Publications by authors named "Marco Cattaneo"

183 Publications

Clinical risk scores for the early prediction of severe outcomes in patients hospitalized for COVID-19.

Intern Emerg Med 2021 Feb 23. Epub 2021 Feb 23.

Università Di Modena E Reggio Emilia, Modena, Italy.

Coronavirus disease of 2019 (COVID-19) is associated with severe acute respiratory failure. Early identification of high-risk COVID-19 patients is crucial. We aimed to derive and validate a simple score for the prediction of severe outcomes. A retrospective cohort study of patients hospitalized for COVID-19 was carried out by the Italian Society of Internal Medicine. Epidemiological, clinical, laboratory, and treatment variables were collected at hospital admission at five hospitals. Three algorithm selection models were used to construct a predictive risk score: backward Selection, Least Absolute Shrinkage and Selection Operator (LASSO), and Random Forest. Severe outcome was defined as the composite of need for non-invasive ventilation, need for orotracheal intubation, or death. A total of 610 patients were included in the analysis, 313 had a severe outcome. The subset for the derivation analysis included 335 patients, the subset for the validation analysis 275 patients. The LASSO selection identified 6 variables (age, history of coronary heart disease, CRP, AST, D-dimer, and neutrophil/lymphocyte ratio) and resulted in the best performing score with an area under the curve of 0.79 in the derivation cohort and 0.80 in the validation cohort. Using a cut-off of 7 out of 13 points, sensitivity was 0.93, specificity 0.34, positive predictive value 0.59, and negative predictive value 0.82. The proposed score can identify patients at low risk for severe outcome who can be safely managed in a low-intensity setting after hospital admission for COVID-19.
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http://dx.doi.org/10.1007/s11739-020-02617-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7900378PMC
February 2021

MgSO anticoagulant prevents pseudothrombocytopenia by preserving the integrity of the platelet GPIIb-IIIa complex.

Br J Haematol 2021 Feb 22. Epub 2021 Feb 22.

Dipartimento di Scienze della Salute, Laboratorio di Emostasi e Trombosi, Università degli Studi di Milano, Milano, Italy.

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http://dx.doi.org/10.1111/bjh.17298DOI Listing
February 2021

Acetylsalicylic acid in essential thrombocythemia.

Wien Klin Wochenschr 2021 Feb 3. Epub 2021 Feb 3.

Laboratory of Hemostasis and Thrombosis, Dipartimento di Scienze della Salute, Università degli Studi di Milano, Via di Rudinì, 8, 20142, Milano, Italy.

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http://dx.doi.org/10.1007/s00508-021-01814-1DOI Listing
February 2021

The Many Faces of Covid-19 at a Glance: A University Hospital Multidisciplinary Account From Milan, Italy.

Front Public Health 2020;8:575029. Epub 2021 Jan 8.

Respiratory Medicine, Department of Health Sciences, San Paolo University Hospital, Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo, University of Milan Medical School, Milan, Italy.

In March 2020, northern Italy became the second country worldwide most affected by Covid-19 and the death toll overtook that in China. Hospital staff soon realized that Covid-19 was far more severe than expected from the few data available at that time. The Covid-19 pandemic forced hospitals to adjust to rapidly changing circumstances. We report our experience in a general teaching hospital in Milan, the capital of Lombardy, the most affected area in Italy. First, we briefly describe Lombardy's regional Covid-19-related health organizational changes as well as general hospital reorganization. We also provide a multidisciplinary report of the main clinical, radiological and pathological Covid-19 findings we observed in our patients.
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http://dx.doi.org/10.3389/fpubh.2020.575029DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7820812PMC
February 2021

A case of newly diagnosed immune thrombocytopenia in the COVID-19 era.

Intern Emerg Med 2020 Nov 12. Epub 2020 Nov 12.

Divisione di Medicina Generale II, Dipartimento di Scienze della Salute, ASST Santi Paolo E Carlo, Università degli Studi di Milano, Via di Rudinì, 8, 20142, Milan, Italy.

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http://dx.doi.org/10.1007/s11739-020-02553-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7658303PMC
November 2020

Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial.

Lancet 2020 11 19;396(10261):1504-1510. Epub 2020 Oct 19.

University Hospital Saarland, Homburg, Germany.

Background: In the treatment of de-novo coronary small vessel disease, drug-coated balloons (DCBs) are non-inferior to drug-eluting stents (DESs) regarding clinical outcome up to 12 months, but data beyond 1 year is sparse. We aimed to test the long-term efficacy and safety of DCBs regarding clinical endpoints in an all-comer population undergoing percutaneous coronary intervention.

Methods: In this prespecified long-term follow-up of a multicentre, randomised, open-label, non-inferiority trial, patients from 14 clinical sites in Germany, Switzerland, and Austria with de-novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention were randomly assigned 1:1 to DCB or second-generation DES and followed over 3 years for major adverse cardiac events (ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation [TVR]), all-cause death, probable or definite stent thrombosis, and major bleeding (Bleeding Academic Research Consortium bleeding type 3-5). Analyses were performed on the full analysis set according to the modified intention-to-treat principle. Dual antiplatelet therapy was recommended for 1 month after DCB and 6 months after DES with stable symptoms, but 12 months with acute coronary syndromes. The study is registered with ClinicalTrials.gov, NCT01574534 and is ongoing.

Findings: Between April 10, 2012, and Feb 1, 2017, of 883 patients assessed, 758 (86%) patients were randomly assigned to the DCB group (n=382) or the DES group (n=376). The Kaplan-Meier estimate of the rate of major adverse cardiac events was 15% in both the DCB and DES groups (hazard ratio [HR] 0·99, 95% CI 0·68-1·45; p=0·95). The two groups were also very similar concerning the single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate 5% vs 4%, HR 1·29, 95% CI 0·63-2·66; p=0·49), non-fatal myocardial infarction (both Kaplan-Meier estimate 6%, HR 0·82, 95% CI 0·45-1·51; p=0·52), and TVR (both Kaplan-Meier estimate 9%, HR 0·95, 95% CI 0·58-1·56; p=0·83). Rates of all-cause death were very similar in DCB versus DES patients (both Kaplan-Meier estimate 8%, HR 1·05, 95% CI 0·62-1·77; p=0·87). Rates of probable or definite stent thrombosis (Kaplan-Meier estimate 1% vs 2%; HR 0·33, 95% CI 0·07-1·64; p=0·18) and major bleeding (Kaplan-Meier estimate 2% vs 4%, HR 0·43, 95% CI 0·17-1·13; p=0·088) were numerically lower in DCB versus DES, however without reaching significance.

Interpretation: There is maintained efficacy and safety of DCB versus DES in the treatment of de-novo coronary small vessel disease up to 3 years.

Funding: Swiss National Science Foundation, Basel Cardiovascular Research Foundation, and B Braun Medical.
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http://dx.doi.org/10.1016/S0140-6736(20)32173-5DOI Listing
November 2020

Patient preferences for allogeneic haematopoietic stem cell transplantation: how much benefit is worthwhile from the patient's perspective?

Support Care Cancer 2020 Oct 17. Epub 2020 Oct 17.

University of Basel, Basel, Switzerland.

Oncological studies have shown that patients consider small benefits sufficient to make adjuvant chemotherapy worthwhile. We sought to determine the minimal survival benefits that patients considered enough to legitimate allogeneic haematopoietic stem cell transplantation (HCT) and the factors associated with patient preferences. One hundred eighty-four patients having previously received allogeneic HCT at our centre were included and completed a questionnaire exploring patient expectations elicited by time trade-off scenarios as well as quality of life (QoL), symptoms of graft-versus host disease (GvHD) and sociodemographic characteristics. The majority of patients considered a minimal survival benefit of at least 5 (38.6%) or 10 years (41.9%) sufficient to justify HCT, with less than 5% considering survival < 1 year sufficient to warrant HCT. In terms of minimal cure rate, a cumulative 14.8% of patients accepted cure rates below 30% and 30.6% rates below 50%. Likelihood-ratio tests were significant for the effect of age at transplant on expected minimal survival (p = 0.007) and cure rates (p = 0.0001); that is, younger patients at HCT were more likely to accept smaller survival and cure rates. Pre-transplant risk score, QoL, GvHD score and sociological factors did not seem to influence patients' expectations. In conclusion, patient expectations of treatment were much higher than what had been reported in oncological studies. Patients who experienced HCT considered a survival superior to 1 year and cure rates above 50% sufficient to make it worthwhile. Younger patients were more likely to accept smaller benefits; no other predictors for preferences could be detected.
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http://dx.doi.org/10.1007/s00520-020-05816-zDOI Listing
October 2020

High rates of pulmonary artery occlusions in COVID-19. A meta-analysis.

Eur J Clin Invest 2021 Jan 31;51(1):e13433. Epub 2020 Oct 31.

Unità di Medicina II, ASST Santi Paolo e Carlo - Dipartimento di Scienze della Salute, Università degli Studi di Milano, Milano, Italy.

Background: COVID-19 patients are considered at high risk of venous thromboembolism (VTE). The real nature of pulmonary artery occlusions (PAO) in COVID-19 has been questioned, suggesting that it is caused also by in situ thrombi, rather than only by emboli (PE) from peripheral thrombi.

Methods: We searched MEDLINE for studies published until 6 June 2020 that included COVID-19 patients or non-COVID-19 medical patients at VTE risk, treated with heparins, in whom VTE (PE and deep vein thrombosis, DVT) had been reported. Systematic review and results reporting were conducted in accordance with PRISMA guidelines. Data were independently extracted by two observers, and estimates were pooled using random-effects meta-analysis.

Results: We identified 17 studies including 3224 COVID-19 patients and 7 including 11 985 non-COVID-19 patients. Two analyses were performed: in all COVID-19 patients and only in those (n = 515) who, like non-COVID-19 patients, were screened systematically for DVT. The latter analysis revealed that the prevalence of DVT was 15.43% (95%CI, 4.08-31.77) in COVID-19 and 4.21% (2.27-6.68) in non-COVID-19 patients (P = .0482). The prevalence of PE was 4.85% (40.33-13.01) in COVID-19 patients and 0.22% (0.03-0.55) in non-COVID-19 patients (P = .0128). The percentage of PE among VTE events was 22.15% (5.31-44.60) in COVID-19 and 6.39% (3.17-10.41) in non-COVID-19 patients (P = .0482). Differences were even more marked when all COVID-19 patients were analysed.

Conclusions: The results of our meta-analysis highlight a disproportion in the prevalence of PE among all VTE events in COVID 19 patients, likely reflecting PAO by pulmonary thrombi, rather than emboli from peripheral vein thrombi.
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http://dx.doi.org/10.1111/eci.13433DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7646003PMC
January 2021

Long-Term Results After Drug-Eluting Versus Bare-Metal Stent Implantation in Saphenous Vein Grafts: Randomized Controlled Trial.

J Am Heart Assoc 2020 10 9;9(20):e017434. Epub 2020 Oct 9.

University Hospital Basel Switzerland.

Background Efficacy data on drug-eluting stents (DES) versus bare-metal stents (BMS) in saphenous vein grafts are controversial. We aimed to compare DES with BMS among patients undergoing saphenous vein grafts intervention regarding long-term outcome. Methods and Results In this multinational trial, patients were randomized to paclitaxel-eluting or BMS. The primary end point was major adverse cardiac events (cardiac death, nonfatal myocardial infarction, and target-vessel revascularization at 1 year. Secondary end points included major adverse cardiac events and its individual components at 5-year follow-up. One hundred seventy-three patients were included in the trial (89 DES versus 84 BMS). One-year major adverse cardiac event rates were lower in DES compared with BMS (2.2% versus 16.0%, hazard ratio, 0.14; 95% CI, 0.03-0.64, =0.01), which was mainly driven by a reduction of subsequent myocardial infarctions and need for target-vessel revascularization. Five-year major adverse cardiac event rates remained lower in the DES compared with the BMS arm (35.5% versus 56.1%, hazard ratio, 0.40; 95% CI, 0.23-0.68, <0.001). A landmark-analysis from 1 to 5 years revealed a persistent benefit of DES over BMS (hazard ratio, 0.33; 95% CI, 0.13-0.74, =0.007) in terms of target-vessel revascularization. More patients in the BMS group underwent multiple target-vessel revascularization procedures throughout the study period compared with the DES group (DES 1.1% [n=1] versus BMS 9.5% [n=8], =0.013). Enrollment was stopped before the target sample size of 240 patients was reached. Conclusions In this randomized controlled trial with prospective long-term follow-up of up to 5 years, DES showed a better efficacy than BMS with sustained benefits over time. DES may be the preferred strategy in this patient population. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT00595647.
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http://dx.doi.org/10.1161/JAHA.120.017434DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7763393PMC
October 2020

Treatment of immune thrombocytopenia (ITP) secondary to malignancy: a systematic review.

Platelets 2020 Sep 23:1-7. Epub 2020 Sep 23.

Unità Di Medicina III, ASST Santi Paolo E Carlo - Dipartimento Di Scienze Della Salute, Università Degli Studi Di Milano , Milano, Italy.

Immune thrombocytopenia (ITP) can be associated with lymphoproliferative diseases (LPD) or solid tumors. A systematic review of published literature was conducted to evaluate response to treatment of ITP secondary to malignancy. Primary outcome was overall response (complete response+response) to first-line treatments [steroids alone or in combination with intravenous immunoglobulins (IVIg)]. Among secondary outcomes, overall response to second-line treatments [splenectomy, rituximab or thrombopoietin receptor agonists (TPO-RA)] and death were evaluated. Of the retrieved 238 text articles, 108 were analyzable, for a total of 154 patients: 142 in 105 case reports and 12 in 3 observational studies. Thirty-nine patients had solid tumors, 114 LPD, and 1 both. The median follow up was 19 months (IQR, 9-40). The overall response was 50% (62% in solid tumors, 46% in LPD) after steroids and 47% (67% in solid tumors, 36% in LPD) after steroids+IVIg, which are lower than historical responses observed in primary ITP (≈80%). The overall responses to rituximab (used in LPD only), splenectomy and TPO-RA (70%, 73% and 92%, respectively) were similar to those observed in primary ITP. Seven patients (6%) died due to bleeding events. ITP secondary to malignancy appears to be associated with unsatisfactory response to first-line treatments.
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http://dx.doi.org/10.1080/09537104.2020.1822521DOI Listing
September 2020

Anticoagulant interventions in hospitalized patients with COVID-19: A scoping review of randomized controlled trials and call for international collaboration.

J Thromb Haemost 2020 11 1;18(11):2958-2967. Epub 2020 Oct 1.

Department of Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.

Introduction: Coronavirus disease (COVID-19) is associated with a high incidence of thrombosis and mortality despite standard anticoagulant thromboprophylaxis. There is equipoise regarding the optimal dose of anticoagulant intervention in hospitalized patients with COVID-19 and consequently, immediate answers from high-quality randomized trials are needed.

Methods: The World Health Organization's International Clinical Trials Registry Platform was searched on June 17, 2020 for randomized controlled trials comparing increased dose to standard dose anticoagulant interventions in hospitalized COVID-19 patients. Two authors independently screened the full records for eligibility and extracted data in duplicate.

Results: A total of 20 trials were included in the review. All trials are open label, 5 trials use an adaptive design, 1 trial uses a factorial design, 2 trials combine multi-arm parallel group and factorial designs in flexible platform trials, and at least 15 trials have multiple study sites. With individual target sample sizes ranging from 30 to 3000 participants, the pooled sample size of all included trials is 12 568 participants. Two trials include only intensive care unit patients, and 10 trials base patient eligibility on elevated D-dimer levels. Therapeutic intensity anticoagulation is evaluated in 14 trials. All-cause mortality is part of the primary outcome in 14 trials.

Discussion: Several trials evaluate different dose regimens of anticoagulant interventions in hospitalized patients with COVID-19. Because these trials compete for sites and study participants, a collaborative effort is needed to complete trials faster, conduct pooled analyses and bring effective interventions to patients more quickly.
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http://dx.doi.org/10.1111/jth.15094DOI Listing
November 2020

Patients with Essential Thrombocythemia may be Poor Responders to Enteric-Coated Aspirin, but not to Plain Aspirin.

Thromb Haemost 2020 Oct 27;120(10):1442-1453. Epub 2020 Jul 27.

Laboratory of Hemostasis and Thrombosis, Dipartimento di Scienze della Salute, Università degli Studi di Milan, Milan, Lombardia, Italy.

Essential thrombocythemia (ET) patients are treated with aspirin (acetylsalicylic acid [ASA]) to prevent thrombosis. Previous studies showed that serum thromboxane (Tx) B was high 24 hours after enteric-coated (EC)-ASA in ET patients, due to increased number of noninhibited reticulated platelets (RPs), consequent to high platelet turnover, and that ASA should be given twice a day to ET patients. We studied ET patients ( = 17) and healthy subjects ( = 10) on 100 mg EC-ASA once daily; experiments were repeated after 14-day treatment with 100 mg plain-ASA once daily. Serum TxB, plasma ASA, and salicylic acid (SA) were measured before the morning dose and up to 8 hours thereafter. Blood activity of ASA-deacethylating esterases, in vitro inhibition of collagen-induced TxB production by ASA (10-1,000 µM), and number of RP were measured. TxB inhibition by ASA in vitro and esterases activities were normal in all subjects. EC-ASA elicited highly variable responses; 6 ET patients were poor responders, as their serum TxB was high after EC-ASA; their plasma levels of ASA and SA were low/undetectable. In contrast to EC-ASA, plain ASA decreased serum TxB and increased plasma ASA and SA in all subjects. Serum TxB was high in ET patients at 24 hours and significantly correlated with RP count (but not RP percentage) and platelet count. Plain ASA should be used in ET patients to inhibit platelets efficiently. The identification of ET patients who might benefit from twice a day ASA could simply be based on their platelet count: since their platelet turnover is not increased, ET patients with normalized platelet count should not need twice a day ASA treatment.
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http://dx.doi.org/10.1055/s-0040-1714351DOI Listing
October 2020

Long-Term Risk of Major Adverse Cardiovascular Events in Patients With Acute Coronary Syndrome: Prognostic Role of Complete Blood Cell Count.

Angiology 2020 10 8;71(9):831-839. Epub 2020 Jul 8.

Division of Cardiology, Ospedale Manzoni, Lecco, Italy.

Individual parameters of complete blood count (CBC) have been associated with worse outcome in patients with acute coronary syndrome (ACS). However, the prognostic role of CBC taken as a whole has never been evaluated for long-term incidence of major adverse cardiovascular events (MACEs). Patients were grouped according to their hematopoietic cells' inflammatory response at different time points during hospital stay. Patients with admission white blood cell count >10 × 10/L, discharge hemoglobin <120 g/L, and discharge platelet count >250 × 10/L were defined as "high-risk CBC." Among 1076 patients with ACS discharged alive, 129 (12%) had a "high-risk CBC" and 947 (88%) had a "low-risk CBC." Patients with "high-risk CBC" were older and had more comorbidities. Over a median follow-up of 665 days, they experienced a higher incidence of MACE compared to "low-risk CBC" patients (18.6% vs 8.1%). After adjustment for age, age-adjusted Charlson comorbidity index, female sex, cardiac arrest, suboptimal discharge therapy, coronary artery bypass, and ejection fraction, a high-risk CBC was significantly associated with increased MACE occurrence (adjusted hazard ratio 1.80; 95% CI: 1.09-3.00). The CBC was a prognostic marker in patients with ACS, and its evaluation at admission and discharge could better classify patient's risk and improve therapeutic management.
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http://dx.doi.org/10.1177/0003319720938619DOI Listing
October 2020

Role of von Willebrand Factor and ADAMTS-13 in the Pathogenesis of Thrombi in SARS-CoV-2 Infection: Time to Rethink.

Thromb Haemost 2020 09 23;120(9):1339-1342. Epub 2020 Jun 23.

Dipartimento di Scienze della Salute, Università Degli Studi di Milano, Milan, Italy.

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http://dx.doi.org/10.1055/s-0040-1713400DOI Listing
September 2020

Is thromboprophylaxis with high-dose enoxaparin really necessary for COVID-19 patients? A new "prudent" randomised clinical trial.

Blood Transfus 2020 05;18(3):237-238

Intensive Cardiac Care Unit and "De Gasperis" Cardio Center, "ASST Grande Ospedale Metropolitano Niguarda", Milan, Italy.

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http://dx.doi.org/10.2450/2020.0109-20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7250693PMC
May 2020

ISTH interim guidance on recognition and management of coagulopathy in COVID-19.

J Thromb Haemost 2020 05 27;18(5):1023-1026. Epub 2020 Apr 27.

Department of Emergency and Disaster Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.

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http://dx.doi.org/10.1111/jth.14810DOI Listing
May 2020

Type and dose of heparin in Covid-19: Reply.

J Thromb Haemost 2020 08 11;18(8):2063-2064. Epub 2020 May 11.

ASST Santi Paolo e Carlo, Dipartimento di Scienze della Salute, Università degli Studi di Milano, Milan, Italy.

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http://dx.doi.org/10.1111/jth.14870DOI Listing
August 2020

Report of a 'consensus' on the lines of therapy for primary immune thrombocytopenia in adults, promoted by the Italian Gruppo di Studio delle Piastrine.

Platelets 2020 May 21;31(4):461-473. Epub 2020 Apr 21.

Medicina 2 ASST Santi Paolo e Carlo, Dipartimento di Scienze della Salute, Università degli Studi di Milano , Milano, Italy.

Despite the publication in 2009 of a paper on 'terms and definitions of immune thrombocytopenia' (ITP), some unresolved issues remain and are reflected by the disagreement in the treatment suggested for primary ITP in adults. Considering that these disagreements could be ascribed to non-shared goals, we generated a 'consensus' on some terms, definitions, and assertions useful for classifying the different lines of treatment for primary ITP in adults according to their indications and goals. Agreement on the appropriateness of the single assertions was obtained by consensus for the following indicators: . classification of four 'lines of therapy'; . acceptance of the expression 'sequences of disease' for the indications of the respective four lines of treatment; . practicability of splenectomy; . acceptance, with only some exceptions, of a 'timing for elective splenectomy of 12 months'; and . 'goals of the four lines of therapy.' On the basis of the consensus, a classification of four lines of treatment for primary ITP in adults was produced. In our opinion, this classification, whose validity is not influenced by the recently published new guidelines of the American Society of Hematology (ASH) and reviews, could reduce the disagreement that still exists regarding the treatment of the disease.
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http://dx.doi.org/10.1080/09537104.2020.1751105DOI Listing
May 2020

DOACs and "newer" hemophilia therapies in COVID-19: Reply.

J Thromb Haemost 2020 07;18(7):1795-1796

Department of Emergency and Disaster Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.

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http://dx.doi.org/10.1111/jth.14841DOI Listing
July 2020

Thrombopoietin receptor agonists for the treatment of primary immune thrombocytopenia: a meta-analysis and systematic review.

Platelets 2020 Apr 12:1-11. Epub 2020 Apr 12.

Unità di Medicina II, ASST Santi Paolo e Carlo - Dipartimento di Scienze della Salute, Università degli Studi di Milano, Milano, Italy.

Previous meta-analyses reported discordant results on the efficacy and safety of thrombopoietin receptor agonists (TPO-RA) as second-line treatment in patients with immune thrombocytopenia (ITP). We conducted a meta-analysis of primary ITP treatment with the TPO-RA Romiplostim, Eltrombopag and Avatrombopag, including additional studies and relevant endpoints. We searched MEDLINE, EMBASE and CENTRAL for randomized clinical trials (RCTs) and cohort studies on TPO-RA in ITP published until December 31, 2018. The primary endpoints were: risk ratio (RR) of treatment failure and bleeding of WHO grade ≥2; rate of remission after discontinuation of treatment. The principal safety outcome was RR and incidence of thrombotic events and liver damage. From 1044 identified records we selected 16 RCTs and 19 cohort studies. RCTs included 909 patients assigned to TPO-RA and 427 to the control arm. Treatment failure was observed in 21% TPO-RA-treated patients and 47% control arm patients (RR = 0.42, 95% CI 0.33-0.53) in RCTs during a median follow-up of 13 weeks, and in 29% TPO-RA-treated patients in cohort studies, during a median follow-up of 69 weeks. The incidence of remission after TPO discontinuation was 18% (5-36%). RR of WHO grade ≥2 bleeding was 0.58 (0.38-0.86) in TPO-RA-treated patients, compared to control arm patients. Adverse events were rare and not significantly different in the two groups of patients. All-cause mortality was significantly lower with TPO-RA (RR 0.21, 95% CI, 0.06-0.68). In conclusion, TPO-RA are effective and safe in patients with ITP, even in the long term.
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http://dx.doi.org/10.1080/09537104.2020.1745168DOI Listing
April 2020

Highlights from the 2019 International Aspirin Foundation Scientific Conference, Rome, 28 June 2019: benefits and risks of antithrombotic therapy for cardiovascular disease prevention.

Ecancermedicalscience 2020 13;14:998. Epub 2020 Jan 13.

Unit of Cardiology, Department of Medicine, Karolinska University Hospital, 171 76 Stockholm, Sweden.

At the 2019 International Aspirin Foundation Scientific Conference 'Benefits and Risks of Antithrombotic Therapy for Cardiovascular Disease Prevention', held in Rome, Italy, international experts sought to discuss and debate the optimal antithrombotic strategy for the secondary prevention of cardiovascular disease (CVD) and to seek agreement around dosing and target populations for aspirin use in primary disease prevention. Getting the best evidence to support real-life decisions in the clinic can be complex, and individualising management in order to balance both the risks and benefits of different disease prevention strategies appears to be the best approach. It is hoped that future decision-making tools and biomarkers will help direct treatments at those most likely to benefit.
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http://dx.doi.org/10.3332/ecancer.2020.998DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7032943PMC
January 2020

The MICELI (MICrofluidic, ELectrical, Impedance): Prototyping a Point-of-Care Impedance Platelet Aggregometer.

Int J Mol Sci 2020 Feb 11;21(4). Epub 2020 Feb 11.

Department of Electronics, Information and Bioengineering, Politecnico di Milano, 20133 Milan, Italy.

As key cellular elements of hemostasis, platelets represent a primary target for thrombosis and bleeding management. Currently, therapeutic manipulations of platelet function (antithrombotic drugs) and count (platelet transfusion) are performed with limited or no real-time monitoring of the desired outcome at the point-of-care. To address the need, we have designed and fabricated an easy-to-use, accurate, and portable impedance aggregometer called "MICELI" (MICrofluidic, ELectrical, Impedance). It improves on current platelet aggregation technology by decreasing footprint, assay complexity, and time to obtain results. The current study aimed to optimize the MICELI protocol; validate sensitivity to aggregation agonists and key blood parameters, i.e., platelet count and hematocrit; and verify the MICELI operational performance as compared to commercial impedance aggregometry. We demonstrated that the MICELI aggregometer could detect platelet aggregation in 250 μL of whole blood or platelet-rich plasma, stimulated by ADP, TRAP-6, collagen, epinephrine, and calcium ionophore. Using hirudin as blood anticoagulant allowed higher aggregation values. Aggregation values obtained by the MICELI strongly correlated with platelet count and were not affected by hematocrit. The operational performance comparison of the MICELI and the Multiplate Analyzer demonstrated strong correlation and similar interdonor distribution of aggregation values obtained between these devices. With the proven reliability of the data obtained by the MICELI aggregometer, it can be further translated into a point-of-care diagnostic device aimed at monitoring platelet function in order to guide pharmacological hemostasis management and platelet transfusions.
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http://dx.doi.org/10.3390/ijms21041174DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7072796PMC
February 2020

Platelet Adhesion and Thrombus Formation in Microchannels: The Effect of Assay-Dependent Variables.

Int J Mol Sci 2020 Jan 23;21(3). Epub 2020 Jan 23.

Department of Electronics, Information and Bioengineering, Politecnico di Milano, 20133 Milan, Italy.

Microfluidic flow chambers (MFCs) allow the study of platelet adhesion and thrombus formation under flow, which may be influenced by several variables. We developed a new MFC, with which we tested the effects of different variables on the results of platelet deposition and thrombus formation on a collagen-coated surface.

Methods: Whole blood was perfused in the MFC over collagen Type I for 4 min at different wall shear rates (WSR) and different concentrations of collagen-coating solutions, keeping blood samples at room temperature or 37 °C before starting the experiments. In addition, we tested the effects of the antiplatelet agent acetylsalicylic acid (ASA) (antagonist of cyclooxygenase-1, 100 µM) and cangrelor (antagonist of P2Y, 1 µM).

Results: Platelet deposition on collagen (I) was not affected by the storage temperature of the blood before perfusion (room temperature vs. 37 °C); (II) was dependent on a shear rate in the range between 300/s and 1700/s; and (III) was influenced by the collagen concentration used to coat the microchannels up to a value of 10 µg/mL. ASA and cangrelor did not cause statistically significant inhibition of platelet accumulation, except for ASA at low collagen concentrations.

Conclusions: Platelet deposition on collagen-coated surfaces is a shear-dependent process, not influenced by the collagen concentration beyond a value of 10 µg/mL. However, the inhibitory effect of antiplatelet drugs is better observed using low concentrations of collagen.
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http://dx.doi.org/10.3390/ijms21030750DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7037340PMC
January 2020

Reduction of corticosteroid use in outpatient treatment of exacerbated COPD - Study protocol for a randomized, double-blind, non-inferiority study, (The RECUT-trial).

Trials 2019 Dec 16;20(1):727. Epub 2019 Dec 16.

University Department of Medicine, Cantonal Hospital Baselland, Rheinstrasse 26, CH - 4410, Liestal, Switzerland.

Background: Chronic obstructive pulmonary disease (COPD) is a major public health issue affecting approximately 4% to 7% of the Swiss population. According to current inpatient guidelines, systemic corticosteroids are important in the treatment of acute COPD exacerbations and should be given for 5 to 7 days. Several studies suggest that corticosteroids accelerate the recovery of FEV1 (forced expiratory volume in 1 second), enhance oxygenation, decrease the duration of hospitalization, and improve clinical outcomes. However, the additional therapeutic benefit regarding FEV1 recovery appears to be most apparent in the first 3 to 5 days. No data are available on the optimum duration of corticosteroid treatment in primary-care patients with acute COPD exacerbations. Given that many COPD patients are treated as outpatients, there is an urgent need to improve the evidence base on COPD management in this setting. The aim of this study is to investigate whether a 3-day treatment with orally administered corticosteroids is non-inferior to a 5-day treatment in acute exacerbations of COPD in a primary-care setting.

Methods/design: This study is a prospective double-blind randomized controlled trial conducted in a primary-care setting. It is anticipated that 470 patients with acutely exacerbated COPD will be recruited. Participants are randomized to receive systemic corticosteroid treatment of 40 mg prednisone daily for 5 days (conventional arm, n = 235) or for 3 days followed by 2 days of placebo (experimental arm, n = 235). Antibiotic treatment for 7 days is given to all patients with CRP ≥ 50 mg/l, those with a known diagnosis of bronchiectasis, or those presenting with Anthonisen type I exacerbation. Additional treatment after inclusion is left at the discretion of the treating general practitioner. Follow-up visits are performed on days 3 and 7, followed by telephone interviews on days 30, 90, and 180 after inclusion in the study. The primary endpoint is the time to next exacerbation during the 6-month follow-up period.

Discussion: The study is designed to assess whether a 3-day course of corticosteroid treatment is not inferior to the conventional 5-day treatment course in outpatients with exacerbated COPD regarding time to next exacerbation. Depending on the results, this trial may lead to a reduction in the cumulative corticosteroid dose in COPD patients.

Trial Registration: ClinicalTrials.gov, NCT02386735. Registered on 12 March 2015.
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http://dx.doi.org/10.1186/s13063-019-3856-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6916452PMC
December 2019

Recurrent stent thrombosis in a patient with acute coronary syndrome and ischemic colitis: between life-threatening thrombosis and life-threatening bleeding.

Platelets 2020 Aug 12;31(6):820-824. Epub 2019 Oct 12.

Division of Cardiology, Ospedale Manzoni , Lecco, Italia.

Complete blood count should always be considered to tailor diagnosis and appropriate management in patients with acute ischemic heart disease. We present a challenging case of recurrent acute coronary syndrome, in the context of very high thrombotic risk due to concomitant inflammatory disease. Although no general guidelines exist for the switch between antiplatelet agents, particularly in the acute setting, in specific cases, the availability of different orally- and i.v.-acting agents and platelet function tests may allow to discriminate among multiple possible mechanisms of drug failure or side effects in the individual patient.
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http://dx.doi.org/10.1080/09537104.2019.1678122DOI Listing
August 2020

High Residual Platelet Reactivity during Aspirin Therapy in Patients with Non-St Segment Elevation Acute Coronary Syndrome: Comparison Between Initial and Late Phases.

Arq Bras Cardiol 2019 15;113(3):357-363. Epub 2019 Aug 15.

Universidade de São Paulo - Faculdade de Medicina Hospital das Clínicas, São Paulo, SP - Brazil.

Background: High platelet reactivity (HPR) during therapy with acetylsalicylic acid (ASA) is a poor prognostic factor in acute coronary syndromes (ACS). The prevalence of HPR during ACS is greater than that reported in stable diseases. However, it is unclear whether this prevalence of HPR is a transient phenomenon or a characteristic of this high-risk population.

Objective: The main objective is to compare the effects of ASA on platelet function in the initial and late phases of ACS in a single population. Secondary objectives are: correlation between the tests between themselves and the relationship between the tests and the variation of the inflammatory markers (C-reactive protein and interleukin-6).

Methods: Seventy patients with non-ST segment elevation (NSTE) ACS in use of 100-200 mg of ASA per day for at least 7 days were prospectively studied. Platelet function was assessed in the first 48 hours and subsequently after 3 months using four methods: VerifyNow™ (VFN), whole blood platelet aggregation (WBPA) with arachidonic acid (AA) and collagen as agonists, and platelet function analyzer (PFA). The level of statistical significance considered was < 0.05.

Results: According to the more specific methods (WBPA with AA and VFN), the incidence of HPR was significantly higher in the early phase than in the late phase: WBPA with AA: 31% versus 13%, p = 0.015; VFN: 32% versus 16%, p = 0.049. The other methods tested, which were less specific for ASA, did not show significant differences between phases. The correlation between the methods was weak or moderate (r ranging from 0.3 to 0.5, p < 0.05), and there were no significant associations between HPR and inflammatory markers.

Conclusion: The prevalence of HPR during AAS therapy, assessed by specific methods for cyclooxygenase 1 (COX-1), is higher during the acute phase than in the late phase of NSTE ACS.
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http://dx.doi.org/10.5935/abc.20190146DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6882399PMC
April 2020

An "unmodifiable" risk factor that has been modified.

Intern Emerg Med 2021 01 8;16(1):157-159. Epub 2019 Aug 8.

U.O. Medicina III, ASST Santi Paolo e Carlo, Dipartimento di Scienze della Salute, Università degli Studi di Milano, Via di Rudinì, 8, 20142, Milano, Italy.

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http://dx.doi.org/10.1007/s11739-019-02170-9DOI Listing
January 2021

Use of PRECISE-DAPT Score and Admission Platelet Count to Predict Mortality Risk in Patients With Acute Coronary Syndrome.

Angiology 2019 Oct 14;70(9):867-877. Epub 2019 May 14.

10 Division of Cardiology, Ospedale Manzoni, Lecco, Italy.

The PREdicting bleeding Complications In patients undergoing Stent implantation and subsEquent Dual Antiplatelet Therapy (PRECISE-DAPT) score has been validated to predict bleeding complications in patients undergoing stent implantation and dual antiplatelet therapy. This score does not include the platelet count (PC), which has been shown to be an independent marker of mortality in patients with acute coronary syndrome (ACS). We assessed the role of the PRECISE-DAPT score calculated on admission for mortality risk prediction and evaluated whether the predictive accuracy of this score improved by adding the PC. In a retrospective cohort study of 1000 patients with ACS, after adjustment for relevant covariates, a PRECISE-DAPT score ≥25 was independently associated with mortality (hazard ratio [HR]: 7.91; 95% confidence interval [CI]: 4.37-14.30). When this score was combined with PC, compared to patients with PRECISE-DAPT <25 and PC ≥150 × 10/L, the adjusted HR was 7.2 (95% CI 2.4-21.6) for those with PRECISE-DAPT <25 and PC <150 × 10/L; 10.7 (95% CI: 5.2-21.9) for those with PRECISE-DAPT ≥25 and PC ≥150 × 10/L; and 17.9 (95% CI 7.0-45.4) for those with PRECISE-DAPT ≥25 and PC <150 × 10/L. Selecting thresholds for high-risk designation, the PRECISE-DAPT score integrated with PC had a higher prediction value, compared to the PRECISE-DAPT and Global Registry of Acute Coronary Events scores.
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http://dx.doi.org/10.1177/0003319719848547DOI Listing
October 2019