A Multicentre, Randomized Trial of Catheter-directed Thrombolysis in Intermediate-high Risk Acute Pulmonary Embolism (PRAGUE-26)

doi:10.1056/nejmoa2608012

PRAGUE-26

Patient / Population Intervention / Exposure Comparison Outcome

In 558 patients with intermediate–high-risk pulmonary embolism, catheter-directed thrombolysis reduced death, recurrent embolism or decompensation at 7 days compared with anticoagulation alone.

N

558patients

Design

Investigator-initiated, academic, prospective, multicentre (eleven Czech centres), open-label, 1:1 randomised, active-controlled, parallel-group phase 4 trial; primary endpoint at 7 days; functional and patient-reported outcomes and cost-effectiveness followed to 2 years

Endpoint

Clinical composite of all-cause mortality, recurrent PE (symptomatic, CTA-confirmed) or cardiorespiratory decompensation/collapse within 7 days of randomisation

Relevance

1Practice-defining — the trial the guideline rests on.

ResultDeath, recurrent embolism or cardiorespiratory decompensation within 7 days 0.7% vs 6.8% (relative risk 0.10, 95% CI 0.02-0.44; P < 0.001). Major bleeding 4.6% vs 5.0% (P = 0.85), with 2 intracranial bleeds after catheter-directed thrombolysis and none on anticoagulation alone.

Kočka V, Kroupa J, et al. Presented at ESC Congress 2026, Hot Line 12, 31 August. 10.1056/nejmoa2608012

Discussion & critique

The first randomised trial to show that catheter-directed thrombolysis prevents early deterioration in intermediate–high-risk pulmonary embolism, and the effect size is large: one event against nineteen. Almost all of it is cardiorespiratory decompensation rather than death, which is what a seven-day endpoint in this population can capture. Major bleeding was equal, but two intracranial haemorrhages occurred in the treated arm and none in the control — 558 patients cannot rule out a rate that matters when the alternative is anticoagulation alone.