Document Detail


Sex, age and normal post-anticoagulation D-dimer as risk factors for recurrence after idiopathic venous thromboembolism in the Prolong study extension.
MedLine Citation:
PMID:  20553388     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The PROLONG randomized study showed that patients with an abnormal D-dimer after anticoagulation suspension for a first unprovoked episode of venous thromboembolism (VTE) benefited from anticoagulation resumption. Patients with normal D-dimer after anticoagulation suspension had a low recurrence rate (4.4% patient-years) but their anticoagulation optimal duration remained uncertain.
OBJECTIVES: To assess whether sex and age, in combination with normal D-dimer, are risk factors for VTE recurrence in patients enrolled in the PROLONG study extended follow-up.
METHODS: D-dimer was measured at 1 month after anticoagulation suspension. Patients with a normal D-dimer did not resume anticoagulants, whereas patients with an abnormal D-dimer were randomized either to resume or not anticoagulants. Primary outcome was recurrent VTE.
RESULTS: After excluding patients resuming anticoagulants for abnormal D-dimer, recurrences were higher in males than females [7.4% patient-years - 47/639 vs. 4.3% patient-years - 27/626; hazard ratio (HR) = 1.7; P = 0.027] and in patients aged 65 or older than in younger patients (8.4% patient-years - 50/598 vs. 3.6% patient-years - 24/667; HR = 2.1; P = 0.003). In patients with normal D-dimer and younger than 65, recurrences were higher in males than in females (5.1% vs. 0.4% patient-years; adjusted HR = 10.6; P = 0.023) and both females and males aged 65 years or older had more recurrences (6.6% and 8.1% patient-years, respectively, adjusted HR: 16.0; P = .008 and 16.0; P = 0.008, respectively) than females younger than 65.
CONCLUSIONS: In patients with idiopathic VTE and a normal D-dimer at 1 month after anticoagulation suspension, females younger than 65 had a very low risk of recurrence.
Authors:
B Cosmi; C Legnani; A Tosetto; V Pengo; A Ghirarduzzi; S Testa; D Prisco; D Poli; A Tripodi; G Palareti;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of thrombosis and haemostasis : JTH     Volume:  8     ISSN:  1538-7836     ISO Abbreviation:  J. Thromb. Haemost.     Publication Date:  2010 Sep 
Date Detail:
Created Date:  2010-10-28     Completed Date:  2011-02-23     Revised Date:  2011-03-28    
Medline Journal Info:
Nlm Unique ID:  101170508     Medline TA:  J Thromb Haemost     Country:  England    
Other Details:
Languages:  eng     Pagination:  1933-42     Citation Subset:  IM    
Copyright Information:
© 2010 International Society on Thrombosis and Haemostasis.
Affiliation:
Department of Angiology & Blood Coagulation Marino Golinelli, S.Orsola-Malpighi University Hospital, Bologna, Italy. benilde.cosmi@unibo.it
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00264277
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MeSH Terms
Descriptor/Qualifier:
Age Factors
Aged
Anticoagulants / therapeutic use*
Female
Fibrin Fibrinogen Degradation Products / therapeutic use*
Follow-Up Studies
Humans
Male
Middle Aged
Recurrence
Risk
Risk Factors
Sex Factors
Time Factors
Treatment Outcome
Venous Thromboembolism / blood*,  therapy*
Chemical
Reg. No./Substance:
0/Anticoagulants; 0/Fibrin Fibrinogen Degradation Products; 0/fibrin fragment D
Investigator
Investigator/Affiliation:
G Palareti / ; B Cosmi / ; C Legnani / ; C Brusi / ; S Testa / ; A Alatri / ; A Ghirarduzzi / ; A Iorio / ; A Tosetto / ; V Pengo / ; C Pegoraro / ; S Iliceto / ; S Siragusa / ; D Prisco / ; D Poli / ; F Baudo / ; R Cappelli / ; N Erba / ; L La Rosa / ; C Pattacini / ; R Quintavalla / ; L Ria / ; E Bucherini / ; E Cerè / ; V Rossi / ; E Tiraferri / ; C Agazzi / ; S Maria / ; C Villani / ; L Frigerio / ; G Scapoli / ; A Trifiletti / ; M Molinatti / ; P Dori Faccini / ; R Santi / ; G Lessiani / ; V Scarmozzino / ; V Imbimbo / ; A Schenone / ; G Palareti / ; B Cosmi / ; C Legnani / ; A Tosetto / ; A Tripodi / ; A Iorio / ; S Testa / ; A Ghirarduzzi / ; C Pattacini / ; V Pengo /

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