Firenze, Italy
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Migliorini A.,Careggi Hospital | Stabile A.,Ospedale Civico | Rodriguez A.E.,Otamendi Hospital | Gandolfo C.,Ospedale Civico | And 6 more authors.
Journal of the American College of Cardiology | Year: 2010

Objectives: The aim of this study was to determine whether rheolytic thrombectomy (RT) before direct infarct artery stenting as compared with direct stenting (DS) alone results in improved myocardial reperfusion and clinical outcome in patients with acute myocardial infarction. Background: The routine removal of thrombus before infarct artery stenting is still a matter of debate. Methods: This is a multicenter, international, randomized, 2-arm, prospective study. Eligible patients were patients with acute myocardial infarction, angiographic evidence of thrombus grade 3 to 5, and a reference vessel diameter <2.5 mm. Coprimary end points were early ST-segment resolution and 99mTc-sestamibi infarct size. An α value = 0.05 achieved by both coprimary surrogate end points or an α value = 0.025 for a single primary surrogate end point would be considered evidence of statistical significance. Other surrogate end points were Thrombolysis In Myocardial Infarction (TIMI) flow grade 3, corrected TIMI frame count, and TIMI grade 3 blush. Clinical end points were a composite of major adverse cardiovascular events at 1, 6, and 12 months. Results: From December 2005 to September 2009, 501 patients were randomly allocated to RT before DS or to DS alone. The ST-segment resolution was more frequent in the RT arm as compared with the DS alone arm: 85.8% and 78.8%, respectively (p = 0.043), while no difference between groups were revealed in the other surrogate end points. The 6-month major adverse cardiovascular events rate was 11.2% in the thrombectomy arm and 19.4% in the DS alone arm (p = 0.011). The 1-year event-free survival rates were 85.2 ± 2.3% for the RT arm, and 75.0 ± 3.1% for the DS alone arm (p = 0.009). Conclusions: Although the primary efficacy end points were not met, the results of this study support the use of RT before infarct artery stenting in patients with acute myocardial infarction and evidence of coronary thrombus. (AngioJet Rheolytic Thrombectomy Before Direct Infarct Artery Stenting in Patients Undergoing Primary PCI for Acute Myocardial Infarction [JETSTENT]; NCT00275990) © 2010 American College of Cardiology Foundation.


Corona G.,Maggiore Bellaria Hospital | Maseroli E.,University of Florence | Rastrelli G.,University of Florence | Isidori A.M.,University of Rome La Sapienza | And 3 more authors.
Expert Opinion on Drug Safety | Year: 2014

Introduction: Recent reports have significantly halted the enthusiasm regarding androgen-boosting; suggesting that testosterone supplementation (TS) increases cardiovascular (CV) events.Areas covered: In order to overcome some of the limitations of the current evidence, the authors performed an updated systematic review and meta-analysis of all placebo-controlled randomized clinical trials (RCTs) on the effect of TS on CV-related problems. Out of 2747 retrieved articles, 75 were analyzed, including 3016 and 2448 patients in TS and placebo groups, respectively, and a mean duration of 34 weeks. Our analyses, performed on the largest number of studies collected so far, indicate that TS is not related to any increase in CV risk, even when composite or single adverse events were considered. In RCTs performed in subjects with metabolic derangements a protective effect of TS on CV risk was observed.Expert opinion: The present systematic review and meta-analysis does not support a causal role between TS and adverse CV events. Our results are in agreement with a large body of literature from the last 20 years supporting TS of hypogonadal men as a valuable strategy in improving a patient's metabolic profile, reducing body fat and increasing lean muscle mass, which would ultimately reduce the risk of heart disease. © 2014 Informa UK, Ltd.


Tamburino C.,University of Catania | Tamburino C.,ETNA Foundation | Barbanti M.,University of Catania | Barbanti M.,ETNA Foundation | And 10 more authors.
Journal of the American College of Cardiology | Year: 2015

Background There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting. Objectives This analysis aims to describe 1-year clinical outcomes of a large series of propensity-matched patients who underwent SAVR and transfemoral TAVR. Methods The OBSERVANT (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) trial is an observational prospective multicenter cohort study that enrolled patients with aortic stenosis (AS) who underwent SAVR or TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year. Results The unadjusted enrolled population (N = 7,618) included 5,707 SAVR patients and 1,911 TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate risk population (mean logistic EuroSCORE 1: 10.2 ± 9.2% vs. 9.5 ± 7.1%, SAVR vs. transfemoral TAVR; p = 0.104). At 1 year, the rate of death from any cause was 13.6% in the surgical group and 13.8% in the transcatheter group (hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.72 to 1.35; p = 0.936). Similarly, there were no significant differences in the rates of MACCE, which were 17.6% in the surgical group and 18.2% in the transcatheter group (HR: 1.03; 95% CI: 0.78 to 1.36; p = 0.831). The cumulative incidence of cerebrovascular events, and rehospitalization due to cardiac reasons and acute heart failure was similar in both groups at 1 year. Conclusions The results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rates of rehospitalization due to cardiac reasons at 1 year. These data need to be confirmed in longer term and dedicated ongoing randomized trials. © 2015 American College of Cardiology Foundation.


Valenti R.,Careggi Hospital | Migliorini A.,Careggi Hospital | Parodi G.,Careggi Hospital | Carrabba N.,Careggi Hospital | And 3 more authors.
Journal of the American College of Cardiology | Year: 2012

Objectives: The goal of this study was to compare the outcomes of patients treated with everolimus-eluting stents (EES) with outcomes of patients treated with first-generation paclitaxel-eluting stents (PES) for unprotected left main disease (ULMD). Background: No data exist about the comparison of these 2 types of stents in ULMD. Methods: The primary endpoint of the study was a 1-year composite of cardiac death, nonfatal myocardial infarction, target vessel revascularization, and stroke (MACE). Secondary endpoints were 1-year target vessel failure (TVF) and 9-month angiographic in-segment restenosis >50%. Results: From 2004 to 2010, a total of 390 patients underwent ULMD percutaneous coronary intervention (224 received PES and 166 EES). The 1-year MACE rate was 21.9% in the PES group and 10.2% in the EES group (p = 0.002). TVF rate was 20.5% in the PES group and 7.8% in the EES group (p < 0.001). The in-segment restenosis rate was 5.2% in the EES group and 15.6% in the PES group (p = 0.002). EES and EuroSCORE were the only variables related to the risk of MACE. EES (odds ratio: 0.32; p = 0.007) was also independently related to the risk of restenosis. Conclusions: EES implantation for ULMD is associated with a reduced incidence of 1-year MACE, TVF, and restenosis as compared with PES implantation. © 2012 American College of Cardiology Foundation.


Parodi G.,Careggi Hospital | Antoniucci D.,Careggi Hospital
American Heart Journal | Year: 2010

Left ventricular (LV) remodeling has been shown to occur in a relevant proportion of patients with acute myocardial infarction successfully treated with primary percutaneous coronary intervention. The development of LV remodeling after primary percutaneous coronary intervention is associated with increased mortality and with shorter event-free survival. Therapy to prevent or limit LV remodeling is of paramount importance, and it should be started in the early phase of reperfusion. Early identification of patients at risk for LV remodeling may have important prognostic and therapeutic implications. The pathophysiology, time course, and predictors of LV remodeling, as well as the relevant diagnostic techniques and therapeutic interventions evaluated to date, will be discussed. © 2010 Mosby, Inc.


Haemoglobin (Hb) stability in faecal samples is an important issue in colorectal cancer screening by the faecal immunochemical test (FIT) for Hb. This study evaluated the performance of the FIT-Hb (OC-Sensor Eiken) used in the Florence screening programme by comparing two different formulations of the buffer, both in an analytical and in a clinical setting. In the laboratory simulation, six faecal pools (three in each buffer type) were stored at different temperatures and analysed eight times in 10 replicates over 21 days. In the clinical setting, 7695 screenees returned two samples, using both the old and the new specimen collection device (SCD). In the laboratory simulation, 5 days from sample preparation with the buffer of the old SCD, the Hb concentration decreased by 40% at room temperature (25°C, range 22–28°C) and up to 60% at outside temperature (29°C, range 16–39°C), whereas with the new one, Hb concentration decreased by 10%. In the clinical setting, a higher mean Hb concentration with the new SCD compared with the old one was found (6.3 vs. 5.0 µg Hb/g faeces, respectively, P<0.001); no statistically significant difference was found in the probability of having a positive result in the two SCDs. Better Hb stability was observed with the new buffer under laboratory conditions, but no difference was found in the clinical performance. In our study, only marginal advantages arise from the new buffer. Improvements in sample stability represent a significant target in the screening setting. Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.


Parodi G.,Careggi Hospital | Valenti R.,Careggi Hospital | Bellandi B.,Careggi Hospital | Migliorini A.,Careggi Hospital | And 7 more authors.
Journal of the American College of Cardiology | Year: 2013

Objectives: This study sought to compare the action of prasugrel and ticagrelor in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PPCI). Background: It has been documented that prasugrel and ticagrelor are able to provide effective platelet inhibition 2 h after a loading dose (LD). However, the pharmacodynamic measurements after prasugrel and ticagrelor LD have been provided by assessing only healthy volunteers or subjects with stable coronary artery disease. Methods: Fifty patients with STEMI undergoing PPCI with bivalirudin monotherapy were randomized to receive 60 mg prasugrel LD (n = 25) or 180 mg ticagrelor LD (n = 25). Residual platelet reactivity was assessed by VerifyNow at baseline and 2, 4, 8, and 12 h after LD. Results: Platelet reactivity units (PRU) 2 h after the LD (study primary endpoint) were 217 (12 to 279) and 275 (88 to 305) in the prasugrel and ticagrelor groups, respectively (p = NS), satisfying pre-specified noninferiority criteria. High residual platelet reactivity (HRPR) (PRU ≥240) was found in 44% and 60% of patients (p = 0.258) at 2 h. The mean time to achieve a PRU <240 was 3 ± 2 h and 5 ± 4 h in the prasugrel and ticagrelor groups, respectively. The independent predictors of HRPR at 2 h were morphine use (odds ratio: 5.29; 95% confidence interval: 1.44 to 19.49; p = 0.012) and baseline PRU value (odds ratio: 1.014; 95% confidence interval: 1.00 to 1.03; p = 0.046). Conclusions: In patients with STEMI, prasugrel showed to be noninferior as compared with ticagrelor in terms of residual platelet reactivity 2 h after the LD. The 2 drugs provide an effective platelet inhibition 2 h after the LD in only a half of patients, and at least 4 h are required to achieve an effective platelet inhibition in the majority of patients. Morphine use is associated with a delayed activity of these agents. (Rapid Activity of Platelet Inhibitor Drugs Study, NCT01510171) © 2013 American College of Cardiology Foundation.


Parodi G.,Careggi Hospital | Marcucci R.,Careggi Hospital | Valenti R.,Careggi Hospital | Gori A.M.,Careggi Hospital | And 6 more authors.
JAMA - Journal of the American Medical Association | Year: 2011

Context: High residual platelet reactivity (HRPR) in patients receiving clopidogrel has been associated with high risk of ischemic events after percutaneous coronary intervention (PCI). Objective: To test the hypothesis that HRPR after clopidogrel loading is an independent prognostic marker of risk of long-term thrombotic events in patients with acute coronary syndromes (ACS) undergoing an invasive procedure and antithrombotic treatment adjusted according to the results of platelet function tests. Design, Setting, and Patients: Prospective, observational, referral center cohort study of 1789 consecutive patients with ACS undergoing PCI from April 2005 to April 2009 at the Division of Cardiology of Careggi Hospital, Florence, Italy, in whom platelet reactivity was prospectively assessed by light transmittance aggregometry. Interventions: All patients received 325 mg of aspirin and a loading dose of 600 mg of clopidogrel followed by a maintenance dosage of 325 mg/d of aspirin and 75 mg/d of clopidogrel for at least 6 months. Patients with HRPR as assessed by adenosine diphosphate test (≥70% platelet aggregation) received an increased dose of clopidogrel (150-300 mg/d) or switched to ticlopidine (500-1000 mg/d) under adenosine diphosphate test guidance. Main Outcome Measures: The primary end point was a composite of cardiac death, myocardial infarction, any urgent coronary revascularization, and stroke at 2-year follow-up. Secondary end points were stent thrombosis and each component of the primary end point. Results: The primary end point event rate was 14.6% (36/247) in patients with HRPR and 8.7% (132/1525) in patients with low residual platelet reactivity (absolute risk increase, 5.9%; 95% CI, 1.6%-11.1%; P=.003). Stent thrombosis was higher in the HRPR group compared with the low residual platelet reactivity group (6.1% [15/247] vs 2.9% [44/1525]; absolute risk increase, 3.2%; 95% CI, 0.4%-6.7%; P=.01). By multivariable analysis, HRPR was independently associated with the primary end point (hazard ratio, 1.49; 95% CI, 1.08-2.05; P=.02) and with cardiac mortality (hazard ratio, 1.81; 95% CI, 1.18-2.76; P=.006). Conclusion: Among patients receiving platelet reactivity-guided antithrombotic medication after PCI, HRPR status was significantly associated with increased risk of ischemic events at short- and long-term follow-up. Trial Registration clinicaltrials.gov Identifier: NCT01231035 ©2011 American Medical Association. All rights reserved.


Ciolli S.,Careggi Hospital
Clinical Cases in Mineral and Bone Metabolism | Year: 2013

Recent biological advances have provided the framework for novel therapeutic strategies in oncology. Many new treatments are now based on standard cytotoxic drugs plus biologic agents. In Multiple Myeloma, a plasma cell neoplasm characterized by a severe bone disease, biologic drugs such as proteasome inhibitors and immunomodulatory agents, above their antineoplastic efficacy have a beneficial effects on bone disease. Bortezomib, a clinically available proteasome inhibitor active against myeloma, induces the differentiation of mesenchymal stem/progenitor cells into osteoblasts, resulting in new bone formation. Immunomodulatory drugs (e.g., thalidomide and lenalidomide), which are active against myeloma, also block the activity of boneresorbing osteoclasts. These data reflect the utility of targeting endogenous mesenchymal stem/progenitor cells for the purpose of tissue repair and suggest that combining different classes of agents that are antineoplastic and also inhibit bone destruction and increase bone formation should be very beneficial for myeloma patients suffering from severe bone disease.


Valenti R.,Careggi Hospital | Vergara R.,Careggi Hospital | Migliorini A.,Careggi Hospital | Parodi G.,Careggi Hospital | And 4 more authors.
Journal of the American College of Cardiology | Year: 2013

Objectives: This study sought to assess the incidence of reocclusion and identification of predictors of angiographic failure after successful chronic total occlusion (CTO) drug-eluting stent-supported percutaneous coronary intervention (PCI). Background: Large registries have shown a survival benefit in patients with successful CTO PCI. Intuitively, sustained vessel patency may be considered as a main variable related to long-term survival. Very few data exist about the angiographic outcome after successful CTO PCI. Methods: The Florence CTO PCI registry started in 2003 and included consecutive patients treated with drug-eluting stents for at least 1 CTO (>3 months). The protocol treatment included routine 6- to 9-month angiographic follow-up. Clinical, angiographic, and procedural variables were included in the model of multivariable binary logistic regression analysis for the identification of the predictors of reocclusion. Results: From 2003 to 2010, 1,035 patients underwent PCI for at least 1 CTO. Of these, 802 (77%) had a successful PCI. The angiographic follow-up rate was 82%. Reocclusion rate was 7.5%, whereas binary restenosis (>50%) or reocclusion rate was 20%. Everolimus-eluting stents were associated with a significantly lower reocclusion rate than were other drug-eluting stents (3.0% vs. 10.1%; p = 0.001). A successful subintimal tracking and re-entry technique was associated with a 57% of reocclusion rate. By multivariable analysis, the subintimal tracking and re-entry technique (odds ratio [OR]: 29.5; p < 0.001) and everolimus-eluting stents (OR: 0.22; p = 0.001) were independently related to the risk of reocclusion. Conclusions: Successful CTO-PCI supported by everolimus-eluting stents is associated with a very high patency rate. Successful subintimal tracking and re-entry technique is associated with a very low patency rate regardless of the type of stent used. © 2013 American College of Cardiology Foundation.

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