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. Methods and Results-A single-center consecutive-patient randomized design (with S-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 mt, 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 B-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.