Comorbidities, alone and in combination with D-dimer, as risk factors for recurrence after a first episode of unprovoked venous thromboembolism in the extended follow-up of the PROLONG study

Benilde Cosmi; Cristina Legnani; Alberto Tosetto; Vittorio Pengo; Angelo Ghirarduzzi; Sophie Testa; Domenico Prisco; Daniela Poli; Armando Tripodi; Gualtiero Palareti; for the PROLONG Investigators; (on behalf of FCSA, Italian Federation of Anticoagulation Clinics)

doi:10.1160/TH09-11-0759

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2010; 103(06): 1152-1160
DOI: 10.1160/TH09-11-0759

Blood Coagulation, Fibrinolysis and Cellular Haemostasis

Schattauer GmbH

Comorbidities, alone and in combination with D-dimer, as risk factors for recurrence after a first episode of unprovoked venous thromboembolism in the extended follow-up of the PROLONG study

Benilde Cosmi

¹Department of Angiology & Blood Coagulation “Marino Golinelli”, S. Orsola-Malpighi University Hospital, Bologna, Italy

,

Cristina Legnani

¹Department of Angiology & Blood Coagulation “Marino Golinelli”, S. Orsola-Malpighi University Hospital, Bologna, Italy

,

Alberto Tosetto

²Department of Hematology, S. Bortolo Hospital, Vicenza, Italy

,

Vittorio Pengo

³Department of Clinical and Experimental Medicine, Division of Clinical Cardiology, University Hospital, Padua, Italy

,

Angelo Ghirarduzzi

⁴Department of Internal Medicine I, Angiology, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy

,

Sophie Testa

⁵Haemostasis & Thrombosis Center, General Hospital, Cremona, Italy

,

Domenico Prisco

⁶Department of Medical and Surgical Critical Care, University of Florence and Centro Trombosi, A.O. U. Careggi , Firenze, Italy

,

Daniela Poli

⁶Department of Medical and Surgical Critical Care, University of Florence and Centro Trombosi, A.O. U. Careggi , Firenze, Italy

,

Armando Tripodi

⁷Angelo Bianchi Bonomi Hemophilia & Thrombosis Center, Department of Internal Medicine, University & IRCCS Maggiore Hospital, Milan, Italy

,

Gualtiero Palareti

⁷Angelo Bianchi Bonomi Hemophilia & Thrombosis Center, Department of Internal Medicine, University & IRCCS Maggiore Hospital, Milan, Italy

,

for the PROLONG Investigators

› Author Affiliations

Abstract

Summary

The PROLONG randomised clinical trial showed that an abnormal D-dimer at one month after vitamin K antagonist (VKA) suspension for a first episode of unprovoked venous thromboembolism (VTE) is associated with a higher risk of recurrence. However, other patient characteristics, such as comorbidities, in combination with D-dimer could also influence the recurrence risk. It was the objective of this study to assess the predictive value of comorbidities and D-dimer in combination for recurrence after withdrawal of VKA in patients enrolled in the PROLONG study. On the day of VKA suspension, the presence of known (coronary, peripheral,cerebral) vascular disease, chronic inflammatory bowel disease, chronic obstructive pulmonary disease, autoimmune disease, diabetes, arterial hypertension, obesity and dyslipidaemias was registered. D-dimer was measured at 30 ± 10 days afterwards. The primary outcome was recurrent objectively documented VTE. Mean follow-up was 2.55 years. An abnormal D-dimer was observed in 44% (135/309) of patients with comorbidities and in 29% (87/299) of patients without (p=0.0003). An on-treatment analysis was conducted in 483 patients in whom VKAs were not resumed. In patients with a normal D-dimer, recurrences were observed in 14.3% (24/168) of patients with comorbidities and 10.8% (22/203) of subjects without (p=ns). In patients with an abnormal D-dimer, recurrences were observed in 24.6% (16/65) patients with comorbidities and 21.3% (10/47) of patients without (p=ns). Although abnormal D-dimer levels were significantly more frequent in patients with comorbidities, D-dimer was an independent risk factor for recurrence and the presence of comorbidities did not increase the risk of recurrence associated with an abnormal post-anticoagulation D-dimer.

ClinicalTrials.gov number: NCT00264277

Keywords

Venous thromboembolism - risk factors - hypercoagulability - oral anticoagulants - atherosclerosis

Full Text

References

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