Department of Cardiology, University Hospital, Basel, Switzerland.
Clin Ther. 2009 Dec;31(12):2886-93. doi: 10.1016/j.clinthera.2009.12.018.
Drug-eluting stents (DESs) are associated with late stent thromboses, but the exact mechanism of action is unknown.
The goal of this article was to assess the clinical interaction of glycoprotein IIb/IIIa inhibitors (GPIs) with different stent and vessel types in unselected patients undergoing percutaneous coronary intervention (PCI).
This was a predefined retrospective analysis of the randomized controlled Basel Stent Kosten Effektivitats Trial (BASKET), which compared DES with bare-metal stents (BMSs) in patients undergoing PCI. Patients were compared for major adverse clinical events in relation to GPI use (abciximab and tirofiban) after 18 months. In a subgroup analysis prespecified in the study protocol, specific regard was given to angiographic groups at different risk levels for late events (high-risk vessels [ie, small vessels with a diameter <3.0 mm and saphenous vein grafts], and low-risk vessels [ie, large native vessels > or =3.0 mm]). Baseline differences between patients with or without GPI use were identified and incorporated into a multivariable Cox proportional hazards regression analysis if different at a <0.05 level.
A total of 826 patients (650 males, 176 females) were enrolled in BASKET; 301 (36%) received GPI therapy. Of these 301 patients, 255 (85%) received abciximab and 46 (15%) received tirofiban. After 18 months, the rate of cardiac death and nonfatal myocardial infarction was higher in patients with GPI use than in those without GPI use (35/301 [12%] vs 32/525 [6%]; P = 0.005). In patients undergoing PCI in anatomically low-risk vessels and receiving GPI therapy, there was a higher rate of cardiac death and nonfatal myocardial infarction at 18 months with a DES versus a BMS (22/151 [15%] vs 3/66 [5%]; P = 0.033). In patients undergoing PCI in anatomically low-risk vessels and without GPI therapy, there was no significant difference for cardiac death and nonfatal myocardial infarction (DES vs BMS, 11/207 [5%] vs 6/134 [4%]). In the multivariable analysis, GPI use (hazard ratio = 2.93; 95% CI, 1.53-5.63; P = 0.001) and age (hazard ratio = 1.034 per year increase; 95% CI, 1.008-1.062; P = 0.012) remained the only significant independent predictors of outcome. Interaction of stent type and GPI use was significant (P = 0.006).
This retrospective analysis of the BASKET data found that GPIs and DESs used in patients with large native vessels may have an adverse interaction in terms of late stent thromboses. However, large prospective studies are needed to confirm these findings.
药物洗脱支架(DES)与晚期支架血栓形成有关,但确切的作用机制尚不清楚。
本文旨在评估不同支架和血管类型的糖蛋白 IIb/IIIa 抑制剂(GPIs)在接受经皮冠状动脉介入治疗(PCI)的未选择患者中的临床相互作用。
这是对随机对照巴塞尔支架成本效益试验(BASKET)的预先设定的回顾性分析,该试验比较了接受 PCI 的患者中 DES 与裸金属支架(BMS)的疗效。在 18 个月时,根据 GPI(阿昔单抗和替罗非班)的使用情况,比较患者的主要不良临床事件。在研究方案中预先指定的亚组分析中,特别关注不同晚期事件风险水平的血管(即直径 <3.0mm 的小血管和大隐静脉移植物)和低风险血管(即直径 >或=3.0mm 的原生大血管)的血管。确定了有或无 GPI 使用的患者之间的基线差异,如果在<0.05 水平存在差异,则将其纳入多变量 Cox 比例风险回归分析。
BASKET 共纳入 826 例患者(650 例男性,176 例女性);301 例(36%)接受 GPI 治疗。在这 301 例患者中,255 例(85%)接受阿昔单抗治疗,46 例(15%)接受替罗非班治疗。18 个月时,使用 GPI 的患者的心脏死亡和非致死性心肌梗死发生率高于未使用 GPI 的患者(35/301[12%]比 32/525[6%];P=0.005)。在接受 PCI 的解剖学低危血管患者中,与 BMS 相比,DES 的心脏死亡和非致死性心肌梗死发生率在 18 个月时更高(22/151[15%]比 3/66[5%];P=0.033)。在接受 PCI 的解剖学低危血管且未使用 GPI 的患者中,心脏死亡和非致死性心肌梗死无显著差异(DES 与 BMS 相比,11/207[5%]比 6/134[4%])。多变量分析显示,GPI 使用率(危险比=2.93;95%CI,1.53-5.63;P=0.001)和年龄(每增加 1 岁,危险比增加 1.034;95%CI,1.008-1.062;P=0.012)是唯一具有显著预后意义的独立预测因素。支架类型和 GPI 使用之间的相互作用具有统计学意义(P=0.006)。
对 BASKET 数据的回顾性分析发现,在接受大原生血管治疗的患者中,使用 GPI 和 DES 可能会导致晚期支架血栓形成的不良相互作用。然而,需要进行大规模前瞻性研究来证实这些发现。