Tamburino Corrado, Ciriminna Saverio, Barbagallo Rossella, Galassi Alfredo Ruggero, Ussia Gianpaolo, Capranzano Piera, Tagliareni Francesco, Tolaro Salvatore, Nicosia Antonino, Stabile Amerigo, Grassi Rosario, Fiscella Antonio, Patti Aldo, Saccone Giovanni
Ferrarotto Hospital, Cardiology Division, University of Catania, Italy.
J Cardiovasc Med (Hagerstown). 2008 Feb;9(2):161-8. doi: 10.2459/JCM.0b013e32815aa7d1.
This is a multicentre, open label, prospective non-randomized registry, with 9-month angiographic follow-up, conducted to evaluate the safety and effectiveness of drug-eluting stents (DES) when used in high restenosis risk patients from the real world.
From June 2004 to February 2005, a total of 1622 consecutive patients were enrolled to the Sicilian DES Registry, according to specific inclusion criteria. Both paclitaxel-eluting and sirolimus-eluting stents were used. The analysis was performed on 1472 patients because 150 patients were excluded from the study. The primary endpoint was to evaluate the rate of major adverse cardiac events (MACE) within 9 months after DES implantation. Major adverse cardiac events were defined as cardiac death, non-Q-wave or Q-wave myocardial infarction (MI) and target vessel revascularization (TVR). The secondary endpoints were procedural success, angiographic binary restenosis and stent thrombosis within 9 months post-procedure.
Patients were more frequently male; 472 (32.1%) were diabetics, of whom 130 (27.5%) were treated with insulin. Mean ejection fraction of the left ventricle was 51.5 +/- 8.7%. Multivessel disease was found and treated in 627 patients (42.6%). A total of 2439 lesions were treated with DES. Final angiographic success was achieved in 2422 (99.3%) lesions. Procedural success was achieved in 1422 (96.6%) patients. The 9-month cumulative incidence of MACE was 7.3% with 0.8% of cardiac deaths, 0.8% non-fatal MI, 7.9% TVR. Binary restenosis was observed in 101 patients (8.3%). Stent thrombosis was documented in 11 patients (0.8%).
Drug-eluting stents appear to be safe and associated with a low incidence of MACE at 9-month follow-up, even in patients selected for their complexity.
这是一项多中心、开放标签、前瞻性非随机注册研究，进行了为期9个月的血管造影随访，旨在评估药物洗脱支架（DES）在现实世界中用于高再狭窄风险患者时的安全性和有效性。
从2004年6月至2005年2月，根据特定纳入标准，共有1622例连续患者被纳入西西里岛DES注册研究。使用了紫杉醇洗脱支架和西罗莫司洗脱支架。对1472例患者进行了分析，因为有150例患者被排除在研究之外。主要终点是评估DES植入后9个月内主要不良心脏事件（MACE）的发生率。主要不良心脏事件定义为心源性死亡、非Q波或Q波心肌梗死（MI）以及靶血管血运重建（TVR）。次要终点是手术成功率、血管造影二元再狭窄以及术后9个月内的支架血栓形成。
患者中男性更为常见；472例（32.1%）为糖尿病患者，其中130例（27.5%）接受胰岛素治疗。左心室平均射血分数为51.5±8.7%。627例患者（42.6%）发现并治疗了多支血管病变。共使用DES治疗了2439处病变。2422处病变（99.3%）实现了最终血管造影成功。1422例患者（96.6%）实现了手术成功。MACE的9个月累积发生率为7.3%，心源性死亡为0.8%，非致命性MI为0.8%，TVR为7.9%。101例患者（8.3%）观察到二元再狭窄。11例患者（0.8%）记录到支架血栓形成。
即使在因病情复杂而入选的患者中，药物洗脱支架在9个月随访时似乎也是安全的，且MACE发生率较低。
