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 vascu lar 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. Methods and Results-A single-center consecutive-patient randomized design ( with S-month angiographic and 2-year clinical follow-up) was used. Consecut ive patients (no chronic total occlusions or emergency procedures) were ran domized to ICUS-guided provisional stenting or standard angiographic guidan ce. Quantitative angiographic minimal lumen diameter (MLD), angiographic re stenosis, clinically driven target lesion revascularization, and major adve rse cardiac events (MACEs) were evaluated. A total of 291 procedures (356 l esions) were included. Procedure success was higher in the ICUS-guided grou p than the group randomized to standard guidance (94.7% versus 87.4%, respe ctively; 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 mt, P=0.23) were n ot 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 stan dard guidance group (1.85+/-0.72 versus 1.67+/-0.76 mm, respectively; P=0.0 2). Angiographic B-month analysis revealed no difference in MLD (1.71+/-0.9 4 versus 1.57+/-0.90, P=0.19) or binary restenosis rate (>50% diameter sten osis) (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 a fter intervention.