What is the clinical evidence from this study?

Study design: Observational. Population: Fatal pulmonary embolism (n=74). Intervention: Factor V Leiden mutation vs. General population. Primary outcome: Presence of factor V Leiden mutation (RR 3).

What does this research mean for the field?

The factor V Leiden mutation confers an approximately threefold relative risk for fatal pulmonary embolism when it is the sole cause of death, but confers no additional risk in patients with severe underlying illness. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To determine whether the inherited factor V Leiden mutation increases the risk of fatal pulmonary embolism in patients with underlying disease compared to those without major acquired risk factors.

January 1, 1998Thrombosis and Haemostasis

Factor V Leiden and Fatal Pulmonary Embolism

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Key result

Factor V Leiden mutation linked to ~3-fold greater risk of fatal PE.

RR 3
n=74

Why the study?

Does the factor V Leiden mutation increase the risk of fatal pulmonary embolism?

Population

74 autopsy cases from Leiden University Hospital, The Netherlands, comprising 44 patients with pulmonary…

Comparison

Factor V Leiden mutation (exposure) vs General population prevalence

Design

Cross-sectional

Authors

PRPieter H. ReitsmaUniversity of Zurich

Discussion

Member takes

Implication

May triple fatal PE risk as sole cause but not with severe illness; hypothesis-generating and should not yet change practice.

Key Points

To determine whether the inherited factor V Leiden mutation increases the risk of fatal pulmonary embolism in patients with underlying disease compared to those without major acquired risk factors.
Extracted DNA from archival paraffin-embedded autopsy tissue across two patient series at Leiden University Hospital, The Netherlands.
Series 1 evaluated consecutive autopsies where pulmonary embolism was noted, primarily in patients with major underlying disease (N=44 successfully tested).
Series 2 evaluated autopsies of patients younger than 70 years where pulmonary embolism was the sole cause of death without major acquired venous thrombosis risk factors (N=30 successfully tested).
In Series 1, factor V Leiden was detected in 1 of 44 patients (2.3%; 95% CI, 0.06% to 12.0%), which did not differ from the Dutch general population prevalence.
In Series 2, factor V Leiden was detected in 3 of 30 patients (10.0%; 95% CI, 2.0% to 26.5%), corresponding to an estimated threefold relative risk, with 11 patients having psychiatric diagnoses.

Study Design

Type

Observational (n=74)

Multicenter

Structured PICO

Does the factor V Leiden mutation increase the risk of fatal pulmonary embolism?

Population

74 autopsy cases of fatal pulmonary embolism from a single center in The Netherlands, divided into those with major underlying disease and those younger than 70 with PE as the sole cause of death.

Exposure

Factor V Leiden mutation (exposure)

Comparator

General population prevalence

Outcome

Fatal pulmonary embolismhard clinical

Main Result

Relative Risk: 3

The factor V Leiden mutation does not play an additional role in the development of pulmonary emboli in the presence of severe illness, but may confer a threefold relative risk for fatal pulmonary embolus as the sole cause of death.

Cite This Study

Pieter H. Reitsma (1998) conducted an observational in Fatal pulmonary embolism (n=74). Factor V Leiden mutation vs. General population was evaluated on Presence of factor V Leiden mutation (RR 3). The factor V Leiden mutation was present in 10% of patients with fatal pulmonary embolism as the sole cause of death, suggesting a threefold relative risk, but plays no additional role in those with severe illness.

synapsesocial.com/papers/6aa50c693a03b8d03ddc3f6d https://doi.org/10.1055/s-0037-1614935

Topics

Pulmonary embolism

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Factor V Leiden and Fatal Pulmonary Embolism

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Topics

Factor V Leiden and Fatal Pulmonary Embolism

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Also Consider

Topics

Also Consider