Liu Hai-Bo, Xu Bo, Yang Yue-Jin, Wang Yang, Qin Xue-Wen, Yao Min, Wu Yong-Jian, Yuan Jin-Qing, Chen Jue, You Shi-Jie, Dai Jun, Ma Wei-Hua, Li Jian-Jun, Qiao Shu-Bin, Chen Ji-Lin, Li Wei, Gao Run-Lin
Department of Cardiology, Fu Wai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.
Chin Med J (Engl). 2009 Mar 20;122(6):681-6.
Several clinical trials have shown that sirolimus-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention (PCI). The FIREBIRD stent (coated with durable polymer) and the EXCEL stent (coated with bioabsorbable polymer) are two different types of sirolimus-eluting stents made in China; both have been approved for clinical use in China by the State Food and Drug Administration. The mid-term (6-month) angiographic and clinical results of both stents have been confirmed exciting perspective outcomes. However, it is unclear whether there are differences in the long-term safety and efficacy between the two types of stents in daily practice.
All consecutive patients undergoing elective PCI with EXCEL or FIREBIRD stents between June 1, 2006 and December 31, 2006 at Fu Wai Hospital in Beijing were included. Patients were classified from the index admission according to stent types (EXCEL or FIREBIRD) used. Clinical and procedural risk factors were collected prospectively. With propensity score matching without replacement, the frequency of major adverse cardiac events (MACE, a composite of death, myocardial infarction or target vessel revascularization) and stent thrombosis during a 2-year follow-up period were compared between the two groups.
A total of 474 patients were treated with EXCEL, and 640 were treated with FIREBIRD. Three hundred and ninety-seven EXCEL patients were matched to 397 FIREBIRD patients, 2-year risk-adjusted MACE rates were 6.1% in EXCEL group and 7.6% in FIREBIRD group (HR 0.84, 95% CI 0.50-1.43), whereas the respective rates for mortality, myocardial infarction and target-vessel revascularization were 2.3% vs 2.8% (HR 0.74, 95% CI 0.30-0.85), 1.8% vs 1.3% (HR 1.41, 95% CI 0.45-4.43) and 2.5% vs 4.0% (HR 0.62, 95% CI 0.28-0.37), respectively. Cumulative incidence of stent thrombosis at 2 years was 1.8% in the EXCEL group vs 1.3% in the FIREBIRD group (P = 0.5610), whereas the rate of very late stent thrombosis was 0.5% vs 1.3% (P = 0.2550).
Results from this long-term, relatively large size, single-center study showed that both of the EXCEL and the FIREBIRD sirolimus-eluting stent had similar and lower incidence of MACE after PCI in daily practice.
多项临床试验表明，西罗莫司洗脱支架可显著降低经皮冠状动脉介入治疗（PCI）后再狭窄的风险。火鸟支架（涂覆耐用聚合物）和艾可塞尔支架（涂覆可生物吸收聚合物）是中国制造的两种不同类型的西罗莫司洗脱支架；二者均已获得国家食品药品监督管理总局批准在中国临床使用。两种支架的中期（6个月）血管造影和临床结果均已证实具有令人振奋的前景。然而，在日常实践中，这两种类型的支架在长期安全性和有效性方面是否存在差异尚不清楚。
纳入2006年6月1日至2006年12月31日在北京阜外医院接受艾可塞尔或火鸟支架选择性PCI的所有连续患者。根据使用的支架类型（艾可塞尔或火鸟）将患者从首次入院开始分类。前瞻性收集临床和手术风险因素。采用无替换倾向评分匹配法，比较两组在2年随访期内主要不良心脏事件（MACE，死亡、心肌梗死或靶血管血运重建的复合事件）的发生频率和支架血栓形成情况。
共474例患者接受了艾可塞尔支架治疗，640例接受了火鸟支架治疗。397例使用艾可塞尔支架的患者与397例使用火鸟支架的患者匹配，艾可塞尔组2年风险调整后的MACE发生率为6.1%，火鸟组为7.6%（HR 0.84，95%CI 0.50 - 1.43），而死亡、心肌梗死和靶血管血运重建的发生率分别为2.3%对2.8%（HR 0.74，95%CI 0.30 - 0.85）、1.8%对1.3%（HR 1.41，95%CI 0.45 - 4.43）和2.5%对4.0%（HR 0.62，95%CI 0.28 - 0.37）。艾可塞尔组2年支架血栓形成的累积发生率为1.8%，火鸟组为1.3%（P = 0.5610），而极晚期支架血栓形成率分别为0.5%对1.3%（P = 0.2550）。
这项长期、相对大样本量的单中心研究结果表明，在日常实践中，艾可塞尔和火鸟西罗莫司洗脱支架在PCI后发生MACE的发生率相似且较低。
