Han Yaling, Jing Quanmin, Xu Bo, Yang Lixia, Liu Huiliang, Shang Xiaoming, Jiang Tieming, Li Zhanquan, Zhang Hua, Li Hui, Qiu Jian, Liu Yingfeng, Li Yi, Chen Xuezhi, Gao Runlin
Department of Cardiology, Shenyang Northern Hospital, Shenyang, China.
JACC Cardiovasc Interv. 2009 Apr;2(4):303-9. doi: 10.1016/j.jcin.2008.12.013.
This study sought to evaluate the safety and efficacy of a biodegradable polymer-coated sirolimus-eluting stent (Excel, JW Medical System, Weihai, China) with 6-month dual antiplatelet therapy in daily practice.
It has been hypothesized that persistent presence of polymer may compromise the safety of drug-eluting stents, and that therefore biodegradable polymer coatings might reduce late adverse events.
Between June and November 2006, 2,077 patients, exclusively treated with Excel stents at 59 centers from 4 countries, were enrolled in this prospective, multicenter registry. Recommended antiplatelet regimen included clopidogrel and aspirin for 6 months followed by chronic aspirin therapy.
The average duration of clopidogrel treatment was 199.8 +/- 52.7 days and 80.5% of discharged patients discontinued clopidogrel at 6 months. The cumulative rates of major adverse cardiac events were 0.9% at 30 days, 2.7% at 1 year, and 3.1% at 18 months. Overall rate of stent thrombosis was 0.87% at 18 months. The rates of acute, subacute, late, and very late stent thrombosis were 0.1%, 0.38%, 0.34%, and 0.05%, respectively. Angiographic follow-up, performed in 974 (31.6%) lesions from 653 patients (31.7%), revealed a mean in-stent late lumen loss of 0.21 +/- 0.39 mm. Binary restenosis rates were 3.8% in-stent and 6.7% in-segment.
This multicenter registry documents satisfactory safety and efficacy profiles, as evidenced by low rates of major adverse cardiac events and stent thrombosis up to 18 months, for the Excel biodegradable polymer-based sirolimus-eluting stent when used with 6 months of dual antiplatelet therapy in a "real-world" setting. (Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent [CREATE]; NCT00331578).
本研究旨在评估一种可生物降解聚合物涂层的西罗莫司洗脱支架（Excel，威海吉威医疗系统有限公司，中国威海）在日常临床实践中联合6个月双重抗血小板治疗的安全性和有效性。
据推测，聚合物的持续存在可能会损害药物洗脱支架的安全性，因此可生物降解聚合物涂层可能会减少晚期不良事件。
2006年6月至11月期间，来自4个国家59个中心的2077例仅接受Excel支架治疗的患者被纳入这项前瞻性多中心注册研究。推荐的抗血小板方案包括氯吡格雷和阿司匹林联合使用6个月，之后长期服用阿司匹林。
氯吡格雷的平均治疗时长为199.8±52.7天，80.5%的出院患者在6个月时停用氯吡格雷。30天时主要不良心脏事件的累积发生率为0.9%，1年时为2.7%，18个月时为3.1%。18个月时支架血栓形成的总体发生率为0.87%。急性、亚急性、晚期和极晚期支架血栓形成的发生率分别为0.1%、0.38%、0.34%和0.05%。对653例患者（31.7%）的974处病变（31.6%）进行了血管造影随访，结果显示支架内平均晚期管腔丢失为0.21±0.39mm。支架内二元再狭窄率为3.8%，节段内为6.7%。
这项多中心注册研究记录了令人满意的安全性和有效性数据，在“真实世界”环境中，当Excel可生物降解聚合物涂层西罗莫司洗脱支架联合6个月双重抗血小板治疗时，主要不良心脏事件和支架血栓形成发生率低，长达18个月的数据均证明了这一点。（Excel可生物降解聚合物药物洗脱支架多中心注册试验[CREATE]；NCT00331578）
