Direct stenting of native de novo coronary artery lesions with the sirolimus-eluting stent: a post hoc subanalysis of the pooled E- and C-SIRIUS trials.

Abstract

We sought to assess the impact of direct stenting (DS) using the sirolimus-eluting stent (SES) on angiographic and clinical outcomes. The SES is superior to bare-metal stents in the treatment of native de novo coronary artery lesions in randomized, controlled trials. A post hoc analysis was performed on 225 patients (158 men; 62 +/- 11 years old) who received SES in the pooled cohorts of the European and Canadian Sirolimus-Eluting Stent in Coronary Lesions (E-SIRIUS and C-SIRIUS, respectively) trials. Of these patients, 57 (25%) had undergone DS at the investigator's discretion. Lesion predilation preceded SES implantation in the remaining 168 patients. Patient and lesion characteristics were no different between the two subgroups, except for a lower prevalence of moderate to severe lesion calcification (5% vs. predilation 19%, p=0.017) and a lower baseline diameter stenosis (61.6% vs. predilation 68.1%, p <0.001) in the DS subgroup. At eight months, in-lesion late loss (0.10 vs. 0.19 mm at predilation, p=0.14) and in-lesion binary restenosis (2.0% vs. 6.1% at predilation, p=0.46) tended to be lower after DS. Clinical follow-up at one year revealed non-significantly reduced incidences of target lesion revascularization (1.8% vs. 5.4% at predilation, p=0.46) and major adverse cardiac events (5.3% vs. 8.9% at predilation, p=0.57). Direct SES deployment performed at the investigator's discretion was as safe and efficacious at mid-term follow-up as stenting preceded by lesion predilation.