The SIRIUS‐DIRECT trial: A multi‐center study of direct stenting using the sirolimus‐eluting stent in patients with de novo native coronary artery lesions

Abstract

Objective: To assess the safety and efficacy of direct stenting using the sirolimus‐eluting BX Velocity™ stent in patients with coronary lesions. Background: Although direct coronary stenting has become a widespread practice, there have been no systematic assessments of direct stenting with drug‐eluting stents. Methods: Total of 225 patients with identical inclusion and exclusion criteria as the original SIRIUS trial were enrolled in this prospective single‐arm study. They were compared in a no‐inferiority design with 412 similar patients from the SIRIUS trial who had sirolimus‐eluting stents deployed after predilatation and were preassigned to angiographic follow‐up evaluation. Results: Direct stenting was successful in 85.8% of the patients. Compared with the predilatation group, direct stenting was associated with shorter median procedure duration (33 min vs. 45 min, P < 0.001). Angiographic follow‐up at 8 months revealed similar late loss (in‐stent—0.19 ± 0.47 mm vs. 0.17 ± 0.44 mm, and in‐lesion—0.23 ± 0.41 mm vs. 0.24 ± 0.47 mm) and similar frequency of binary restenosis (in‐stent—4.6% vs. 3.2% and in‐lesion—6.1% vs. 8.9%) between the two treatment strategies. However, stent‐edge restenosis was lower with direct stenting than in the predilatation control group (2.1% vs. 6.9%, P = 0.02). At 12‐months, there were no significant differences in target lesion revascularization (3.7% vs. 5.1%, P = ns) or composite major adverse cardiac events (7.0% vs. 8.3%, P = ns). Conclusions: In patients similar to those treated in the SIRIUS trial, direct stenting using sirolimus‐eluting stents achieves excellent short‐ and long‐term clinical and angiographic results with shorter procedure time and less frequent stent edge restenosis compared with predilation stent implantation techniques.