patients, in both ASCVD and No-ASCVD groups. Peak CK-MB levels were lower in statin users (10 versus 25 ng/ml, P?0.0001). There was lower all-cause death in-hospital and within 1 year for subjects with ASCVD already on statins independent of other baseline variables. There were no differences in all-cause death for No-ASCVD patients whether or not on statins.
CONCLUSIONS:
statin pretreatment was associated with more favourable ACS presentation and lower myocardial damage in older ACS patients both ASCVD and No-ASCVD. The incidence of all-cause death (in-hospital and within 1 year) was significantly lower in the statin treated ASCVD patients.
© The Author(s) 2022. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.
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[ESC/EACTS Guidelines for the management of valvular heart disease: what's new from the cardiologist's perspective].
G Ital Cardiol (Rome) -
Predictors of fractional flow reserve/instantaneous wave-free ratio discordance: impact of tailored diagnostic cut-offs on clinical outcomes of deferred lesions.
J Cardiovasc Med (Hagerstown)2022 Feb;23(2):106-115. doi: 10.2459/JCM.0000000000001264.
De Filippo Ovidio, Gallone Guglielmo, D'Ascenzo Fabrizio, Leone Antonio Maria, Mancone Massimo, Quadri Giorgio, Barbieri Lucia, Bossi Irene, Boccuzzi Giacomo, Montone Rocco Antonio, Burzotta Francesco, Iannaccone Mario, Montefusco Antonio, Carugo Stefano, Castelli Chiara, Oreglia Jacopo, Cerrato Enrico, Peirone Andrea, Zaccardo Giuseppe, Sardella Gennaro, Niccoli Giampaolo, Omedè Pierluigi, Varbella Ferdinando, Rognoni Andrea, Trani Carlo, Conrotto Federico, Escaned Javier, De Ferrari Gaetano Maria
Abstract
BACKGROUND:
Patient-related and lesion-related factors may influence instantaneous wave-free ratio (iFR)/fractional flow reserve (FFR) concordance, potentially affecting the safety of revascularization deferral.
METHODS:
Consecutive patients with at least an intermediate coronary stenosis evaluated by both iFR and FFR were retrospectively enrolled. The agreement between iFR and FFR at their diagnostic cut-offs (FFR 0.80, iFR 0.89) was assessed. Predictors of discordance were assessed using multivariate analyses. Tailored iFR cut-offs according to predictors of discordance best matching an FFR of 0.80 were identified. The impact of reclassification according to tailored iFR cut-offs on major cardiovascular events (MACE: cardiovascular death, myocardial infarction or target-lesion revascularization) among deferred lesions was investigated.
RESULTS:
Two hundred and ninety-nine intermediate coronary stenosis [FFR 0.84 (0.78-0.89), iFR 0.91 (0.87-0.95), 202 left main/left anterior descending (LM/LAD) vessels, 67.6%] of 260 patients were studied. Discordance rate was 23.4% (n?=?70, 10.7% iFR-negative discordant, 12.7% iFR-positive discordant). Predictors of discordance were LM/LAD disease, multivessel disease, non-ST-elevation myocardial infarction, smoking, reduced eGFR and hypertension. Lesion reclassification with tailored iFR cut-offs based on patient-level predictors carried no prognostic value among deferred lesions. Reclassification according to lesion location, which was entirely driven by LM/LAD lesions (iFR cut-offs: 0.93 for LM/LAD, 0.89 for non-LM/LAD), identified increased MACE among lesions deferred based on a negative FFR, between patients with a positive as compared with a negative iFR (19.4 vs. 6.1%, P?=?0.044), whereas the same association was not observed with the conventional 0.89 iFR cut-off (15 vs. 8.6%, P?=?0.303).
CONCLUSION:
Tailored vessel-based iFR cut-offs carry prognostic value among FFR-negative lesions, suggesting that a one-size-fit-all iFR cut-off might be clinically unsatisfactory.
Copyright © 2021 Italian Federation of Cardiology - I.F.C. All rights reserved.
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Uric acid in chronic coronary syndromes: Relationship with coronary artery disease severity and left ventricular diastolic parameter.
Nutr Metab Cardiovasc Dis2021 May;31(5):1501-1508. doi: 10.1016/j.numecd.2021.01.023.
Maloberti Alessandro, Bossi Irene, Tassistro Elena, Rebora Paola, Racioppi Angelo, Nava Stefano, Soriano Francesco, Piccaluga Emanuela, Piccalò Giacomo, Oreglia Jacopo, Vallerio Paola, Pirola Roberto, De Chiara Benedetta, Oliva Fabrizio, Moreo Antonella, Valsecchi Maria Grazia, Giannattasio Cristina
Abstract
BACKGROUND AND AIMS:
Uric Acid (UA) has been related to the development of Cardio-Vascular (CV) events in patients affected by Chronic Coronary Syndromes (CCS). Among various hypothesis, two arise: UA may negatively act on coronary artery determining a higher degree of atherosclerotic disease, and/or on heart determining a higher prevalence of diastolic dysfunction. Both the above hypothesized effects are object of our investigation.
METHODS AND RESULTS:
231 patients who were admitted to the cardiological department of the Niguarda Hospital (Milan, Italy) for CCS from January 2017 to June 2018 were enrolled. Coronary atherosclerotic burden was evaluated from coronary angiography as the number and type of involved vessels, as well as with both Gensini and Syntax scores. All subjects underwent a complete echocardiogram. At unadjusted and adjusted/multivariable analysis, UA levels were not significantly associated with variables analysed from the coronary angiography (number and type of vessels involved, neither the Gensini and Syntax scores) as well as with echocardiographic parameters regarding systolic and diastolic function.
CONCLUSIONS:
In conclusion, the main finding of our work is the absence of a role for UA in determining coronary arteries disease as well as LV diastolic dysfunction in CCS subjects. Taking together the results of previous studies with ours, we hypothesize that UA could act on heart (both on coronary arteries and on LV function) in an early phase of the disease, whereas while in the advanced stages other factors (previous myocardial infarction, previous myocardial revascularization and so on) may overshadow its effects.
Copyright © 2021 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.
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Clinical performance of a novel sirolimus-coated balloon in coronary artery disease: EASTBOURNE registry.
J Cardiovasc Med (Hagerstown)2021 Feb;22(2):94-100. doi: 10.2459/JCM.0000000000001070.
Cortese Bernardo, Testa Luca, Di Palma Gaetano, Heang Tay M, Bossi Irene, Nuruddin Amin A, Ielasi Alfonso, Tespili Maurizio, Perez Ignacio S, Milazzo Diego, Benincasa Susanna, Latib Azeem, Cacucci Michele, Caiazzo Gianluca, Seresini Giuseppe, Tomai Fabrizio, Ocaranza Raymundo, Torres Alfonso, Perotto Anna, Bedogni Francesco, Colombo Antonio
Abstract
AIMS:
The purpose of the EASTBOURNE registry is to evaluate the immediate and long-term clinical performance of a novel sirolimus-coated balloon (SCB) in a real-world population of patients with coronary artery disease. We here present the prespecified interim analysis after the enrollment of the first 642 patients who obtained 1-year clinical follow-up.
METHODS:
EASTBOURNE is a prospective, international, multicenter, all-comer investigator-driven clinical registry, which is enrolling consecutive patients treated with SCB at 42 European and Asiatic centers. Primary study endpoint is target-lesion revascularization (TLR) at 12 months. Secondary endpoints are procedural success and major adverse cardiac events through 36 months.
RESULTS:
Diabetes mellitus was present in 41% of patients. Acute coronary syndrome was present in 45% of patients and de novo lesions were 55%; 83% of the in-stent restenosis (ISR) patients had drug-eluting stents restenosis. Lesion predilatation was performed in 95% of the cases and bailout stenting occurred in 7.5%. So far, 642 patients have a complete 12-month follow-up. TLR occurred in 2.5%, myocardial infarction in 2.3%, total death in 1% and major adverse cardiac events in 5.8% of patients. A prespecified analysis of comparison between ISR and de-novo lesions showed a significantly higher occurrence of TLR in the ISR population (5.4 vs. 0.2%, P?=?0.0008).
CONCLUSION:
The current interim analysis of 12-month follow-up of the EASTBOURNE registry shows good immediate performance and an adequate and encouraging safety profile through 12 months for this novel SCB.
Copyright © 2020 Italian Federation of Cardiology - I.F.C. All rights reserved.
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Residual SYNTAX Score and One-Year Outcome in Elderly Patients With Acute Coronary Syndrome.
CJC Open2020 Jul;2(4):236-243. doi: 10.1016/j.cjco.2020.03.005.
Morici Nuccia, Alicandro Gianfranco, Ferri Luca A, Piatti Luigi, Grosseto Daniele, Sganzerla Paolo, Tortorella Giovanni, Ferrario Maurizio, Crimi Gabriele, Bossi Irene, Tondi Stefano, Petronio Anna Sonia, Mariani Matteo, Toso Anna, Ravera Amelia, Corrada Elena, Cao Davide, Di Ascenzo Leonardo, La Vecchia Carlo, De Servi Stefano, Savonitto Stefano
Abstract
BACKGROUND:
The residual burden of coronary artery disease after percutaneous coronary intervention (PCI) has been associated with worse ischemic outcome. However, data are conflicting in elderly patients. The aim of our study was to verify the incremental value of the residual ergy Between Percutaneous Coronary Intervention With us and Cardiac Surgery (SYNTAX) score (rSS) over clinical variables and baseline SYNTAX score (bSS) in predicting 1-year mortality or cardiovascular events.
METHODS:
A post hoc analysis of data collected in the Elderly-ACS 2 multicenter randomized trial was performed. We included 630 patients aged > 75 years with multivessel coronary disease undergoing PCI for acute coronary syndrome (ACS). The primary outcome was a composite of death, recurrent myocardial infarction, and stroke at 1-year follow up. Change in c-statistic and standardized net benefit were used to evaluate the incremental value of the rSS.
RESULTS:
Event rates were significantly higher in patients with incomplete revascularization (rSS > 8). When the rSS was included in a core Cox regression model containing age, previous myocardial infarction, and ACS type, the hazard ratio for patients with score values > 8 was 2.47 (95% confidence interval, 1.51-4.06). However, the core model with rSS did not increase the c-statistic compared with the core model with the bSS (from 0.69 to 0.70) and gave little incremental value in the standardized net benefit.
CONCLUSIONS:
In elderly patients with ACS with multivessel disease undergoing PCI, incomplete revascularization was associated with worse outcome at 1-year follow-up. However, there was no clear incremental value of the rSS in the prediction of 1-year adverse outcome compared with a model including clinical variables and bSS.
© 2020 Canadian Cardiovascular Society. Published by Elsevier Inc.
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Clinical Impact of Valvular Heart Disease in Elderly Patients Admitted for Acute Coronary Syndrome: Insights From the Elderly-ACS 2 Study.
Can J Cardiol2020 Jul;36(7):1104-1111. doi: 10.1016/j.cjca.2019.11.014.
Crimi Gabriele, Montalto Claudio, Ferri Luca Angelo, Piatti Luigi, Bossi Irene, Morici Nuccia, Mandurino-Mirizzi Alessandro, Grosseto Daniele, Tortorella Giovanni, Savonitto Stefano, De Servi Stefano,
Abstract
BACKGROUND:
Elderly patients are under-represented in clinical trials and registries, and a gap of evidence exists for clinical decision making in the setting of acute coronary syndromes (ACS). We aimed to assess the prevalence and independent prognostic impact of valvular heart disease (VHD) diagnosed during the index hospitalization on clinical outcomes among elderly patients with ACS. Included VHDs were moderate-to-severe mitral regurgitation (MR), moderate-to-severe aortic stenosis (AS), or both combined.
METHODS:
We explored the Elderly-ACS 2 dataset, which includes patients older than 74 years of age diagnosed with ACS and managed invasively. The primary endpoint was a composite of all-cause death, myocardial infarction, disabling stroke, and rehospitalization for heart failure at 1 year; the secondary endpoint was death for cardiovascular causes. Patients were stratified into 4 groups: no VHD, moderate-to-severe MR, moderate-to-severe AS, and both moderate-to-severe MR and AS.
RESULTS:
Of the 1443 subjects enrolled, 190 (13.2%) had moderate-to-severe MR, 26 (1.8%) had moderate-to-severe AS, and 13 (0.9%) had both moderate-to-severe MR and AS. When compared with those with no VHD, patients with moderate-to-severe MR had hazard ratios (HRs) for the primary endpoint of 2.04 (95% confidence interval [CI], 1.36-3.07], those with moderate-to-severe AS had HRs of 3.10 (95% CI, 1.39-6.93), and those with both moderate-to-severe MR and AS had HRs of 4.00 (95% CI, 1.65-9.73] (all P
CONCLUSIONS:
In a contemporary cohort of elderly patients admitted for ACS, VHD was found in 1 of 5 subjects and had an independent, consistent impact on prognosis.
Copyright © 2019 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
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Impact of diabetes on clinical outcome among elderly patients with acute coronary syndrome treated with percutaneous coronary intervention: insights from the ELDERLY ACS 2 trial.
J Cardiovasc Med (Hagerstown)2020 Jun;21(6):453-459. doi: 10.2459/JCM.0000000000000978.
De Luca Giuseppe, Verdoia Monica, Savonitto Stefano, Piatti Luigi, Grosseto Daniele, Morici Nuccia, Bossi Irene, Sganzerla Paolo, Tortorella Giovanni, Cacucci Michele, Murena Ernesto, Toso Anna, Bongioanni Sergio, Ravera Amelia, Corrada Elena, Mariani Matteo, Di Ascenzo Leonardo, Petronio Anna S, Cavallini Claudio, Vitrella Giancarlo, Antonicelli Roberto, Rogacka Renata, De Servi Stefano,
Abstract
BACKGROUND:
Despite recent improvements in percutaneous coronary revascularization and antithrombotic therapies for the treatment of acute coronary syndromes, the outcome is still unsatisfactory in high-risk patients, such as the elderly and patients with diabetes. The aim of the current study was to investigate the prognostic impact of diabetes on clinical outcome among patients included in the Elderly-ACS 2 trial, a randomized, open-label, blinded endpoint study carried out at 32 centers in Italy.
METHODS:
Our population is represented by 1443 patients included in the Elderly-ACS 2 trial. Diabetes was defined as known history of diabetes at admission. The primary endpoint of this analysis was cardiovascular mortality, while secondary endpoints were all-cause death, recurrent myocardial infarction, Bleeding Academic Research Consortium type 2 or 3 bleeding, and rehospitalization for cardiovascular event or stent thrombosis within 12 months after index admission.
RESULTS:
Diabetes was present in 419 (29%) out of 1443 patients. Diabetic status was significantly associated with major cardiovascular risk factors and history of previous coronary disease, presentation with non-ST segment elevation myocardial infarction (P?=?0.01) more extensive coronary disease (P?=?0.02), more advanced Killip class at presentation (P?=?0.003), use at admission of statins (P?=?0.004) and diuretics at discharge (P?0.001). Median follow-up was 367 days (interquartile range: 337-378 days). Diabetic status was associated with an absolute increase in the rate of cardiovascular mortality as compared with patients without diabetes [5.5 vs. 3.3%, hazard ratio (HR) 1.7 (0.99-2.8), P?=?0.054], particularly among those treated with clopidogrel [HR (95% confidence interval (CI))?=?1.89 (0.93-3.87), P?=?0.08]. However, this difference disappeared after correction for baseline differences [Adjusted HR (95% CI) 1.1(0.4-2.9), P?=?0.86]. Similar findings were observed for other secondary endpoints, except for bleeding complications, significantly more frequent in diabetic patients [HR (95% CI) 2.02 (1.14-3.6), P?=?0.02; adjusted HR (95% CI)?=?2.1 (1.01-4.3), P?=?0.05]. No significant interaction was observed between type of dual antiplatelet therapy, diabetic status and outcome.
CONCLUSION:
Among elderly patients with acute coronary syndromes, diabetic status was associated with higher rates of comorbidities, more severe cardiovascular risk profile and major bleeding complications fully accounting for the absolute increase in mortality. In fact, diabetes mellitus did not emerge as an independent predictor of survival in advanced age.
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Characteristics and Outcome of Patients ?75 Years of Age With Prior Coronary Artery Bypass Grafting Admitted for an Acute Coronary Syndrome.
Am J Cardiol2020 Jun;125(12):1788-1793. doi: 10.1016/j.amjcard.2020.03.021.
Morici Nuccia, De Rosa Roberta, Crimi Gabriele, De Luca Leonardo, Ferri Luca A, Lenatti Laura, Piatti Luigi, Tortorella Giovanni, Grosseto Daniele, Franco Nicoletta, Bossi Irene, Montalto Claudio, Antonicelli Roberto, Alicandro Gianfranco, De Luca Giuseppe, De Servi Stefano, Savonitto Stefano
Abstract
The prognostic role of previous coronary artery bypass (CABG) in elderly patients admitted to hospital for an acute coronary syndrome (ACS) is unclear. Therefore, the aim of this study was to compare the prognosis of patients aged ?75 years admitted for an ACS with or without previous history of CABG. The primary outcome of the study was a composite of overall mortality, recurrent nonfatal myocardial infarction, nonfatal stroke, and rehospitalization for heart failure at 1-year follow-up. We included 2,253 ACS patients, aged 81 (78 to 85) years enrolled in 3 multicenter studies (the Italian Elderly ACS study, the LADIES ACS study, and the Elderly ACS 2 randomised trial) - 178 (7.9%) with previous CABG, 2,075 (92.1%) without. Patients with previous CABG had a higher burden of cardiovascular risk factors, lower ejection fraction, and higher creatinine values on admission. However, both at univariate analysis and after adjustment for the most relevant covariates (sex, age, previous myocardial infarction, type of ACS, left ventricular ejection fraction, and serum creatinine on admission), previous CABG did not show any statistically significant association with 1-year outcome (adjusted hazard ratio 0.85; 95% confidence interval 0.61 to 1.19; p?=?0.353). In conclusion, our study suggests that elderly ACS patients with previous CABG have worse basal clinical characteristics. Nevertheless, in a broad cohort of patients mostly treated with percutaneous coronary intervention during the index event, previous CABG did not confer independent additional risk of major adverse cardiovascular events at 1-year follow-up.
Copyright © 2020 Elsevier Inc. All rights reserved.
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Impact of body mass index on clinical outcome among elderly patients with acute coronary syndrome treated with percutaneous coronary intervention: Insights from the ELDERLY ACS 2 trial.
Nutr Metab Cardiovasc Dis2020 May;30(5):730-737. doi: 10.1016/j.numecd.2020.01.001.
De Luca Giuseppe, Verdoia Monica, Savonitto Stefano, Ferri Luca A, Piatti Luigi, Grosseto Daniele, Morici Nuccia, Bossi Irene, Sganzerla Paolo, Tortorella Giovanni, Cacucci Michele, Ferrario Maurizio, Murena Ernesto, Sibilio Girolamo, Tondi Stefano, Toso Anna, Bongioanni Sergio, Ravera Amelia, Corrada Elena, Mariani Matteo, Di Ascenzo Leonardo, Petronio A Sonia, Cavallini Claudio, Vitrella Giancarlo, Antonicelli Roberto, Rogacka Renata, De Servi Stefano,
Abstract
BACKGROUND AND AIM:
Elderly patients are at increased risk of hemorrhagic and thrombotic complications after an acute coronary syndrome (ACS). Frailty, comorbidities and low body weight have emerged as conditioning the prognostic impact of dual antiplatelet therapy (DAPT). The aim of the present study was to investigate the prognostic impact of body mass index (BMI) on clinical outcome among patients included in the Elderly-ACS 2 trial, a randomized, open-label, blinded endpoint study comparing low-dose (5 mg) prasugrel vs clopidogrel among elderly patients with ACS.
METHODS AND RESULTS:
Our population is represented by 1408 patients enrolled in the Elderly-ACS 2 trial. BMI was calculated at admission. The primary endpoint of this analysis was cardiovascular (CV) mortality. Secondary endpoints were all-cause death, recurrent MI, Bleeding Academic Research Consortium (BARC) type 2 or 3 bleeding, and re-hospitalization for cardiovascular reasons or stent thrombosis within 12 months after index admission. Patients were grouped according to median values of BMI (
CONCLUSIONS:
Among elderly patients with ACS, BMI did not condition the survival or the risk of major cardiovascular and bleeding complications. The results were consistent across several patient risk categories.
Copyright © 2020 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.
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Kounis Syndrome: Report of Two Cases with Peculiar Presentation and Diagnostic Issues.
High Blood Press Cardiovasc Prev2019 Apr;26(2):145-149. doi: 10.1007/s40292-019-00312-w.
Maloberti Alessandro, Pansera Francesco, Sala Oscar, Fusco Rossana, Pierri Alessandra, Bossi Irene, Giannattasio Cristina
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Outcomes of Elderly Patients with ST-Elevation or Non-ST-Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention.
Am J Med2019 Feb;132(2):209-216. doi: 10.1016/j.amjmed.2018.10.027.
Morici Nuccia, Savonitto Stefano, Ferri Luca A, Grosseto Daniele, Bossi Irene, Sganzerla Paolo, Tortorella Giovanni, Cacucci Michele, Ferrario Maurizio, Crimi Gabriele, Murena Ernesto, Tondi Stefano, Toso Anna, Gandolfo Nicola, Ravera Amelia, Corrada Elena, Mariani Matteo, Di Ascenzo Leonardo, Petronio A Sonia, Cavallini Claudio, Vitrella Giancarlo, Antonicelli Roberto, Piscione Federico, Rogacka Renata, Antolini Laura, Alicandro Gianfranco, La Vecchia Carlo, Piatti Luigi, De Servi Stefano,
Abstract
INTRODUCTION:
Acute coronary syndromes (ACS) have been classified according to the finding of ST-segment elevation on the presenting electrocardiogram, with different treatment strategies and practice guidelines. However, a comparative description of the clinical characteristics and outcomes of acute coronary syndrome elderly patients undergoing percutaneous coronary intervention during index admission has not been published so far.
METHODS:
Retrospective cohort study of patients enrolled in the Elderly ACS-2 multicenter randomized trial. Main outcome measures were crude cumulative incidence and cause-specific hazard ratio (cHR) of cardiovascular death, noncardiovascular death, reinfarction, and stroke.
RESULTS:
Of 1443 ACS patients aged >75 years (median age 80 years, interquartile range 77-84), 41% were classified as ST-elevation myocardial infarction (STEMI), and 59% had non-ST-elevation ACS (NSTEACS) (48% NSTEMI and 11% unstable angina). As compared with those with NSTEACS, STEMI patients had more favorable baseline risk factors, fewer prior cardiovascular events, and less severe coronary disease, but lower ejection fraction (45% vs 50%, P
CONCLUSIONS:
Despite more favorable baseline characteristics, elderly STEMI patients have worse survival and a higher risk of stroke compared with NSTEACS patients after percutaneous coronary intervention.
Copyright © 2018. Published by Elsevier Inc.
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Mycotic coronary aneurysms.
J Cardiovasc Med (Hagerstown)2019 Jan;20(1):10-15. doi: 10.2459/JCM.0000000000000734.
Buono Andrea, Maloberti Alessandro, Bossi Irene M, Piccaluga Emanuela, Piccalò Giacomo, Oreglia Jacopo A, Moreo Antonella, Russo Claudio F, Oliva Fabrizio, Giannattasio Cristina
Abstract
: Mycotic coronary aneurysm is a rare infective disease of arterial vessel walls. Their development could be linked to the presence of an infective endocarditis or could represent a primary infection at the site of an implanted intracoronary stent. Bacterial agents, particularly Staphylococcus aureus, are the most common etiological agents. Due to an aspecific clinical presentation and examination, diagnosis could be challenging. Multiple imaging techniques (both invasive and noninvasive) are often required to reach the final diagnosis. Prognosis is characterized by high morbidity and mortality rates and, in fact, a tempestive treatment is required, although, to date, scanty data concerning the optimal treatment choice are present in literature.
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[Paclitaxel-coated balloons for in-stent restenosis treatment: long-term clinical results and predictors of recurrent target lesion revascularization].
G Ital Cardiol (Rome)2018 Apr;19(4):232-238. doi: 10.1714/2898.29217.
Bossi Irene, D'Anna Margherita, Vaccaro Valentina, Caria Maria Paola, Colombo Paola, De Marco Federico, Oreglia Jacopo, Piccalò Giacomo, Piccaluga Emanuela, Soriano Francesco, Oliva Fabrizio, Klugmann Silvio
Abstract
BACKGROUND:
The aim of this study was to report clinical outcomes in patients treated with paclitaxel-coated balloons (PCB) for in-stent restenosis (ISR) in both bare metal (BMS) and drug-eluting stent (DES).
METHODS:
Between May 2009 and December 2015, we treated 155 ISR in 140 patients. At recruitment, 35% of patients had diabetes. Among the lesions, 125 were first occurrence (55 within BMS and 70 within DES) and 30 recurrent; 24 ISR were multi-metal layered. Mean reference diameter was 2.79 ± 0.52 mm and mean lesion length 13.2 ± 7.1 mm. PCB use included 32 Dior I, 97 InPact Falcon, 18 Panthera Lux, and 8 Restore DEB.
RESULTS:
At a median follow-up of 442 days, we observed 18 target lesion revascularizations (TLR), one myocardial infarction, 3 cardiac deaths, and 5 non-cardiac deaths. TLR occurrence differed according to type of ISR (4% within BMS, 14% within DES, 28% within recurrent ISR; p
CONCLUSIONS:
Our results confirm the safety and efficacy of PCB for ISR treatment both within BMS and DES. PCB type and recurrent ISR correlate with subsequent TLR.
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Comparison of Reduced-Dose Prasugrel and Standard-Dose Clopidogrel in Elderly Patients With Acute Coronary Syndromes Undergoing Early Percutaneous Revascularization.
Circulation2018 Jun;137(23):2435-2445. doi: 10.1161/CIRCULATIONAHA.117.032180.
Savonitto Stefano, Ferri Luca A, Piatti Luigi, Grosseto Daniele, Piovaccari Giancarlo, Morici Nuccia, Bossi Irene, Sganzerla Paolo, Tortorella Giovanni, Cacucci Michele, Ferrario Maurizio, Murena Ernesto, Sibilio Girolamo, Tondi Stefano, Toso Anna, Bongioanni Sergio, Ravera Amelia, Corrada Elena, Mariani Matteo, Di Ascenzo Leonardo, Petronio A Sonia, Cavallini Claudio, Vitrella Giancarlo, Rogacka Renata, Antonicelli Roberto, Cesana Bruno M, De Luca Leonardo, Ottani Filippo, De Luca Giuseppe, Piscione Federico, Moffa Nadia, De Servi Stefano,
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; =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; =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; =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.
© 2018 American Heart Association, Inc.
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Aspirin Desensitization in Patients With Coronary Artery Disease: Results of the Multicenter ADAPTED Registry (Aspirin Desensitization in Patients With Coronary Artery Disease).
Circ Cardiovasc Interv2017 Feb;10(2):. doi: e004368.
Rossini Roberta, Iorio Annamaria, Pozzi Roberto, Bianco Matteo, Musumeci Giuseppe, Leonardi Sergio, Lettieri Corrado, Bossi Irene, Colombo Paola, Rigattieri Stefano, Dossena Cinzia, Anzuini Angelo, Capodanno Davide, Senni Michele, Angiolillo Dominick J
Abstract
BACKGROUND:
There are limited data on aspirin (ASA) desensitization for patients with coronary artery disease. The aim of the present study was to assess the safety and efficacy of a standard rapid desensitization protocol in patients with ASA sensitivity undergoing coronary angiography.
METHODS AND RESULTS:
This is a prospective, multicenter, observational study including 7 Italian centers including patients with a history of ASA sensitivity undergoing coronary angiography with intent to undergo percutaneous coronary intervention. A total of 330 patients with history of ASA sensitivity with known/suspected stable coronary artery disease or presenting with an acute coronary syndrome, including ST-segment-elevation myocardial infarction were enrolled. Adverse effects to aspirin included urticaria (n=177, 53.6%), angioedema (n=69, 20.9%), asthma (n=65, 19.7%), and anaphylactic reaction (n=19, 5.8%). Among patients with urticaria/angioedema, 13 patients (3.9%) had a history of idiopathic chronic urticaria. All patients underwent a rapid ASA (5.5 hours) desensitization procedure. The desensitization procedure was performed before cardiac catheterization in all patients, except for those (n=78, 23.6%) presenting with ST-segment-elevation myocardial infarction who underwent the desensitization after primary percutaneous coronary intervention. Percutaneous coronary intervention was performed in 235 patients (71%) of the overall study population. The desensitization procedure was successful in 315 patients (95.4%) and in all patients with a history of anaphylactic reaction. Among the 15 patients (4.6%) who did not successfully respond to the desensitization protocol, adverse reactions were minor and responded to treatment with corticosteroids and antihistamines. Among patients with successful in-hospital ASA desensitization, 253 patients (80.3%) continued ASA for at least 12 months. Discontinuation of ASA in the 62 patients (19.7%) who had responded to the desensitization protocol was because of medical decision and not because of hypersensitivity reactions.
CONCLUSIONS:
A standard rapid desensitization protocol is safe and effective across a broad spectrum of patients, irrespective of the type of aspirin sensitivity manifestation, with indications to undergo coronary angiography with intent to perform percutaneous coronary intervention.
CLINICAL TRIAL REGISTRATION:
URL: http://www.clinicaltrials.gov. Unique identifier: NCT02848339.
© 2017 American Heart Association, Inc.
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A comparison of reduced-dose prasugrel and standard-dose clopidogrel in elderly patients with acute coronary syndromes undergoing early percutaneous revascularization: Design and rationale of the randomized Elderly-ACS 2 study.
Am Heart J2016 Nov;181():101-106. doi: 10.1016/j.ahj.2016.08.010.
Ferri Luca A, Morici Nuccia, Grosseto Daniele, Tortorella Giovanni, Bossi Irene, Sganzerla Paolo, Cacucci Michele, Sibilio Girolamo, Tondi Stefano, Toso Anna, Ferrario Maurizio, Gandolfo Nicola, Ravera Amelia, Mariani Matteo, Corrada Elena, Di Ascenzo Leonardo, Petronio Anna Sonia, Cavallini Claudio, Moffa Nadia, De Servi Stefano, Savonitto Stefano
Abstract
BACKGROUND:
Elderly patients display higher on clopidogrel platelet reactivity as compared with younger patients. Treatment with prasugrel 5mg has been shown to provide more predictable and homogenous antiplatelet effect, as compared with clopidogrel, suggesting the possibility of reducing ischemic events after an acute coronary syndrome (ACS) without increasing bleeding.
STUDY DESIGN:
The Elderly-ACS 2 study is a multicenter, randomized, parallel-group, open-label trial designed to demonstrate the superiority of a strategy of dual antiplatelet treatment using a reduced 5-mg daily dose of prasugrel over a standard strategy with a daily clopidogrel dose of 75mg in patients older than 74years with ACS (either ST- or non-ST-elevation myocardial infarction) undergoing early percutaneous revascularization. The primary end point is the composite of all-cause mortality, myocardial reinfarction, disabling stroke, and rehospitalization for cardiovascular causes or bleeding within 1 year. Taking advantage of the planned size of 2,000 patients, the secondary objective is to assess the prognostic impact of selected prerandomization variables (age, sex, diabetic status, serum creatinine level, electrocardiogram changes, abnormal troponin levels, basal and residual SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery [SYNTAX] score).
CONCLUSION:
The Elderly-ACS 2 study is a multicenter, randomized trial comparing a strategy of dual antiplatelet therapy with a reduced dose of prasugrel with a standard dose of clopidogrel in elderly patients with ACS undergoing percutaneous revascularization (the Elderly ACS 2 trial: NCT01777503).
Copyright © 2016 Elsevier Inc. All rights reserved.
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[A simple but very complicated angioplasty: management of coronary artery perforation and dual antiplatelet therapy. A case report and literature review].
G Ital Cardiol (Rome)2015 May;16(5):311-5. doi: 10.1714/1870.20436.
Soriano Francesco, Oreglia Jacopo, Bossi Irene, Colombo Paola, Piccalò Giacomo, De Marco Federico, Bruschi Giuseppe, Klugmann Silvio
Abstract
Coronary artery perforation is a rare but potentially fatal complication. Therefore, it is crucial for interventional cardiologists to have knowledge of this condition and what management strategies are available, particularly in the case of procedures with a high level of complexity. Notwithstanding this, even simple procedures are not immune to serious complications, as described in this case report where coronary angioplasty was complicated by left anterior descending artery perforation with cardiac tamponade, giving rise to multiple complications of difficult management. The case presented here also provides the opportunity to investigate the optimal duration of dual antiplatelet therapy after implantation of drug-eluting stents, a topic much debated in recent years.
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A risk score for predicting 1-year mortality in patients ?75 years of age presenting with non-ST-elevation acute coronary syndrome.
Am J Cardiol2015 Jul;116(2):208-13. doi: 10.1016/j.amjcard.2015.04.015.
Angeli Fabio, Cavallini Claudio, Verdecchia Paolo, Morici Nuccia, Del Pinto Maurizio, Petronio Anna Sonia, Antonicelli Roberto, Murena Ernesto, Bossi Irene, De Servi Stefano, Savonitto Stefano
Abstract
Approximately 1/3 of patients with non-ST-segment elevation (NSTE) acute coronary syndromes (ACS) are ?75 years of age. Risk stratification in these patients is generally difficult because supporting evidence is scarce. The investigators developed and validated a simple risk prediction score for 1-year mortality in patients ?75 years of age presenting with NSTE ACS. The derivation cohort was the Italian Elderly ACS trial, which included 313 patients with NSTE ACS aged ?75 years. A logistic regression model was developed to predict 1-year mortality. The validation cohort was a registry cohort of 332 patients with NSTE ACS meeting the same inclusion criteria as for the Italian Elderly ACS trial but excluded from the trial for any reason. The risk score included 5 statistically significant covariates: previous vascular event, hemoglobin level, estimated glomerular filtration rate, ischemic electrocardiographic changes, and elevated troponin level. The model allowed a maximum score of 6. The score demonstrated a good discriminating power (C statistic = 0.739) and calibration, even among subgroups defined by gender and age. When validated in the registry cohort, the scoring system confirmed a strong association with the risk for all-cause death. Moreover, a score ?3 (the highest baseline risk group) identified a subset of patients with NSTE ACS most likely to benefit from an invasive approach. In conclusion, the risk for 1-year mortality in patients ?75 years of age with NSTE ACS is substantial and can be predicted through a score that can be easily derived at the bedside at hospital presentation. The score may help in guiding treatment strategy.
Copyright © 2015 Elsevier Inc. All rights reserved.
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Tako-Tsubo like syndrome triggered by meperidine.
Med J Malaysia2011 Dec;66(5):520-1.
Sacco Alice, Morici Nuccia, Belli Oriana, Bossi Irene, Mafrici Antonio, Klugmann Silvio
Abstract
We present a case of "inverted Tako-Tsubo" syndrome in a woman sedated with meperidine before undergoing a colonscopy. We discuss possible etiology of this ventricular dysfunction.
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[Percutaneous heart valves: clinical role].
G Ital Cardiol (Rome)2008 Mar;9(3):155-66.
Colombo Paola, Bruschi Giuseppe, Bossi Irene, Pirola Roberto, Klugmann Silvio
Abstract
Percutaneous valve therapy is said to be the last frontier in interventional cardiology. Over the past few years the work of decades has come to fruition. The first percutaneous implantation of a cardiac stent-valve in a human was reported by Bonhoeffer and colleagues in 2000. The first percutaneous aortic valve placement was performed by Cribier in 2002 using an antegrade approach in a patient with critical aortic stenosis. Attempts at percutaneous mitral valve repair are as varied as the pathophysiological mechanisms of mitral regurgitation. We are now embarking on a new era in the treatment of valvular heart disease with the introduction of percutaneous and minimally invasive devices and techniques to address valve dysfunction without conventional surgical repair/replacement. Pathology of all four cardiac valves has now been treated in early stage clinical feasibility (pilot) trials. There are at least 30 percutaneous valve programs currently being developed by 24 different companies. Two of the percutaneous aortic valve devices and five of the mitral valve devices are in various stages of clinical trials, ranging from feasibility to pivotal at the present time. Large-scale trials comparing percutaneous valve replacement and repair with surgery are just beginning. In this article we will look at the various technologies and advances in percutaneous valve replacement and repair, with an emphasis on those devices that are currently being utilized in the clinical realm.
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Functional derangement and cardiac innervation in the apical ballooning syndrome: a 123I-meta-iodobenzylguanidine scintigraphic and dobutamine stress echocardiographic study.
J Cardiovasc Med (Hagerstown)2007 Mar;8(3):205-9.
Moreo Antonella, De Chiara Benedetta, Possa Mario, Sara Roberto, Bossi Irene, Orrego Pedro Silva, Nicolosi Elisa, Mauri Francesco, Parodi Oberdan
Abstract
Several cases of transient left ventricular apical ballooning syndrome have already been described, but the pathophysiological mechanisms of this syndrome still remain unclear. We report the case of a patient evaluated in the acute phase of apical ballooning by coronary angiography and echocardiography who was submitted to I-meta-iodobenzylguanidine (MIBG) myocardial scintigraphy and dobutamine stress echocardiography one month after the discharge. MIBG scintigraphy demonstrated a decreased tracer uptake in the apical and periapical anterior regions, whilst myocardial perfusion at rest was normal. Dobutamine induced an increased left ventricular outflow tract gradient and hypokinesis in the apical and periapical segments, mimicking the findings that occurred in the acute phase, and in agreement with the location of MIBG abnormalities. After a two-month treatment with carvedilol, MIBG uptake increased in the apical and periapical anterior regions.
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Thrombus aspiration before primary angioplasty improves myocardial reperfusion in acute myocardial infarction: the DEAR-MI (Dethrombosis to Enhance Acute Reperfusion in Myocardial Infarction) study.
J Am Coll Cardiol2006 Oct;48(8):1552-9.
Silva-Orrego Pedro, Colombo Paola, Bigi Riccardo, Gregori Dario, Delgado Anabella, Salvade Paolo, Oreglia Jacopo, Orrico Paola, de Biase Anna, Piccalò Giacomo, Bossi Irene, Klugmann Silvio
Abstract
OBJECTIVES:
This study sought to test the hypothesis that thrombus removal, with a new manual thrombus-aspirating device, before primary percutaneous coronary intervention (PPCI) may improve myocardial reperfusion compared with standard PPCI in patients with ST-segment elevation acute myocardial infarction (STEMI).
BACKGROUND:
In STEMI patients, PPCI may cause thrombus dislodgment and impaired microcirculatory reperfusion. Controversial results have been reported with different systems of distal protection or thrombus removal.
METHODS:
One-hundred forty-eight consecutive STEMI patients, admitted within 12 h of symptom onset and scheduled for PPCI, were randomly assigned to PPCI (group 1) or manual thrombus aspiration before standard PPCI (group 2). Patients with cardiogenic shock, previous infarction, or thrombolytic therapy were excluded. Primary end points were complete (>70%) ST-segment resolution (STR) and myocardial blush grade (MBG) 3.
RESULTS:
Baseline clinical and angiographic characteristics were similar in the 2 groups. Comparing groups 1 and 2: complete STR 50% versus 68% (p
CONCLUSIONS:
Manual thrombus aspiration before PPCI leads to better myocardial reperfusion and is associated with lower creatine kinase mass band fraction release, lower risk of distal embolization, and no reflow compared with standard PPCI. (Thrombus Aspiration Before Standard Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction; http://clinicaltrials.gov/ct/show/NCT00257153).
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[The elderly with acute coronary syndrome: the higher the risk, the lesser the treatment].
G Ital Cardiol (Rome)2006 Apr;7(4 Suppl 1):21S-29S.
Savonitto Stefano, Colombo Paola, Bossi Irene, Klugmann Silvio
Abstract
Patients older than 75 years represent about one third of those admitted to the Italian coronary care units due to an acute coronary syndrome, with a greater prevalence of the form without ST-segment elevation. Compared to younger patients, the elderly have higher risk characteristics and more adverse outcomes, particularly mortality and heart failure. Despite this, they receive less effective treatments, and especially less coronary reperfusion therapy. This attitude is only partially motivated by the fear of the potential adverse effects of antithrombotic and invasive treatments in the elderly, on the basis of misleading meta-analyses and observational studies. A more objective approach is taking fuel by recent randomized studies showing that the treatment effect is even greater in the elderly (particularly when evaluated in terms of "number of lives saved"), whereas the benefit is often hardly seen in the younger population. Also, the idea that the elderly may have little room for percutaneous coronary intervention has been progressively wiped away by the experience of those Centers that have started systematic coronary angiography regardless of the patients' age. The presence of severe copathologies has been often considered to limit intervention in the elderly. This real difficulty (although more typical of the seventh and eighth decade than at older age) should be rather considered specifically and not as a mere consequence of age. The elderly patient is at higher risk of iatrogenic bleeding: therapeutic regimens should be adjusted specifically in order to reduce this untoward effect of effective treatments.
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[Percutaneous coronary interventions in elderly patients: clinical indications and adjunctive medical treatment. The Italian Drug Evaluation in Angioplasty (IDEA) study].
G Ital Cardiol (Rome)2006 Feb;7(2):136-44.
Bossi Irene, Piccaluga Emanuela, Scatturin Melania, Corvaja Nicola, Pasquetto Giampaolo, Steffanon Luigi, Oberhollenzer Rainer, Colombo Paola, Bolognese Leonardo, Savonitto Stefano
Abstract
BACKGROUND:
Specific guidelines for interventional cardiology in elderly patients are not available, and it appears that aged patients are treated more conservatively. Nevertheless data on the real clinical practice are lacking. The aim of the study was to describe different therapeutic strategies in elderly patients enrolled in the Italian Drug Evaluation in Angioplasty (IDEA) study.
METHODS:
The IDEA study is a registry of consecutive percutaneous coronary interventions (PCI) performed from September 15 to 29, 2003, at 79 Italian cath-labs.
RESULTS:
Out of 1517 consecutive PCI patients, 491 (32%) were aged > or = 70 years. Compared to younger patients, those > or = 70 years old showed more frequently (p or = 70 years, acute coronary syndrome was the more frequent clinical indication for PCI (54 vs 49% in patients or = 70 years (2.9 vs 0.9%, p = 0.004), particularly in patients treated for acute coronary syndromes (5.5 vs 1.4%, p = 0.002). In these patients, more bleeding complications (7.1 vs 3.9%, p
CONCLUSIONS:
Compared to younger patients, elderly patients enrolled in the IDEA study had a higher risk profile and higher in-hospital morbidity and mortality. Except for a lower use of glycoprotein IIb/IIIa receptor antagonists for acute myocardial infarction, no discriminations were observed in elderly patients in terms of clinical indications, antiplatelet therapy and drug-eluting stent use.
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Cardiac death and heart failure following primary angioplasty in extensive myocardial infarction: incremental prognostic value of clinical, functional and angiographic data.
Ital Heart J2004 Dec;5(12):912-8.
Corrada Elena, Bigi Riccardo, Colombo Paola, Bossi Irene, De Biase Anna Maria, Mafrici Antonio, Parodi Oberdan, Klugmann Silvio
Abstract
BACKGROUND:
The incidence of late severe heart failure after primary angioplasty is not clear and few data are available about the clinical prognostic predictors of this event. The aims of our study were a) to evaluate the incidence of cardiac death and heart failure after an extensive acute myocardial infarction treated with primary angioplasty, and b) to identify, among clinical, ECG, functional, and angiographic variables, the outcome predictors and their incremental prognostic value.
METHODS:
Two hundred and thirty-three patients with ST-segment elevation in > or = 4 leads, without cardiogenic shock, underwent primary angioplasty within 12 hours of symptom onset and were prospectively followed up for a median of 21 months for the combined endpoint of cardiac death and heart failure. The effects of clinical, ECG, functional, and angiographic data on the combined endpoint were evaluated using Cox's analysis. Separate models were developed including all variables of a given model plus significant variables of previous models to reproduce the usual clinical information flow.
RESULTS:
Twelve (5%) deaths and 23 (10%) heart failures occurred. Diabetes (hazard ratio [HR] 6.46, 95% confidence interval [CI] 1.99-20.98) and peak creatine kinase-MB (HR 1.002, 95% CI 1.001-1.004 per unit increment), wall motion score index (HR 1.46, 95% CI 0.35-6.15 per 0.1 unit increment), and TIMI flow grade
CONCLUSIONS:
At mid-term follow-up, extensive acute myocardial infarction patients undergoing primary angioplasty have a moderate heart failure event rate. The integrated evaluation of data routinely available from diagnostic work-up allows accurate prediction of the outcome; functional and angiographic data provide incremental prognostic information over clinical and ECG variables.
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The alpha1-adrenergic blocker urapidil improves contractile function in patients 3 months after coronary stenting: a randomized, double-blinded study.
Am Heart J2004 Feb;147(2):E6.
Kozàkovà Michaela, Marco Jean, Heusch Gerd, Bernies Monique, Bossi Irene M, Palombo Carlo, Anguissola Gian Battista, Donatelli Francesco, Laurent Jean Pierre, Gregorini Luisa
Abstract
BACKGROUND:
The recovery of left ventricular function (LVF) after revascularization takes time. alpha-Adrenergic blockade acutely improves coronary blood flow and LVF, whereas the effects of more prolonged alpha-adrenergic blockade on LVF recovery after stenting are unknown.
METHODS:
In 32 patients (age 58 +/- 12 y) with an 82% +/- 6% stenosis, ejection fraction (EF) and systolic thickening (%Th) were measured by transthoracic echocardiography before and 30 minutes to 2 hours after revascularization. In a double-blinded protocol, either 200 microg/kg urapidil or placebo was given intravenously, and LVF was measured 10 minutes later. Two hours later, oral treatment with 30 mg/d drug or placebo was started, and LVF measured again after 24 hours and 3 months.
RESULTS:
Before revascularization, EF was 49.4% +/- 8.5% (+/-SD) and 51.3% +/- 8.8% in the urapidil-treated and the placebo groups, respectively. Thirty minutes to 2 hours after coronary stenting, EF was unchanged. After intravenous drug administration, EF increased to 56.5% +/- 9.7%). At 24 hours and 3 months after revascularization, EF became 59.5% +/- 7.9% and 59.6% +/- 8.2% in the urapidil-treated group, respectively, whereas EF in the placebo group did not change (50.4% +/- 5.7% and 49.7% +/- 4.9%, respectively). Revascularization did not acutely improve %Th. Intravenous urapidil improved %Th from 31.4% +/- 17.6% to 44.2% +/- 11.6%, whereas there was no change in the placebo group. At 3 months, %Th was 49.5% +/- 12.9% in the urapidil-treated group and 39.7% +/- 8.9% in the placebo group.
CONCLUSIONS:
These data suggest that long-term alpha-adrenergic blockade might improve LVF at midterm after coronary revascularization.
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Effects of selective alpha1- and alpha2-adrenergic blockade on coronary flow reserve after coronary stenting.
Circulation2002 Dec;106(23):2901-7.
Gregorini Luisa, Marco Jean, Farah Bruno, Bernies Monique, Palombo Carlo, Kozàkovà Michaela, Bossi Irene M, Cassagneau Bernard, Fajadet Jean, Di Mario Carlo, Albiero Remo, Cugno Massimo, Grossi Adalberto, Heusch Gerd
Abstract
BACKGROUND:
Coronary flow reserve (CFR) is not normalized shortly after coronary stenting. We hypothesized that alpha-adrenergic coronary vasoconstriction acts to limit CFR.
METHODS AND RESULTS:
We assessed flow velocity by Doppler wires and cross-sectional area by angiography in 46 patients undergoing coronary culprit lesion stenting (81+/-4% stenosis). Hyperemia was induced by adenosine (24 micro g IC or 140 micro g/kg per minute IV) before and after stenting. Finally, either the alpha(1)-antagonist urapidil (10 mg IC) or the alpha(2)-antagonist yohimbine (3 mg IC) was randomly combined with adenosine. In 8 subjects with angiographically normal coronary arteries, CFR was increased from 3.21+/-0.30 to 3.74+/-0.43 by yohimbine and to 4.58+/-0.65 by urapidil, respectively (P=0.0001). Patients were divided according to the cutoff of CFR > or =3.0 (n=18) or 3.0 and
CONCLUSIONS:
Urapidil and yohimbine attenuated the CFR impairment occurring after revascularization by increasing both the epicardial vasodilator effect of adenosine and the blood flow velocity, thus suggesting that the adrenergic system plays an important role in limiting the capacity of the coronary circulation to dilate.
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[Predictive elements and prevention of myocardial damage during angioplasty/stenting].
Ital Heart J Suppl2002 Mar;3(3):275-85.
Bossi Irene, Savonitto Stefano, Cavallini Claudio, Delgado Anabella, Pirola Roberto, Klugmann Silvio
Abstract
Cardiac enzyme elevation is observed in 5-30% of patients after percutaneous intervention and appears associated with higher subsequent cardiac events and mortality. The cause of myocardial enzyme release could be an obvious angiographic complication of the procedure but, most frequently, is neither clinically nor angiographically clear. Different clinical series have identified clinical, angiographic and procedural risk factors for CK-MB elevation after otherwise successful coronary intervention, including unstable angina, diffuse atherosclerosis and aggressive procedures such as atheroablation. Microembolization of atherothrombotic plaque material appears to be the pathogenetic mechanism. Periprocedural administration of platelet glycoprotein IIb/IIIa inhibitors has been shown to reduce subsequent myocardial infarction and long-term mortality. Beta-blockers may also have a protective effect against post-procedural CK-MB elevations and follow-up cardiac events. New distal protection devices are under investigation and appear promising. The risk of inducing myocardial damage during percutaneous intervention should be considered before attempting the procedure. The use of platelet IIb/IIIa inhibitors and protection devices should be considered in high-risk patients.
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