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MARCO MARIETTA

Docente a contratto
Dipartimento di Scienze Mediche e Chirurgiche Materno-Infantili e dell'Adulto

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Pubblicazioni

2023 - A new progestin-only pill (POP): the impact of drospirenone-only pill 4 mg 24 + 4 on coagulation markers and bleeding patterns [Articolo su rivista]
Guida, M.; Quercitelli, L.; De Franciscis, P.; Ferrara, C.; Marietta, M.; Iaccheri, M.; Facchinetti, F.; Capasso, F.; Grandi, G.
abstract

Purpose: Progestin-only pills (POPs), compared to combined, are not associated with an increased risk of venous thromboembolism, but are associated with a poor cycle control. The aim of this study was to evaluate the impact of a new POP [4 mg drospirenone (DRSP) for 24 days with a 4-day hormone-free interval] on some coagulation markers (both procoagulant and fibrinolytic) and to describe its impact on bleeding patterns. Materials and methods: This is a prospective trial, based on serum evaluation of following coagulation markers and tests: Factor (F) X, F VIII, F V, INR, aPTT, Protein S and antithrombin III. A ‘bleeding diary’ was used to categorise women as having (1) unscheduled bleeding, (2) scheduled bleeding and (3) amenorrhoea. Thirty patients were followed for six 28-day intake cycles, with a follow-up at the end of the 3rd and 6th cycles. Results: There was a significant decrease of F X (p = 0.03) (-5.7% at cycle 6). No significant changes have been observed for F VII, F V and INR. A significant increase in aPTT (p = 0.01 at 3 cycles), Protein S (p = 0.0006 at 3 cycles) and antithrombin III (p < 0.0001 at 3 cycles) was recorded. This non-deteriorating coagulation impact was associated with a significant and progressive reduction of days of scheduled and unscheduled bleeding in users between cycles 4 and 6 (from 1.3 ± 0.2 days at cycle 4 to 0.8 ± 0.1 days at cycle 6 and from 2.6 ± 0.4 days at cycle 4 to 0.6 ± 0.2 days at cycle 6, respectively, p < 0.0001). Conclusions: DRSP 24 + 4 use was associated with a non-deteriorating effect on coagulation markers and a significant progressive reduction of days of scheduled and unscheduled bleeding.

2022 - Monkeypox outbreak: after COVID-19, another challenge for the hemostatic system? [Articolo su rivista]
Marietta, M.; Coluccio, V.; Luppi, M.
abstract

2022 - Potential mechanisms of vaccine-induced thrombosis [Articolo su rivista]
Marietta, M.; Coluccio, V.; Luppi, M.
abstract

Vaccine-induced immune thrombocytopenia and thrombosis (VITT) is a rare syndrome characterized by high-titer anti-platelet factor 4 (PF4) antibodies, thrombocytopenia and arterial and venous thrombosis in unusual sites, as cerebral venous sinuses and splanchnic veins. VITT has been described to occur almost exclusively after administration of ChAdOx1 nCoV-19 and Ad26.COV2.S adenovirus vector- based COVID-19 vaccines. Clinical and laboratory features of VITT resemble those of heparin-induced thrombocytopenia (HIT). It has been hypothesized that negatively charged polyadenylated hexone proteins of the AdV vectors could act as heparin to induce the conformational changes of PF4 molecule that lead to the formation of anti-PF4/polyanion antibodies. The anti-PF4 immune response in VITT is fostered by the presence of a proinflammatory milieu, elicited by some impurities found in ChAdOx1 nCoV-19 vaccine, as well as by soluble spike protein resulting from alternative splice events. Anti-PF4 antibodies bind PF4, forming immune complexes which activate platelets, monocytes and granulocytes, resulting in the VITT's immunothrombosis. The reason why only a tiny minority of patents receiving AdV-based COVID-19 vaccines develop VITT is still unknown. It has been hypothesized that individual intrinsic factors, either acquired (i.e., pre-priming of B cells to produce anti-PF4 antibodies by previous contacts with bacteria or viruses) or inherited (i.e., differences in platelet T-cell ubiquitin ligand-2 [TULA-2] expression) can predispose a few subjects to develop VITT. A better knowledge of the mechanistic basis of VITT is essential to improve the safety and the effectiveness of future vaccines and gene therapies using adenovirus vectors.

2021 - Long-term outcomes of postoperative atrial fibrillation following non cardiac surgery: A systematic review and metanalysis [Articolo su rivista]
Albini, A.; Malavasi, V. L.; Vitolo, M.; Imberti, J. F.; Marietta, M.; Lip, G. Y. H.; Boriani, G.
abstract

Background: New-onset atrial fibrillation (AF) in non-cardiac postoperative setting is common and is associated with a high risk of in-hospital mortality and morbidity. The long-term risks of stroke, mortality and AF recurrence rate in patients with postoperative AF (POAF) are unclear. Methods: We performed a systematic literature review in electronic databases from inception to March 5th, 2020 of studies reporting the incidence of stroke, mortality and AF recurrence in patients with POAF. We confined our analysis to studies with a cohort of at least 150 patients with POAF and with a median follow-up of 12 months as a minimum. Odds Ratios (OR) were pooled using a random-effects model. Results: Qualitative analysis included 8 studies (7 observational cohort studies and 1 randomized controlled trial) enrolling 3,718,587 patients. Six studies underwent metanalysis comprising 17,684 postoperative patients with POAF and 2,169,248 postoperative patients without POAF. The development of POAF conferred a four-fold increased risk of stroke in the long-term [OR 4.05; 95% confidence interval (CI) 2.91–5.62]. Mortality in the two studies reporting long-term data was higher in patients with POAF compared to those without POAF (OR 3.59; CI 95% 2.84–4.53). Data about recurrence were too heterogeneous to undergo metanalysis. Conclusions: POAF is associated with a greater risk of stroke and mortality over the long-term period. Studies focusing on AF recurrence are needed to address the perception of POAF as a benign transient entity. The increased mortality risk following POAF should encourage systematic detection and prevention of this arrhythmia.

2020 - COVID-19, coagulopathy and venous thromboembolism: more questions than answers [Articolo su rivista]
Marietta, M.; Coluccio, V.; Luppi, M.
abstract

The acute respiratory illnesses caused by severe acquired respiratory syndrome corona Virus-2 (SARS-CoV-2) is a global health emergency, involving more than 8.6 million people worldwide with more than 450,000 deaths. Among the clinical manifestations of COVID-19, the disease that results from SARS-CoV-2 infection in humans, a prominent feature is a pro-thrombotic derangement of the hemostatic system, possibly representing a peculiar clinicopathologic manifestation of viral sepsis. The severity of the derangement of coagulation parameters in COVID-19 patients has been associated with a poor prognosis, and the use of low molecular weight heparin (LMWH) at doses registered for prevention of venous thromboembolism (VTE) has been endorsed by the World Health Organization and by Several Scientific societies. However, some relevant issues on the relationships between COVID-19, coagulopathy and VTE have yet to be fully elucidated. This review is particularly focused on four clinical questions: What is the incidence of VTE in COVID-19 patients? How do we frame the COVID-19 associated coagulopathy? Which role, if any, do antiphospolipid antibodies have? How do we tackle COVID-19 coagulopathy? In the complex scenario of an overwhelming pandemic, most everyday clinical decisions have to be taken without delay, although not yet supported by a sound scientific evidence. This review discusses the most recent findings of basic and clinical research about the COVID-associated coagulopathy, to foster a more thorough knowledge of the mechanisms underlying this compelling disease.

2020 - COVID-19-associated vasculitis and thrombotic complications: from pathological findings to multidisciplinary discussion [Articolo su rivista]
Vacchi, Caterina; Meschiari, Marianna; Milic, Jovana; Marietta, Marco; Tonelli, Roberto; Alfano, Gaetano; Volpi, Sara; Faltoni, Matteo; Franceschi, Giacomo; Ciusa, Giacomo; Bacca, Erica; Tutone, Marco; Raimondi, Alessandro; Menozzi, Marianna; Franceschini, Erica; Cuomo, Gianluca; Orlando, Gabriella; Santoro, Antonella; Di Gaetano, Margherita; Puzzolante, Cinzia; Carli, Federica; Bedini, Andrea; Cossarizza, Andrea; Castaniere, Ivana; Ligabue, Guido; De Ruvo, Nicola; Manco, Gianrocco; Rolando, Giovanni; Gelmini, Roberta; Maiorana, Antonino; Girardis, Massimo; Mascia, Maria Teresa; Mussini, Cristina; Salvarani, Carlo; Guaraldi, Giovanni
abstract

Neutrophilic arterial vasculitis in COVID-19 represents a novel finding and could be responsible for thrombotic complications.

2020 - Effects of Anti-vitamin k oral anticoagulants on bone and cardiovascular health [Articolo su rivista]
Marietta, M.; Coluccio, V.; Boriani, G.; Luppi, M.
abstract

Vitamin K antagonist oral anticoagulants (VKAs) have been proven over 50 years to be highly effective and acceptably safe in many settings and are still used by millions of people worldwide. The main concern about the safety of VKAs regards the risk of bleeding, but there is accumulation evidence of their potentially negative effects beyond hemostasis. Indeed, VKAs impair the action of several Vitamin-K Dependent Proteins (VKDP), such as Bone Gla protein, Matrix Gla protein, Gas6 Protein, Periostin and Gla-Ric Protein, involved in bone and vascular metabolism, thus exerting a detrimental effect on bone and vascular health. Indeed, although the evidence regarding this issue is not compelling, it has been shown that VKAs use decreases bone mass density, increases the risk of bone fractures and accelerates the process of vascular and valvular calcification. Vascular calcification is a major concern in Chronic Kidney Disease (CKD) patients, also in absence of VKAs, because of mineral metabolism derangement, chronic inflammation and oxidative stress. Direct Oral AntiCoagulants (DOACs) do not affect VKDP involved in vascular and valvular calcification, and do not induce calcific valve degeneration in animal models, being a possible alternative to AVK for CKD patients. However, the efficacy and safety of DOACs in this population, suggested by some recent observations, requires confirmation by dedicated, randomized study. We reviewed here the effects of VKAs in bone and vascular health as compared to DOACs, in order to provide the physicians with some data useful to wisely choose the most suitable anticoagulant for every patient.

2020 - Multi-centre, three arm, randomized controlled trial on the use of methylprednisolone and unfractionated heparin in critically ill ventilated patients with pneumonia from SARS-CoV-2 infection: A structured summary of a study protocol for a randomised controlled trial [Articolo su rivista]
Busani, S.; Tosi, M.; Mighali, P.; Vandelli, P.; D'Amico, R.; Marietta, M.; Forfori, F.; Donati, A.; Cinnella, G.; De Monte, A.; Pasero, D.; Bellani, G.; Tascini, C.; Foti, G.; Ranieri, M.; Girardis, M.
abstract

OBJECTIVES: To assess the hypothesis that an adjunctive therapy with methylprednisolone and unfractionated heparin (UFH) or with methylprednisolone and low molecular weight heparin (LMWH) are more effective in reducing any-cause mortality in critically-ill ventilated patients with pneumonia from SARS-CoV-2 infection compared to LMWH alone. TRIAL DESIGN: The study is designed as a multi-centre, interventional, parallel group, superiority, randomized, investigator sponsored, three arms study. Patients, who satisfy all inclusion criteria and no exclusion criteria, will be randomly assigned to one of the three treatment groups in a ratio 1:1:1. PARTICIPANTS: Inpatients will be recruited from 8 Italian Academic and non-Academic Intensive Care Units INCLUSION CRITERIA (ALL REQUIRED): 1. Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material) 2. Positive pressure ventilation (either non-invasive or invasive) from > 24 hours 3. Invasive mechanical ventilation from < 96 hours 4. PaO2/FiO2 ratio lower than 150 mmHg 5. D-dimer level > 6 times the upper limit of normal reference range 6. C-reactive Protein > 6-fold upper the limit of normal reference range EXCLUSION CRITERIA: 1. Age < 18 years 2. On-going treatment with anticoagulant drugs 3. Platelet count < 100.000/mm3 4. History of heparin-induced thrombocytopenia 5. Allergy to sodium enoxaparin or other LMWH, UFH or methylprednisolone 6. Active bleeding or on-going clinical condition deemed at high risk of bleeding contraindicating anticoagulant treatment 7. Recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery 8. Chronic assumption or oral corticosteroids 9. Pregnancy or breastfeeding or positive pregnancy test. In childbearing age women, before inclusion, a pregnancy test will be performed if not available 10. Clinical decision to withhold life-sustaining treatment or "too sick to benefit" 11. Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition) 12. Lack or withdrawal of informed consent INTERVENTION AND COMPARATOR: • LMWH group: patients in this group will be administered enoxaparin at standard prophylactic dosage. • LMWH + steroid group: patients in this group will receive enoxaparin at standard prophylactic dosage and methylprednisolone. • UFH + steroid group: patients in this group will receive UFH at therapeutic dosages and methylprednisolone. UFH will be administered intravenously in UFH + steroid group at therapeutic doses. The infusion will be started at an infusion rate of 18 UI/kg/hour and then modified to obtain aPTT Ratio in between the range of 1.5-2.0. aPTT will be periodically checked at intervals no longer than 12 hours. The treatment with UFH will be administered up to ICU discharge. After ICU discharge anticoagulant therapy may be interrupted or switched to prophylaxis with LMWH in the destination ward up to clinical judgement of the attending physician. Enoxaparin will be administered in both LMWH group and LMWH + steroid group at standard prophylactic dose (i.e., 4000 UI once day, increased to 6000 UI once day for patients weighting more than 90 kg). The treatment will be administered subcutaneously once a day up to ICU discharge. After ICU discharge it may be continued or interrupted in the destination ward up to clinical judgement of the attending physician. Methylprednisolone will be administered in both LMWH + steroid group and UHF + steroid group intravenously with an initial bolus of 0,5 mg/kg followed by administration of 0,5 mg/kg 4 times daily for 7 days, 0,5 mg/kg 3 times daily from day 8 to day 10, 0,5 mg/kg 2 times daily at days 11 and 12 and 0,5 mg/kg once daily at days 13 and 14. MAIN OUTCOMES: Primary Efficacy Endpoint: All-cause mortality at day 28 Secondary Efficacy Endpoints: - Ventilation free days (VFDs) at day 28, defined

2019 - Atrial fibrillation in patients with active malignancy and use of anticoagulants: Under-prescription but no adverse impact on all-cause mortality [Articolo su rivista]
Malavasi, Vincenzo Livio; Fantecchi, Elisa; Gianolio, Laura; Pesce, Francesca; Longo, Giuseppe; Marietta, Marco; Cascinu, Stefano; Lip, Gregory Y. H.; Boriani, Giuseppe
abstract

Prescription of anticoagulants (ACs) in patients with cancer and atrial fibrillation (AF) is challenging and the impact on survival is not defined. In this study data prospectively collected in Oncology Units were retrospectively evaluated. Among 4664 patients admitted for malignancy, 394 patients (8.4%) had documented AF (mean age of 74 ± 9) and AC was prescribed to 155 patients (40%). Neither the type of cancer, the stage of the disease (metastatic or not) nor the ongoing treatments were significantly associated with prescription of AC, which was independently associated with BMI (OR 1.10; CI 95% 1.03–1.17; p =.003), valvular heart disease (OR 3.76; CI95% 1.59–8.87; p =.002), and previous venous thromboembolism (OR 6.67; 95%CI 2.67–16.70; p <.001). During a median follow-up of 212 days, survival from all-cause death was 37%, 28% and 18% at 6 months, 1 and 2 years, respectively. Only variables related to neoplastic disease or to patient clinical complexity were independently associated with mortality. A CHA2DS2VASc ≥ 4 was significantly associated with mortality (HR 1.33; 95%CI 1.06–1.67; p =.013). Treatment with ACs was not significantly related to mortality, neither in the whole cohort of patients, nor in patients with metastatic malignancies. In conclusion the prescription of ACs in patients with AF and active cancer was suboptimal, with one fourth of the patients not treated with ACs and one third using LMWH at prophylactic, non-therapeutic doses. Only few variables (BMI, valvular heart disease and previous venous thromboembolism) predicted prescription of ACs. Prescription of ACs was not associated with all-cause mortality, even in the subgroup with metastasis.

2019 - Cancer and atrial fibrillation. Author's reply [Articolo su rivista]
Malavasi, V. L.; Marietta, M.; Lip, G. Y. H.; Boriani, G.
abstract

2019 - Direct oral anticoagulants for atrial fibrillation in patients with congenital factor VII deficiency [Articolo su rivista]
Arletti, L.; Coluccio, V.; Romagnoli, E.; Luppi, M.; Marietta, M.
abstract

The management of anticoagulant therapy (OAT) in patients with factor VII (FVII) deficiency is a very challenging clinical issue, as warfarin further reduces FVII levels, thus potentially increasing bleeding risk. On the other hand, the International Normalized Ratio test is misleading in such patients, as they do not reflect the actual level of global inhibition of the coagulation system. We report here three cases of patients with a moderate FVII deficiency and receiving direct oral anticoagulants (DOAC) for prevention of cardioembolism in atrial fibrillation. Of note, two of them experienced a treatment failure while on warfarin, while DOAC treatment was not associated with thrombotic or hemorrhagic adverse events. DOAC are very attractive for the management of OAT in FVII deficient patients, because they do not require monitoring by tests affected by the inherited defect, and their mechanism of action is FVII-independent.

2019 - Direct oral anticoagulants vs non-vitamin K antagonist in atrial fibrillation: A prospective, propensity score adjusted cohort study [Articolo su rivista]
Marietta, M.; Banchelli, F.; Pavesi, P.; Manotti, C.; Quintavalla, R.; Sinigaglia, T.; Guazzaloca, G.; Pattacini, C.; Urbinati, S.; Malavasi, V. L.; Boriani, G.; Voci, C.; D'Amico, R.; Magrini, N.
abstract

2018 - Clinical impact of application of risk assessment models (Padua Prediction Score and Improve Bleeding Score) on venous thromboembolism, major hemorrhage and health expenditure associated with pharmacologic VTE prophylaxis: a “real life” prospective and retrospective observational study on patients hospitalized in a Single Internal Medicine Unit (the STIME study) [Articolo su rivista]
Depietri, Luca; Marietta, Marco; Scarlini, Stefania; Marcacci, Matteo; Corradini, Elena; Pietrangelo, Antonello; Ventura, Paolo
abstract

International guidelines recommend the use of pharmacological prophylaxis in hospitalized medical patients at high risk of venous thromboembolism (VTE). The same international guidelines suggest the employment of standardized risk assessment models (RAMs) when evaluating the administration of pharmacological prophylaxis in acutely ill medical patients. The Padua Prediction Score and the Improve Bleeding Score have been indicated as the best available RAMs to predict thrombotic and haemorrhagic risk in hospitalized medical patients, but it is still unknown whether their combined use may lead to a significant reduction in thrombotic and haemorrhagic events. It is also unclear whether their extensive use can affect to some extent health expenditure associated with pharmacological VTE prophylaxis. The purpose of this single-centre, prospective and retrospective observational study is to investigate these unanswered questions. All patients admitted to our Internal Medicine Department between May 2015 and August 2015, i.e., before the introduction and extensive use of RAMs, were consecutively enrolled (retrospective group). Similarly, all patients admitted between November 2016 and February 2017—once RAMs clinical use became a consolidated practice—have also been consecutively recruited (prospective group). Consecutively, 203 patients were enrolled in the retrospective group and 210 patients were enrolled in the prospective group. Three events of major bleeding and one event of pulmonary embolism were observed in the prospective group; three events of major hemorrhage and two events of pulmonary embolism were observed in the retrospective group (p = not significant). A statistically significant decrease in pharmacological VTE prophylaxis among study groups was detected: 43.3% of prospective group patients and 56.7% of retrospective group patients received pharmacological prophylaxis (p = .028). Overall, 299 drug doses for VTE prophylaxis have been spared after RAMs introduction (p = .0001) and health expenditure decreased by 27.2% (i.e., 1.67 € saved for each single patient). In conclusion, the extensive use of RAMs in our population of hospitalized medical patients did not statistically affect VTE rate or incidence of major bleeding, but it resulted in a significant drop in health expenditure related with pharmacological prophylaxis. Awaiting new clinical trials, a broad use of RAMs may be a safe strategy for reducing health expenditure associated with VTE prophylaxis in hospitalized medical patients.

2018 - Is there a role for intervention radiology for the treatment of lower limb deep vein thrombosis in the era of direct oral anticoagulants? A comprehensive review [Articolo su rivista]
Marietta, Marco; Romagnoli, Elisa; Cosmi, Benilde; Coluccio, Valeria; Luppi, Mario
abstract

Despite recent advances in the treatment of Deep Vein Thrombosis (DVT) provided by Direct Oral Anticoagulants (DOAC), a substantial proportion of lower limb DVT patients will develop some degree of post-thrombotic syndrome (PTS) within 2 years. Systemic thrombolysis, although effective in reducing the risk of PTS and leg ulceration, is associated with a high risk of major bleeding, making it unsuitable for the vast majority of patients. A local approach, aimed at delivering the fibrinolytic drug directly into, or near to, the thrombus surface, is attractive because of the possibility of lowering of the administered drug dose, thus reducing the bleeding risks. However, even after the recent publication of the ATTRACT trial, only weak evidence is available about the efficacy and safety of Catheter Directed Thrombolysis (CDT), either alone (pharmacological technique) or in combination with additional endovascular approaches (pharmacomechanical technique, PMT) including percutaneous mechanical thrombectomy, angioplasty with or without stenting and ultrasound-assisted CDT. The present review is aimed at providing the physicians with a comprehensive evaluation of the current evidence about this relevant topic, in order to build a reliable conceptual framework for a more appropriate use of this resource.

2018 - Non-replacement therapy for haemophilia treatment: Fetching the east by the west [Articolo su rivista]
Marietta, Marco; Luppi, Mario
abstract

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2016 - Hemostatic balance in patients with liver cirrhosis: Report of a consensus conference [Articolo su rivista]
Andriulli, Angelo; Tripodi, Armando; Angeli, Paolo; Senzolo, Marco; Primignani, Massimo; Giannini, Edoardo G.; Riggio, Oliviero; Colli, Agostino; Prati, Daniele; Sacerdoti, David; Merkel, Carlo; Basili, Stefania; Ferro, Domenico; Villa, Erica; Di Minno, Giovanni; Caraceni, Paolo; Marzioni, Marco; Mannucci, Pier Mannuccio; Violi, Francesco; Piscaglia, Fabio; Calvaruso, Vincenza; De Pietri, Lesley; Falcone, Marco; Feltracco, Paolo; Grandone, Elvira; La Mura, Vincenzo; Licata, Anna; Lucidi, Cristina; Maimone, Sergio; Marietta, Marco; Morisco, Filomena; Napoleone, Laura; Piano, Salvatore; Raparelli, Valeria; Rebulla, Paolo; Ribero, Dario; Sartori, Maria Teresa; Scalera, Antonella; Schepis, Filippo; Sicilianom, Massimo; Baroni, Gianluca Svegliati; Tufano, Antonella; Vitale, Alessandro; Zuin, Massimo
abstract

Patients with cirrhosis present with hemostatic alterations secondary to reduced availability of pro-coagulant and anti-coagulant factors. The net effect of these changes is a rebalanced hemostatic system. The Italian Association of the Study of the Liver (AISF) and the Italian Society of Internal Medicine (SIMI) promoted a consensus conference on the hemostatic balance in patients with cirrhosis. The consensus process started with the review of the literature by a scientific board of experts and ended with a formal consensus meeting in Rome in December 2014. The statements were graded according to quality of evidence and strength of recommendations, and approved by an independent jury. The statements presented here highlight strengths and weaknesses of current laboratory tests to assess bleeding and thrombotic risk in cirrhotic patients, the pathophysiology of hemostatic perturbations in this condition, and outline the optimal management of bleeding and thrombosis in patients with liver cirrhosis.

2015 - Safety profile of Erwinia asparaginase treatment in adults with newly diagnosed acute lymphoblastic leukemia: a retrospective monocenter study [Articolo su rivista]
Bigliardi, Sara; Morselli, Monica; Potenza, Leonardo; Coluccio, Valeria; Maccaferri, Monica; Paolini, Ambra; Colaci, Elisabetta; Fantuzzi, Valeria; Faglioni, Laura; Soci, Francesco; Nasillo, Vincenzo; Messerotti, Andrea; Pedrazzi, Paola; Marietta, Marco; Luppi, Mario; Forghieri, Fabio
abstract

Safety profile of Erwinia asparaginase treatment in adults with newly diagnosed acute lymphoblastic leukemia: a retrospective monocenter study.

2011 - ENOXAPARIN PREVENTS PORTAL VEIN THROMBOSIS (PVT) AND DECOMPENSATION IN ADVANCED CIRRHOTIC PATIENTS: FINAL REPORT OF A PROSPECTIVE RANDOMIZED CONTROLLED STUDY [Abstract in Atti di Convegno]
Villa, E; Zecchini, R; Marietta, M; Bernabucci, V; Lei, B; Vukotic, R; Ferrari, A; De Maria, N; Schepis, F; Fornaciari, G; Schianchi, S
abstract

BACKGROUND & AIMS: We performed a randomized controlled trial to evaluate the safety and efficacy of enoxaparin, a low-molecular-weight heparin, in preventing portal vein thrombosis (PVT) in patients with advanced cirrhosis. METHODS: In a nonblinded, single-center study, 70 outpatients with cirrhosis (Child-Pugh classes B7-C10) with demonstrated patent portal veins and without hepatocellular carcinoma were assigned randomly to groups that were given enoxaparin (4000 IU/day, subcutaneously for 48 weeks; n = 34) or no treatment (controls, n = 36). Ultrasonography (every 3 months) and computed tomography (every 6 months) were performed to check the portal vein axis. The primary outcome was prevention of PVT. Radiologists and hepatologists that assessed outcomes were blinded to group assignments. Analysis was by intention to treat. RESULTS: At 48 weeks, none of the patients in the enoxaparin group had developed PVT, compared with 6 of 36 (16.6%) controls (P = .025). At 96 weeks, no patient developed PVT in the enoxaparin group, compared with 10 of 36 (27.7%) controls (P = .001). At the end of the follow-up period, 8.8% of patients in the enoxaparin group and 27.7% of controls developed PVT (P = .048). The actuarial probability of PVT was lower in the enoxaparin group (P = .006). Liver decompensation was less frequent among patients given enoxaparin (11.7%) than controls (59.4%) (P < .0001); overall values were 38.2% vs 83.0%, respectively (P < .0001). The actuarial probability of liver decompensation was lower in the enoxaparin group (P < .0001). Eight patients in the enoxaparin group and 13 controls died. The actuarial probability of survival was higher in the enoxaparin group (P = .020). No relevant side effects or hemorrhagic events were reported. CONCLUSIONS: In a small randomized controlled trial, a 12-month course of enoxaparin was safe and effective in preventing PVT in patients with cirrhosis and a Child-Pugh score of 7-10. Enoxaparin appeared to delay the occurrence of hepatic decompensation and to improve survival.

2010 - ANTICOAGULANT THERAPY IS SAFE AND EFFECTIVE IN PREVENTING PORTAL VEIN THROMBOSIS (PVT) IN ADVANCED CIRRHOTIC PATIENTS: A PROSPECTIVE RANDOMIZED CONTROLLED STUDY [Abstract in Atti di Convegno]
Zecchini, R; Ferrari, A; Bernabucci, V; Lei, B; Vukotic, R; De Maria, N; Schepis, F; Marietta, M; Fornaciari, G; Schianchi, S; Villa, E
abstract

BACKGROUND & AIMS: We performed a randomized controlled trial to evaluate the safety and efficacy of enoxaparin, a low-molecular-weight heparin, in preventing portal vein thrombosis (PVT) in patients with advanced cirrhosis. METHODS: In a nonblinded, single-center study, 70 outpatients with cirrhosis (Child-Pugh classes B7-C10) with demonstrated patent portal veins and without hepatocellular carcinoma were assigned randomly to groups that were given enoxaparin (4000 IU/day, subcutaneously for 48 weeks; n = 34) or no treatment (controls, n = 36). Ultrasonography (every 3 months) and computed tomography (every 6 months) were performed to check the portal vein axis. The primary outcome was prevention of PVT. Radiologists and hepatologists that assessed outcomes were blinded to group assignments. Analysis was by intention to treat. RESULTS: At 48 weeks, none of the patients in the enoxaparin group had developed PVT, compared with 6 of 36 (16.6%) controls (P = .025). At 96 weeks, no patient developed PVT in the enoxaparin group, compared with 10 of 36 (27.7%) controls (P = .001). At the end of the follow-up period, 8.8% of patients in the enoxaparin group and 27.7% of controls developed PVT (P = .048). The actuarial probability of PVT was lower in the enoxaparin group (P = .006). Liver decompensation was less frequent among patients given enoxaparin (11.7%) than controls (59.4%) (P < .0001); overall values were 38.2% vs 83.0%, respectively (P < .0001). The actuarial probability of liver decompensation was lower in the enoxaparin group (P < .0001). Eight patients in the enoxaparin group and 13 controls died. The actuarial probability of survival was higher in the enoxaparin group (P = .020). No relevant side effects or hemorrhagic events were reported. CONCLUSIONS: In a small randomized controlled trial, a 12-month course of enoxaparin was safe and effective in preventing PVT in patients with cirrhosis and a Child-Pugh score of 7-10. Enoxaparin appeared to delay the occurrence of hepatic decompensation and to improve survival.

2003 - A simple and safe nomogram for the management of oral anticoagulation prior to minor surgery [Articolo su rivista]
Marietta, M.; Bertesi, M.; Simoni, L.; Pozzi, S.; Castelli, I.; Cappi, C.; Torelli, G.
abstract

In 80 consecutive, anticoagulated patients scheduled for minor surgery, we reduced warfarin daily dosage by 50% on days 4, 3 and 2 before the surgery, restoring the original dose the day immediately before surgery. The evening after surgery, patients took a double warfarin dose, and then the usual maintenance dose was reintroduced. The mean International Normalized Ratio (INR) value assessed 1 week before surgery was 2.63 (range 1.88-3.87); it decreased at the moment of performing surgery to 1.68 (range 1.42-2.20; P &lt; 0.05 with respect to the preoperative value), and returned to 2.43 7 days after (range 1.96-3.51, P = ns with respect to the preoperative value). No significant difference was found comparing prothrombin fragment 1.2 (F1.2) levels 1 week before surgery and on the morning of surgery (0.49 ng/ml vs 0.67 ng/ml, P = ns), suggesting that no activation of blood coagulation had taken place following the reduction of anticoagulant therapy. Patients developed neither major nor minor bleeding, nor thromboembolism during the procedures or up to I month after surgery. In our experience, this method for the management of anticoagulation before minor surgery has been shown to be safe and useful, avoiding the cumbersome shift to either intravenous or subcutaneous heparin.

2002 - Low-molecular-weight heparin for vertebral artery dissection [Articolo su rivista]
Marietta, M; Bertesi, M; Rozzi, N; Cano, Mc; Vallone, S; Cappi, C; Pozzi, S; Torelli, Giuseppe; Giuseppe,
abstract

A case of vertebral artery dissection and consequent basilar artery thrombosis in a 6-year-old patient is reported. The patient was treated with subcutaneous low-molecular-weight heparin at therapeutic doses (enoxaparin, 100 IU/kg twice daily) for 3 weeks, then reduced to 2,000 IU/day for 3 more weeks. After this time a magnetic resonance angiogram was obtained that showed complete recanalization of the left basilar artery. Enoxaparin proved to be a safe and useful therapy for thrombosis accompanying vertebral artery dissection.