Abstract 17024: Are the Clinical Outcomes with Everolimus-eluting versus Paclitaxel-eluting Coronary Stents Different in Patients With and Without Diabetes? Insights from the SPIRIT II, SPIRIT III, SPIRIT IV and COMPARE Randomized Trials
Introduction: Prior studies have been inconclusive as to whether the clinical outcomes with rapamycin analogue-eluting versus paclitaxel-eluting stents (PES) differ in pts with and without diabetes mellitus (DM), and no single trial has been adequately powered to definitively address this question. We therefore analyzed the 1-year clinical outcomes in patients randomized to XIENCE V everolimus-eluting stents (EES) compared to TAXUS Express2 or Liberté paclitaxel-eluting stents (PES) from a large pooled database of 4 randomized 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 clinical event rates were calculated with Kaplan-Meier methods and compared with the log-rank test according to the presence or absence of DM.
Results: DM was present in 1,869/6,780 pts (27.6%), including 494 pts (7.3%) requiring insulin (DM status was unknown in 8 pts). Pts with DM were older, more often women, more frequently had hypertension, hyperlipidemia, prior MI, PCI and CABG, and greater body mass index, but were less likely to be smokers. At 1-year pts with DM had higher rates of death (1.9% vs. 1.1%, P=0.005), cardiac death (1.2% vs. 0.5%, P=0.003), and ischemic TVR (5.6% vs. 4.1%, P=0.01), with non significantly higher rates of MI and stent thrombosis. Event rates at 1 year according to DM status and stent randomization appear in the Table. A significant interaction was present between stent type and the presence of DM for MACE (death, MI or TLR) (p<0.0001).
Conclusions: In pts without DM, EES vs. PES resulted in significant 1-year reductions in death (total and cardiac), MI (Q-wave and non Q-wave), stent thrombosis, TLR, and TVR. In contrast, there were no significant differences in clinical outcomes between stent types among 1,869 randomized pts with DM.
- © 2010 by American Heart Association, Inc.