Abstract 5993: One-Year Clinical Outcomes of Sirolimus-Eluting vs. Paclitaxel-Eluting Stents in Unselected Patients: Results from the Multicenter EVENT Registry
Background: Several randomized trials have demonstrated that PCI with sirolimus-eluting stents (SES) compared with paclitaxel-eluting stents (PES) is associated with lower rates of angiographic restenosis and target lesion revascularization (TLR). Since many of these trials have included angiographic follow-up, the generalizability of these results to routine clinical practice remains controversial.
Methods and Results: We used data from the EVENT Registry a multicenter, observational study of unselected patients undergoing PCI in more than 40 US centers to compare in-hospital and 1-year clinical outcomes among patients treated with SES (n=3443) or PES (n=2592). The primary endpoint was the composite of cardiac death or MI at one year. Secondary endpoints included TLR and ARC definite or probable stent thrombosis. Logistic regression or Cox proportional hazards models were used to adjust for baseline clinical and demographic characteristics, lesion characteristics, procedural characteristics, and site characteristics (proportion SES use).
Results: Baseline characteristics were generally similar between the 2 groups; however patients receiving PES were more likely to have undergone PCI in the setting of an ACS. Intervention in LAD lesions and totally occluded lesions were more common in the SES group. At 1-yr there was no difference in the composite primary end-point between the groups (SES 9.1% vs. PES 10.0%; see Table⇓). Incidence of death, MI and stent thrombosis did not differ between the groups. TLR rates were higher in the SES group (4.4% vs. 3.3%, p=0.048), but this difference was no longer significant after adjustment for baseline covariates including site characteristics.
Conclusions: Among unselected patients undergoing non-emergent PCI, SES and PES appear to be comparable in terms of clinical outcomes at 1 year. These findings suggest that previously observed differences in TLR may be largely related to the “oculostenotic reflex”.