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Le Grazie di Ancona, Italy

Savonitto S.,Azienda Ospedaliera Santa Maria Nuova | Cavallini C.,Azienda Ospedaliera Ospedale Santa Maria della Misericordia | Petronio A.S.,Azienda Ospedaliera Universitaria Pisana | Murena E.,Ospedale S. Maria delle Grazie | And 14 more authors.
JACC: Cardiovascular Interventions | Year: 2012

Objectives: This study sought to determine the risk versus benefit ratio of an early aggressive (EA) approach in elderly patients with non-ST-segment elevation acute coronary syndromes (NSTEACS). Background: Elderly patients have been scarcely represented in trials comparing treatment strategies in NSTEACS. Methods: A total of 313 patients <75 years of age (mean 82 years) with NSTEACS within 48 h from qualifying symptoms were randomly allocated to an EA strategy (coronary angiography and, when indicated, revascularization within 72 h) or an initially conservative (IC) strategy (angiography and revascularization only for recurrent ischemia). The primary endpoint was the composite of death, myocardial infarction, disabling stroke, and repeat hospital stay for cardiovascular causes or severe bleeding within 1 year. Results: During admission, 88% of the patients in the EA group underwent angiography (55% revascularization), compared with 29% (23% revascularization) in the IC group. The primary outcome occurred in 43 patients (27.9%) in the EA group and 55 (34.6%) in the IC group (hazard ratio [HR]: 0.80; 95% confidence interval [CI]: 0.53 to 1.19; p = 0.26). The rates of mortality (HR: 0.87; 95% CI: 0.49 to 1.56), myocardial infarction (HR: 0.67; 95% CI: 0.33 to 1.36), and repeat hospital stay (HR: 0.81; 95% CI: 0.45 to 1.46) did not differ between groups. The primary endpoint was significantly reduced in patients with elevated troponin on admission (HR: 0.43; 95% CI: 0.23 to 0.80), but not in those with normal troponin (HR: 1.67; 95% CI: 0.75 to 3.70; p for interaction = 0.03). Conclusions: The present study does not allow a definite conclusion about the benefit of an EA approach when applied systematically among elderly patients with NSTEACS. The finding of a significant interaction for the treatment effect according to troponin status at baseline should be confirmed in a larger size trial. (Italian Elderly ACS Study; NCT00510185) © 2012 American College of Cardiology Foundation.

Gradilone A.,University of Rome La Sapienza | Petracca A.,University of Rome La Sapienza | Nicolazzo C.,University of Rome La Sapienza | Gianni W.,INRCA | And 8 more authors.
BJU International | Year: 2010

OBJECTIVE To evaluate the prognostic significance of survivin in tumour tissues and that of survivin-expressing circulating tumour cells (CTCs) in T1G3 bladder tumours, as the prognosis of T1G3 bladder cancer is highly variable and unpredictable from clinical and pathological prognostic factors. PATIENTS AND METHODS The study included 54 patients with T1G3 non-muscle-invasive bladder cancer. Additional inclusion criteria were: tumour size <3 cm, absence of carcinoma in situ and multifocality. The planned follow-up was 24 months. Survivin was evaluated by reverse transcription-polymerase chain reaction in tumour tissues. CTCs were isolated from blood by CELLectionTM Dynabeads (Invitrogen, Carlsbad, CA, USA) coated with the monoclonal antibody towards the human epithelial cell adhesion molecule. Cells were lysed and Dynabeads Oligo(dT) was used to capture poly A + mRNA. cDNA was synthesized and analysed for the expression of CD45, CK8 and survivin. The primary endpoint was disease-free survival (DFS); the favourable group at 24 months was defined as that with no clinical evidence of disease; the unfavourable group was that with evidence of recurrent disease or progressive disease. Tumour survivin expression and presence of CTC were correlated with DFS. Multivariate analysis was used to investigate whether the presence of CTC was an independent indicator of DFS. RESULTS Survivin was found in half of the tumours; patients with survivin-negative tumours had a longer DFS than those with survivin-positive tumours (chi-square, P = 0.029). CTCs were found in 2454 patients (44%); 92% of CTC expressed survivin. The difference in DFS between CTC-ve and CTC+ve patients was statistically significant (chi-square, P < 0.001). The presence of CTC was an independent prognostic factor for DFS (P < 0.001). CONCLUSION The presence of CTC is an independent prognostic factor in patients with T1G3 bladder cancer. © 2010 BJU INTERNATIONAL.

Ruggiero C.,University of Perugia | Dellaquila G.,University of Perugia | Gasperini B.,University of Perugia | Onder G.,Catholic University of the Sacred Heart | And 6 more authors.
Drugs and Aging | Year: 2010

Background: Potentially inappropriate medications in older patients increase the risk of adverse drug events, which are an important cause of hospital admission and death among hospitalized patients. Little information is available about the prevalence of potentially inappropriate drug prescriptions (PIDPs) and the related health adverse outcomes among nursing home (NH) residents. Objective: To estimate the prevalence of PIDPs and the association with adverse outcomes in NH residents. Methods: A total of 1716 long-term residents aged 65 years participating in the ULISSE (Un Link Informatico sui Servizi Sanitari Esistenti per lanziano [AComputerized Network on Health Care Services for Older People]) project were evaluated using a standardized comprehensive geriatric assessment instrument, i.e. the interResident Assessment Instrument Minimum Data Set. A thorough evaluation of residents drug use, medical diagnoses and healthcare resource utilization was performed. APIDP was defined according to the most recent update of the Beers criteria. Results: Almost one out of two persons (48%) had at least one PIDP and almost one out of five had two or more PIDPs (18%). Residents with a higher number of PIDPs had a higher likelihood of being hospitalized. Compared with residents without PIDPs, those with two or more PIDPs at baseline had a higher probability of being hospitalized (hazard ratio 1.73; 95% CI 1.14, 2.60) during the following 12 months. Risk of PIDP was positively associated with the total number of drugs and diseases, but negatively with age. PIDPs defined according to specific conditions (n = 780; 55%) were slightly more frequent than PIDPs based on single medications irrespective of specific indication (n = 639; 45%). Conclusions: PIDP is a significant problem among Italian NH residents. There is an urgent need for intervention trials to test strategies to reduce inappropriate drug use and its associated adverse health outcomes. © 2010 Adis Data Information BV. All rights reserved.

Raimondi C.,University of Rome La Sapienza | Naso G.,University of Rome La Sapienza | Gradilone A.,University of Rome La Sapienza | Gianni W.,INRCA | And 2 more authors.
Current Cancer Drug Targets | Year: 2010

What clinical oncologists learned about the metastatic process, is that it is the main cause of cancer-related deaths. What scientists learned about the metastatic disease, is that it is due to a highly selective process, which involves a minority of tumor cells that are able to survive within the bloodstream, and to initiate a new growth in distant sites. These cells "in transit" are known as circulating tumor cells (CTCs). Although their nature is not fully understood, what is widely accepted, is that they are drug resistant, and that their presence may represent the main reason for treatment failure. Despite this body of evidence, the pharmacological approach against cancer, with both chemotherapic and biological drugs, is still targeted on the primary tumor, raising the question as to whether we are missing the target. Targeting circulating tumor cells, may represent a new promising approach to individualize anticancer therapy. © 2010 Bentham Science Publishers Ltd.

De Carlo M.,Cardiac Catheterization Laboratory | Morici N.,Ospedale Niguarda Ca Granda | Savonitto S.,Ospedale Manzoni | Grassia V.,Ospedale S. Maria delle Grazie | And 7 more authors.
JACC: Cardiovascular Interventions | Year: 2015

Objectives This study sought to investigate sex-related differences in treatment and outcomes in elderly patients with non-ST-segment elevation acute coronary syndromes (NSTEACS). Background Female sex and older age are usually associated with worse outcome in NSTEACS. The Italian Elderly ACS study enrolled NSTEACS patients aged 75 years of age and older in a randomized trial comparing an early aggressive with an initially conservative strategy and in a registry of patients with ≥1 exclusion criteria of the trial. Methods We compared sexes in the pooled populations of the trial and registry. Results A total of 645 patients (313 from the trial and 332 from the registry), including 301 women (47%), were enrolled. Women were slightly older than men (82.1 ± 5.0 years vs. 81.2 ± 4.5 years; p = 0.02), had lower hemoglobin levels (12.5 ± 1.6 g/dl vs. 13.3 ± 1.9 g/dl; p < 0.001), and underwent fewer coronary revascularizations during the index admission (37.2% vs. 45.0%; p = 0.04). In-hospital adverse event rates were similar in both sexes; severe bleeding was uncommon (0.3% vs. 0%). The 1-year primary endpoint (composite of death, nonfatal myocardial infarction, disabling stroke, cardiac rehospitalization, and severe bleeding) occurred less often in women (27.6% vs. 38.7%; p < 0.01). Women not undergoing revascularization showed a 3-fold higher mortality, both in-hospital (8.5% vs. 2.7%; p = 0.05) and at 1 year (21.6% vs. 8.1%; p = 0.002). Conclusions Elderly women had a similar in-hospital outcome and better 1-year outcome compared with men. Coronary revascularization in women was associated with lower 1-year mortality, without an increase in severe bleeding. Elderly women with NSTEACS should always be considered for early revascularization. © 2015 American College of Cardiology Foundation.

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