Fan Lin, Chen Liang-long, Lin Chao-gui, Peng Ya-fei, Zheng Xing-chun, Luo Yu-kun, Zhang Fei-long, Chen Jian-hua, Yan Xiao-ping, Huang Zheng-rong
Department of Cardiology, Union Hospital, Fujian Medical University & Fujian Provincial Institute of Coronary Disease, Fuzhou, Fujian 350001, China.
Chin Med J (Engl). 2008 Aug 20;121(16):1518-23.
As a kind of sirolimus-eluting stent (SES) made in China, Firebird SES is more effective than bare metal stent (BMS) and not inferior to Cypher SES for short coronary lesions in terms of reduction of restenosis and revascularization. However, Firebird SES does not show any benefits in patients with a very long coronary lesion (VLCL). The present study was undertaken to evaluate the safety and efficacy of Firebird SES for VLCL by comparison of Cypher SES and BMS.
In this prospective, nonrandomized and comparative study, eligible patients with de novo coronary lesion (> or = 30 mm) between January 2005 and June 2006 were allocated into Firebird SES group, Cypher SES group or BMS group. They were subjected to an angiographic follow-up of 6 months and a clinical follow-up of 12 months. The primary endpoints constitute the in-stent and in-segment restenosis rates at 6 months. The secondary endpoint was defined as a major adverse cardiovascular event (MACE) that was a 12-month combined endpoint of all-cause deaths, reinfarction or in-stent thrombosis, and target-lesion revascularization. The 12-month in-stent thrombosis was also evaluated to address the safety of Firebird SES implantation exceptionally.
A total of 468 patients were assessed for eligibility. Of 113 patients who were finally included according to the prior inclusion and exclusion criteria, 39 (41 lesions) were treated with Firebird SES, 37 (39 lesions) with Cypher SES, and 37 (37 lesions) with BMS. There were no significant differences in the baseline characteristics between the three groups; but there were longer lesions, more frequent use of overlapping stent in the Firebird SES group and the Cypher SES group. Angiographic follow-up showed that the rates of binary stenosis were similar between the Firebird SES group and the Cypher SES group (in-segment: 14.6% vs 12.8%, relative risk (RR) 1.14, P = 0.81; in-stent: 9.8% vs 10.3%, RR 0.95, P = 0.94), and significantly lower than those in the BMS group (in-segment: vs. 36.1%, RR 0.41 or 0.36, P = 0.04 or 0.03, respectively; in-stent: vs 30.6%, RR 0.32 or 0.34, P = 0.03 or 0.04, respectively). The total MACE rate up to 12 months was also similar in both SES groups (7.7% vs 5.4%, P = 1.000), and significantly lower than that in the BMS group (27.0%, P = 0.034 or 0.024, respectively). The in-stent thrombosis rate in the follow-up period was 2.6% in the Firebird SES group, not higher in the Cypher SES and BMS groups (2.7% and 2.7%, respectively, P = 1.000).
In the treatment of VLCL, Firebird SES would be safer and more effective than BMS. Firebird SES may be not inferior to Cypher SES in terms of restenosis and MACE.
作为一种国产西罗莫司洗脱支架（SES），Firebird SES在减少冠状动脉短病变的再狭窄和血运重建方面比裸金属支架（BMS）更有效，且不劣于Cypher SES。然而，Firebird SES在治疗冠状动脉极长病变（VLCL）患者时未显示出任何优势。本研究旨在通过对比Cypher SES和BMS来评估Firebird SES治疗VLCL的安全性和有效性。
在这项前瞻性、非随机对照研究中，2005年1月至2006年6月符合条件的初发冠状动脉病变（≥30 mm）患者被分为Firebird SES组、Cypher SES组或BMS组。对他们进行6个月的血管造影随访和12个月的临床随访。主要终点为6个月时的支架内再狭窄率和节段内再狭窄率。次要终点定义为主要不良心血管事件（MACE），即12个月时全因死亡、再梗死或支架内血栓形成以及靶病变血运重建的联合终点。还评估了12个月时的支架内血栓形成情况，以特别探讨Firebird SES植入的安全性。
共评估了468例患者的入选资格。根据先前的纳入和排除标准，最终纳入的113例患者中，39例（41处病变）接受了Firebird SES治疗，37例（39处病变）接受了Cypher SES治疗，37例（37处病变）接受了BMS治疗。三组患者的基线特征无显著差异；但Firebird SES组和Cypher SES组的病变更长，重叠支架的使用更频繁。血管造影随访显示，Firebird SES组和Cypher SES组的二元狭窄率相似（节段内：14.6%对12.8%，相对危险度（RR）1.14，P = 0.81；支架内：9.8%对10.3%，RR 0.95，P = 0.94），且显著低于BMS组（节段内：对36.1%，RR 0.41或0.36，P分别为0.04或0.03；支架内：对30.6%，RR 0.32或0.34，P分别为0.03或0.04）。两个SES组至12个月时的总MACE率也相似（7.7%对5.4%，P = 1.000），且显著低于BMS组（27.0%，P分别为0.034或0.024）。随访期内Firebird SES组的支架内血栓形成率为2.6%，Cypher SES组和BMS组不高于此（分别为2.7%和2.7%，P = 1.000）。
在治疗VLCL时，Firebird SES比BMS更安全、更有效。在再狭窄和MACE方面，Firebird SES可能不劣于Cypher SES。
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