Aim: Randomized trials in ST-elevation myocardial infarction (STEMI) showed improved early outcomes after primary percutaneous coronary intervention (p-PCI) compared with thrombolysis (TL). It is less known whether the early benefit is sustained during the long-term follow-up.
Methods and results: The PRAGUE-2 trial enrolled 850 STEMI patients presenting to community hospitals without cath-labs within 12 h of symptom onset. Patients were randomized into the groups 'TL in community hospital' (n = 421) and 'interhospital transfer for p-PCI' (n = 429). Follow-up data were available in 416 (98.8%) patients in the TL group and 428 (99.8%) in the p-PCI group. At 5 year follow-up, the cumulative incidence of composite endpoint (death from any cause or recurrent infarction or stroke or revascularization) was 53% in TL patients compared with 40% in p-PCI patients (HR 1.8; 95% CI 1.38-2.33; P < 0.001). The respective cumulative incidence of death from any cause was 23 and 19% (HR 1.34; 95% CI 0.99-1.82; P = 0.06), recurrent infarction 19 vs. 12% (HR 1.72; 95% CI 1.15-2.58; P = 0.009), stroke 8 vs. 8% (HR 1.65; 95% CI 0.84-2.23; P = 0.18), revascularization 51 vs. 34% (HR 1.81; 95% CI 1.21-2.35; P < 0.001).
Conclusion: The early benefit from the p-PCI strategy (over TL) is sustained during the 5 years' follow-up. It can be almost exclusively derived from differences in event rate during the first month.