Schampaert Erick, Cohen Eric A, Schlüter Michael, Reeves François, Traboulsi Mouhieddin, Title Lawrence M, Kuntz Richard E, Popma Jeffrey J
Hôpital du Sacré-Coeur de Montréal, 5400 Bl. Gouin O., Montréal, Québec, Canada H4J 1C5.
J Am Coll Cardiol. 2004 Mar 17;43(6):1110-5. doi: 10.1016/j.jacc.2004.01.024.
We assessed the safety and effectiveness of the sirolimus-eluting stent (SES) in treating single de novo long lesions in small native coronary arteries compared to an identical bare metal stent (BMS).
The SES was previously demonstrated to reduce restenosis significantly. However, patients with long lesions in small vessels have not been well studied and may define a group at very high risk.
The Canadian Study of the Sirolimus-Eluting Stent in the Treatment of Patients With Long De Novo Lesions in Small Native Coronary Arteries (C-SIRIUS) was a multicenter, randomized, double-blind trial comparing SES versus identical BMS. The primary end point was in-stent minimal lumen diameter (MLD) at eight months. Secondary end points included angiographic restenosis at 8 months, target lesion revascularization (TLR), and major adverse cardiac events (MACE) at 270 days.
A total of 100 patients were enrolled at eight Canadian sites. The in-stent MLD at eight months was 2.46 +/- 0.37 mm in the SES compared with 1.49 +/- 0.75 mm in the BMS (a 65% increase, p < 0.001). Angiographic restenosis occurred in 1 of 44 SES patients (2.3%, with no in-stent restenosis) and in 23 of 44 BMS patients (52.3%, p < 0.001). At 270 days, there were two clinically driven TLRs in the SES (4%) and nine in the BMS (18%, p = 0.05). The Kaplan-Meier estimate of freedom from MACE at 270 days was 96.0% for SES patients and 81.7% for BMS patients (p = 0.029).
Patients with long lesions in small vessels are at very high risk of restenosis. In these patients, the SES dramatically reduces the risk of restenosis at eight months, translating into an excellent clinical outcome at nine months.
我们评估了与相同的裸金属支架（BMS）相比，西罗莫司洗脱支架（SES）治疗小的自身冠状动脉单处初发长病变的安全性和有效性。
此前已证明SES能显著降低再狭窄率。然而，小血管长病变患者尚未得到充分研究，这类患者可能属于极高风险人群。
加拿大小的自身冠状动脉单处初发长病变患者西罗莫司洗脱支架治疗研究（C-SIRIUS）是一项多中心、随机、双盲试验，比较SES与相同的BMS。主要终点是8个月时支架内最小管腔直径（MLD）。次要终点包括8个月时的血管造影再狭窄、靶病变血运重建（TLR）以及270天时的主要不良心脏事件（MACE）。
加拿大8个中心共纳入100例患者。SES组8个月时支架内MLD为2.46±0.37mm，而BMS组为1.49±0.75mm（增加65%，p<0.001）。44例SES患者中有1例发生血管造影再狭窄（2.3%，支架内无再狭窄），44例BMS患者中有23例发生（52.3%，p<0.001）。270天时，SES组有2例因临床原因进行TLR（4%），BMS组有9例（18%，p=0.05）。SES组患者270天时无MACE的Kaplan-Meier估计值为96.0%，BMS组为81.7%（p=0.029）。
小血管长病变患者再狭窄风险极高。在这些患者中，SES在8个月时显著降低了再狭窄风险，在9个月时带来了优异的临床结局。
