Comparison of paclitaxal vs. sirolimus eluting stents with bio-degradable polymer for the treatment of coronary bifurcation lesions: subgroup analysis from DKCRUSH-I and DKCRUSH-II studies.

Abstract

The difference in clinical outcome between paclitaxal-eluting stents (PES) and sirolimus-eluting stents with bio-degradable polymer (SES-BDP) for bifurcation lesions remains unclear. The present study aimed to investigate the one-year clinical outcome after DK crush stenting using PES (Taxus(TM)) vs. SES-BDP (Excel(TM)) from our database. A total of 275 patients (90 from the DKCRUSH-I and 185 from the DKCRUSH-II study) were studied. The primary endpoint was the occurrence of major adverse cardiac events (MACE) at 12 months; including cardiac death, myocardial infarction (MI), or target vessel revascularization (TVR). The rate of binary restenosis and stent thrombosis served as secondary endpoints. At follow-up, minimal luminal diameter (MLD) in the Taxus group was (2.11 ± 0.66) mm, with resultant increased target lesion revascularization (TLR) 12.2% and TVR 14.4%, significantly different from the Excel group; (2.47 ± 0.56) mm, P < 0.001, 3.2%, P = 0.006, 4.9%, P = 0.019, respectively. As a result there was a significant difference in MACE between the Taxus (20.0%) and Excel (10.3%, P = 0.038) groups. Overall stent thrombosis was monitored in 11 patients (4.0%), with five in the Excel group (2.7%) and six in the Taxus group (6.7%). All stent thrombosis in the Excel group was classified as early, and all were defined as late in the Taxus group. The Excel stent had lower rate of stent thrombosis, TLR, TVR, and composite MACE at 12-month after an indexed stenting procedure, compared to the Taxus stent.