背景:在接受非心脏手术的老年患者中,通过LMWH桥接治疗停止抗血小板治疗的安全性和有效性知之甚少。这项随机试验旨在比较通过LMWH桥接治疗停用抗血小板药物的临床获益和风险。
方法:患者1:1随机接受皮下注射达肝素钠或安慰剂。主要疗效终点为心脑血管事件。主要安全终点为大出血。
结果:在2476名随机患者中,变量(性别,年龄,身体质量指数,合并症,药物,和程序特征)和经皮冠状动脉介入治疗信息在桥接和非桥接组之间没有显着差异。在后续期间,桥接组的联合终点发生率明显低于非桥接组(5.79%vs.8.42%,p=0.012)。桥接组心肌损伤发生率明显低于非桥接组(3.14%vs.5.19%,p=0.011)。非桥接组的深静脉血栓发生率更高(1.21%vs.0.4%,p=0.024),肺栓塞的发生率有较高的趋势(0.32%vs.0.08%,p=0.177)。两组之间的急性心肌梗死发生率没有显着差异(0.81%vs.1.38%),心源性死亡(0.24%vs.0.41%),中风(0.16%vs.0.24%),或大出血(1.22%vs.1.45%)。多变量分析表明,LMWH桥接,肌酐清除率<30mL/min,术前血红蛋白<10g/dL,和糖尿病是缺血事件的独立预测因子。LMWH桥接和术前血小板计数<70×109/L是轻微出血事件的独立预测因子。
结论:这项研究表明,在接受非心脏手术的12个月以上冠状动脉支架植入的老年患者中,围手术期LMWH桥接治疗的安全性和有效性。另一种方法可能是使用半剂量LMWH的桥接治疗。
背景:ISRCTN65203415。
BACKGROUND: Little is known about the safety and efficacy of discontinuing antiplatelet therapy via LMWH bridging therapy in elderly patients with coronary stents implanted for > 12 months undergoing non-cardiac surgery. This randomized
trial was designed to compare the clinical benefits and risks of antiplatelet drug discontinuation via LMWH bridging therapy.
METHODS: Patients were randomized 1:1 to receive subcutaneous injections of either dalteparin sodium or placebo. The primary efficacy endpoint was cardiac or cerebrovascular events. The primary safety endpoint was major bleeding.
RESULTS: Among 2476 randomized patients, the variables (sex, age, body mass index, comorbidities, medications, and procedural characteristics) and percutaneous coronary intervention information were not significantly different between the bridging and non-bridging groups. During the follow-up period, the rate of the combined endpoint in the bridging group was significantly lower than in the non-bridging group (5.79% vs. 8.42%, p = 0.012). The incidence of myocardial injury in the bridging group was significantly lower than in the non-bridging group (3.14% vs. 5.19%, p = 0.011). Deep vein thrombosis occurred more frequently in the non-bridging group (1.21% vs. 0.4%, p = 0.024), and there was a trend toward a higher rate of pulmonary embolism (0.32% vs. 0.08%, p = 0.177). There was no significant difference between the groups in the rates of acute myocardial infarction (0.81% vs. 1.38%), cardiac death (0.24% vs. 0.41%), stroke (0.16% vs. 0.24%), or major bleeding (1.22% vs. 1.45%). Multivariable analysis showed that LMWH bridging, creatinine clearance < 30 mL/min, preoperative hemoglobin < 10 g/dL, and diabetes mellitus were independent predictors of ischemic events. LMWH bridging and a preoperative platelet count of < 70 × 109/L were independent predictors of minor bleeding events.
CONCLUSIONS: This
study showed the safety and efficacy of perioperative LMWH bridging therapy in elderly patients with coronary stents implanted > 12 months undergoing non-cardiac surgery. An alternative approach might be the use of bridging therapy with half-dose LMWH.
BACKGROUND: ISRCTN65203415.