Reperfusion treatment strategies in acute pulmonary embolism : Study protocol for a multicenter prospective observational study in the Nordic countries (PE-NORDIC)
(2026) In Thrombosis Research 260.- Abstract
Background: Guidelines recommend systemic thrombolysis (ST) as first-line reperfusion therapy for highrisk pulmonary embolism (PE), however, clinical concerns regarding bleeding risk frequently limit its use in clinical practice. Catheter-directed therapy (CDT) should be considered when ST is contraindicated or has failed but is increasingly used outside these recommendations despite limited guideline support. Prospective data on short- and long-term outcomes after CDT, particularly in relation to a concurrent ST–treated population, remain scarce. PE-NORDIC aims to evaluate short- and long-term outcomes after CDT and ST for PE in the Nordic countries. Methods: In this multicenter prospective observational study conducted in the Nordics,... (More)
Background: Guidelines recommend systemic thrombolysis (ST) as first-line reperfusion therapy for highrisk pulmonary embolism (PE), however, clinical concerns regarding bleeding risk frequently limit its use in clinical practice. Catheter-directed therapy (CDT) should be considered when ST is contraindicated or has failed but is increasingly used outside these recommendations despite limited guideline support. Prospective data on short- and long-term outcomes after CDT, particularly in relation to a concurrent ST–treated population, remain scarce. PE-NORDIC aims to evaluate short- and long-term outcomes after CDT and ST for PE in the Nordic countries. Methods: In this multicenter prospective observational study conducted in the Nordics, 244 adult patients with confirmed acute PE treated with CDT or ST will be enrolled and followed for up to 1 year. The primary outcome is a composite of all-cause mortality or severe bleeding within 30 days. Secondary outcomes include the individual components of the primary composite, need for rescue treatment, recurrent PE, length of stay in intensive care unit and hospital, right ventricular function, functional capacity, dyspnea, health-related quality of life, health economics, and PE complications. Analyses will be performed using multivariable regression models adjusted for relevant clinical confounders, with complementary propensity score-based methods. Strengths and limitations of this study: •Multicenter prospective real-world study with comprehensive short- and long-term data collection in a rare patient population.•Broad inclusion criteria enhancing generalizability.•Pragmatic inclusion reflecting routine clinical practice, combined with structured and active follow-up.•Non-randomized design with risk of confounding by indication and residual confounding, despite statistical adjustment.
(Less)
- author
- author collaboration
- organization
- publishing date
- 2026-04
- type
- Contribution to journal
- publication status
- published
- subject
- in
- Thrombosis Research
- volume
- 260
- article number
- 109635
- publisher
- Elsevier
- external identifiers
-
- scopus:105035659944
- pmid:41812431
- ISSN
- 0049-3848
- DOI
- 10.1016/j.thromres.2026.109635
- language
- English
- LU publication?
- yes
- id
- 08e96b3c-6c90-48f0-8587-15f8fb0c11dd
- date added to LUP
- 2026-06-01 14:16:12
- date last changed
- 2026-06-29 16:24:18
@article{08e96b3c-6c90-48f0-8587-15f8fb0c11dd,
abstract = {{<p>Background: Guidelines recommend systemic thrombolysis (ST) as first-line reperfusion therapy for highrisk pulmonary embolism (PE), however, clinical concerns regarding bleeding risk frequently limit its use in clinical practice. Catheter-directed therapy (CDT) should be considered when ST is contraindicated or has failed but is increasingly used outside these recommendations despite limited guideline support. Prospective data on short- and long-term outcomes after CDT, particularly in relation to a concurrent ST–treated population, remain scarce. PE-NORDIC aims to evaluate short- and long-term outcomes after CDT and ST for PE in the Nordic countries. Methods: In this multicenter prospective observational study conducted in the Nordics, 244 adult patients with confirmed acute PE treated with CDT or ST will be enrolled and followed for up to 1 year. The primary outcome is a composite of all-cause mortality or severe bleeding within 30 days. Secondary outcomes include the individual components of the primary composite, need for rescue treatment, recurrent PE, length of stay in intensive care unit and hospital, right ventricular function, functional capacity, dyspnea, health-related quality of life, health economics, and PE complications. Analyses will be performed using multivariable regression models adjusted for relevant clinical confounders, with complementary propensity score-based methods. Strengths and limitations of this study: •Multicenter prospective real-world study with comprehensive short- and long-term data collection in a rare patient population.•Broad inclusion criteria enhancing generalizability.•Pragmatic inclusion reflecting routine clinical practice, combined with structured and active follow-up.•Non-randomized design with risk of confounding by indication and residual confounding, despite statistical adjustment.</p>}},
author = {{Einarsson Askeli, Freyr and Andersen, Asger and Glise Sandblad, Katarina and Martinell, Louise and Pivodic, Aldina and Rylander, Christian and Tavoly, Mazdak and Svennerholm, Kristina and Westerlund, Eli and Nurmi, Kasper Sanaei and Skeppholm, Mika and Hassler, Adrian and Maru, Emy and Engström, Jan and Djärv, Therese and Holmström, Margareta and Vorel, Petr and Odenstedt, Annika and Danielsbacka, Jenny and Roupe, Maria and Falkenberg, Mårten and Völz, Sebastian and Elf, Johan and Yndigegn, Troels and Andersson, Olle and Awsa, Sawin Youssef and Witt, Nils and Hegner, Tobias and Bruno, Erik and Vikman, Sofia and Calais, Fredrik and Gustafsson, Robin and Schultz, Jacob Gammelgaard and Kjærgaard, Jesper and Egholm, Gro and Nahoui, Hamza and Øvrebotten, Tarjei and Svingen, Gard Frodahl Tveitevåg and Giil, Lasse Melvær and Kvisvik, Brede and Stokkeland, Pål Johan and Cooper, Trond}},
issn = {{0049-3848}},
language = {{eng}},
publisher = {{Elsevier}},
series = {{Thrombosis Research}},
title = {{Reperfusion treatment strategies in acute pulmonary embolism : Study protocol for a multicenter prospective observational study in the Nordic countries (PE-NORDIC)}},
url = {{http://dx.doi.org/10.1016/j.thromres.2026.109635}},
doi = {{10.1016/j.thromres.2026.109635}},
volume = {{260}},
year = {{2026}},
}