Abstract
Background: Unsolved issue about Sirolimus-eluting stent is thrombosis, especially, the potential for late stent thrombosis (ST). Methods: To clarify the incidence and predictors of ST, two-year data of the j-Cypher Registry were examined using ARC definition. Design of this registry was multi-center prospective enrollment of 15,216 consecutive patients (pts) with anti-platelet regimen of aspirin and ticlopidine in Japan. Results: Pts’ characteristics of this cohort were as follows, age 68+/−10 years, male in 75%, diabetes in 42%, emergency procedure in 6.6%, hemodialysis in 5%, CKD ( CCr<60, non-Hemodialysis ) in 51% and off-label use in 77%. Bifurcation lesion was observed in 19%. The other characteristics of lesions were as follows, in-stent restenosis in 12%, CTO in 9%, STEMI culprit in 6.3%. Cumulative ST (ARC definite/probable) rates within two-year were 0.62% at six-month, 0.71% at one-year and 0.93% at two-year as shown in the table . Annual increase slope of late ST (ARC definite) was 0.25% per year. During follow-up, 439 Surgical operations excluding endovascular and CABG were needed. Within 30 days of operation, clinical event rates were death in 2.2%, MI in 0.65% and ST in 0.44%. Multivariate analysis identified 3 independent predictors of early ST (within three-month); Hemodialysis: Odds Ratio (OR) = 1.75 (95%CI 1.02–2.69) p=0.042, Male gender: OR = 2.00 (1.20–4.08) p=0.0051, and Emergency procedure: OR = 2.15 (1.36–3.22) p= 0.0017. Also, multivariate analysis identified one independent predictor of late ST (beyond three-month); Hemodialysis: OR = 2.44 (1.29–4.14) p=0.042. Conclusions : Stent thrombosis rate up to two years under Ticlopidine anti-platelet regimen in Japan seemed to be lower as compared with those reported from other registries in the real world, despite the fact that high risk pts were more prevalent in the j-Cypher registry. Hemodialysis was identified to be independent predictor of early and late stent thrombosis through two years. Cumulative stent thrombosis rates in j-Cypher registry
Published Version
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