TY - JOUR
T1 - Randomized study to assess the effect of thrombus aspiration on flow area in patients with ST-elevation myocardial infarction
T2 - An optical frequency domain imaging study - TROFI trial
AU - Onuma, Yoshinobu
AU - Thuesen, Leif
AU - Van Geuns, Robert Jan
AU - Van Der Ent, Martin
AU - Desch, Steffen
AU - Fajadet, Jean
AU - Christiansen, Evald
AU - Smits, Peter
AU - Ramsing Holm, Niels
AU - Regar, Evelyn
AU - Van Mieghem, Nicolas
AU - Borovicanin, Vladimir
AU - Paunovic, Dragica
AU - Senshu, Kazuhisa
AU - Van Es, Gerrit Anne
AU - Muramatsu, Takashi
AU - Lee, Il Soo
AU - Schuler, Gerhard
AU - Zijlstra, Felix
AU - Garcia-Garcia, Hector M.
AU - Serruys, Patrick W.
N1 - Funding Information:
This study was sponsored by TERUMO Europe.
PY - 2013/4/7
Y1 - 2013/4/7
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/84876235019
UR - https://www.scopus.com/pages/publications/84876235019#tab=citedBy
U2 - 10.1093/eurheartj/ehs456
DO - 10.1093/eurheartj/ehs456
M3 - Article
C2 - 23396493
AN - SCOPUS:84876235019
SN - 0195-668X
VL - 34
SP - 1050-1060b
JO - European heart journal
JF - European heart journal
IS - 14
ER -