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July 25, 2025The Egyptian Heart JournalOpen Access

Comparison of half-dose alteplase and LMWH in intermediate-high risk pulmonary embolism: a single-center observational study

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Why the study?

The use of thrombolytics in intermediate-high risk pulmonary embolism remains controversial.

Does half-dose alteplase improve mortality and clinical outcomes compared to LMWH in patients with intermediate-high risk pulmonary embolism?

Comparison

Half-dose alteplase (50 mg) vs anticoagulation with LMWH (enoxaparin)

Design

Single-center observational study with prospective and retrospective cohorts

Follow-up

One year

Key result

Half-dose alteplase did not significantly reduce one-month mortality (6.7% vs 15.8%, p=0.18) or one-year mortality compared to low molecular weight heparin in patients with intermediate-high risk pulmonary embolism.

Authors

ÖUÖmer Selim UnatPEPervin Korkmaz EkrenAÇAkın Çinkooğlu

Discussion

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Overview

Half-dose alteplase may improve oxygenation without major bleeding in intermediate-high risk PE; leaves open mortality benefit pending randomized trials.

Study Design

Type

Observational (n=97)

Multicenter

No

Structured PICO

Does half-dose alteplase improve mortality and clinical outcomes compared to LMWH in patients with intermediate-high risk pulmonary embolism?

P
Population
97 adult patients with intermediate-high risk pulmonary embolism, followed for up to one year to compare the efficacy and safety of half-dose alteplase versus low molecular weight heparin.
I
Intervention
Half-dose thrombolysis with alteplase 50 mg administered by intravenous infusion over two hours, followed by maintenance anticoagulation with enoxaparin.
C
Comparator
Anticoagulation with enoxaparin 1 mg/kg administered subcutaneously every 12 hours (historical control group).
O
Outcome
One-month and one-year all-cause mortality after the diagnosis time of PE.hard clinical

Main Result

Absolute Event Rate: 6.7% vs 15.8%

p-value: p=0.18

Half-dose alteplase significantly improved oxygenation and pulse rate without increasing major bleeding in intermediate-high risk pulmonary embolism, though it did not demonstrate a statistically significant mortality benefit compared to LMWH.

Limitations

  • Single-center, observational design limits generalizability and may introduce observer bias.
  • Use of a retrospective historical control group for the anticoagulant arm may have introduced selection and documentation bias.
  • Small sample size (97 patients) resulted in the study being underpowered (29.3%) to detect a significant difference in mortality.
  • Not a randomized controlled trial.
  • Patients requiring dose escalation or with deteriorating hemodynamics were excluded.
  • Follow-up during the COVID-19 pandemic was challenging.
  • Underpowered to detect a significant difference in mortality (post-hoc power 29.3%)
  • Observational design with a retrospective historical control group

Cite This Study

Unat et al. (2025) conducted an observational in Intermediate-high risk pulmonary embolism (n=97). Half-dose alteplase vs. Low molecular weight heparin (enoxaparin) was evaluated on One-month mortality (p=0.18). Half-dose alteplase did not significantly reduce one-month mortality (6.7% vs 15.8%, p=0.18) or one-year mortality compared to low molecular weight heparin in patients with intermediate-high risk pulmonary embolism.

synapsesocial.com/papers/6a79b4af02ab7a73dd0280e5https://doi.org/10.1186/s43044-025-00669-5
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