What does this research mean for the field?

Incidental VTE in cancer patients is associated with different clinical features at presentation, a numerically lower incidence of recurrent VTE (4.3% vs 7.4%; HR 0.57, 95% CI 0.29-1.10), and a numerically higher incidence of major bleeding compared to symptomatic VTE. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

July 14, 2021Journal of Thrombosis and HaemostasisOpen Access

Clinical characteristics and outcomes of incidental venous thromboembolism in cancer patients: Insights from the Caravaggio study

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Cancer-associated venous thromboembolism (n=1155). Intervention: Incidental venous thromboembolism vs. Symptomatic venous thromboembolism. Primary outcome: Recurrent venous thromboembolism (HR 0.57, 95% CI 0.29-1.10).

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Key result

Incidental VTE shows no significant difference in recurrent events or bleeding vs symptomatic VTE.

HR 0.57
95% CI 0.29-1.10
n=1,155

Why the study?

Clinical guidelines advise similar anticoagulant treatment for symptomatic and incidental cancer-associated VTE, but the clinical features, outcomes, and relative efficacy and safety of apixaban versus dalteparin in these subgroups warranted investigation.

Do cancer patients with incidental VTE have different rates of recurrent VTE and major bleeding compared to those with symptomatic VTE when treated with anticoagulation?

Population

Two hundred thirty patients with incidental and 925 with symptomatic cancer-associated VTE

Comparison

Incidental vs symptomatic VTE, and apixaban vs dalteparin within each group

Design

Predefined sub-analysis of a randomized study

Follow-up

6-month

Authors

MGMichela GiustozziUniversity of Perugia JCJean M. ConnorsCardio-Oncology ABAna BlancoUniversidad Cardenal Herrera CEU

Discussion

Member takes

Implication

Supports similar anticoagulation for incidental and symptomatic cancer VTE; extends Caravaggio data to refine guidelines.

Study Design

Type

Cohort (n=1,155)

Blinding

Open-label

Randomization

1:1 ratio (in parent RCT)

Multicenter

Yes

Structured PICO

Do cancer patients with incidental VTE have different rates of recurrent VTE and major bleeding compared to those with symptomatic VTE when treated with anticoagulation?

Population

1,155 patients with cancer and symptomatic or incidental acute proximal deep vein thrombosis or pulmonary embolism, followed for 6 months.

Exposure

Apixaban 10 mg oral twice daily for 7 days followed by 5 mg twice daily for 6 months

Comparator

Dalteparin 200 IU/kg subcutaneous once daily for 1 month followed by 150 IU/kg once daily for 6 months

Outcome

Recurrent VTE (composite of objectively confirmed symptomatic, incidental, or fatal PE, symptomatic or incidental proximal DVT of the lower limbs, and symptomatic DVT of the upper limbs) and major bleeding occurring during the 6-month study periodcomposite

Main Result

Hazard Ratio: 0.57 (95% CI 0.29–1.1)

Absolute Event Rate: 4.3% vs 7.4%

Cancer patients with incidental VTE have a considerable risk of recurrence (4.3%) and major bleeding (5.2%) at 6 months, supporting current guidelines to anticoagulate these patients similarly to those with symptomatic VTE.

Limitations

A limited number of patients with incidental VTE were randomized in the Caravaggio study as the proportion of these patients was set by the study protocol at a maximum of 20% of the study population.
Symptoms in patients with incidental VTE were not adequately collected, making it impossible to distinguish between truly asymptomatic and those with symptoms attributed to underlying disease.
The location of symptomatic and incidental PE was not made available, so the clinical relevance of proximal or segmental PE was not assessed.
Limited number of patients with incidental VTE randomized (capped at 20% of study population)
Symptoms in patients with incidental VTE were not adequately collected
Location of symptomatic and incidental PE was not made available

Cite This Study

Giustozzi et al. (2021) conducted a cohort in Cancer-associated venous thromboembolism (n=1,155). Incidental venous thromboembolism vs. Symptomatic venous thromboembolism was evaluated on Recurrent venous thromboembolism (HR 0.57, 95% CI 0.29-1.10). Cancer patients with incidental VTE had a numerically lower incidence of recurrent VTE (4.3% vs 7.4%; HR 0.57) and a numerically higher incidence of major bleeding compared to those with symptomatic VTE.

synapsesocial.com/papers/6a1c2a79ea84844e355f8965 https://doi.org/10.1111/jth.15461

Topics

Anticoagulation in AF

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Clinical characteristics and outcomes of incidental venous thromboembolism in cancer patients: Insights from the Caravaggio study

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Topics

Clinical characteristics and outcomes of incidental venous thromboembolism in cancer patients: Insights from the Caravaggio study

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Also Consider

Topics

Also Consider