Matteo Giorgi‐Pierfranceschi

Istituti Ospitalieri di Cremona

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Francesco Dentali

University of Insubria

Nicola Mumoli

Ospedale di Livorno

Pierpaolo Di Micco

Fatebenefratelli Hospital

Josè Vitale

Aziende Socio Sanitarie Territoriale Ovest Milanese

Manuel Monréal

Universidad Católica San Antonio de Murcia

Daniela Mastroiacovo

University of Perugia

Marco Cei

Aziende Socio Sanitarie Territoriale Ovest Milanese

Walter Ageno

University of Insubria

Giovanni Barillari

Ospedale Santa Maria della Misericordia di Udine

J.B. López‐Sáez

Hospital Universitario Puerto Real

Cooperative Institutions

Istituti di Ricovero e Cura a Carattere Scientifico

361

University of Milan

164

Universidad Católica San Antonio de Murcia

151

University of Perugia

136

Hospital Universitari Germans Trias i Pujol

127

University of Brescia

121

University of Padua

119

Sapienza University of Rome

112

Ospedale Garibaldi

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial

Journal of Translational Medicine (2020)

Francesco Perrone Maria Carmela Piccirillo Paolo A. Ascierto Carlo Salvarani Roberto Parrella

Abstract Background Tocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6), involved in pathogenesis of pneumonia the most frequent cause of death in COVID-19 patients. Methods A multicenter, single-arm, hypothesis-driven trial was planned, according to a phase 2 design, to study the effect of tocilizumab on lethality rates at 14 and 30 days (co-primary endpoints, a priori expected rates being 20 and 35%, respectively). A further prospective cohort of patients, consecutively enrolled after the first cohort was accomplished, was used as a secondary validation dataset. The two cohorts were evaluated jointly in an exploratory multivariable logistic regression model to assess prognostic variables on survival. Results In the primary intention-to-treat (ITT) phase 2 population, 180/301 (59.8%) subjects received tocilizumab, and 67 deaths were observed overall. Lethality rates were equal to 18.4% (97.5% CI: 13.6–24.0, P = 0.52) and 22.4% (97.5% CI: 17.2–28.3, P < 0.001) at 14 and 30 days, respectively. Lethality rates were lower in the validation dataset, that included 920 patients. No signal of specific drug toxicity was reported. In the exploratory multivariable logistic regression analysis, older age and lower PaO2/FiO2 ratio negatively affected survival, while the concurrent use of steroids was associated with greater survival. A statistically significant interaction was found between tocilizumab and respiratory support, suggesting that tocilizumab might be more effective in patients not requiring mechanical respiratory support at baseline. Conclusions Tocilizumab reduced lethality rate at 30 days compared with null hypothesis, without significant toxicity. Possibly, this effect could be limited to patients not requiring mechanical respiratory support at baseline. Registration EudraCT (2020-001110-38); clinicaltrials.gov (NCT04317092).

Tocilizumab

Clinical endpoint

10.1186/s12967-020-02573-9

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Citations (108)

Long‐term outcomes of patients with cerebral vein thrombosis: a multicenter study

Journal of Thrombosis and Haemostasis (2012)

Francesco Dentali Daniela Poli Umberto Scoditti Matteo Nicola Dario Di Minno Valerio De Stefano

10.1111/j.1538-7836.2012.04774.x

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Citations (151)

Prevention and treatment of venous thromboembolism in patients with solid brain neoplasms: results of a survey among Italian physicians

Internal and Emergency Medicine (2016)

Nicola Mumoli Stefano Barco Marco Cei Matteo Giorgi‐Pierfranceschi Mauro Campanini

Fondaparinux

Concomitant

Regimen

10.1007/s11739-016-1578-4

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Citations (5)

The use of thrombophilia and pharmacological thromboprophylaxis screening in women: The benefits of the RIETE registry

Pierpaolo Di Micco Angeles Blanco Molina Donatella Colaizzo Francesco Dentali Andrea Fontanella

Source

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Citations (0)

Prevalence and risk factors for pulmonary embolism in patients with suspected acute exacerbation of COPD: a multi-center study.

European Journal of Internal Medicine (2020)

Francesco Dentali Fulvio Pomero Pierpaolo Di Micco Micaela La Regina Federica Landini

10.1016/j.ejim.2020.05.006

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Citations (18)

Platelet Count and Major Bleeding in Patients Receiving Vitamin K Antagonists for Acute Venous Thromboembolism, Findings From Real World Clinical Practice

Medicine (2015)

Matteo Giorgi‐Pierfranceschi Pierpaolo Di Micco Chiara Cattabiani Anna Guida B. Pagán

The outcome of patients with acute venous thromboembolism (VTE) and abnormal platelet count (PlC) at baseline has not been consistently studied. In real-world clinical practice, a number of patients with abnormal PlC receive vitamin K antagonists (VKAs) to treat acute VTE despite their higher risk of bleeding.We used the Registro Informatizado de Enfermedad TromboEmbólica registry database to compare the rate of major bleeding in patients receiving VKA for long-term therapy of acute VTE according to PlC levels at baseline. Patients were categorized as having very low (<100,000/μL), low (100,000-150,000/μL), normal (150,000-300,000/μL), high (300,000-450,000/μL), or very high (>450,000/μL) PlC at baseline.Of 55,369 patients recruited as of January 2015, 37,000 (67%) received long-term therapy with VKA. Of these, 611 patients (1.6%) had very low PlC, 4006 (10.8%) had low PlC, 25,598 (69%) had normal PlC, 5801 (15.6%) had high PlC, and 984 (2.6%) had very high PlC at baseline. During the course of VKA therapy (mean, 192 days), there were no differences in the duration or intensity (as measured by international normalized ratio levels) of treatment between subgroups. The rate of major bleeding was 3.6%, 2.1%, 1.9%, 2.1%, and 3.7%, respectively, and the rate of fatal bleeding was 0.98%, 0.17%, 0.29%, 0.34%, and 0.50%, respectively. Patients with very low or very high PlC levels were more likely to have severe comorbidities.We found a nonlinear "U-shaped" relationship between PlC at baseline and major bleeding during therapy with VKA for VTE. Consistent alteration of PlC values at baseline suggested a greater frailty.

Major bleeding

10.1097/md.0000000000001915

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Citations (9)

Sepsis in internal wards: results of an Italian multicenter prospective study

Italian Journal of Medicine (2016)

Matteo Giorgi‐Pierfranceschi Francesco Dentali

Sepsis is a frequent inflammatory disease with a high mortality and morbidity rate. Most of the data about epidemiology, management and prognosis of patients with sepsis came mainly from studies conducted within Intensive Care Units (ICUs). A consistent number of studies suggest that a proportion of patients with sepsis and severe sepsis are admitted to internal medicine units, and not transferred to an ICU. In this article, we presented the data of an Italian study, a multicenter study, evaluating consecutive patients, with an objective diagnosis of sepsis treated in internal medicine units.

10.4081/itjm.2016.791

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Citations (0)

Symptomatic subsegmental versus more central pulmonary embolism: Clinical outcomes during anticoagulation

Research and Practice in Thrombosis and Haemostasis (2020)

Carmen Fernández‐Capitán Ana Rodríguez Cobo David Jiménez Olga Madridano Maurizio Ciammaichella

The optimal therapy of patients with acute subsegmental pulmonary embolism (PE) is controversial.

10.1002/rth2.12446

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Citations (20)

Correction to: Tocilizumab for patients with COVID-19 pneumonia. The single-arm TOCIVID-19 prospective trial

Journal of Translational Medicine (2021)

Francesco Perrone Maria Carmela Piccirillo Paolo A. Ascierto Carlo Salvarani Roberto Parrella

Tocilizumab

2019-20 coronavirus outbreak

Betacoronavirus

Coronavirus Infections

10.1186/s12967-021-03094-9

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Citations (1)

General Practitioner–Performed Compression Ultrasonography for Diagnosis of Deep Vein Thrombosis of the Leg: A Multicenter, Prospective Cohort Study

The Annals of Family Medicine (2017)

Nicola Mumoli Josè Vitale Matteo Giorgi‐Pierfranceschi Silvia Sabatini Renato Tulino

BACKGROUND

Patients with suspected deep vein thrombosis (DVT) of the lower limb represent a diagnostic dilemma for general practitioners. Compression ultrasonography (US) is universally recognized as the best test of choice. We assessed the diagnostic accuracy of compression US performed by general practitioners given short training in the management of symptomatic proximal DVT.

METHODS

From May 2014 to May 2016, we evaluated in a multicenter, prospective cohort study all consecutive outpatients with suspected DVT; bilateral proximal lower limb compression US was performed by general practitioners and by physicians expert in vascular US, each group blinded to the other's findings. In all examinations with a negative or nondiagnostic result, compression US was repeated by the same operator after 5 to 7 days. Inter-observer agreement and accuracy were calculated.

RESULTS

We enrolled a total of 1,107 patients. The expert physicians diagnosed DVT in 200 patients, corresponding to an overall prevalence of 18.1% (95% CI, 15.8%–20.3%). The agreement between the trained general practitioners and the experts was excellent (Cohen κ = 0.86; 95% CI, 0.84–0.88). Compression US performed by general practitioners had a sensitivity of 90.0% (95% CI, 88.2%–91.8%) and a specificity of 97.1% (95% CI, 96.2%–98.1%) with a diagnostic accuracy for DVT of 95.8% (95% CI, 94.7%–97.0%).

CONCLUSIONS

Our results suggest that, even in hands of physicians not expert in vascular US, compression US can be a reliable tool in the diagnosis of DVT. We found that the sensitivity achieved by general practitioners appeared suboptimal, however, so future studies should evaluate the implementation of proper training strategies to maximize skill.

10.1370/afm.2109

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Citations (27)