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Akram Shibani: HI-PEITHO Trial Reminds Us Why Composite Endpoints Deserve Careful Scrutiny
Akram Shibani/LinkedIn
Apr 12, 2026, 14:58

Akram Shibani: HI-PEITHO Trial Reminds Us Why Composite Endpoints Deserve Careful Scrutiny

Akram Shibani, Medical Director of Pulmonary and Critical Service Line at Ascension St. Vincent’s, shared on LinkedIn about a recent article by Kenneth Rosenfield et al, published in NEJM:

”The HI-PEITHO trial is an important addition to the PE literature, but it also reminds us why composite endpoints deserve careful scrutiny.

The trial met its primary endpoint, which will understandably generate enthusiasm for catheter-directed therapy in intermediate-high-risk PE.

But a closer look shows that the signal was driven largely by the cardiopulmonary decompensation/collapse component of the composite endpoint, rather than by a clear mortality benefit.

Even more importantly, a meaningful portion of that decompensation signal appears to have been driven by reliance on the NEWS score threshold, not just harder events such as shock, intubation, ECMO, or cardiac arrest.

That distinction matters.

Preventing clinical deterioration is meaningful. But when a positive trial is driven by a composite endpoint that includes a physiologic warning score, we should be careful not to overstate what was actually proven.

Bottom line:

HI-PEITHO is encouraging and clinically relevant, but it is not a blank check for broad adoption.

It supports careful patient selection and disciplined interpretation more than sweeping conclusions.”

Title: Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for Acute Pulmonary Embolism

Authors: Kenneth Rosenfield, Frederikus Klok, Gregory Piazza, Andrew Sharp, Fionnuala Ní Áinle, Michael Jaff, Stefano Barco, Samuel Goldhaber, Nils Kucher, Irene Lang, Irene Schmidtmann, Keith Sterling, Aleksander Araszkiewicz, Vishal Arora, Rafael Cires-Drouet, John Coghlan, Lukas Hobohm, Wulf Ito, Kurt Jacobson, Christoph Kaiser, Grzegorz Kopec, Kristin Marx, Samuel McElwee, Nicolas Meneveau, Peter Monteleone, Jose Montero-Cabezas, Christoph Olivier, John Park, Marek Roik, Rahul Sakhuja, Andi Tego, Markus Theurl, Gautam Visveswaran, Jan Albert Vos, Michael Young, Federico Asch, Stavros Konstantinides for the HI-PEITHO Investigators

Read the Full Article on NEJM

Akram Shibani: HI-PEITHO Trial Reminds Us Why Composite Endpoints Deserve Careful Scrutiny

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Akram Shibani Aleksander Araszkiewicz Andi Tego Andrew Sharp Christoph Kaiser Christoph Olivier DVT ECMO Federico Asch Fionnuala Ní Áinle Frederikus Klok Gautam Visveswaran Gregory Piazza Grzegorz Kopec Health Hematology Hemostasis Hemostasis News Hemostasis Today HI-PEITHO Irene Lang Irene Schmidtmann Jan Albert Vos John Coghlan John Park Jose Montero-Cabezas Keith Sterling Kenneth Rosenfield Kristin Marx Kurt Jacobson Lukas Hobohm Marek Roik Markus Theurl Medicine Michael Jaff Michael Young Nicolas Meneveau Nils Kucher PE Peter Monteleone Pulmonary embolism Rafael Cires-Drouet Rahul Sakhuja Samuel Goldhaber Samuel McElwee Stavros Konstantinides Stefano Barco thrombosis Vishal Arora VTE Wulf Ito
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