Very Late Stent Thrombosis and Late Target Lesion Revascularization after Sirolimus-Eluting Stent Implantation: Five-year Outcome of the j-Cypher Registry
Background—There is a scarcity of long-term data from large-scale drug-eluting stent registries with enough sample size to evaluate low-frequency events such as stent thrombosis (ST).
Methods and Results—Five-year outcomes were evaluated in 12812 consecutive patients undergoing sirolimus-eluting stents (SES) implantation in the j-Cypher registry. Cumulative incidence of definite ST was low (30-day: 0.3%, 1-year: 0.6%, and 5-year: 1.6%). However, late and very late ST continued to occur without attenuation up to 5 years after SES implantation (0.26%/year). Cumulative incidence of target lesion revascularization (TLR) within the first year was low (7.3%). However, late TLR beyond 1 year also continued to occur without attenuation up to 5 years (2.2%/year). Independent risk factors of ST were completely different according to the timing of ST onset, suggesting presence of different pathophysiologic mechanisms of ST according to the timing of ST onset; acute coronary syndrome and target of proximal left anterior descending coronary artery for early ST, side-branch stenting, diabetes mellitus, and end-stage renal disease with or without hemodialysis for late ST, and current smoking and total stent length >28mm for very late ST. Independent risk factors of late TLR beyond 1 year were generally similar to those risk factors identified for early TLR.
Conclusions—Late adverse events such as very late ST and late TLR are the continuous hazard lasting at least up to 5 years after implantation of the first generation drug-eluting stents (SES), which should be the targets in developing improved coronary stents.
- Received May 31, 2011.
- Accepted November 7, 2011.
- Copyright © 2011, American Heart Association, Inc. All rights reserved. Unauthorized use prohibited