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Tosetto A.,S Bortolo Hospital | Iorio A.,McMaster University | Marcucci M.,University of Perugia | Baglin T.,Addenbrookes Hospital | And 6 more authors.
Journal of Thrombosis and Haemostasis | Year: 2012

Background: In patients with unprovoked venous thromboembolism (VTE), the optimal duration of anticoagulation is anchored on estimating the risk of disease recurrence. Objectives: We aimed to develop a score that could predict the recurrence risk following a first episode of unprovoked VTE, pooling individual patient data from seven prospective studies. Methods: One thousand eight hundred and eighteen cases with unprovoked VTE treated for at least 3months with a vitamin K antagonist were available for analysis. Optimism-corrected Cox regression coefficients were used to develop a recurrence score that was subsequently internally validated by bootstrap analysis. Results: Abnormal D-dimer after stopping anticoagulation, age <50years, male sex and VTE not associated with hormonal therapy (in women) were the main predictors of recurrence and were used to derive a prognostic recurrence score (DASH, D-dimer, Age, Sex, Hormonal therapy) showing a satisfactory predictive capability (ROC area=0.71). The annualized recurrence risk was 3.1% (95% confidence interval [CI], 2.3-3.9) for a score≤1, 6.4% (95% CI, 4.8-7.9) for a score=2 and 12.3% (95% CI, 9.9-14.7) for a score≥3. By considering at low recurrence risk those patients with a score≤1, life-long anticoagulation might be avoided in about half of patients with unprovoked VTE. Conclusions: The DASH prediction rule appears to predict recurrence risk in patients with a first unprovoked VTE and may be useful to decide whether anticoagulant therapy should be continued indefinitely or stopped after an initial treatment period of at least 3 months. © 2012 International Society on Thrombosis and Haemostasis.


Poli D.,Thrombosis Center | Antonucci E.,University of Florence | Dentali F.,University of Insubria | Erba N.,Presidio | And 3 more authors.
Neurology | Year: 2014

Objective: To evaluate the risk of recurrent intracranial hemorrhage (ICH) in patients on vitamin K antagonists (VKAs) after a first episode of ICH. Methods: The Cerebral Haemorrhage in patients Restarting Oral Anticoagulant Therapy (CHIRONE) Study collected data of patients eligible for the study from the database of 27 centers affiliated with the Italian Federation of Anticoagulation Clinics. Results: We enrolled 267 patients (163 male, median age 73.9 years) who had received VKA anticoagulation after an ICH event. During the total period of follow-up (778 patient-years), ICH recurred in 20 patients (7.5%; rate 2.56 3 100 patient-years) at a median time of 16.5 months, and was fatal in 5 patients (25%; rate 0.4 3 100 patient-years). Male sex, hypertension, prosthetic valves, previous ischemic stroke, renal failure, cancer, and spontaneous events were associated with the risk of recurrence, though none of them in isolation reached statistical significance. More than one-third of spontaneous recurrences occurred in patients with a posttraumatic index event. Conclusions: Our results show that patients with a history of ICH carry a significant risk of recurrent ICH when treated with VKA anticoagulation. The risk is also present, though to a lower degree, in patients with previous posttraumatic events. All patients with a history of ICH require a careful evaluation of their thromboembolic risk to estimate the net clinical benefit of (re)starting anticoagulation with VKAs. © 2014 American Academy of Neurology.


Poli D.,Thrombosis Center | Antonucci E.,University of Florence | Testa S.,Haemostasis and Thrombosis Center | Ageno W.,University of Insubria | Palareti G.,S. Orsola Malpighi University Hospital
Thrombosis Research | Year: 2013

Introduction: The prevalence of AF is higher in men and increases with age. However, the number of elderly women is higher than that of elderly men, and AF should be considered to affect men and women equally. Little information exists on elderly AF patients, and in particular, whether stroke and bleeding risk differs between elderly women and elderly men remains unknown. Methods: We have performed the EPICA Study, a large, multicentre observational study including 4093 elderly patients who started VKA treatment after the age of 80 years. In this study, we will focus our analysis on 3015 AF patients followed for 7620 patient-years (pt-yrs) to evaluate if bleeding and stroke risks were different between genders. Results: During follow-up, we recorded 112 ischemic cerebral events (rate 1.5 × 100 pt-years) with no difference between genders. History of previous stroke/TIA, hypertension and artery vascular disease are independently associated with stroke/TIA during treatment. We recorded 132 major bleeds (rate 1.7 × 100 pt-years); males showed a higher risk of bleeding (OR 1.5), even if not statistically significant. At multivariate analysis, history of major bleeds, history of falls and active cancer are risk factors independently associated to bleeding. Conclusion: Elderly patients with AF do not show clear gender related differences in the risk of major adverse events. However, elderly males showed a higher rate of bleeding complications, and females showed a slightly higher rate of stroke, thus suggesting the possibility of a higher net clinical benefit of anticoagulant treatment in females. © 2012 Elsevier Ltd. All rights reserved.


News Article | November 15, 2016
Site: www.marketwired.com

INDIANAPOLIS, IN--(Marketwired - November 15, 2016) - USA Funds® announces the election of Edward R. Schmidt as chairman of its board of trustees, for a three-year term beginning Jan. 1, 2017. Schmidt has served on the USA Funds board for nearly 20 years. He is a member of the board's compensation committee and serves as chair of its governance committee. "I look forward to working with my fellow trustees and USA Funds' management to help more students finish what they start when they enroll in postsecondary education programs and to ensure they are ready to launch into rewarding careers," Schmidt said. Schmidt is president & CEO of Silver Creek Partners LLC, based in suburban Indianapolis. He is a retired partner of the Indianapolis-based law firm Krieg, DeVault LLP and the former executive vice president, general counsel and corporate secretary of USA Group Inc. Schmidt received a bachelor's degree from Susquehanna University, where he serves as vice chair of the board of trustees. He received his law degree from the University of Notre Dame, where he serves as a member of the Law School Advisory Council. Schmidt is a member of the American, Indiana and Indianapolis Bar Associations. In addition to serving on the board of trustees of Susquehanna University, he also serves on the boards of Indiana Hemophilia & Thrombosis Center, HCEI Inc., as well as the board of chancellors of the Indiana State Chapter of JDRF (the Juvenile Diabetes Research Foundation). He was a founding board member of the Lumina Foundation for Education board, serving from 2000 to 2009. Schmidt will succeed Ike G. Batalis, who is completing his three-year term as chairman of the USA Funds board. Batalis will continue to serve on the USA Funds board. USA Funds is a nonprofit organization that supports Completion With a Purpose®, building a more purposeful path for America's students to and through college and on to rewarding careers and successful lives. USA Funds pursues its nonprofit mission through philanthropic activities and partnerships, policy research, and programs and services that enhance preparation for, access to and success in higher education. Learn more at www.usafunds.org.


Poli D.,Thrombosis Center | Testa S.,Haemostasis and Thrombosis Center | Antonucci E.,University of Florence | Grifoni E.,University of Florence | And 2 more authors.
Chest | Year: 2011

Background: All stroke risk stratification schemes categorize a history of stroke as a "truly high" risk factor. Therefore, stratifying stroke risk in atrial fibrillation (AF) should perhaps concentrate on primary prevention. However, the risk factors for stroke also lead to an increase in the risk of bleeding. Our objective was to evaluate the agreement among the currently used stroke risk stratification schemes in "real-world" patients with AF in the primary prevention setting, their correlation with adverse events recorded during warfarin treatment, and the relationship between stroke and bleeding risk. Methods: We prospectively followed up 3,302 patients with AF taking warfarin for primary prevention. Stroke risk was assessed using the CHADS 2 (congestive heart failure, hypertension, age ≥ 75 years, diabetes, previous stroke or transient ischemic attack), Atrial Fibrillation Investigators, American College of Chest Physicians Conference on Antithrombotic and Thrombolytic Therapy, American College of Cardiology/American Heart Association/European Society of Cardiology, and National Institute for Health and Clinical Excellence schemas, and for bleeding risk, the outpatient bleeding risk index was calculated. Bleeding and thrombotic events occurring during follow-up were recorded. Results: Patients classified into various stroke risk categories differed widely for different schemes, especially for the moderate- and high-risk categories. The rates of bleeding and thrombotic events during follow-up were 1.24 and 0.76 per 100 patient-years, respectively. All stroke stratification schemes correlated closely to bleeding risk. Stroke rate increased progressively from lowto moderate- to high-risk patients. Conclusions: Stroke risk stratification models differed widely when categorizing subjects into the moderate- and high-stroke-risk categories. Bleeding and stroke risk were closely correlated and both were low among low-risk patients and were similarly high among moderate/high-risk groups.© 2011 American College of Chest Physicians.


Poli D.,Thrombosis Center | Antonucci E.,University of Florence
International Journal of Women's Health | Year: 2015

Atrial fbrillation (AF) is the most common arrhythmia and has become a serious public health problem. Moreover, epidemiological data demonstrate that incidence and prevalence of AF are increasing. Several differences in epidemiological patterns, clinical manifestations, and incidence of stroke have been reported between AF in women and in men, particularly in elderly women. Elderly women have higher blood pressure than men and a higher prevalence of heart failure with preserved ejection fraction, both independent risk factors for stroke. On the basis of the evidence on the higher stroke risk among AF in women, recently, female sex has been accepted as a risk factor for stroke and adopted to stratify patients, especially if they are not at high risk for stroke. This review focuses on available evidence on sex differences in AF patients, and examines factors contributing to different stroke risk, diagnosis, and prognosis of arrhythmia in women, with the aim to provide an analysis of the available evidence. © 2015 Poli and Antonucci.


Poli D.,Thrombosis Center | Palareti G.,University of Bologna
Current Opinion in Pulmonary Medicine | Year: 2013

PURPOSE OF REVIEW: Venous thromboembolism (VTE) is a chronic disease, associated with a significant rate of recurrence, lower in patients with events provoked by transient risk factors and higher in unprovoked cases. Short-term treatment is indicated for provoked VTE, long-term treatment should be considered for unprovoked. The aim of this review is to evaluate the risk factors for recurrence and the decisional algorithms available to guide patients' management. RECENT FINDINGS: To identify patients who carry a high recurrent risk and require long-term treatment, three algorithms have been proposed: the HERDOO2, the Vienna prediction model, and the DASH score. All identify male sex and elevated D-dimer levels as important risk factors for recurrence. However, important differences among the models should be outlined: in the HERDOO2 model, D-dimer levels are measured during anticoagulation and not after its withdrawal; furthermore, it indicates age greater than 65 as a risk factor for recurrence, whereas the DASH score attributes a higher risk to age less than 50. The Vienna model is complex for routine use. SUMMARY: Further studies are needed to clarify these discrepancies. A management study based on D-dimer levels after anticoagulation withdrawal is ongoing and could indicate a simple way to safely manage these patients. © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins.


Poli D.,Thrombosis Center | Lip G.Y.,University of Birmingham | Antonucci E.,Thrombosis Center | Grifoni E.,Thrombosis Center | Lane D.,University of Birmingham
Journal of Cardiovascular Electrophysiology | Year: 2011

Stroke Risk Stratification. Introduction: Appropriate stroke risk stratification is essential to ensure suitable tailoring of antithrombotic therapy. The objective of this study was to assess the predictive value of stroke risk classification schemes and to identify patients with atrial fibrillation (AF) who are at substantial risk of stroke despite optimal anticoagulant therapy, in a "real world" consecutive elderly AF cohort. Methods: Six hundred and sixty-two consecutive AF patients (mean [SD] age 74 [7.7] years; 36.1% female) referred to the Anticoagulation Clinic of the Azienda Ospedaliera Careggi of Florence, Italy, were included and followed-up for a mean 3.6 ± 2.7 years for the incidence of thromboembolic (TE) events. The ability of the new CHA2DS2-VASc schema to predict TE was compared with other contemporary stroke risk schema (including CHADS2, NICE 2006, ACC/AHA/ESC 2006, and ACCP 2008), by determining the c-statistic. Results: Univariate predictors of TE events were female gender (odds ratio 1.9; 95%CI [confidence intervals] 1.01-3.70) and previous stroke/transient ischemic attack (TIA)/TE (OR 5.6; 95%CI 2.70-11.45), although after adjustment only previous stroke/TIA/TE was an independent predictor of TE (OR 5.5; 95%CI 2.68-11.31; P = 0.0001). All stroke risk schema had modest discriminating ability, with c-statistics ranging from 0.54 (atrial fibrillation investigators [AFI]) to 0.72 (CHA2DS2-VASc). The CHADS2 and CHA2DS2-VASc schemes having the best c-statistics (0.717 and 0.724, respectively) with significant discriminating value between risk strata (both P < 0.001). The proportion of patients assigned to individual risk categories varied widely across the schema, with those categorized as "moderate-risk" ranging from 5.3% (CHA 2DS2-VASc) to 49.2% (CHADS2-classical). Conclusion: In this "real world" cohort, current published risk schemas have modest predictive ability, with the CHADS2 and CHA 2DS2-VASc schemes having the best predictive value for thromboembolism. Future trials could assess the value of alternative strategies for thromboprophylaxis in high-risk anticoagulated patients identified by these schemes. © 2010 Wiley Periodicals, Inc.


Poli D.,Thrombosis Center | Antonucci E.,University of Florence | Testa S.,Haemostasis and Thrombosis Center | Lip G.Y.H.,University of Birmingham
Internal and Emergency Medicine | Year: 2014

Stroke prevention, achieved with oral anticoagulation therapy (OAT), is central to the management of patients with atrial fibrillation (AF). Well-managed OAT, as reflected by a long time in therapeutic range (TTR), is associated with good clinical outcomes. The SAME-TT2R2 score has been proposed to identify patients who will maintain a high average TTR on vitamin K antagonists (VKA) treatment. The objective of the study was to validate this score in a cohort of AF patients followed by an anticoagulation clinic. We applied the SAME-TT2R2 score to 1,089 patients with AF on VKAs followed by two anticoagulation clinics. The median TTR overall for the whole cohort was 73.0 %. There was a significant decline in mean (or median) TTR in relation to the SAME-TT2R2 score (p = 0.042). When the SAME-TT2R2 scores were categorized we find a TTR 74.0 % for score ≤2 and 68.0 % for score >2 (p = 0.006). The rate of major bleeding events and stroke/TIA was 1.78 × 100 patient-years (pt-yrs) and 1.26 × 100 pt-yrs, respectively. No relationship exists between the SAME-TT2R2 score and adverse events. We describe the first validation of the SAME-TT2R2 score in AF patients where, despite an overall good quality of anticoagulation, the SAME-TT2R2 score is able to identify the patients who are less likely to do well on VKA therapy if this is the chosen OAT. © 2014 SIMI.


Pengo V.,Thrombosis Center | Bison E.,Thrombosis Center | Denas G.,Thrombosis Center | Jose S.P.,Thrombosis Center | And 2 more authors.
Seminars in Thrombosis and Hemostasis | Year: 2014

A unique coagulation inhibitor prolonging whole-blood clotting time was described more than 50 years ago in two patients with systemic lupus erythematosus (SLE). The immunoglobulin nature of the inhibitor and its interaction with antiphospholipid antibodies was later demonstrated and the term lupus anticoagulant (LA) was coined to describe this laboratory finding. It soon became apparent that LA was a misnomer as it is often found in plasma from patients with clinical conditions other than SLE and is associated with thromboembolic events that may occur in otherwise healthy individuals. Individuals with LA have circulating autoantibodies that inhibits blood coagulation. These are mostly of IgG or IgM class and mainly directed against a phospholipid (PL)-binding plasma protein, β2-glycoprotein I (β2GPI). The presence of β2GPI-dependent LA represents a well-recognized risk factor for venous and arterial thromboembolism, as well as pregnancy loss and morbidity. β2GPI-dependent LA in the presence of documented previous thromboembolism, or history of pregnancy loss/morbidity, identifies definite anti-PL syndrome. Laboratory diagnosis of LA is thus of particular importance, as it may assign patients with a common event (thrombosis) to a group with a high risk for recurrence, which is a prerequisite for long-term oral antithrombotic treatment. Copyright © 2014 by Thieme Medical Publishers, Inc.

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