What is the clinical evidence from this study?

Study design: Cohort. Population: Acute deep vein thrombosis (DVT) or pulmonary embolism (PE) (n=12744). Intervention: Solid cancer vs. No malignancy. Primary outcome: Recurrent venous thromboembolism (VTE) at 3 months (HR 3.5, 95% CI 2.5-4.7).

August 29, 2008HaematologicaOpen Access

Recurrent thromboembolism and major bleeding during oral anticoagulant therapy in patients with solid cancer: findings from the RIETE registry

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Key result

Solid cancer was associated with a significantly increased risk of recurrent venous thromboembolism at 3 months compared to no malignancy in patients receiving vitamin K antagonists (adjusted HR 3.5).

Why the study?

Does oral anticoagulant therapy with vitamin K antagonists increase the risk of recurrent VTE and major bleeding in patients with solid cancer compared to patients without malignancy?

Population

12,744 patients with symptomatic, acute DVT or PE confirmed by objective tests, who had an initial treatment…

Comparison

Oral anticoagulant therapy with vitamin K… vs Oral anticoagulant therapy with vitamin K…

Design

Cohort

Follow-up

3 months

Authors

PPPaolo PrandoniANT Foundation Italy Onlus JTJavier Trujillo‐SantosHospital General Universitario Santa María del Rosell TST. Surico

Discussion

Member takes

Implication

Supports caution with VKA for VTE in solid cancer; leaves open LMWH superiority in prospective trials.

Study Design

Type

Cohort (n=12,744)

Multicenter

Yes

Structured PICO

Does oral anticoagulant therapy with vitamin K antagonists increase the risk of recurrent VTE and major bleeding in patients with solid cancer compared to patients without malignancy?

Population

12,744 patients with symptomatic acute DVT or PE treated with vitamin K antagonists, including 1,379 with solid cancer and 11,365 without malignancy, followed for 3 months.

Exposure

Oral anticoagulant therapy with vitamin K antagonists (VKA) targeting an INR between 2.0 and 3.0 in patients with solid cancer (with or without distant metastases).

Comparator

Oral anticoagulant therapy with vitamin K antagonists (VKA) targeting an INR between 2.0 and 3.0 in patients without malignancy.

Outcome

Recurrent venous thromboembolism (VTE) and major bleeding at 3-month follow-up.hard clinical

Main Result

Hazard Ratio: 3.5 (95% CI 2.5–4.7)

Absolute Event Rate: 4.2% vs 1.4%

Cancer patients treated with vitamin K antagonists for VTE have a substantially higher risk of both recurrent thromboembolism and major bleeding compared to non-cancer patients, supporting guidelines that recommend LMWH over VKA in this population.

Limitations

Exclusion of a relevant number of patients (almost 30% with cancer) who received anticoagulant treatment other than VKA
Lack of an independent adjudication committee to confirm cancer diagnosis, disease stage, recurrent VTE, and major bleeding
Information on the quality of anticoagulation achieved during VKA treatment was not available
A relevant number of patients (almost 30% affected by cancer) had an anticoagulant treatment other than VKA and were excluded.
Data concerning the diagnosis of cancer, disease stage, recurrent VTE, and major bleeding were accepted on assessments made at each participating center and could not be confirmed by an independent adjudication committee.
Information on the quality of anticoagulation achieved during the treatment with VKA was not available.

Cite This Study

Prandoni et al. (2008) conducted a cohort in Acute deep vein thrombosis (DVT) or pulmonary embolism (PE) (n=12,744). Solid cancer vs. No malignancy was evaluated on Recurrent venous thromboembolism (VTE) at 3 months (HR 3.5, 95% CI 2.5-4.7). Solid cancer was associated with a significantly increased risk of recurrent venous thromboembolism at 3 months compared to no malignancy in patients receiving vitamin K antagonists (adjusted HR 3.5).

synapsesocial.com/papers/6a943c3fbbea1c735e92ded5 https://doi.org/10.3324/haematol.13055

Topics

Anticoagulation in AF

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Recurrent thromboembolism and major bleeding during oral anticoagulant therapy in patients with solid cancer: findings from the RIETE registry

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Topics

Recurrent thromboembolism and major bleeding during oral anticoagulant therapy in patients with solid cancer: findings from the RIETE registry

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Also Consider

Topics

Also Consider