Ginebra ferreiraSep 30
Interesting
ESC 2026View all trials
Catheter-Directed Thrombolysis in Intermediate-High–Risk Pulmonary Embolism
Viktor KočkaJ KroupaMartin RadvanJan MrozekMartin SlukaŠtěpán JiroušOta HlinomazMilan PlívaJan PudilHana VoběrkováKarolína BartoškováMartin PoloczekM KamenikM BrabecEva LichnerováMartin HutyraIvo BernátMartin NovakJohana HorakovaLucie JelínkováTomas KnizePetr ToušekCyril StechovskyFilip VarhanikZdenek CoufalJ Jarkovsky
What happened
Catheter-directed thrombolysis reduces mortality, PE recurrence, or decompensation ~90% vs standard anticoagulation.
- RR 0.10
- 95% CI 0.02 to 0.44
- P<0.001
- n=558
- 0.7% vs 6.8% at 7 days (primary endpoint)
Key points
- Context & question: To determine whether catheter-directed thrombolysis plus anticoagulation improves early clinical outcomes compared with standard anticoagulation alone in acute intermediate-high-risk pulmonary embolism.
- Methods & population: Multicenter randomized trial (11 Czech centres); 558 patients with acute intermediate-high-risk PE; median age 64, 41% women; Catheter-directed thrombolysis vs standard anticoagulation alone; 7 days (primary endpoint) follow-up.
- Finding & limits: The primary composite outcome occurred in 0.7% (2/280) of patients in the catheter-directed thrombolysis group versus 6.8% (19/278) in the standard care group (.02 to 0.44;; risk difference -6.1%.2 to -3.0). Statistical certainty: Very few primary events (0.7% with CDT) make the effect estimate imprecise (CI 0.02–0.44).
Discussion
Expert perspectives 4
Author’s perspective
Dr. Viktor KočkaCharles University and University Hospital Kralovske Vinohrady
“Using the blueprint already employed for heart attacks, we were able to demonstrate that specialised interventional treatment can be delivered in tertiary care centres across our national network. This may pave the way for an improved, standardised approach to the treatment of pulmonary embolism, reducing the acute risks that patients face.”
Dr. Viktor Kočka
Elad Asher
Practice takeInterventional / Structural Cardiology · Shaare Zedek Medical Center
Promising results, but not yet a mandate for routine CDT in intermediate-high-risk PE.
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MD Kemal Karaagac
@kemalkaraaa1
“PRAGUE-26 supports considering earlier catheter-directed therapy in selected intermediate-high-risk PE pts, particularly those with confirmed RV dysf.But the potential intracr. bleeding risk highlights the need for further evidence. @escardio.”
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Radovan Malý
@radovanmaly
“Catheter-Directed Thrombolysis in Intermediate-High–Risk Pulmonary Embolism | New England Journal of Medicine CRB:4.6% in the thrombolysis group vs 5.0% in the standard-care. MB in 1.4% vs 2.2% and intracranial hemorrhage in 2 (0.7%) and none.”
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Full evidence
Why the trial, tables, limitations, PICO, abstract, media & sources
Full evidence
Why the trial, tables, limitations, PICO, abstract, media & sources
Why the trial?
In intermediate-high-risk pulmonary embolism, anticoagulation alone leaves some patients to deteriorate while systemic thrombolysis causes major bleeding, and catheter-directed thrombolysis had not been proven in a randomised outcomes trial. Prague 26 addressed that gap.
Does catheter-directed thrombolysis with alteplase plus anticoagulation reduce the composite of all-cause mortality, recurrent pulmonary embolism, or cardiorespiratory decompensation or collapse in patients with intermediate-high-risk pulmonary embolism compared to anticoagulation alone?
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Evidence details
What drove the result?
| Outcome | CDT | Anticoag |
|---|---|---|
| Death, PE recurrence, or cardiorespiratory decompensation/collapse at 7 days Primary composite · RR 0.10 (95% CI 0.02-0.44; p<0.001); driven mainly by less decompensation or collapse | CDT 0.7% | Anticoag 6.8% |
Limitations & tradeoffs
- Safety
- Bleeding at 7 days was 4.6% vs 5.0% (p=0.846), with 2 intracranial bleeds in the CDT arm vs 0.
- Statistical certainty
- Very few primary events (0.7% with CDT) make the effect estimate imprecise (CI 0.02–0.44).
- Subgroup caution
- The benefit was driven mainly by decompensation or collapse, a softer component than death or recurrence.
- Design limitations
- Only 7 days of follow-up are reported in the record.
Structured PICO
Does catheter-directed thrombolysis with alteplase plus anticoagulation reduce the composite of all-cause mortality, recurrent pulmonary embolism, or cardiorespiratory decompensation or collapse in patients with intermediate-high-risk pulmonary embolism compared to anticoagulation alone?
Population
558 adults (median age 64, 41% female) with acute intermediate-high-risk pulmonary embolism, followed for 7 to 30 days.
Intervention
Catheter-directed thrombolysis (CDT) with alteplase (mean total dose 19.9 mg for bilateral PE and 10.0 mg for unilateral PE, over a mean duration of 9.3 hours) plus anticoagulation.
Comparator
Standard anticoagulation alone (unfractionated heparin or low-molecular-weight heparin).
Outcome
Composite of all-cause mortality, recurrent pulmonary embolism, or cardiorespiratory decompensation or collapse within 7 days after randomization.composite endpoint
Main Result
Relative Risk0.1 (95% CI 0.02–0.44)
Absolute Event Rate0.7% vs 6.8%
Absolute Risk Reduction6.1%
p-valuep=<0.001
In patients with intermediate-high-risk pulmonary embolism, conventional catheter-directed thrombolysis significantly reduced the 7-day risk of death, recurrent PE, or cardiorespiratory decompensation compared to anticoagulation alone, driven primarily by prevention of decompensation.
Limitations
- Single country with predominantly White population
- Open-label design without blinded adjudication
- Not powered to exclude small differences in rare but serious adverse events
- Excluded patients older than 80 years
- Conducted in a single country with a predominantly White population, limiting generalizability
- Screening logs were not collected, limiting the ability to assess representativeness
- Open-label design with unblinded Clinical Events Committee may have influenced management decisions and outcome reporting
- Not designed to compare with ultrasound-facilitated CDT, systemic thrombolysis, or mechanical thrombectomy
- Exclusion of patients older than 80 years precludes conclusions regarding this elderly population
Where experts stand
Pulmonary embolism evidence still formingEarly reaction reads Prague 26 as a promising win for catheter-directed thrombolysis in intermediate-high-risk pulmonary embolism, but not yet a reason to use it routinely, with intracranial bleeding the main worry.
The few clinicians who weighed in accept that clot-dissolving therapy delivered by catheter prevented early deterioration compared with blood thinners alone. Their caution centers on safety and patient selection rather than on whether the benefit is real. The open question is whether the small intracranial bleeding signal and the need for more evidence will hold back wider use.
Still unclear
Commenters point to intracranial hemorrhage occurring only in the thrombolysis group and say more evidence is needed. Which intermediate-high-risk patients should be selected, such as those with confirmed RV dysfunction, is still unsettled.
Implication
Supports catheter-directed thrombolysis for intermediate-high-risk pulmonary embolism to prevent early decompensation; extends randomized evidence beyond anticoagulation alone and may inform guideline updates.
Abstract
PRAGUE-26 randomised 558 patients with acute intermediate-high-risk pulmonary embolism at 11 Czech centres to conventional catheter-directed thrombolysis or standard anticoagulation alone. Median age was 64 years and 41% were women. The primary endpoint was a composite of all-cause mortality, pulmonary-embolism recurrence, or cardiorespiratory decompensation or collapse within seven days. CDT reduced the primary endpoint (0.7% vs 6.8%; RR 0.10, 95% CI 0.02 to 0.44; p<0.001), driven mainly by less decompensation or collapse. Seven-day bleeding was 4.6% versus 5.0% (p=0.846), with two intracranial bleeds in the CDT group and none in standard care. Simultaneous publication in NEJM. Source: ESC Congress 2026 press, 31 August 2026.
Cite This Study
Kroupa et al. (2026) conducted an RCT in Acute intermediate-high-risk pulmonary embolism (n=558). Catheter-directed thrombolysis with alteplase plus anticoagulation vs. Standard anticoagulation alone was evaluated on Composite of all-cause mortality, recurrent pulmonary embolism, or cardiorespiratory decompensation or collapse within 7 days (RR 0.10, 95% CI 0.02 to 0.44, p=<0.001). Catheter-directed thrombolysis reduced the 7-day composite of mortality, recurrent pulmonary embolism, or cardiorespiratory decompensation by 90% compared to anticoagulation alone.