- Design
- Multicentre, randomised, open-label trial
- Population
- 558 haemodynamically stable adults with intermediate-high-risk acute PE
- Primary outcome
- Death, recurrent PE or cardiorespiratory decompensation within 7 days
- Effect
- 0.7% vs 6.8%, RR 0.10 (95% CI 0.02 to 0.44)
PRAGUE-26 randomised 558 haemodynamically stable patients with acute pulmonary embolism, right ventricular dysfunction and a raised troponin or natriuretic peptide to catheter-directed alteplase plus anticoagulation, or anticoagulation alone. It was open-label, at Czech centres.
Death, recurrent embolism or cardiorespiratory decompensation within 7 days occurred in 0.7% against 6.8% (RR 0.10, 0.02 to 0.44), driven mainly by fewer collapses. Clinically relevant bleeding (4.6% against 5.0%) and major bleeding (1.4% against 2.2%) did not differ, but 2 intracranial haemorrhages occurred with thrombolysis and none with anticoagulation alone. Four patients died within 7 days on anticoagulation alone.
For the patient who is stable but has a strained right ventricle, this is the strongest randomised evidence yet for doing more than anticoagulation. Its reach depends on access to an interventional team; most hospitals will still need a clear plan for early transfer or rescue systemic thrombolysis.
- Risk-stratify every PE: blood pressure, sPESI, RV on echo or CT, and troponin
- Identify intermediate-high-risk patients early and involve a PE response or interventional team
- Monitor these patients closely for the first 72 hours
- Agree a local plan for rescue thrombolysis if the patient deteriorates
Why it matters
Anticoagulation alone left about 1 in 15 of these 'stable' patients collapsing or dying within a week.
Don't overread it
The benefit was mainly in decompensation, a softer and open-label-assessed outcome; mortality was not a separate powered endpoint.
The statistics, in plain English
A relative risk of 0.10 means about 90% fewer events, but with only 21 events in total the interval is wide (0.02 to 0.44). Even the least favourable end of that interval is still a halving. The absolute difference is about 6 percentage points, roughly one event prevented for every 16 patients treated. Two intracranial bleeds against none is too few to estimate risk precisely, but it is the complication to discuss.
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