Abstract 2144: Long-term Clinical Follow-up Of 6129 Consecutive All Comers Treated With Bare-metal, Sirolimus- Or Paclitaxel- Eluting Stents
Purpose: Sirolimus- and paclitaxel-eluting stents have been shown to produce a sustained reduction in restenosis and repeat revascularizations and proved to be associated with a comparable safety profile as compared to bare-metal stents up to 4 years, at least for on-label indications. However, both their effect on long-term survival and a possible erosion of the initial treatment effect due to stent thrombosis have not been appropriately assessed in an all-comer population.
Methods: Between January 1, 2000 and December 31, 2005 a total of 6129 consecutive patients were treated during three sequential periods with either bare-metal stents (n=2428; January, 2000 to April, 2002), sirolimus-eluting stents (n=866; April 2000 to February 2003) or paclitaxel-eluting stents (n=2835; February 2003 to December 2005). Four-year survival information was obtained from municipal civil registries and causes of death were classified according to the International Classification of Diseases and Related Health Problems, 10th Revision (ICD-10).
Results: Baseline clinical and procedural complexity increased over time. At 3 years, the cumulative survival rate was significantly higher in the sirolimus-eluting stent group (92.1%) than in both the bare and paclitaxel-eluting stent groups (88.9%), in part due to a benefit in the first 3 months. The adjusted 3-year hazard ratios for death in the sirolimus-eluting stent group were 0.74 (95% CI 0.56–0.98) and 0.77 (95% CI 0.56–1.02) compared to the bare-metal and paclitaxel-eluting stent groups, respectively. No significant heterogeneity in the treatment effects was observed in any of the prespecified characteristics. Four year follow-up on survival, myocardial infarction, repeat revascularization and stent thrombosis is currently ongoing.
Conclusions: The use of sirolimus-eluting stents resulted in a significant 3-year survival benefit as compared to bare-metal stents and a non-significant survival benefit as compared to paclitaxel-eluting stents. Complete 4-year clinical follow-up data will be presented at the meeting.