Abstract
The 2015 Research Consensus Panel (RCP) on submassive pulmonary embolism (PE) set priorities for research in submassive PE and identified a rigorous randomized trial of catheter-directed therapy plus anticoagulation versus anticoagulation alone as the highest research priority. This update, written 8 years after the RCP was convened, describes the current state of endovascular PE practice and the Pulmonary Embolism–Thrombus Removal with Catheter-Directed Therapy trial, the main output from the RCP.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1658-1663 |
| Number of pages | 6 |
| Journal | Journal of Vascular and Interventional Radiology |
| Volume | 34 |
| Issue number | 10 |
| DOIs | |
| State | Published - Oct 2023 |
Funding
Thus, PE-TRACT may be considered the main output of the RCP because it seeks to address the questions and issues raised by the panel ( Table 3 ). The initial protocol was developed in January 2014, approximately 2 years before the RCP, and was substantially informed by the design and structure of the NIH-sponsored ATTRACT trial ( 11 ) (which itself had been developed with support from a SIR Foundation RCP in 2004) ( 12 ). A first submission to the Patient-Centered Outcomes Research Institute in the fall of 2014 failed to secure funding. Although that submission facilitated the formation of a network of PE clinical trial centers, solidified trial leadership, and positioned PE-TRACT as an acute PE interventional trial primarily seeking to assess outcomes past 30 days, the final trial design was ultimately shaped by the 2015 RCP and subsequent events. In 2016, 1 year after the RCP, PE-TRACT was submitted to NHLBI. The findings of the RCP were cited in this first and subsequent applications to NHLBI, and reviewers viewed the trial favorably in light of the research needs identified by the 2015 panel. Both the 2016 application and the 2017 resubmission failed to receive the scientific priority score needed for funding. However, in 2018, trial leadership successfully obtained funding for a clinical trial planning grant (U34HL147347). Unique to this planning grant was a collaboration with an Innovative Clinical Trial Resource, which was a methodological clinical trial design consulting group that advised trial leaders on innovative solutions to overcome difficulties specific to a project. In particular, the trial leaders and Innovative Clinical Trial Resource conducted a careful reanalysis of multiple possible outcome assessment plans and changed the primary outcome from the 6-minute walk distance assessed at 12 months to a dual primary outcome approach, with a first physiologic outcome (peak oxygen uptake measured during cardiopulmonary exercise testing) assessed at 3 months and a second patient-reported functional outcome (New York Heart Association class) assessed at 12 months. This approach was viewed favorably in a new submission to NHLBI in February 2020, although the project was not given a fundable score until a resubmission in July 2021. The notice of award was issued in August 2022. On December 16, 2015, a Research Consensus Panel (RCP) of 19 pulmonary embolism (PE) experts from multiple disciplines was convened in Herndon, Virginia, to discuss the topic “Submassive PE Short- and Long-term Outcomes: Where Are We and Where Do We Need to Be?” ( 1 ). The meeting was sponsored by the Society of Interventional Radiology (SIR) Foundation. One individual joined from Europe via webinar, and invited guests included representatives from the U.S. Food and Drug Administration (FDA), National Heart, Lung, and Blood Institute (NHLBI), and industry.
ASJC Scopus subject areas
- Radiology Nuclear Medicine and imaging
- Cardiology and Cardiovascular Medicine
