Abstract 14593: Stent Thrombosis After Everolimus-eluting versus Paclitaxel-eluting Coronary Stents: Insights from the SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE Pooled Database
Introduction: First-generation TAXUS paclitaxel-eluting stents (PES) have substantially reduced restenosis rates compared to bare metal stents but have raised concerns due to higher rates and protracted propensity for stent thrombosis (ST), especially in high risk patients. Studies have suggested that newer generation XIENCE V everolimus-eluting stents (EES) might reduce ST, but no individual trial has been adequately powered to examine the incidence, timing and predictors of ST. We therefore analysed ST rates and distribution during the first year after EES compared to PES from a large pooled-database of 4 randomised trials.
Methods: Baseline clinical, angiographic and procedural data from the SPIRIT II, III, IV and COMPARE trials, each of which assigned pts to EES vs. PES, were pooled in a database of 6,788 randomized pts. One-year acute (<24 hrs), sub-acute (24 hrs – 30 days) and late (30 days – 1 yr) ARC definite/probable ST rates were calculated using Kaplan-Meier methods and compared with the log-rank test. Cox proportional hazard regression models were used to identify the baseline predictors of 1-year ST.
Results: As shown in the Table, EES compared to PES significantly reduced the rates of subacute, late and overall ST at 1 year, as well as composite cardiac death or MI. By multivariable analysis, current smoking, previous MI, previous PCI, and lesion length were independent determinates of 1-year ST, while use of EES rather than PES was a powerful predictor of freedom from ST (HR[95%CI] = 0.41 [0.21, 0.77], P<0.0001).
Conclusions: In this large pooled analysis from 4 randomized trials, EES resulted in a 59% reduction in the rate of ST at 1 year compared to PES. This reduction was due to significantly lower rates of sub-acute and late ST with EES, but not acute ST. Lower ST rates with EES correlated with a significant reduction in the composite rate of cardiac death or MI.
- © 2010 by American Heart Association, Inc.