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Randomized comparison of primary percutaneous coronary intervention with combined proximal embolic protection and thrombus aspiration versus primary percutaneous coronary intervention alone in ST-segment elevation myocardial infarction: the PREPARE (PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-Elevation) study.

Publication ,  Journal Article
Haeck, JDE; Koch, KT; Bilodeau, L; Van der Schaaf, RJ; Henriques, JPS; Vis, MM; Baan, J; Van der Wal, AC; Piek, JJ; Tijssen, JGP; Krucoff, MW ...
Published in: JACC Cardiovasc Interv
October 2009

OBJECTIVES: The purpose of this study was to evaluate the effectiveness of combined proximal embolic protection with thrombus aspiration (Proxis Embolic Protection System [St. Jude Medical, St. Paul, Minnesota]) in ST-segment elevation myocardial infarction patients. BACKGROUND: Embolization during primary percutaneous coronary intervention (PCI) may result in microvascular obstruction, reduced myocardial perfusion, and impaired prognosis. METHODS: Two hundred eight-four patients were randomized to primary PCI with the Proxis system versus primary PCI alone after angiography. The primary end point was the occurrence of complete (> or =70%) ST-segment resolution (STR) at 60 min measured by continuous ST-segment Holter. RESULTS: There was no significant difference in the occurrence of the primary end point (80% vs. 72%, p = 0.14). However, immediate complete STR (at time of last contrast) occurred in 66% of Proxis-treated patients and 50% in control patients (absolute difference, 16.3%; 95% confidence interval: 4.3% to 28.2%; p = 0.009). A significant lower ST-segment curve area (0 to 3 h after primary PCI) was observed in the Proxis arm (5,192 microV/min vs. 6,250 microV/min, p = 0.037). Major adverse cardiac and cerebral events at 30 days occurred with similar frequency in both groups (6 vs. 10). CONCLUSIONS: There was no significant difference in complete STR at 60 min in this proof-of-concept study. However, we observed a significant difference in immediate complete STR in Proxis-treated patients, better STR at later time points, and a reduction of electrocardiogram injury current over time, compared with control patients. The results suggest that primary PCI with the Proxis system may lead to better immediate microvascular flow in ST-segment elevation myocardial infarction patients. (The PREPARE Study; ISRCTN71104460).

Duke Scholars

Published In

JACC Cardiovasc Interv

DOI

EISSN

1876-7605

Publication Date

October 2009

Volume

2

Issue

10

Start / End Page

934 / 943

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Thrombectomy
  • Suction
  • Platelet Aggregation Inhibitors
  • Netherlands
  • Myocardial Infarction
  • Middle Aged
  • Microcirculation
  • Male
 

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Haeck, Joost D. E., Karel T. Koch, Luc Bilodeau, René J. Van der Schaaf, José P. S. Henriques, Marije M. Vis, Jan Baan, et al. “Randomized comparison of primary percutaneous coronary intervention with combined proximal embolic protection and thrombus aspiration versus primary percutaneous coronary intervention alone in ST-segment elevation myocardial infarction: the PREPARE (PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-Elevation) study.JACC Cardiovasc Interv 2, no. 10 (October 2009): 934–43. https://doi.org/10.1016/j.jcin.2009.07.013.
Journal cover image

Published In

JACC Cardiovasc Interv

DOI

EISSN

1876-7605

Publication Date

October 2009

Volume

2

Issue

10

Start / End Page

934 / 943

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Thrombectomy
  • Suction
  • Platelet Aggregation Inhibitors
  • Netherlands
  • Myocardial Infarction
  • Middle Aged
  • Microcirculation
  • Male