Lemos Pedro A, Lee Chi-hang, Degertekin Muzaffer, Saia Francesco, Tanabe Kengo, Arampatzis Chourmouzios A, Hoye Angela, van Duuren Marco, Sianos Giorgios, Smits Pieter C, de Feyter Pim, van der Giessen Willem J, van Domburg Ron T, Serruys Patrick W
Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Dr Molewaterplein 40, NL-3015 GD Rotterdam, the Netherlands.
J Am Coll Cardiol. 2003 Jun 4;41(11):2093-9. doi: 10.1016/s0735-1097(03)00429-7.
This study evaluated the early outcomes of patients with acute coronary syndromes (ACS) treated with sirolimus-eluting stents (SES).
The safety of SES implantation in patients with a high risk for early thrombotic complications is currently unknown.
Sirolimus-eluting stents have been utilized as the device of choice for all percutaneous procedures in our institution, as part of the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. After four months of enrollment, 198 patients with ACS had been treated exclusively with SES (64% of those treated in the period) and were compared with a control group composed of 301 consecutive patients treated with bare stents in the same time period immediately before this study. The incidence of major adverse cardiac events (MACE) during the first month was evaluated (death, nonfatal myocardial infarction [MI], or re-intervention).
Compared with control patients, patients treated with SES had more primary angioplasty (95% vs. 77%; p < 0.01), more bifurcation stenting (13% vs. 5%; p < 0.01), less previous MI (28% vs. 45%; p < 0.01), and less glycoprotein IIb/IIIa inhibitor utilization (27% vs. 42%; p < 0.01). The 30-day MACE rate was similar between both groups (SES 6.1% vs. control patients 6.6%; p = 0.8), with most complications occurring during the first week. Stent thrombosis occurred in 0.5% of SES patients and in 1.7% of control patients (p = 0.4). In multivariate analysis, SES utilization did not influence the incidence of MACE (odds ratio 1.0 [95% confidence interval: 0.4 to 2.2]; p = 0.97).
Sirolimus-eluting stent implantation for patients with ACS is safe, with early outcomes comparable with bare metal stents.
本研究评估了接受西罗莫司洗脱支架（SES）治疗的急性冠状动脉综合征（ACS）患者的早期预后。
目前尚不清楚在有早期血栓形成并发症高风险的患者中植入SES的安全性。
作为鹿特丹心脏病医院西罗莫司洗脱支架评估（RESEARCH）注册研究的一部分，在我们机构中，西罗莫司洗脱支架已被用作所有经皮手术的首选器械。入组四个月后，198例ACS患者仅接受了SES治疗（占该时期治疗患者的64%），并与在本研究之前同一时期连续接受裸支架治疗的301例患者组成的对照组进行比较。评估了第一个月内主要不良心脏事件（MACE）的发生率（死亡、非致命性心肌梗死[MI]或再次干预）。
与对照患者相比，接受SES治疗的患者接受直接经皮冠状动脉腔内血管成形术（PTCA）的比例更高（95%对77%；p<0.01），分叉支架置入术更多（13%对5%；p<0.01），既往MI更少（28%对45%；p<0.01），糖蛋白IIb/IIIa抑制剂使用率更低（27%对42%；p<0.01）。两组的30天MACE发生率相似（SES组为6.1%，对照患者为6.6%；p = 0.8），大多数并发症发生在第一周。SES患者中支架血栓形成的发生率为0.5%，对照患者中为1.7%（p = 至0.4）。在多变量分析中，使用SES并未影响MACE的发生率（优势比1.0[95%置信区间：0.4至2.2]；p = 0.97）。
ACS患者植入西罗莫司洗脱支架是安全的，早期预后与裸金属支架相当。
