Key result
Patients in the Japanese j-Cypher registry had a significantly lower adjusted risk of definite stent thrombosis (HR 0.46; 95% CI 0.35-0.61) and mortality compared to the European registry.
Why the study?
Does the risk of mortality and stent thrombosis after sirolimus-eluting stent implantation differ between Japanese and European patient cohorts?
Observational (n=16,647)
Yes
Does the risk of mortality and stent thrombosis after sirolimus-eluting stent implantation differ between Japanese and European patient cohorts?
Effect estimate: HR 0.46 (95% CI 0.35-0.61)
Absolute Event Rate: 1.6% vs 3.3%
p-value: p=<0.001
Japanese patients undergoing SES implantation have significantly lower adjusted risks of 5-year mortality and stent thrombosis compared to European patients, despite differing baseline risk profiles.
Lower thrombosis and mortality risks in Japanese versus European cohorts should not change practice; leaves open mechanisms and generalizability.
AIMS: The reported rate of stent thrombosis (ST) after drug-eluting stent (DES) implantation varies among registries. To investigate differences in baseline characteristics and clinical outcome in European and Japanese all-comers registries, we performed a pooled analysis of patient-level data. METHODS AND RESULTS: The j-Cypher registry (JC) is a multicentre observational study conducted in Japan, including 12,824 patients undergoing SES implantation. From the Bern-Rotterdam registry (BR) enrolled at two academic hospitals in Switzerland and the Netherlands, 3,823 patients with SES were included in the current analysis. Patients in BR were younger, more frequently smokers and presented more frequently with ST-elevation myocardial infarction (MI). Conversely, JC patients more frequently had diabetes and hypertension. At five years, the definite ST rate was significantly lower in JC than BR (JC 1.6% vs. BR 3.3%, p<0.001), while the unadjusted mortality tended to be lower in BR than in JC (BR 13.2% vs. JC 14.4%, log-rank p=0.052). After adjustment, the j-Cypher registry was associated with a significantly lower risk of all-cause mortality (HR 0.56, 95% CI: 0.49-0.64) as well as definite stent thrombosis (HR 0.46, 95% CI: 0.35-0.61). CONCLUSIONS: The baseline characteristics of the two large registries were different. After statistical adjustment, JC was associated with lower mortality and ST.
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Onuma et al. (2015) conducted an observational in Percutaneous coronary intervention with sirolimus-eluting stent implantation (n=16,647). j-Cypher registry (Japan) vs. Bern-Rotterdam registry (Europe) was evaluated on Definite stent thrombosis (HR 0.46, 95% CI 0.35-0.61, p=<0.001). Patients in the Japanese j-Cypher registry had a significantly lower adjusted risk of definite stent thrombosis (HR 0.46; 95% CI 0.35-0.61) and mortality compared to the European registry.
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