TCT-184 Late Adverse Events After Implantation of Sirolimus-eluting Stent and Bare-metal Stent: 4-7 years follow-up of the CREDO-Kyoto Registry Cohort-2

Abstract

Background: Late adverse events such as very late stent thrombosis (VLST) or late target-lesion revascularization (TLR) have emerged as new problems after drugeluting stent implantation. However, there is a paucity of data from long-term followup studies evaluating late adverse events after sirolimus-eluting stents (SES) implantation in comparison with bare-metal stent (BMS) implantation. Methods: Among 13058 consecutive patients undergoing first percutaneous coronary intervention in the CREDO-Kyoto registry Cohort-2, 5078 patients were treated with SES only and 5392 patients were treated with BMS only. Median follow-up duration was 1974 (inter-quartile range: 1700-2225) days. Results: During 4-7 years follow-up after SES implantation, VLST and late TLR beyond 1-year occurred constantly and without attenuation at 0.24%/year, and 2.0%/ year, respectively. Cumulative 7-year incidence of VLST was significantly higher in the SES group than in the BMS group (1.43% vs. 0.68%, P<0.0001). However, there was no excess of all-cause death beyond 1-year in the SES group as compared with the BMS group (20.8% vs. 19.6%, P1⁄40.91), although the cumulative incidence of sudden death beyond 1-year was slightly but significantly higher in the SES group than in the BMS group (3.0% vs. 1.8%, P1⁄40.02). Cumulative 7-year incidences of late TLR and clinically-driven late TLR were also significantly higher in the SES group than in the BMS group (12.0% vs. 4.1%, P<0.0001 and 8.5% vs. 2.6%, P<0.0001, respectively), leading to significant late catch-up of the SES group to the BMS group regarding the cumulative incidence of over-all and clinically-driven TLR through 7-year (18.8% vs. 25.2%, and 10.6% vs. 10.2%, respectively). Clinical indication of late TLR in the SES group included acute myocardial infarction (13.1%), unstable angina (8.1%), stable angina (34.0%), asymptomatic ischemia (7.9%) and non-clinically driven (36.9%). Conclusions: During 4-7 years follow-up after SES implantation, late adverse events including VLST and late TLR continued to occur without attenuation of their incidences. Late catch-up phenomenon of SES relative to BMS in terms of TLR was real and should be the target for the development of drug-eluting stents.