title: Protection of Distal Embolization in High-Risk Patients with Acute ST-Segment Elevation Myocardial Infarction (PREMIAR).
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.
authors.affiliation: Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina. fcura@icba-cardiovascular.com.ar
authors.forename: Fernando A
authors.initials: FA
authors.lastname: Cura
authors.forename: Alejandro Garcia
authors.initials: AG
authors.lastname: Escudero
authors.forename: Daniel
authors.initials: D
authors.lastname: Berrocal
authors.forename: Oscar
authors.initials: O
authors.lastname: Mendiz
authors.forename: Marcelo S
authors.initials: MS
authors.lastname: Trivi
authors.forename: Juan
authors.initials: J
authors.lastname: Fernandez
authors.forename: Alejandro
authors.initials: A
authors.lastname: Palacios
authors.forename: Mariano
authors.initials: M
authors.lastname: Albertal
authors.forename: Ruben
authors.initials: R
authors.lastname: Piraino
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: Riccitelli
authors.forename: Luis
authors.initials: L
authors.lastname: Gruberg
authors.forename: Miguel
authors.initials: M
authors.lastname: Ballarino
authors.forename: Jose
authors.initials: J
authors.lastname: Milei
authors.forename: Ricardo
authors.initials: R
authors.lastname: Baeza
authors.forename: Jorge
authors.initials: J
authors.lastname: Thierer
authors.forename: Liliana
authors.initials: L
authors.lastname: Grinfeld
authors.forename: Mitchell
authors.initials: M
authors.lastname: Krucoff
authors.forename: William
authors.initials: W
authors.lastname: O'Neill
authors.forename: Jorge
authors.initials: J
authors.lastname: Belardi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization / Q000379:methods*; D017023:Coronary Angiography; D003328:Coronary Thrombosis / Q000139:chemically induced / Q000000981:diagnostic imaging / Q000517:prevention & control*; D003331:Coronary Vessels; D015716:Electrocardiography, Ambulatory / Q000187:drug effects*; D004867:Equipment Design; D005260:Female; D005374:Filtration / Q000295:instrumentation; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects*; D011446:Prospective Studies; D015912:Thrombolytic Therapy / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors