A new generation of biodegradable polymer-coated sirolimus-eluting stents for the treatment of coronary artery disease: final 5-year clinical outcomes from the CREATE study

作者：Han, Ya-Ling^*; Zhang, Lei; Yang, Li-Xia; Liu, Hui-Liang; Qu, Peng; Li, Wei-Min; Jiang, Tie-Min; Li, Shu-Mei; Jing, Quan-Min; Zhang, Quan-Yu; Xu, Bo; Li, Yi; Gao, Run-Lin

来源：Eurointervention, 2012, 8(7): 815-822.

DOI：10.4244/EIJV8I7A124

• biodegradable polymer
• CREATE study
• drug-eluting stent
• outcome
• percutaneous coronary intervention

Aims: The aim of the present study was to evaluate the five-year safety and efficacy of a biodegradable polymer-coated sirolimus-eluting stent with six months dual antiplatelet therapy in daily practice. @@@ Methods and results: Two thousand and seventy-seven daily practice patients, exclusively treated with biodegradable polymer-coated sirolimus-eluting stents (EXCEL; JW Medical Systems, Weihai, China), were prospectively enrolled in the multicentre CREATE study. Clinical follow-up was completed in 1,982 patients (95.4%) at five-year follow-up. The rates of cardiac death, non-fatal myocardial infarction (MI), target lesion revascularisation and overall major adverse cardiac events (MACE) at five-year follow-up were 3.0%, 1.5%, 3.7% and 7.4%, respectively. The rates of definite or probable stent thrombosis (ST) at five years and definite ST from one to five years were 1.1% and 0.3%, respectively. Heart failure (hazard ratio [HR]: 3.324, 95% confidence interval [CI]: 1.729-6.391, p < 0.001) and prior MI (HR: 2.664, 95% CI: 1.358-5.227, p=0.004) were independent predictors of ST. Landmark analysis of a propensity score matched patient cohort showed that patients with or without clopidogrel treatment after six months had similar clinical outcomes. @@@ Conclusions: The present study demonstrates satisfactory and sustained five-year clinical safety and efficacy profiles as evidenced by the low rates of MACE and ST for the EXCEL, a biodegradable polymer-based sirolimus-eluting stent, when patients were treated with six months dual antiplatelet therapy in daily practice.

• 出版日期2012-11
• 单位中国医学科学院阜外医院; 吉林大学; 成都军区昆明总医院; 大连医科大学; 中国人民武装警察部队后勤学院; 中国人民武装警察部队总医院; 哈尔滨医科大学