Abstract 14062: The Unrestricted Use of Sirolimus- and Paclitaxel-Eluting Stents Results in Better Clinical Outcomes During 6-Years Follow-up than Bare-Metal Stents. An analysis of the RESEARCH and T-SEARCH registries.
Objectives: To assess the six-year clinical outcome after unrestricted use of SES or PES as compared with BMS in consecutive de novo patients undergoing percutaneous coronary intervention (PCI).
Background: Sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) have been shown to significantly decrease target-vessel revascularization (TVR) rates compared to bare-metal stents (BMS) in “real world” registries. However, possible higher rates of very-late stent thrombosis and a restenosis “catch-up” trend may jeopardize the benefit.
Methods: Three PCI-cohorts, each with exclusive use of one stent type (BMS=450; SES=508; PES=576), were systematically followed for the occurrence of major adverse cardiac events (MACE).
Results: Very-late stent thrombosis was more common in SES- and PES-patients than BMS-patients (2.4% vs 0.9% vs. 0.4%, respectively; p-value=0.02), however there were no significant differences between the stent types for all-cause mortality and all-cause mortality/myocardial infarction at 6-years follow-up. Sixty-nine SES-patients (Kaplan-Meier estimate 14%) and 72 PES-patients (14%) had a TVR, as compared to 79 BMS-patients (18% Log-rank p=0.02), which maintained significance after adjustment for (potential) confounders. Multivariate analysis showed that DES-implantation is associated with lower incidence of TVR and MACE than BMS-implantation (aHR=0.65, 95%CI:0.49–0.86; p=0.003; aHR=0.79, 95%CI:0.65–0.97; p=0.02, respectively). Incidence of MACE was also lower in SES- and PES-patients (30% and 30%) than in BMS-patients (34%), however significance was borderline.
Conclusions: The unrestricted use of both DES resulted in a sustained advantage in decreasing TVR and to a lesser extent MACE compared to BMS at 6-years. SES and PES are equally safe and effective in the treatment of coronary lesions.
- © 2010 by American Heart Association, Inc.