Randomized study to assess the effect of thrombus aspiration on flow area in patients with ST-elevation myocardial infarction: an optical frequency domain imaging study--TROFI trial

Eur Heart J. 2013 Apr;34(14):1050-60. doi: 10.1093/eurheartj/ehs456. Epub 2013 Feb 8.

Abstract

Aims: Primary percutaneous coronary intervention (PPCI) with thrombectomy (TB) seems to reduce the thrombus burden, resulting in a larger flow area as measured with optical frequency domain imaging (OFDI).

Methods and results: In a multi-centre study, 141 patients with ST elevation myocardial infarction <12 h from onset were randomized to either PPCI with TB using an Eliminate catheter (TB: n = 71) or without TB (non-TB: n = 70), having operators blinded for the OFDI results. The primary endpoint was minimum flow area (MinFA) post-procedure assessed by OFDI, defined as: [stent area + incomplete stent apposition (ISA) area] - (intraluminal defect + tissue prolapse area). Sample size was based on the expected difference of 0.72 mm(2) in MinFA. Baseline demographics, pre-procedural quantitative coronary angiography (QCA), and procedural characteristics were well matched between the two groups. On OFDI, the stent area (TB: 7.62 ± 2.23 mm(2), non-TB: 7.05 ± 2.12 mm(2), P = 0.14) and MinFA (TB: 7.08 ± 2.14 mm(2) vs. non-TB: 6.51 ± 1.99 mm(2), Δ0.57 mm(2), P = 0.12) were not different. In addition, the amount of protrusion, intraluminal defect, and ISA area were similar in the both groups.

Conclusion: PPCI with TB was associated with a similar flow area as well as stent area to PPCI without TB.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Blood Flow Velocity / physiology
  • Cardiac Imaging Techniques / methods
  • Coronary Circulation / physiology
  • Coronary Thrombosis / physiopathology
  • Coronary Thrombosis / therapy*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Myocardial Infarction / physiopathology
  • Myocardial Infarction / therapy*
  • Percutaneous Coronary Intervention / methods*
  • Prospective Studies
  • Thrombectomy / methods*
  • Treatment Outcome