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

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.

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