Introduction and objectives: Coronary stenting without balloon predilatation is a safe technique associated with similar clinical results and lower costs, use of contrast and exposure to radiation in comparison to stenting with predilatation. After direct stenting, expansion may be reduced if the stenotic lesion was not predilatated. This study compared a). stent expansion with and without balloon predilatation (direct stenting), observed by intracoronary ultrasound, and b). angiographic results after 6 months and 1 year with the two implantation techniques.
Patients and method: 100 consecutive lesions eligible for direct stenting were randomized to stent implantation with or without balloon predilatation. Only <or=25 mm Multilink Duet/Tri-Star/Tetra or NIR Sox/Elite stents were used. When the angiographic result was considered optimal, an independent operator who had not been involved in the procedure performed an intracoronary ultrasound study. The ultrasound examination was not used in decision making unless there was a potential risk for the patient. Ultrasound parameters of expansion were compared in the two implantation techniques with systematic 6- to 9-month angiographic examinations and 1-year clinical follow-up.
Results: There were no clinical or baseline angiographic differences between the two groups. No significant differences were observed in the ultrasound expansion parameters or the rate of clinical events after 12 months of follow-up. Binary angiographic restenosis (23% vs 20%) and late loss index (0.92 [0.81] vs 0.88 [0.60]) did not differ significantly between the predilatation and direct stenting groups.
Conclusions: Direct stenting was not associated with different ultrasound expansion parameters in comparison to the conventional technique. Angiographic restenosis and the rate of long-term clinical events were similar with both techniques.