ABSTRACT
BACKGROUND: Intravascular ultrasound (IVUS) is the reference method for in vivo assessment of vessel dimensions and coronary plaque composition, which can influence device selection as well as stent sizing. OBJECTIVES: The objective of this prospective multicenter-study was to test the application, safety, and feasibility of a new combined IVUS and stent delivery system. METHODS: A total of 32 patients with planned direct stent implantation under IVUS guidance were included in the study. Procedural as well as angiographical and IVUS characteristics of the stent implantation with the combined IVUS and stent delivery system were assessed and compared to a historical control cohort where IVUS-guided stenting was performed with a separate IVUS catheter. RESULTS: Direct stent placement was successfully performed in all patients and no malfunctions of the system were noted. A post-interventional IVUS assessment was possible in 27 (87%) of the 31 patients. The IVUS information led to a change in therapeutic strategy in 16 (50%) of the 32 patients. In the study group, both the procedural time and the amount of contrast dye were significantly lower than in the historical IVUS-guided stenting control group. A clinical 12-month follow-up revealed a 89% event-free survival and a target vessel revascularization rate of 7%. CONCLUSION: The use of a combined IVUS and stent delivery device is safe, easy to handle, and can provide helpful additional information to guide a percutaneous coronary interventions procedure. Beyond angiography, these informations had significant impact on the interventional strategy in these patients, which resulted in a low rate of major adverse cardiac events. The concept of combining IVUS information and a stent delivery system may be increasingly attractive with evolving imaging modalities like virtual histology or a combination with drug-eluting stents.
