Abstract 3038: Long-term Outcomes After Treatment Of In-stent Restenosis With Bare-metal Stent And Drug-eluting Stent: Insights From Research And T-search Registry
Background: Since drug-eluting stents (DES) have been shown to be superior to conventional brachytherapy, the only FDA-approved treatment for in-stent restenosis for treatment of stenting, sirolimus-eluting (SES) or paclitaxel-eluting stents (PES) are commonly used for treatment of in-stent restenosis, but little is known regarding their long-term outcome.
Methods: Between January 1, 2000 and December 31, 2004, 592 consecutive patients with in-stent restenotic lesion were treated with either BMS (n=290; January, 2000 to April, 2002), SES (n=118; April 2002 to February 2003) or PES (n=184; March 2003 to December 2004). The occurrence of death (obtain from municipal civil registries) and clinical events were collected. Primary endpoint was a composite of major adverse events (MACE: all-cause death, myocardial infarction of the stented or non-stented vascular territory or target-vessel revascularization [TVR]). Survival curves were generated by the Kaplan-Meier method, and survival among groups was compared with the log-rank test. Cox multivariate regression analysis was performed to identify independent predictor of MACE event.
Results: Mean duration of follow-up is 1567 days. At 3 years, the all-cause mortality rate was comparable among the three groups: 13.5% in the BMS group vs. 9.6% and 10.5% in the SES and PES groups, respectively (p=0.36). TVR rate was 27.4% in BMS group, 22.8% in SES, 18.7% in PES (P = 0.10). The composite endpoint of MACE was found comparable among 3 groups (37.7%, 31.5% and 30.2% in BMS, SES and PES group, respectively, p=0.23). Cox regression analysis revealed previous myocardial infarction (hazard ratio [HR] 1.45 [95%CI: 1.01–2.09]), history of bypass surgery (HR 1.54 [95%CI: 1.03–2.30]), chronic total occlusion (HR 2.07 [95%CI: 1.26 –3.38]) and recommended clopidogrel duration in month as independent predictor of MACE, while indication of stable angina was found protective (HR 0.61 [95% CI: 0.42– 0.88]). Stent type was not identified as a predictor.
Conclusion: Three-year after stenting, there are no significant differences in MACE between BMS, SES and PES when used in patients with in-stent restenosis.