The aim of the PRAGUE-2 study was to compare the therapeutic effects of intravenous streptokinase with the immediate transport for primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI), admitted to hospitals without PCI facilities in the Czech Republic, where the distance between primary hospitals and tertiary PCI centres does not exceed 120 km.
In the PRAGUE-2 study, 850 patients with acute STEMI presenting within 12 h of symptom onset to the nearest community hospital without a catheter laboratory (located <120 km from the next PCI centre) were randomised to either thrombolysis administered at the initial receiving hospital (thrombolysis group, n=421) or immediate transport (within 30 min of randomisation) for primary PCI (PCI group, n=429).
The primary endpoint was mortality at 30 days (death from any cause within 30 days after randomisation).
Secondary endpoints included the presence of any serious clinical event (death/non-fatal re-infarction/non-fatal stroke) at 30 days, and mortality at 30 days among subgroups of patients treated within 0–3 h and 3–12 h after symptom onset.
A non-significant reduction in mortality for the PCI group compared with the thrombolysis group (6.8% versus 10.0%; p=0.12) was observed at 30-days.
Prague-2: 30-day mortality (n=850)
While mortality was similar between groups for the 551 patients that were randomised within 3 h (mean: 1 h 41 min), mortality for the 299 patients that were randomised after 3 h (mean: 5 h 6 min) was significantly higher in the thrombolysis group (15.3% versus 6.0%; p>0.02). This difference led the ethical committee to stop the trial prematurely.
Prague-2: Time delay: PCI versus thrombolysis (n=850)
At long-term follow up (5 years), the benefit of primary PCI persisted. There was a reduction in the cumulative incidence of primary endpoint (death, re-infarction, stroke or revascularisation) for the PCI group (40% versus 53%; p<0.001). This benefit was almost exclusively derived from differences in event rate during the first 30 days.
- Thrombolysis is less effective than primary PCI in “late presenters” (i.e. those patients presenting >3 h) and therefore these patients should be routinely transferred for primary PCI.
- The results of this study are limited since streptokinase was used rather than a more potent thrombolytic; however, results were in good agreement with those from DANAMI-2, in which alteplase, a tissue plasminogen activator, was used.
- Widimsky P, et al. Long-term outcomes of patients with acute myocardial infarction presenting to hospitals without catheterization laboratory and randomized to immediate thrombolysis or interhospital transport for primary percutaneous coronary intervention. Five years' follow-up of the PRAGUE-2 trial. Eur Heart J 2007;28:679-684.
- Widimský P, et al. Long distance transport for primary angioplasty vs immediate thrombolysis in acute myocardial infarction: Final results of the randomized national multicentre trial—PRAGUE-2. Eur Heart J 2003;24:94-104.