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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
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Key result
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
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?
Key Points
- To assess the efficacy and safety of catheter-directed thrombolysis with alteplase plus anticoagulation compared with anticoagulation alone in patients with acute intermediate-high-risk pulmonary embolism.
- Multicenter, randomized, open-label trial (PRAGUE-26, NCT05493163) conducted across 11 tertiary cardiovascular centers in the Czech Republic involving 558 patients.
- Patients were randomly assigned in a 1:1 ratio to receive catheter-directed thrombolysis (CDT) with alteplase plus anticoagulation (n=280) or standard anticoagulation alone (n=278).
- Follow-up for the primary composite endpoint was completed through 7 days in 100% of participants, with additional safety follow-up through 30 days.
- Catheter-directed thrombolysis significantly reduced the 7-day primary composite endpoint of all-cause mortality, recurrent pulmonary embolism, or cardiorespiratory decompensation or collapse (0.7% vs 6.8%; RR 0.10, 95% CI 0.02 to 0.44; p<0.001).
- The reduction in the primary endpoint was driven primarily by fewer cardiorespiratory decompensation or collapse events in the CDT group compared with standard care (0.7% vs 5.4%; RR 0.13, 95% CI 0.03 to 0.57).
- Clinically relevant bleeding through day 7 occurred in 4.6% of patients in the CDT group versus 5.0% in the standard care group (p=0.846), with 2 intracranial bleeds (0.7%) occurring in the CDT group and none in standard care.
Evidence details
What drove the result?
| Outcome | CDT | Anticoag |
|---|---|---|
| Death, PE recurrence, or cardiorespiratory decompensation/collapse at 7 days | 0.7% | 6.8% |
| Primary composite · RR 0.10 (95% CI 0.02-0.44; p<0.001); driven mainly by less decompensation or collapse | ||
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?
P
Population
558 adults (median age 64, 41% female) with acute intermediate-high-risk pulmonary embolism, followed for 7 to 30 days.
I
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.
C
Comparator
Standard anticoagulation alone (unfractionated heparin or low-molecular-weight heparin).
O
Outcome
Composite of all-cause mortality, recurrent pulmonary embolism, or cardiorespiratory decompensation or collapse within 7 days after randomization.composite
Main Result
Relative Risk: 0.1 (95% CI 0.02–0.44)
Absolute Event Rate: 0.7% vs 6.8%
Absolute Risk Reduction: 6.1%
p-value: p=<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
Discussion
1 takeKey questions
Member takes
Where experts stand
Experts see PRAGUE-26 as a strong signal favoring catheter-directed thrombolysis in intermediate-high-risk PE, but most stop short of calling it a mandate for routine adoption, citing bleeding concerns and the need for more evidence.
Cardiologists and critical care voices are broadly encouraged by the large reduction in early decompensation with catheter-directed thrombolysis, viewing it as the strongest interventional evidence yet in this patient population. However, the reaction is tempered: clinicians flag intracranial bleeding events and emphasize that the results support consideration of the approach in selected patients rather than wholesale practice change. The live question is whether these findings will move guidelines toward earlier catheter-directed therapy and which patients should be prioritized.
Still unclear
Whether guidelines will endorse catheter-directed thrombolysis as a preferred strategy over anticoagulation alone in intermediate-high-risk PE, or reserve it for selected subgroups. The intracranial bleeding signal, though numerically small, leaves open the question of which patients' risk-benefit profile truly favors intervention.
Key expert perspectives
“As a clinician, preventing hemodynamic deterioration in the intermediate-high-risk group is meaningful. If these findings are replicated and reflected in future guideline updates, there may be a shift from reactive management towards a more proactive reperfusion strategy in carefully selected intermediate-risk pulmonary embolism patients.”
Promising NNT of 17, but not yet a mandate for routine CDT
Highlights the reduction in the primary endpoint from 6.8% to 0.7%, translating to an NNT of 17 driven mainly by preventing cardiorespiratory deterioration. Calls the results promising but explicitly stops short of endorsing routine catheter-directed thrombolysis.
Distilled from their postX post
C. Michael GibsonInterventional / Structural Cardiology · Beth Israel Deaconess Medical CenterResults readoutAug 31CDT reduced the primary composite versus standard anticoagulation at 7 days
Summarizes the trial's key finding that catheter-directed thrombolysis lowered the composite of all-cause mortality, PE recurrence, and cardiorespiratory decompensation or collapse compared with anticoagulation alone.
Distilled from their postX post
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.
NEJM · ESC 2026 · RCT. Intermediate-high-risk PE: catheter-directed thrombolysis cut early death, recurrence, decompensation by 90% Prague 26: Catheter-Directed Thrombolysis in Intermediate-High–Risk Pulmonary Embolism 558 patients: Stable PE, right ventricular dysfunction, raised biomarkers. Randomised in the Czech Republic: CDT alteplase + anticoagulation vs Anticoagulation alone. 7-day death, recurrence or decompensation: CDT 0.7% vs Anticoag 6.8%. RR 0.10 (95% CI 0.02–0.44), P<0.001. Driven mainly by less decompensation or collapse. Bleeding similar through day 7; ICH only CDT: CDT 4.6%, Anticoag 5.0%, 2 intracranial (CDT). Bottom line: Supports catheter-directed thrombolysis to prevent early decompensation in intermediate-high-risk PE.
Coverage & sources
Journal, society, and media accounts. Useful signal, not independent expert judgment.
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% (RR 0.10, p<0.001) compared to anticoagulation alone.
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