D-dimer time course after stopping anticoagulation after a first episode of idiopathic venous thromboembolism: the PROLONG II prospective study
Abstract number: OC-TH-003
Cosmi1 B., Legnani1 C., Tosetto2 A., Pengo3 V., Ghirarduzzi4 A., Alatri5 A., Testa5 S., Prisco6 D., Poli6 D., Tripodi7 A., Palareti1 G.
11Department of Angiology and Blood Coagulation, S.Orsola-Malpighi University Hospital, Bologna 22Department Hematology, S. Bortolo Hospital, Vicenza 33Department Clinical and Experimental Medicine, Division of Clinical Cardiology, University Hospital, Padova 44Department Internal Medicine I, Angiology, Arcispedale Santa Maria Nuova, Reggio Emilia 55Centro Emostasi e Trombosi, General Hospital, Cremona 66Centro Trombosi, A.O. di Careggi; Università di Firenze, Firenze 77Centro Emofilia e Trombosi Angelo Bianchi Bonomi, Dipartimento di Medicina Interna, Universita’ e IRCCS Ospedale Maggiore, Fondazione Mangiagalli and Regina Elena, Milano, Italy
How-to-cite Cosmi B, Legnani C, Tosetto A, Pengo V, Ghirarduzzi A, Alatri A, Testa S, Prisco D, Poli D, Tripodi A, Palareti G. D-dimer time course after stopping anticoagulation after a first episode of idiopathic venous thromboembolism: the PROLONG II prospective study. Journal of Thrombosis and Haemostasis 2009; Volume 7, Supplement 2: Abstract OC-TH-003
The PROLONG study (N Engl J Med 2006;355:1780–9) showed that an abnormal D-dimer (Dd) at 1 month after vitamin K antagonists (VKAs) suspension in patients with unprovoked venous thromboembolism (VTE) is associated with a significant higher risk for recurrence as compared with normal Dd. However it is unknown whether D-d changes in the subsequent follow-up. The aim of the PROLONG II was to assess the natural history of Dd in patients with a normal Dd after VKA suspension after a first episode of unprovoked VTE.
Methods: In a prospective multi-center (15 centres) study, patients were enrolled after at least 6 months of VKA. Dd was measured during VKAs with a qualitative method (Clearview Simplify D-dimer; Instrumentation Laboratory, Milan). If Dd was abnormal, VKAs were prolonged, while if Dd was normal anticoagulation was stopped. Dd was reassessed after one month, when patients with abnormal Dd resumed VKA, while patients with normal Dd underwent serial bi-monthly D-d measurements over a year. Recurrent VTE was the primary outcome measure.
Results: A total of 355 patients were enrolled; 85 out of 334 (25.4%; 95%CI:14–33%) had a normal D-d at 1 month after VKA suspension. Recurrent events occurred in 6 (3.7%; 95% CI:1–8%) of 162 patients (69%) with persistently normal Dd. Among the 68 patients (20%) with persistently positive Dd from the 3rd month or afterwards, 10 recurrences (15%;95% CI:7–25%) were observed (P = 0.007 with RR:3.9–95% CI:1.5–10.5 vs. normal Dd).
Conclusions: recurrences are low among patients with persistently normal Dd over a year after anticoagulation suspension for a first episode of unprovoked VTE.
Disclosure of interest: Drs. Cosmi, Legnani, Palareti, Pengo, Testa and Tripodi report having been paid lecture fees by the Instrumentation Laboratory company, Milan Italy.