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November 11, 2023Journal of the Society for Cardiovascular Angiography & InterventionsOpen Access

Endovascular Therapies for Pulmonary Embolism: A Landscape of Uncertainties and Opportunities

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Why the study?

Advanced endovascular therapies are increasingly used for pulmonary embolism, but high-quality head-to-head comparative safety data between devices frequently used in clinical practice are lacking.

Does mechanical thrombectomy improve clinical outcomes or safety compared to ultrasound-assisted catheter-directed thrombolysis in patients with pulmonary embolism?

Population

2259 patients with PE treated with USCDT or MT

Comparison

USCDT vs MT

Design

Retrospective electronic health record-based platform analysis

Follow-up

30 days

Key result

Mechanical thrombectomy for pulmonary embolism was associated with a higher risk of ISTH-modeled major bleeding compared to USCDT (15.4% vs 11.8%; OR 1.37; 95% CI 1.10-1.74; P<0.001).

Authors

LOLuis Ortega-PazBBBehnood Bikdeli

Discussion

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Member takes

Overview

Mechanical thrombectomy's higher bleeding risk warrants caution versus USCDT; leaves open whether randomized trials will confirm observational differences in pulmonary embolism.

Structured PICO

Does mechanical thrombectomy improve clinical outcomes or safety compared to ultrasound-assisted catheter-directed thrombolysis in patients with pulmonary embolism?

P
Population
2,259 patients with pulmonary embolism treated with ultrasound-assisted catheter-directed thrombolysis or mechanical thrombectomy (primary analysis cohort identified from an electronic health record platform of 83 million patients).
I
Intervention
Mechanical thrombectomy (MT)
C
Comparator
Ultrasound-assisted catheter-directed thrombolysis (USCDT)
O
Outcome
In-hospital mortality, 30-day all-cause readmission, and major bleeding (modeled using ISTH and BARC 3b definitions)hard clinical

Main Result

Effect estimate: OR 1.37 (95% CI 1.10-1.74)

Absolute Event Rate: 15.4% vs 11.8%

p-value: p=<0.001

In a real-world analysis, mechanical thrombectomy for pulmonary embolism showed similar short-term mortality to ultrasound-assisted catheter-directed thrombolysis but was associated with higher rates of major bleeding and intracranial hemorrhage, though unmeasured confounding may exist.

Limitations

  • Baseline imbalances between cohorts, with MT patients being older, having a higher frequency of cancer-associated PE, and lower use of prior direct oral anticoagulants.
  • Reliance on administrative claims codes for outcome ascertainment without validation against patient-level records.
  • Lack of clinical event committee adjudication for bleeding and stroke events.
  • Use of administrative claims codes without validation against patient-level records by independent physicians
  • Baseline imbalances between groups (MT patients were older, had more cancer-associated PE, and lower prior DOAC use)
  • Marginal use of mechanical thrombectomy in clinical practice prior to 2018

Cite This Study

Ortega-Paz et al. (2023) conducted an editorial in Pulmonary embolism (n=2,259). Mechanical thrombectomy (MT) vs. Ultrasound-assisted catheter-directed thrombolysis (USCDT) was evaluated on ISTH-modeled major bleeding (OR 1.37, 95% CI 1.10-1.74, p=<0.001). Mechanical thrombectomy for pulmonary embolism was associated with a higher risk of ISTH-modeled major bleeding compared to USCDT (15.4% vs 11.8%; OR 1.37; 95% CI 1.10-1.74; P<0.001).

synapsesocial.com/papers/6a1236f345487b7639a61002https://doi.org/10.1016/j.jscai.2023.101221
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