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.

OBJECTIVES We sought to assess the impact of direct stenting (DS) using the sirolimus-eluting stent (SES) on angiographic and clinical outcomes. BACKGROUND The SES is superior to bare-metal stents in the treatment of native de novo coronary artery lesions in randomized, controlled trials. METHODS 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. RESULTS 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). CONCLUSIONS 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.