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Article ; Online: Six-week low-molecular-weight heparin versus 12-week warfarin for calf deep vein thrombosis: A randomized, prospective, open-label study.

Sartori, Michelangelo / Iotti, Matteo / Camporese, Giuseppe / Siragusa, Sergio / Imberti, Davide / Bucherini, Eugenio / Corradini, Sara / Ageno, Walter / Prandoni, Paolo / Ghirarduzzi, Angelo

American journal of hematology

2024 Volume 99, Issue 5, Page(s) 854–861

Abstract: Current guidelines suggest a 3-month anticoagulant treatment course for isolated distal deep vein thrombosis (IDDVT), but shorter durations of treatment are frequently prescribed in clinical practice. We investigated whether a 6-week treatment with low- ... ...

Abstract	Current guidelines suggest a 3-month anticoagulant treatment course for isolated distal deep vein thrombosis (IDDVT), but shorter durations of treatment are frequently prescribed in clinical practice. We investigated whether a 6-week treatment with low-molecular-weight heparin (LMWH) at intermediate dosage can be an effective and safe alternative to vitamin K antagonists (VKA) in patients with IDDVT (non-inferiority trial). In a multicenter, open-label, randomized trial, 260 outpatients with symptomatic IDDVT were randomly assigned to receive either LMWH followed by VKA for 12 weeks or LMWH 1 mg/kg subcutaneously twice a day for 2 weeks followed by 1 mg/kg subcutaneously once a day for 4 weeks. The follow-up was 6 months and the primary endpoint was the composite measure of recurrent venous thromboembolism (VTE) defined as: recurrence or extension of IDDVT, proximal DVT, and pulmonary embolism (PE). The study was stopped prematurely due to slow recruiting rates. The primary efficacy outcome occurred in 14 patients receiving LMWH (10.8%) and in five patients receiving VKA (3.8%); risk difference was 0.069 (95% CI: 0.006-0.132), hazard ratio 2.8 (95% CI: 1.04-7.55). There was one PE in the VKA group and one proximal DVT in the LMWH group. IDDVT recurrence was 10.0% in the LMWH group versus 3.1% in the VKA group (p = .024). Two patients had clinically relevant bleedings (1.6%) in the LMWH group versus one (0.8%) in VKA group (p = .56). In conclusion, VKA for 12 weeks seems superior to LMWH for 6 weeks in reducing the risk of VTE recurrences in our cohort of outpatients with IDDVT.
MeSH term(s)	Humans ; Heparin, Low-Molecular-Weight/adverse effects ; Warfarin/adverse effects ; Venous Thromboembolism/drug therapy ; Mesenteric Ischemia ; Prospective Studies ; Venous Thrombosis/drug therapy ; Anticoagulants/adverse effects ; Pulmonary Embolism/drug therapy ; Fibrinolytic Agents/therapeutic use ; Recurrence
Chemical Substances	Heparin, Low-Molecular-Weight ; Warfarin (5Q7ZVV76EI) ; Anticoagulants ; Fibrinolytic Agents
Language	English
Publishing date	2024-02-20
Publishing country	United States
Document type	Randomized Controlled Trial ; Multicenter Study ; Journal Article
ZDB-ID	196767-8
ISSN	1096-8652 ; 0361-8609
ISSN (online)	1096-8652
ISSN	0361-8609
DOI	10.1002/ajh.27255
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Article: Long-Term Outcomes in Two-Year Follow-Up after Primary Treatment in Patients with a Prior Venous Thromboembolic Event: A Prospective, Observational, Real-Life Study.

Palareti, Gualtiero / Antonucci, Emilia / Bucherini, Eugenio / Caronna, Antonella / Chistolini, Antonio / Di Giorgio, Angela / Di Giulio, Rosella / Falanga, Anna / Fregoni, Vittorio / Garzia, Mariagrazia / Mastroiacovo, Daniela / Marzolo, Marco / Pancani, Roberta / Pastori, Daniele / Podda, Gian Marco / Rigoni, Anna Maria / Ria, Luigi / Sivera, Piera / Testa, Sophie /

Visonà, Adriana / Parisi, Roberto / Poli, Daniela / On Behalf Of The Start Post Vte Investigators

Journal of clinical medicine

2024 Volume 13, Issue 5

Abstract: Background: Patients with acute venous thromboembolism (VTE) need anticoagulation (AC) therapy for at least 3/6 months (primary treatment); after that period, they should receive a decision on the duration of therapy.: Methods: This study examined ... ...

Abstract	Background: Patients with acute venous thromboembolism (VTE) need anticoagulation (AC) therapy for at least 3/6 months (primary treatment); after that period, they should receive a decision on the duration of therapy. Methods: This study examined the complications occurring during two years of follow-up (FU) in patients with a first VTE who were recruited in 20 clinical centers and had discontinued or prolonged AC. They were included in the START2-POST-VTE prospective observational study. Results: A total of 720 patients (53.5% males) who, after the completion of primary treatment, had received the decision to continue ( Conclusion: Physicians' decisions about AC duration were independent of the unprovoked/provoked nature of the index event. The bleeding rate was higher in patients who continued AC using standard-dose DOACs. Surprisingly, the rate of thrombotic recurrence was not different between those who continued or discontinued AC. Randomized studies comparing different procedures to decide on the duration of AC after a first VTE are needed.
Language	English
Publishing date	2024-02-27
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662592-1
ISSN	2077-0383
ISSN	2077-0383
DOI	10.3390/jcm13051343
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Article: Inappropriate Underdosing of Direct Oral Anticoagulants in Atrial Fibrillation Patients: Results from the START2-AF Registry.

Journal of clinical medicine

2024 Volume 13, Issue 7

Abstract: Background: ...

Abstract	Background:
Language	English
Publishing date	2024-03-29
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662592-1
ISSN	2077-0383
ISSN	2077-0383
DOI	10.3390/jcm13072009
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Article ; Online: Venous thromboembolism secondary to hospitalization for COVID-19: patient management and long-term outcomes.

Ageno, Walter / Antonucci, Emilia / Poli, Daniela / Bucherini, Eugenio / Chistolini, Antonio / Fregoni, Vittorio / Lerede, Teresa / Pancani, Roberta / Pedrini, Simona / Pieralli, Filippo / Pignatelli, Pasquale / Pizzini, Attilia Maria / Podda, Gian Marco / Potere, Nicola / Sarti, Luca / Testa, Sophie / Visonà, Adriana / Palareti, Gualtiero

Research and practice in thrombosis and haemostasis

2023 Volume 7, Issue 4, Page(s) 100167

Abstract: Background: Venous thromboembolism (VTE) is a complication of COVID-19 in hospitalized patients. Little information is available on long-term outcomes of VTE in this population.: Objectives: We aimed to compare the characteristics, management ... ...

Abstract	Background: Venous thromboembolism (VTE) is a complication of COVID-19 in hospitalized patients. Little information is available on long-term outcomes of VTE in this population. Objectives: We aimed to compare the characteristics, management strategies, and long-term clinical outcomes between patients with COVID-19-associated VTE and patients with VTE provoked by hospitalization for other acute medical illnesses. Methods: This is an observational cohort study, with a prospective cohort of 278 patients with COVID-19-associated VTE enrolled between 2020 and 2021 and a comparison cohort of 300 patients without COVID-19 enrolled in the ongoing START2-Register between 2018 and 2020. Exclusion criteria included age <18 years, other indications to anticoagulant treatment, active cancer, recent (<3 months) major surgery, trauma, pregnancy, and participation in interventional studies. All patients were followed up for a minimum of 12 months after treatment discontinuation. Primary end point was the occurrence of venous and arterial thrombotic events. Results: Patients with VTE secondary to COVID-19 had more frequent pulmonary embolism without deep vein thrombosis than controls (83.1% vs 46.2%, Conclusion: The risk of recurrent thrombotic events in patients with COVID-19-associated VTE is low and similar to the risk observed in patients with VTE secondary to hospitalization for other medical diseases.
Language	English
Publishing date	2023-04-26
Publishing country	United States
Document type	Journal Article
ISSN	2475-0379
ISSN (online)	2475-0379
DOI	10.1016/j.rpth.2023.100167
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Article ; Online: Rivaroxaban treatment for six weeks versus three months in patients with symptomatic isolated distal deep vein thrombosis: randomised controlled trial.

Ageno, Walter / Bertù, Lorenza / Bucherini, Eugenio / Camporese, Giuseppe / Dentali, Francesco / Iotti, Matteo / Lessiani, Gianfranco / Parisi, Roberto / Prandoni, Paolo / Sartori, Michelangelo / Visonà, Adriana / Bigagli, Elisabetta / Palareti, Gualtiero

BMJ (Clinical research ed.)

2022 Volume 379, Page(s) e072623

Abstract: Objective: To compare two different treatment durations of rivaroxaban in patients with symptomatic isolated distal deep vein thrombosis (DVT).: Design: Randomised, double blind, placebo controlled clinical trial.: Setting: 28 outpatient clinics ... ...

Abstract	Objective: To compare two different treatment durations of rivaroxaban in patients with symptomatic isolated distal deep vein thrombosis (DVT). Design: Randomised, double blind, placebo controlled clinical trial. Setting: 28 outpatient clinics specialising in venous thromboembolism. Participants: 402 adults (≥18 years) with symptomatic isolated distal DVT. Interventions: After receiving standard dose rivaroxaban for six weeks, participants were randomly assigned to receive rivaroxaban 20 mg or placebo once daily for an additional six weeks. Follow-up was for 24 months from study inclusion. Main outcomes measures: The primary efficacy outcome was recurrent venous thromboembolism during follow-up after randomisation, defined as the composite of progression of isolated distal DVT, recurrent isolated distal DVT, proximal DVT, symptomatic pulmonary embolism, or fatal pulmonary embolism. The primary safety outcome was major bleeding after randomisation until two days from the last dose of rivaroxaban or placebo. An independent committee adjudicated the outcomes. Results: 200 adults were randomised to receive additional rivaroxaban treatment and 202 to receive placebo. Isolated distal DVT was unprovoked in 81 (40%) and 86 (43%) patients, respectively. The primary efficacy outcome occurred in 23 (11%) patients in the rivaroxaban arm and 39 (19%) in the placebo arm (relative risk 0.59, 95% confidence interval 0.36 to 0.95; P=0.03, number needed to treat 13, 95% confidence interval 7 to 126). Recurrent isolated distal DVT occurred in 16 (8%) patients in the rivaroxaban arm and 31 (15%) in the placebo arm (P=0.02). Proximal DVT or pulmonary embolism occurred in seven (3%) patients in the rivaroxaban arm and eight (4%) in the placebo arm (P=0.80). No major bleeding events occurred. Conclusions: Rivaroxaban administered for six additional weeks in patients with isolated distal DVT who had an uneventful six week treatment course reduces the risk of recurrent venous thromboembolism, mainly recurrent isolated distal DVT, over a two year follow-up without increasing the risk of haemorrhage. Trial registration: EudraCT 2016-000958-36; ClinicalTrials.gov NCT02722447.
MeSH term(s)	Adult ; Humans ; Rivaroxaban/adverse effects ; Venous Thromboembolism/drug therapy ; Anticoagulants/therapeutic use ; Venous Thrombosis/drug therapy ; Venous Thrombosis/chemically induced ; Pulmonary Embolism/drug therapy ; Hemorrhage/chemically induced ; Hemorrhage/drug therapy
Chemical Substances	Rivaroxaban (9NDF7JZ4M3) ; Anticoagulants
Language	English
Publishing date	2022-11-23
Publishing country	England
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	1362901-3
ISSN	1756-1833 ; 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
ISSN (online)	1756-1833
ISSN	0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
DOI	10.1136/bmj-2022-072623
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Article ; Online: Management and Outcomes of Isolated Distal Deep Vein Thromboses: A Questionable Trend toward Long-Lasting Anticoagulation Treatment. Results from the START-Register.

Palareti, Gualtiero / Legnani, Cristina / Antonucci, Emilia / Testa, Sophie / Mastroiacovo, Daniela / Cosmi, Benilde / Poli, Daniela / Bucherini, Eugenio / Dentali, Francesco / Fontanella, Andrea / Mumoli, Nicola / Imberti, Davide / Falanga, Anna / Ageno, Walter / Pomero, Fulvio

TH open : companion journal to thrombosis and haemostasis

2021 Volume 5, Issue 3, Page(s) e239–e250

Abstract: ... ...

Abstract	Background
Language	English
Publishing date	2021-07-08
Publishing country	Germany
Document type	Journal Article
ZDB-ID	2901738-5
ISSN	2512-9465 ; 2567-3459
ISSN (online)	2512-9465
ISSN	2567-3459
DOI	10.1055/s-0041-1730038
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Article ; Online: Anticoagulation in Italian patients with venous thromboembolism and thrombophilic alterations: findings from START2 register study.

Margaglione, Maurizio / Antonucci, Emilia / D'Andrea, Giovanna / Migliaccio, Ludovica / Ageno, Walter / Bucherini, Eugenio / Cosmi, Benilde / Falanga, Anna / Martini, Giuliana / Mastroiacovo, Daniela / Paparo, Carmelo / Poli, Daniela / Testa, Sophie / Palareti, Gualtiero

Blood transfusion = Trasfusione del sangue

2020 Volume 18, Issue 6, Page(s) 486–495

Abstract: Background: Randomised control trials have assessed the efficacy and safety of direct oral anticoagulants in the prophylaxis and treatment of venous thromboembolism (VTE). Positive but limited results have been reported in patients with inherited ... ...

Abstract	Background: Randomised control trials have assessed the efficacy and safety of direct oral anticoagulants in the prophylaxis and treatment of venous thromboembolism (VTE). Positive but limited results have been reported in patients with inherited thrombophilia. Using an Italian, multicentre, prospective registry of consecutive patients presenting with symptomatic, acute VTE, we aimed to assess which factors are involved in making the choice of the drug that best fits the patient's risk profile in a large real-world setting of VTE patients. Materials and methods: We investigated 4,866 VTE patients who took oral anticoagulants in the period between 2012 and April 2018 to prevent a new thromboembolic episode. Results: The large majority of patients who underwent thrombophilic screening, regardless of the results obtained, were prescribed direct oral anticoagulants rather than conventional anticoagulant therapy (p<0.001). During anticoagulation, bleeding events occurred more frequently in patients on conventional anticoagulant therapy (4.2%) than in those receiving direct oral anticoagulants (1.8%) and an increase in bleeding events was observed in patients who tested positive at the thrombophilic screening. Overall, a higher number of recurrent VTE was observed in patients not screened for thrombophilia (n=36; 1.7%) than in those screened (n=20; 0.7%; adjusted odds ratio: 2.2; 95% confidence interval: 1.2-4.1). Discussion: The present data confirm previous findings from other post-marketing registries and suggest that the choice of oral anticoagulation is strongly driven by patients' characteristics and VTE manifestations. Factors leading to the prescription of thrombophilic screening may identify a patient with a lower risk of VTE recurrence during anticoagulation.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Anticoagulants/therapeutic use ; Antithrombins/therapeutic use ; Blood Coagulation Factors/genetics ; Comorbidity ; Female ; Humans ; Italy/epidemiology ; Male ; Mass Screening ; Middle Aged ; Prospective Studies ; Recurrence ; Registries/statistics & numerical data ; Risk ; Thrombophilia/diagnosis ; Thrombophilia/drug therapy ; Thrombophilia/epidemiology ; Thrombophilia/genetics ; Venous Thromboembolism/drug therapy ; Venous Thromboembolism/epidemiology ; Venous Thromboembolism/etiology ; Venous Thromboembolism/prevention & control ; Young Adult
Chemical Substances	Anticoagulants ; Antithrombins ; Blood Coagulation Factors
Language	English
Publishing date	2020-09-18
Publishing country	Italy
Document type	Journal Article ; Multicenter Study ; Observational Study
ZDB-ID	2135732-8
ISSN	2385-2070 ; 0041-1787 ; 1723-2007
ISSN (online)	2385-2070
ISSN	0041-1787 ; 1723-2007
DOI	10.2450/2020.0091-20
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Article ; Online: Thromboembolic Complications in COVID-19 Patients Hospitalized in Italian Ordinary Wards: Data from the Multicenter Observational START-COVID Register.

Poli, Daniela / Antonucci, Emilia / Ageno, Walter / Prandoni, Paolo / Barillari, Giovanni / Bitti, Giuseppina / Imbalzano, Egidio / Bucherini, Eugenio / Chistolini, Antonio / Fregoni, Vittorio / Galliazzo, Silvia / Gandolfo, Alberto / Grifoni, Elisa / Mastroianni, Franco / Panarello, Serena / Pesavento, Raffaele / Pedrini, Simona / Sala, Girolamo / Pignatelli, Pasquale /

Preti, Paola / Simonetti, Federico / Sivera, Piera / Visonà, Adriana / Villalta, Sabina / Marcucci, Rossella / Palareti, Gualtiero

TH open : companion journal to thrombosis and haemostasis

2022 Volume 6, Issue 3, Page(s) e251–e256

Abstract: ... ...

Abstract	Background
Language	English
Publishing date	2022-09-12
Publishing country	Germany
Document type	Journal Article
ZDB-ID	2901738-5
ISSN	2512-9465 ; 2567-3459
ISSN (online)	2512-9465
ISSN	2567-3459
DOI	10.1055/a-1878-6806
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Article ; Online: D-dimer and reduced-dose apixaban for extended treatment after unprovoked venous thromboembolism: the Apidulcis study.

Palareti, Gualtiero / Poli, Daniela / Ageno, Walter / Legnani, Cristina / Antonucci, Emilia / Bucherini, Eugenio / Testa, Sophie / Paoletti, Oriana / Chistolini, Antonio / Serrao, Alessandra / Martinelli, Ida / Bucciarelli, Paolo / Falanga, Anna / Tosetto, Alberto / Sarti, Luca / Mastroiacovo, Daniela / Cosmi, Benilde / Visonà, Adriana / Santoro, Rita Carlotta /

Zanatta, Nello / Grandone, Elvira / Bertù, Lorenza / Pengo, Vittorio / Caiano, Lucia / Prandoni, Paolo

Blood advances

2022 Volume 6, Issue 23, Page(s) 6005–6015

Abstract: D-dimer assay is used to stratify patients with unprovoked venous thromboembolism (VTE) for the risk of recurrence. However, this approach was never evaluated since direct oral anticoagulants are available. With this multicenter, prospective cohort study, ...

Abstract	D-dimer assay is used to stratify patients with unprovoked venous thromboembolism (VTE) for the risk of recurrence. However, this approach was never evaluated since direct oral anticoagulants are available. With this multicenter, prospective cohort study, we aimed to assess the value of an algorithm incorporating serial D-dimer testing and administration of reduced-dose apixaban (2.5 mg twice daily) only to patients with a positive test. A total of 732 outpatients aged 18 to 74 years, anticoagulated for ≥12 months after a first unprovoked VTE, were included. Patients underwent D-dimer testing with commercial assays and preestablished cutoffs. If the baseline D-dimer during anticoagulation was negative, anticoagulation was stopped and testing repeated after 15, 30, and 60 days. Patients with serially negative results (286 [39.1%]) were left without anticoagulation. At the first positive result, the remaining 446 patients (60.9%) were given apixaban for 18 months. All patients underwent follow-up planned for 18 months. The study was interrupted after a planned interim analysis for the high rate of primary outcomes (7.3%; 95% confidence interval [CI], 4.5-11.2), including symptomatic proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) recurrence, death for VTE, and major bleeding occurring in patients off anticoagulation vs that in those receiving apixaban (1.1%; 95% CI, 0.4-2.6; adjusted hazard ratio [HR], 8.2; 95% CI, 3.2-25.3). In conclusion, in patients anticoagulated for ≥1 year after a first unprovoked VTE, the decision to further extend anticoagulation should not be based on D-dimer testing. The results confirmed the high efficacy and safety of reduced-dose apixaban against recurrences. This trial was registered at www.clinicaltrials.gov as #NCT03678506.
MeSH term(s)	Humans ; Anticoagulants/therapeutic use ; Prospective Studies ; Recurrence ; Venous Thromboembolism/diagnosis ; Venous Thromboembolism/drug therapy
Chemical Substances	Anticoagulants ; apixaban (3Z9Y7UWC1J) ; fibrin fragment D
Language	English
Publishing date	2022-07-29
Publishing country	United States
Document type	Multicenter Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2915908-8
ISSN	2473-9537 ; 2473-9529
ISSN (online)	2473-9537
ISSN	2473-9529
DOI	10.1182/bloodadvances.2022007973
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Article ; Online: Rivaroxaban for the treatment of noncirrhotic splanchnic vein thrombosis: an interventional prospective cohort study.

Blood advances

2022 Volume 6, Issue 12, Page(s) 3569–3578

Abstract: Heparins and vitamin K antagonists are the mainstay of treatment of splanchnic vein thrombosis (SVT). Rivaroxaban is a potential alternative, but data to support its use are limited. We aimed to evaluate the safety and efficacy of rivaroxaban for the ... ...

Abstract	Heparins and vitamin K antagonists are the mainstay of treatment of splanchnic vein thrombosis (SVT). Rivaroxaban is a potential alternative, but data to support its use are limited. We aimed to evaluate the safety and efficacy of rivaroxaban for the treatment of acute SVT. In an international, single-arm clinical trial, adult patients with a first episode of noncirrhotic, symptomatic, objectively diagnosed SVT received rivaroxaban 15 mg twice daily for 3 weeks, followed by 20 mg daily for an intended duration of 3 months. Patients with Budd-Chiari syndrome and those receiving full-dose anticoagulation for >7 days prior to enrollment were excluded. Primary outcome was major bleeding; secondary outcomes included death, recurrent SVT, and complete vein recanalization within 3 months. Patients were followed for a total of 6 months. A total of 103 patients were enrolled; 100 were eligible for the analysis. Mean age was 54.4 years; 64% were men. SVT risk factors included abdominal inflammation/infection (28%), solid cancer (9%), myeloproliferative neoplasms (9%), and hormonal therapy (9%); 43% of cases were unprovoked. JAK2 V617F mutation was detected in 26% of 50 tested patients. At 3 months, 2 patients (2.1%; 95% confidence interval, 0.6-7.2) had major bleeding events (both gastrointestinal). One (1.0%) patient died due to a non-SVT-related cause, 2 had recurrent SVT (2.1%). Complete recanalization was documented in 47.3% of patients. One additional major bleeding event and 1 recurrent SVT occurred at 6 months. Rivaroxaban appears as a potential alternative to standard anticoagulation for the treatment of SVT in non-cirrhotic patients. This trial was registered at www.clinicaltrials.gov as #NCT02627053 and at eudract.ema.europa.eu as #2014-005162-29-36.
MeSH term(s)	Adult ; Anticoagulants/therapeutic use ; Female ; Hemorrhage/chemically induced ; Humans ; Male ; Middle Aged ; Prospective Studies ; Rivaroxaban/adverse effects ; Splanchnic Circulation ; Venous Thrombosis/drug therapy
Chemical Substances	Anticoagulants ; Rivaroxaban (9NDF7JZ4M3)
Language	English
Publishing date	2022-10-12
Publishing country	United States
Document type	Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2915908-8
ISSN	2473-9537 ; 2473-9529
ISSN (online)	2473-9537
ISSN	2473-9529
DOI	10.1182/bloodadvances.2022007397
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