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HI-PEITHO Trial Demonstrates Boston Scientific EKOS™ Endovascular System Is Superior to Standard of Care for Treatment of Acute Pulmonary Embolism

The EKOS system cut clinical events by 61% in a 544-patient trial of intermediate-risk pulmonary embolism with no increase in major bleeding or brain hemorrhage.

  • On Saturday, Boston Scientific announced positive results from the HI-PEITHO trial at the American College of Cardiology meeting, showing the EKOS Endovascular System reduced composite clinical events by 61% in intermediate-risk pulmonary embolism patients versus anticoagulation alone.
  • Intermediate-Risk pulmonary embolism patients have historically occupied a treatment gray area; the 2014 PEITHO trial using systemic thrombolysis showed mixed results with significant bleeding risks, leaving clinicians uncertain how to intervene.
  • The 544-patient study showed a composite event rate of 4.0% with the EKOS device compared to 10.3% for standard anticoagulation at 7 days, with major bleeding rates at 7 days comparable between groups .
  • Joshua Beckman, chief of vascular medicine at University of Texas Southwestern Medical School in Dallas, called the strategy a "breakthrough," though Lauren Westafer of UMass Chan Medical School-Baystate cautioned that "health systems must weigh increased resource utilization" against marginal benefits.
  • Clinicians await 6- and 12-month follow-up data to confirm durability of results, as the field shifts toward preserving long-term quality of life; nearly 50% of pulmonary embolism patients remain significantly impaired 1 year after diagnosis.
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HI-PEITHO trial demonstrates Boston Scientific EKOS™ Endovascular System is superior to standard of care for treatment of acute pulmonary embolism

MARLBOROUGH, Mass. and NEW ORLEANS, March 28, 2026

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Medscape broke the news in United States on Saturday, March 28, 2026.
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