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Protection of Distal Embolization in High-Risk Patients With Acute ST-Segment Elevation Myocardial Infarction (PREMIAR)

Authors :
Miguel A. Riccitelli
William W. O'Neill
Luis Gruberg
Alejandro García Escudero
Oscar Mendiz
Fernando Cura
Mariano Albertal
Marcelo Trivi
José Milei
Mitchell W. Krucoff
Juan Fernandez
Daniel Berrocal
Jorge A. Belardi
Miguel Ballarino
Alejandro Palacios
Liliana Grinfeld
Ruben Piraino
Ricardo Baeza
Jorge Thierer
Source :
The American Journal of Cardiology. 99:357-363
Publication Year :
2007
Publisher :
Elsevier BV, 2007.

Abstract

Distal embolization may decrease myocardial reperfusion after primary percutaneous coronary intervention (PCI). Nonetheless, results of previous trials assessing the role of distal protection during primary PCI have been controversial. The Protection of Distal Embolization in High-Risk Patients with Acute ST-Segment Elevation Myocardial Infarction Trial (PREMIAR) was a prospective, randomized, controlled study designed to evaluate the role of filter-based distal protection during PCI in patients with acute ST-segment elevation myocardial infarction at high risk of embolic events (including only baseline Thrombolysis In Myocardial Infarction grade 0 to 2 flow). The primary end point was continuous monitoring of ST-segment resolution. Secondary end points included core laboratory analysis of angiographic myocardial blush, ejection fraction measured by cardiac ultrasound, and adverse cardiac events at 6 months. From a total of 194 enrolled patients, 140 subjects were randomized to PCI with or without embolic protection, and 54 were included in a registry arm due to the presence of angiographic exclusion criteria. Baseline characteristics were comparable between arms. The rate of complete ST-segment resolution (>or=70%) at 60 minutes was similar in patients treated with or without distal protection (61.2% vs 60.3%, respectively, p = 0.85). Angiographic myocardial blush (67% vs 70.7%, p = 0.73), in-hospital ejection fraction (47.4 +/- 9.9% vs 45.3 +/- 7.3%, p = 0.29), and combined end point of death, heart failure, or reinfarction at 6 months (14.3% vs 15.7%, p = 0.81) were consistently achieved in a similar proportion in the 2 groups. In conclusion, the use of filter-based distal protection is safe and effectively retrieves debris; however, such use does not translate into an improvement of myocardial reperfusion, left ventricular performance, or clinical outcomes.

Details

ISSN :
00029149
Volume :
99
Database :
OpenAIRE
Journal :
The American Journal of Cardiology
Accession number :
edsair.doi.dedup.....f706e350990d93853ceb14612af3b295
Full Text :
https://doi.org/10.1016/j.amjcard.2006.08.038