Ultrasound-guided strategy for provisional stenting with focal balloon combination catheter: results from the randomized Strategy for Intracoronary Ultrasound-guided PTCA and Stenting (SIPS) trial.
BACKGROUND
Intracoronary ultrasound (ICUS) has provided insights into vascular pathology and interventional therapy. The Strategy for ICUS-Guided PTCA and Stenting (SIPS) trial tested the hypothesis that routine ICUS guidance of coronary interventions improves outcome.


RESULTS
A single-center consecutive-patient randomized design (with 6-month angiographic and 2-year clinical follow-up) was used. Consecutive patients (no chronic total occlusions or emergency procedures) were randomized to ICUS-guided provisional stenting or standard angiographic guidance. Quantitative angiographic minimal lumen diameter (MLD), angiographic restenosis, clinically driven target lesion revascularization, and major adverse cardiac events (MACEs) were evaluated. A total of 291 procedures (356 lesions) were included. Procedure success was higher in the ICUS-guided group than the group randomized to standard guidance (94. 7% versus 87.4%, respectively; P:=0.033), whereas time (65.2+/-31.0 versus 60.5+/-34.0 minutes, P:=0.18) and contrast use (209.3+/-94.1 versus 197.5+/-89.5 mL, P:=0.23) were not significantly different. Stenting rates were similar (49.7% versus 49.5%, P:=0.89). Acute gain was greater in the ICUS-guided group than in the standard guidance group (1.85+/-0.72 versus 1.67+/-0.76 mm, respectively; P:=0.02). Angiographic 6-month analysis revealed no difference in MLD (1.71+/-0.94 versus 1.57+/-0.90, P:=0.19) or binary restenosis rate (>50% diameter stenosis) (29% versus 35%, P:=0.42). Clinical follow-up (602+/-307 days) showed a significant decrease in clinically driven target lesion revascularization in the ICUS group compared with the standard guidance group (17% versus 29%, respectively; P:=0.02).


CONCLUSIONS
Although angiographic MLD did not differ significantly after 6 months, ICUS-guided provisional stenting improved 2-year clinical results after intervention.
Frey
A W
AW
Department of Clinical Research, Herz-Zentrum, Bad Krozingen, Germany. axelfrey@t-online.de
Hodgson
J M
JM
Müller
C
C
Bestehorn
H P
HP
Roskamm
H
H
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods*; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging* / Q000601:surgery*; D019160:Endosonography; D005260:Female; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000175:diagnosis / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D015607:Stents / Q000009:adverse effects; D013995:Time; D016896:Treatment Outcome; D014654:Vascular Patency