Hot Lines and Clinical Trial Updates

Session Number : 708007 Session Title: Clinical Trial Update III Core syllabus topic : Acute Coronary Syndromes (ACS)
Date : 4 September 2006 Reported by : Widimsky, P. Discussant: Gitt, A.K.
PRAGUE 2 trial - Five years follow-up.
Summary This study tested, whether the early benefit from primary PCI (p-PCI) strategy over thrombolysis (TL) is sustained during the long-term follow-up. The PRAGUE-2 trial enrolled 850 STEMI patients, presenting to community hospitals without cathlab within 12 hours of symptom onset. Patients were randomized into group “on-site TL” (n=421, TL given in the community hospital) and group “transport to p-PCI” (n=429, p-PCI was performed in the nearest PCI center immediately after interhospital transport). Results Follow-up data were available in 416 (98,8%) patients in the TL group and 428 (99.8%) in the p-PCI group. During the mean follow-up of 58 months (range, 43 to 70 months), the primary end-point (death / reinfarction / stroke / additional revascularization) was reached by 263 of 409 patients assigned to TL and 220 of 428 patients assigned to p-PCI (73,3% vs. 58,5%, p < 0.0001). The rates of individual components of primary end-point in the TL group and the p-PCI group were as follows: death from any cause 24,2% and 20,8% (p=ns), recurrent infarction 20% vs. 13,3% (p < 0,01), stroke 8,2% vs. 5,2% (p=ns), revascularization 67,9% vs. 47,6% (p< 0,0001). The early benefit from the p-PCI strategy (over thrombolysis) is sustained (but not increased) during the 5-year follow-up. It can be almost exclusively derived from differences in event rate during the first month.
Discussant: Gitt, A.G. The PRAGUE-2 study randomised patients with acute ST-elevation myocardial infarction presenting to community hospitals without PCI facilities within 12 hours after symptom onset to either thrombolysis (TL) with streptokinase or immediate transfer for primary PCI (PPCI). The primary endpoint of 30 day mortality was 10.0% for TL and 6.8% for PPCI and did not reach statistical significance whereas the secondary endpoint of death, MI or stroke was significantly lower in PPCI than in TL. These findings are consistent with the results of other similar trials like DANAMI-2. The limitations of PRAGUE-2 are mainly the use of streptokinase in the TL group as well as a possible selection bias towards patients with lower risk (low rate of prior MI / prior coronary interventions / anterior wall infarctions) included into the trial.. Today, Widimsky et al. presented the 5 years follow-up of PRAGUE-2, during which this early benefit in death / recurrent MI / stroke from PPCI was sustained. Similar to the 30-day results, this benefit is mainly driven by the lower rate of recurrent myocardial infarction, whereas no significant difference was observed in death from any cause and stroke during follow-up. PRAGUE-2 is the first study comparing TL with immediate transfer for PPCI showing this long-term benefit of PPCI over TL and therefore completes the rationale for early transfer for PPCI in STEMI. PRAGUE-2 clearly demonstrates that PPCI can be applied in large areas even of partly urbanized Europe with good results. But there still exists a huge gap between clinical practice and guidelines´ recommendations, as current data of the Euro Heart Survey on ACS II show that only 38% of consecutive patients with STEMI in Europe do receive PPCI. Knowing is not enough; we must apply. Willing is not enough; we must do. (Johann Wolfgang Goethe, 1749-1832). It is now time for widespread implementation of PPCI for STEMI in Europe, if necessary also providing inter-hospital transport if applicable. Dr. Anselm Kai Gitt