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 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.