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

Yoshinobu Onuma, Leif Thuesen, Robert Jan Van Geuns, Martin Van Der Ent, Steffen Desch, Jean Fajadet, Evald Christiansen, Peter Smits, Niels Ramsing Holm, Evelyn Regar, Nicolas Van Mieghem, Vladimir Borovicanin, Dragica Paunovic, Kazuhisa Senshu, Gerrit Anne Van Es, Takashi Muramatsu, Il Soo Lee, Gerhard Schuler, Felix Zijlstra, Hector M. Garcia-GarciaPatrick W. Serruys

Research output: Contribution to journalArticlepeer-review

88 Citations (Scopus)

Abstract

AimsPrimary 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 resultsIn 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 mm2 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 mm2, non-TB: 7.05 ± 2.12 mm 2, P = 0.14) and MinFA (TB: 7.08 ± 2.14 mm2 vs. non-TB: 6.51 ± 1.99 mm2, Δ0.57 mm2, P = 0.12) were not different. In addition, the amount of protrusion, intraluminal defect, and ISA area were similar in the both groups.ConclusionPPCI with TB was associated with a similar flow area as well as stent area to PPCI without TB.

Original languageEnglish
Pages (from-to)1050-1060b
JournalEuropean heart journal
Volume34
Issue number14
DOIs
Publication statusPublished - 07-04-2013
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

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