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Dr Petr Widimsky
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Barcelona, Spain - Long-term results from the PRAGUE 2 trial confirm that the early benefit gained by transporting STEMI patients for PCI rather than administering thrombolysis is sustained and, furthermore, is reflected in lower mortality rates at five years [1].
Dr Petr Widimsky (University Hospital Vinohrady, Prague, Czech Republic) reported the latest findings from PRAGUE 2 at the hotline session at the World Congress of Cardiology 2006 today.
Discussant Dr Anselm K Gitt (Herzzentrum, Ludwigshafen, Germany) said: "These findings are applicable and show that primary PCI provides benefit in an acute setting and in long-term survival. We must endeavor to make this strategy available to all STEMI patients through local and national networks."
Five-year benefits derived from differences in early event rates
PRAGUE 2first reported four years agorandomized 850 patients within 12 hours of STEMI onset to either treatment with thrombolysis (streptokinase) at their local hospital or to transport to a larger center where PCI could be performed.
The primary end point of 30-day mortality was lower in the PCI patients (6.8% vs 10% for thrombolysis patients), but the difference was not significant. However, the combined end point of death, MI, and stroke was significantly reduced, from 15.2% in the thrombolysis group to 8.4% in the PCI group (intention-to-treat analysis; p=0.003).
"But what we did not know was whether this effect would be sustained over the long term," Widimsky said.
The new data show that this early benefit persisted, leading to a significant difference in mortality between the groups at five years, he noted.
PRAGUE 2 five-year results|
Outcome
|
Thrombolysis group
(n=416), % |
Transfer PCI group
(n=428), % |
p
|
|
Death/MI/stroke/
revascularization |
73.3 |
58.5 |
<0.0001 |
|
Death
|
43.3 |
36.5 |
0.0417 |
"What this tells us is that the five-year benefits are derived from the differences in event rates in the first month of the trial," Widimsky concluded.
Next step is to spring into action
This tells us is that the five-year benefits are derived from the differences in event rates in the first month of the trial.
Discussant Gitt said that a number of trials and a recently published meta-analysis [2] have confirmed the benefit of early transfer for PCI over thrombolysis for STEMI.
The main limitation of PRAGUE 2the use of streptokinase as the thromobolytichas already been much discussed, he noted, but the DANAMI-2 results using tPA were similar to those of the Czech trial, laying to rest those criticisms.
One of the key strengths of PRAGUE 2, he explained, was the median transfer time for PCI48 minuteswhich "is well within the recommended time window of 90 minutes."
"Some small trials have shown a long-term benefit of the transport strategy, but the larger PRAGUE 2 results confirm this, and we see that the beneficial effect is sustained over the five years."
"These new results shows us that willing is not enough, we must 'do,' " he concluded.
- Widimsky P. PRAGUE 2 trialfive years follow-up. World Congress of Cardiology; September 4, 2006; Barcelona, Spain. Presentation 1741.
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Boersma E, The Primary Coronary Angioplasty vs Thrombolysis Group. Does time matter? A pooled analysis of randomized clinical trials comparing primary percutaneous coronary intervention and in-hospital fibrinolysis in acute myocardial infarction patients. Eur Heart J 2006; 27:779-788.
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