D-dimer and risk of venous thromboembolism recurrence: Comparison of two studies with similar designs but different laboratory and clinical results.

D-dimer Recurrence Reduced dose Apixaban Venous thromboembolism Vitamin K antagonists

Journal

Thrombosis research
ISSN: 1879-2472
Titre abrégé: Thromb Res
Pays: United States
ID NLM: 0326377

Informations de publication

Date de publication:
18 Apr 2024
Historique:
received: 15 11 2023
revised: 03 04 2024
accepted: 17 04 2024
medline: 27 4 2024
pubmed: 27 4 2024
entrez: 26 4 2024
Statut: aheadofprint

Résumé

D-dimer testing may help deciding the duration of anticoagulation in subjects at high risk of venous thromboembolism (VTE) recurrence. Two management studies on this issue have been published (DULCIS in 2014 and APIDULCIS in 2022). They had similar designs but had important different results. Aim of this article is to compare their results. Both studies were finalized to extend anticoagulation [with vitamin K anticoagulants (VKAs) in DULCIS or apixaban 2.5 mg BID (kindly provided by BMS-Pfizer Collaboration) in APIDULCIS] only in patients with positive D-dimer results. More D-dimer assays resulted positive in APIDULCIS than in DULCIS (61.1 % vs 47.7 %, respectively; p < 0.0001). While only 4 (0.5 %) refused low dose apixaban in APIDULCIS, the 22.6 % of patients with positive D-dimer refused to resume VKAs in DULCIS; their rates of recurrence were 187 and 8.8 per 100 person-years, respectively (incidence rate ratio [IRR]: 21.2). The incidence of bleeding was low in those receiving apixaban vs those who resumed VKAs (0.4 vs 2.3 per 100 person-years, respectively; IRR 0.17;). While the recurrence rate was low and similar in the studies in subjects who resumed anticoagulation, it was significantly higher in APIDULCIS than in DULCIS in those who stopped anticoagulation for negative D-dimer (5.6 vs 3.0 per 100 person-years, respectively; IRR 1.9). The low dose Apixaban for extended VTE treatment is effective and safe, and well accepted by patients. Why subjects who stopped anticoagulation for negative D-dimer had a higher recurrence rate in APIDULCIS than in DULCIS remains to be explained.

Sections du résumé

BACKGROUND BACKGROUND
D-dimer testing may help deciding the duration of anticoagulation in subjects at high risk of venous thromboembolism (VTE) recurrence. Two management studies on this issue have been published (DULCIS in 2014 and APIDULCIS in 2022). They had similar designs but had important different results. Aim of this article is to compare their results.
METHODS METHODS
Both studies were finalized to extend anticoagulation [with vitamin K anticoagulants (VKAs) in DULCIS or apixaban 2.5 mg BID (kindly provided by BMS-Pfizer Collaboration) in APIDULCIS] only in patients with positive D-dimer results.
RESULTS RESULTS
More D-dimer assays resulted positive in APIDULCIS than in DULCIS (61.1 % vs 47.7 %, respectively; p < 0.0001). While only 4 (0.5 %) refused low dose apixaban in APIDULCIS, the 22.6 % of patients with positive D-dimer refused to resume VKAs in DULCIS; their rates of recurrence were 187 and 8.8 per 100 person-years, respectively (incidence rate ratio [IRR]: 21.2). The incidence of bleeding was low in those receiving apixaban vs those who resumed VKAs (0.4 vs 2.3 per 100 person-years, respectively; IRR 0.17;). While the recurrence rate was low and similar in the studies in subjects who resumed anticoagulation, it was significantly higher in APIDULCIS than in DULCIS in those who stopped anticoagulation for negative D-dimer (5.6 vs 3.0 per 100 person-years, respectively; IRR 1.9).
CONCLUSION CONCLUSIONS
The low dose Apixaban for extended VTE treatment is effective and safe, and well accepted by patients. Why subjects who stopped anticoagulation for negative D-dimer had a higher recurrence rate in APIDULCIS than in DULCIS remains to be explained.

Identifiants

pubmed: 38669963
pii: S0049-3848(24)00130-0
doi: 10.1016/j.thromres.2024.04.018
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

52-59

Informations de copyright

Copyright © 2024. Published by Elsevier Ltd.

Déclaration de conflit d'intérêts

Declaration of competing interest BC declares speakers' fees from Techdow and from Werfen; all other authors declare no competing financial interests.

Auteurs

Gualtiero Palareti (G)

Fondazione Arianna Anticoagulazione, Bologna, Italy. Electronic address: gualtiero.palareti@unibo.it.

Cristina Legnani (C)

Fondazione Arianna Anticoagulazione, Bologna, Italy.

Alberto Tosetto (A)

UOC Ematologia, Centro Malattie Emorragiche e Trombotiche (CMET), AULSS 8 Berica Ospedale S. Bortolo, Vicenza, Italy.

Daniela Poli (D)

Malattie Aterotrombotiche, AOU Careggi, Firenze, Italy.

Sophie Testa (S)

Centro Emostasi e Trombosi, UUOO Laboratorio Analisi chimico-cliniche e microbiologiche, ASST Cremona, Cremona, Italy.

Walter Ageno (W)

Dipartimento di Medicina e Chirurgia, Università degli Studi dell'Insubria, UOC Pronto Soccorso, Medicina d'Urgenza e Centro Trombosi ed Emostasi, ASST dei Sette Laghi, Varese, Italy.

Vittorio Pengo (V)

Clinica Cardiologica, Azienda Ospedaliera di Padova, Padova, Italy.

Benilde Cosmi (B)

UO di Angiologia e Malattie della Coagulazione, Dipartimento Medicina Specialistica, Diagnostica e Sperimentale, Università di Bologna, Azienda Ospedaliero Universitaria S. Orsola-Malpighi, I.R.C.C.S., Bologna, Italy.

Paolo Prandoni (P)

Fondazione Arianna Anticoagulazione, Bologna, Italy.

Classifications MeSH