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November 19, 2019BMC MedicineOpen Access

Hospitalised bleeding without markers of severity was associated with an increased risk of all-cause mortality (HR 1.99) compared to no bleeding in patients with cardiovascular disease.

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Why the study?

Clinical guidelines and public health authorities lack recommendations on scalable approaches to defining and monitoring the occurrence and severity of bleeding in populations prescribed antithrombotic therapy.

Does antithrombotic therapy increase bleeding risk and what is the prognostic impact of bleeding in patients with newly diagnosed cardiovascular disease?

Population

128,815 patients with newly diagnosed AF, acute MI, unstable angina, or stable angina in England

Comparison

Bleeding events vs no bleeding

Design

Linked electronic health record cohort study

Key result

Hospitalised bleeding without markers of severity was associated with an increased risk of all-cause mortality (HR 1.99) compared to no bleeding in patients with cardiovascular disease.

Authors

LPLaura PaseaSCSheng‐Chia ChungMPMar Pujades‐Rodríguez

Discussion

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Member takes

Overview

May indicate rising bleeding risk with antithrombotic regimens over time; leaves open drivers and mitigation strategies.

Study Design

Type

Cohort (n=128,815)

Multicenter

Yes

Structured PICO

Does antithrombotic therapy increase bleeding risk and what is the prognostic impact of bleeding in patients with newly diagnosed cardiovascular disease?

P
Population
128,815 adults aged 18 and older with newly diagnosed atrial fibrillation, acute myocardial infarction, unstable angina, or stable angina in England, followed for a median of 3.7 years.
E
Exposure
Antithrombotic therapy (aspirin, ADP receptor inhibitor, dual antiplatelet therapy, vitamin K antagonist, or combinations)
C
Comparator
No antithrombotic therapy
O
Outcome
Incidence of bleeding events (fatal, hospitalised, primary care) and prognosis (all-cause mortality, atherothrombotic events)safety

Main Result

Hazard Ratio: 1.99 (95% CI 1.92–2.05)

Bleeding affects one in four cardiovascular disease patients prescribed antithrombotic therapy and is associated with a significantly increased risk of all-cause mortality and atherothrombotic events.

Limitations

  • Lack of structured information and inconsistency of data models in different EHR systems
  • Much of the information in EHR systems is in free text, which is difficult to access for research and to interpret
  • Lack of acute haemoglobin change, number of units transfused, and other details of bleeding to support the classification of bleeding severity
  • Prescribing data was confined to primary care and did not include drugs prescribed during hospitalisation or over-the-counter aspirin
  • Cannot claim causal associations between bleeding and prognosis

Cite This Study

Pasea et al. (2019) conducted a cohort in Atrial fibrillation, acute myocardial infarction, unstable angina, or stable angina (n=128,815). Hospitalised bleeding without markers of severity vs. No bleeding was evaluated on All-cause mortality (HR 1.99, 95% CI 1.92, 2.05). Hospitalised bleeding without markers of severity was associated with an increased risk of all-cause mortality (HR 1.99) compared to no bleeding in patients with cardiovascular disease.

synapsesocial.com/papers/6a406567eae9a54d59b27f9ehttps://doi.org/10.1186/s12916-019-1438-y
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