Use of D-dimer testing to determine duration of anticoagulation, risk of cardiovascular events and occult cancer after a first episode of idiopathic venous thromboembolism: the extended follow-up of the PROLONG study.

Abstract

BACKGROUND:

The PROLONG study showed that D-dimer (D-d) testing could help tailor the duration of anticoagulation after idiopathic venous thromboembolism (VTE). In this report the initial 18 month study follow-up was extended for 1 year.

MATERIALS AND METHODS:

D-d was measured 1 month after anticoagulation withdrawal for a first episode of idiopathic VTE. Patients with a normal D-d did not resume anticoagulation, while patients with an abnormal D-d were randomized to either resume or not resume treatment. The primary outcome was the composite of recurrent VTE and major bleeding. Secondary end-points were cardiovascular events, newly diagnosed cancers and deaths.

RESULTS:

D-d was abnormal in 222/608 (36.5%) patients. Average follow-up was 2.55 years. Twenty-eight events occurred in the 121 patients who stopped anticoagulation (23.1%, 9.6% person-years) and five in the 101 patients who resumed anticoagulation (5.0%, 2.0% person-years, adjusted hazard ratio-HR = 3.76; P = 0.008). Recurrence rate was higher in patients with abnormal D-d who stopped anticoagulation than in patients with normal D-d (51 events in 386 patients -13.2%; 5% person-years; adjusted HR 1.70; P = 0.045). The adjusted HR ratio associated with normal D-d versus abnormal D-d in patients who resumed anticoagulation was 2.7 (P = 0.042). An abnormal D-d was associated with a non significant higher risk of cardiovascular events and newly diagnosed cancers vs normal D-d.

CONCLUSIONS:

Patients with an abnormal D-d at 1 month after withdrawal of VKA have a significant risk of recurrence over a 2.55 year follow-up and they benefit from resuming anticoagulation.

• Authors: Benilde Cosmi, Cristina Legnani, Alberto Tosetto, Vittorio Pengo, Angelo Ghirarduzzi, Adriano Alatri, Domenico Prisco, Daniela Poli, Armando Tripodi, Gualtiero Palareti
• Journal: Journal of thrombosis and thrombolysis (J Thromb Thrombolysis) Vol. 28 Issue 4 Pg. 381-8 (Nov 2009) ISSN: 1573-742X [Electronic] Netherlands
• PMID: 19288181 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticoagulants
• Fibrin Fibrinogen Degradation Products
• fibrin fragment D

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Anticoagulants (administration & dosage, adverse effects)
• Cardiovascular Diseases (blood, etiology)
• Diagnostic Tests, Routine (statistics & numerical data)
• Drug Administration Schedule
• Female
• Fibrin Fibrinogen Degradation Products (analysis)
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Neoplasms (blood, etiology)
• Occult Blood
• Risk Factors
• Time Factors
• Treatment Outcome
• Venous Thromboembolism (blood, drug therapy)
• Young Adult