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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

by
Gualtiero Palareti
1,*,
Emilia Antonucci
1,
Eugenio Bucherini
2,
Antonella Caronna
3,
Antonio Chistolini
4,
Angela Di Giorgio
5,
Rosella Di Giulio
6,
Anna Falanga
7,8,
Vittorio Fregoni
9,
Mariagrazia Garzia
10,
Daniela Mastroiacovo
11,
Marco Marzolo
12,
Roberta Pancani
13,
Daniele Pastori
14,
Gian Marco Podda
15,
Anna Maria Rigoni
16,
Luigi Ria
17,
Piera Sivera
18,
Sophie Testa
19,
Adriana Visonà
20,
Roberto Parisi
21,
Daniela Poli
22 and
on behalf of the START POST VTE Investigators
†add Show full author list remove Hide full author list
1
Fondazione Arianna Anticoagulazione, 40138 Bologna, Italy
2
SS Medicina Vascolare e Angiologia, AUSL Romagna, 48121 Ravenna, Italy
3
Centro per la Diagnosi e la Sorveglianza della Malattia Tromboembolica, UO Medicina Interna D’urgenza, Azienda Ospedaliero Universitaria Policlinico di Modena, Ospedale Civile Baggiovara, 41124 Modena, Italy
4
Dipartimento di Medicina Traslazionale e di Precisione Sapienza Università di Roma, 00197 Roma, Italy
5
Angiologia Diagnostica Vascolare Non Invasiva, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, 00168 Roma, Italy
6
U.O. Programma Dipartimentale di Ecografia-AUSL, 40133 Bologna, Italy
7
School of Medicine, Università di Milano Bicocca, 20126 Milano, Italy
8
Immunoematologia e Medicina Trasfusionale ASST Papa Giovanni XXIII, 24127 Bergamo, Italy
9
U.O.C. Medicina Generale, Ospedale di Sondalo, ASST della Valtellina e dell’Alto Lario, 23035 Sondalo, Italy
10
UOC Ematologia-Trapianto Cellule Staminali, Azienda Ospedaliera S.Camillo-Forlanini, 00152 Roma, Italy
11
UOSD Angiologia e Diagnostica Vascolare, Ospedale SS Filippo e Nicola, Avezzano (L’Aquila), 67051 L’Aquila, Italy
12
UOS Angiologia Medica, Ospedale di Rovigo, 45100 Rovigo, Italy
13
U.O. Pneumologia, Dipartimento Cardiotoraco-Vascolare, Azienda Ospedaliero-Universitaria Pisana, Ospedale di Cisanello, 56126 Pisa, Italy
14
Department of Clinical Internal, Anesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, 00197 Roma, Italy
15
Medicina Generale 2, ASST Santi Paolo e Carlo, Università degli Studi di Milano, 20142 Milano, Italy
16
UOC di Angiologia, Azienda Ospedaliero Universitaria Integrata, 37126 Verona, Italy
17
UO Medicina Interna, Presidio Ospedaliero di Gallipoli (Lecce), 73014, Gallipoli, Italy
18
S.C.D.U. EMATOLOGIA Azienda Ospedaliera Ordine Mauriziano, 10128 Torino, Italy
19
Centro Emostasi e Trombosi, ASST Cremona, 26100 Cremona, Italy
20
UOC Angiologia, Dipartimento di Medicina Clinica, Azienda ULSS 2 Marca Trevigiana, Ospedale San Giacomo Apostolo, 31033 Castelfranco Veneto, Italy
21
UOSD Ipertensione e Patologie Endocrine Metaboliche Angiologiche, Ospedale SS. Giovanni e Paolo, 30122 Venezia, Italy
22
SOD Malattie Aterotrombotiche, Azienda Ospedaliero Universitaria-Careggi, 50134 Firenze, Italy
 
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*
Author to whom correspondence should be addressed.
†
Membership of the START-POST-VTE Investigators is provided in the acknowledgements.
J. Clin. Med. 2024, 13(5), 1343; https://doi.org/10.3390/jcm13051343
Submission received: 24 January 2024 / Revised: 9 February 2024 / Accepted: 14 February 2024 / Published: 27 February 2024
(This article belongs to the Special Issue Advances in Thrombotic Disorders and Antithrombotic Treatments)
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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 (n = 281, 39%; 76.1% with a DOAC) or discontinue (n = 439, 61%) AC were followed up for 2 years (total FU = 1318 years). The decision to prolong or suspend AC was made in similar proportions in patients with unprovoked or provoked index events. Courses of sulodexide treatment or Aspirin (100 mg daily) were prescribed to 20.3% and 4.5%, respectively, of the patients who discontinued AC. The bleeding rate was significantly higher in patients who extended AC (1.6% pt/y) than in those who stopped AC (0.1% pt/y; p = 0.001) and was higher in patients using standard-dose DOACs (3.1% pt/y) than in those using reduced-dose DOACs (0.4% pt/y). The recurrent VTE rates were similar between the two groups (2.2% pt/y during AC vs. 3% pt/y off AC). 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.
Keywords: venous thromboembolism; anticoagulant treatment; bleeding; long-term follow-up; recurrence venous thromboembolism; anticoagulant treatment; bleeding; long-term follow-up; recurrence

Share and Cite

MDPI and ACS Style

Palareti, G.; Antonucci, E.; Bucherini, E.; Caronna, A.; Chistolini, A.; Di Giorgio, A.; Di Giulio, R.; Falanga, A.; Fregoni, V.; Garzia, M.; et al. 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. J. Clin. Med. 2024, 13, 1343. https://doi.org/10.3390/jcm13051343

AMA Style

Palareti G, Antonucci E, Bucherini E, Caronna A, Chistolini A, Di Giorgio A, Di Giulio R, Falanga A, Fregoni V, Garzia M, et al. 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. Journal of Clinical Medicine. 2024; 13(5):1343. https://doi.org/10.3390/jcm13051343

Chicago/Turabian Style

Palareti, Gualtiero, Emilia Antonucci, Eugenio Bucherini, Antonella Caronna, Antonio Chistolini, Angela Di Giorgio, Rosella Di Giulio, Anna Falanga, Vittorio Fregoni, Mariagrazia Garzia, and et al. 2024. "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" Journal of Clinical Medicine 13, no. 5: 1343. https://doi.org/10.3390/jcm13051343

APA Style

Palareti, G., Antonucci, E., Bucherini, E., Caronna, A., Chistolini, A., Di Giorgio, A., Di Giulio, R., Falanga, A., Fregoni, V., Garzia, M., Mastroiacovo, D., Marzolo, M., Pancani, R., Pastori, D., Podda, G. M., Rigoni, A. M., Ria, L., Sivera, P., Testa, S., ... on behalf of the START POST VTE Investigators. (2024). 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. Journal of Clinical Medicine, 13(5), 1343. https://doi.org/10.3390/jcm13051343

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