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Villa Poma, Italy

Paciaroni M.,University of Perugia | Inzitari D.,University of Florence | Agnelli G.,University of Perugia | Caso V.,University of Perugia | And 72 more authors.
Journal of Neurology | Year: 2014

The aim of the ICARO-3 study was to evaluate whether intra-arterial treatment, compared to intravenous thrombolysis, increases the rate of favourable functional outcome at 3 months in acute ischemic stroke and extracranial ICA occlusion. ICARO-3 was a non-randomized therapeutic trial that performed a non-blind assessment of outcomes using retrospective data collected prospectively from 37 centres in 7 countries. Patients treated with endovascular treatment within 6 h from stroke onset (cases) were matched with patients treated with intravenous thrombolysis within 4.5 h from symptom onset (controls). Patients receiving either intravenous or endovascular therapy were included among the cases. The efficacy outcome was disability at 90 days assessed by the modified Rankin Scale (mRS), dichotomized as favourable (score of 0–2) or unfavourable (score of 3–6). Safety outcomes were death and any intracranial bleeding. Included in the analysis were 324 cases and 324 controls: 105 cases (32.4 %) had a favourable outcome as compared with 89 controls (27.4 %) [adjusted odds ratio (OR) 1.25, 95 % confidence interval (CI) 0.88–1.79, p = 0.1]. In the adjusted analysis, treatment with intra-arterial procedures was significantly associated with a reduction of mortality (OR 0.61, 95 % CI 0.40–0.93, p = 0.022). The rates of patients with severe disability or death (mRS 5–6) were similar in cases and controls (30.5 versus 32.4 %, p = 0.67). For the ordinal analysis, adjusted for age, sex, NIHSS, presence of diabetes mellitus and atrial fibrillation, the common odds ratio was 1.15 (95 % IC 0.86–1.54), p = 0.33. There were more cases of intracranial bleeding (37.0 versus 17.3 %, p = 0.0001) in the intra-arterial procedure group than in the intravenous group. After the exclusion of the 135 cases treated with the combination of I.V. thrombolysis and I.A. procedures, 67/189 of those treated with I.A. procedures (35.3 %) had a favourable outcome, compared to 89/324 of those treated with I.V. thrombolysis (27.4 %) (adjusted OR 1.75, 95 % CI 1.00–3.03, p = 0.05). Endovascular treatment of patients with acute ICA occlusion did not result in a better functional outcome than treatment with intravenous thrombolysis, but was associated with a higher rate of intracranial bleeding. Overall mortality was significantly reduced in patients treated with endovascular treatment but the rates of patients with severe disability or death were similar. When excluding all patients treated with the combination of I.V. thrombolysis and I.A. procedures, a potential benefit of I.A. treatment alone compared to I.V. thrombolysis was observed. © 2014, Springer-Verlag Berlin Heidelberg.

Pacetti P.,Azienda U.S.L. | Paganini G.,Azienda U.S.L. | Orlandi M.,Azienda U.S.L. | Mambrini A.,Azienda U.S.L. | And 3 more authors.
Supportive Care in Cancer | Year: 2015

Purpose: Chemotherapy near the end of life is an issue frequently discussed nowadays, but literature is generally poor. We analyzed patients with cancer who received chemotherapy in their last month of life. Methods: The study involved all patients treated in our oncological department between 2010 and 2012; our attention focused on patients receiving chemotherapy in their last month of life. The hematologic malignancies are excluded. Results: During the covered period, 2164 pts received chemotherapy, 162 received chemotherapy in their last month of life (24.3 %). The median age of this subgroup was 67.8 years, and median Eastern Cooperative Oncology Group (ECOG) performance status was 2. One hundred and five patients (64.8 %) were males. All patients presented a metastatic disease. Causes of death are as follows: 64.8 % progressive disease, sudden death in 4.9 %, toxicity in 3.1 %, and not available in 27.2 %. Conclusions: Twenty-four percent of patients treated with chemotherapy received their last regimen within 1 month of death. Percentage is in line with existing results. It is commonly acknowledged that age, performance status, tumor sensitivity, survival prognosis, and comorbidities should be considered in every chemotherapy decision-making; nevertheless, some studies show that age is not a crucial factor. At present, individual clinician is the only predictor for continuing chemotherapy in the last 4 weeks of life. Although appropriateness criteria were applied, patients were submitted to chemotherapy within 1 month of life; we hope that development of simultaneous care could help in end-life decision-making. © 2015, Springer-Verlag Berlin Heidelberg.

Paciaroni M.,University of Perugia | Balucani C.,University of Birmingham | Balucani C.,University of Perugia | Balucani C.,University of Texas Health Science Center at Houston | And 62 more authors.
Stroke | Year: 2012

Background and Purpose-: The beneficial effect of intravenous thrombolytic therapy in patients with acute ischemic stroke attributable to internal carotid artery (ICA) occlusion remains unclear. The aim of this study was to evaluate the efficacy and safety of intravenous recombinant tissue-type plasminogen activator in these patients. Methods-: ICARO was a case-control multicenter study on prospectively collected data. Patients with acute ischemic stroke and ICA occlusion treated with intravenous recombinant tissue-type plasminogen activator within 4.5 hours from symptom onset (cases) were compared to matched patients with acute stroke and ICA occlusion not treated with recombinant tissue-type plasminogen activator (controls). Cases and controls were matched for age, gender, and stroke severity. The efficacy outcome was disability at 90 days assessed by the modified Rankin Scale, dichotomized as favorable (score of 0-2) or unfavorable (score of 3-6). Safety outcomes were death and any intracranial bleeding. Results-: Included in the analysis were 253 cases and 253 controls. Seventy-three cases (28.9%) had a favorable outcome as compared with 52 controls (20.6%; adjusted odds ratio (OR), 1.80; 95% confidence interval [CI], 1.03-3.15; P=0.037). A total of 104 patients died, 65 cases (25.7%) and 39 controls (15.4%; adjusted OR, 2.28; 95% CI, 1.36-3.22; P=0.001). There were more fatal bleedings (2.8% versus 0.4%; OR, 7.17; 95% CI, 0.87-58.71; P=0.068) in the cases than in the controls. Conclusions-: In patients with stroke attributable to ICA occlusion, thrombolytic therapy Results in a significant reduction in the proportion of patients dependent in activities of daily living. Increases in death and any intracranial bleeding were the trade-offs for this clinical benefit. © 2011 American Heart Association. All rights reserved.

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