title: The negative predictive value of D-dimer on the risk of recurrent venous thromboembolism in patients with multiple previous events: a prospective cohort study (the PROLONG PLUS study).
abstract: The optimal duration of anticoagulation after recurrent venous thromboembolism(VTE) is poorly established [1,2]. Recent studies suggested that D-dimer may identify patients at low risk of recurrence after a first VTE [3,4]. In a pilot, prospective, cohort study we aimed to assess the negative predictive value of D-dimer in patients with recurrent VTE. Patients with negative D-dimer while on treatment stopped anti coagulation and underwent repeated testing after 7, 15, and 30 days; treatment was resumed if D-dimer turned positive and permanently stopped if it remained negative. The study was interrupted after the enrolment of 75 patients. At that time, treating physicians decided treatment resumption in 12.2% of the patients, but the majority of events were distal or superficial vein thromboses. The rate of objectively documented recurrent proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE) was 2.56% (95% CI 0.13, 15.07%) in the 39 patients with persistently negative D-dimer at 30 days, for an annual incidence of VTE of 5.65 events/100 patient/years. These preliminary findings suggest that negative D-dimer may identify patients with history of previous VTE at low risk of recurrences, but this approach should be tested in larger trials in highly selected patients.
authors.affiliation: Dipartimento di Medicina Clinica, Università dell'Insubria, Varese, Italy. agewal@yahoo.com
authors.forename: Walter
authors.initials: W
authors.lastname: Ageno
authors.forename: Benilde
authors.initials: B
authors.lastname: Cosmi
authors.forename: Angelo
authors.initials: A
authors.lastname: Ghirarduzzi
authors.forename: Rita
authors.initials: R
authors.lastname: Santoro
authors.forename: Eugenio
authors.initials: E
authors.lastname: Bucherini
authors.forename: Daniela
authors.initials: D
authors.lastname: Poli
authors.forename: Domenico
authors.initials: D
authors.lastname: Prisco
authors.forename: Adriano
authors.initials: A
authors.lastname: Alatri
authors.forename: Vittorio
authors.initials: V
authors.lastname: Pengo
authors.forename: Luca
authors.initials: L
authors.lastname: Galli
authors.forename: Francesco
authors.initials: F
authors.lastname: Dentali
authors.forename: Gualtiero
authors.initials: G
authors.lastname: Palareti
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage / Q000627:therapeutic use*; D015331:Cohort Studies; D016903:Drug Monitoring; D057239:Early Termination of Clinical Trials; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011655:Pulmonary Embolism / Q000453:epidemiology / Q000209:etiology; D012307:Risk Factors; D055502:Secondary Prevention; D054556:Venous Thromboembolism / Q000097:blood* / Q000188:drug therapy* / Q000503:physiopathology / Q000517:prevention & control; D020246:Venous Thrombosis / Q000453:epidemiology / Q000209:etiology; D014812:Vitamin K / Q000037:antagonists & inhibitors
chemical_list: D000925:Anticoagulants; D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D; D014812:Vitamin K