Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York3Associate Editor, JAMA Cardiology.
JAMA Cardiol. 2017 Jun 1;2(6):673-677. doi: 10.1001/jamacardio.2016.5669.
Bivalirudin has been associated with reduced bleeding and mortality during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI). However, increased rates of acute stent thrombosis (AST) have been noted when bivalirudin is discontinued at the end of the procedure, which is perhaps related to this medication's short half-life.
To evaluate the clinical effect of procedure duration on AST when either bivalirudin or heparin plus glycoprotein IIb/IIIa receptor inhibitor (GPI) is used.
DESIGN, SETTING, AND PARTICIPANTS: An ad hoc analysis of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) clinical trial was performed between March 1, 2015, and April 30, 2016, on patients who underwent primary percutaneous coronary intervention with stents and were randomized 1:1 to bivalirudin or heparin plus GPI. Defined as the difference between the patient's arrival at the catheterization laboratory and the patient's final angiogram. Participants included 3602 patients with STEMI, aged 18 years or older, who were undergoing primary percutaneous coronary intervention and presenting less than 12 hours from symptom onset.
Clinical events committee-adjudicated definite AST (occurring ≤24 hours after percutaneous coronary intervention).
Among patients included in this analysis, procedure time was identified in 1286 receiving bivalirudin and 1412 receiving heparin plus GPI. Shorter procedures were defined as the lowest quartile of duration (<45 minutes). Patients undergoing shorter procedures were younger and less likely to be hypertensive and smokers. Shorter procedures were less complicated with fewer stents implanted, less multivessel stenting, less thrombus, and less no-reflow. An increased risk of definite AST was associated with shorter than with longer procedures with bivalirudin (7 [2.1%] vs 7 [0.7%]; relative risk, 2.87; 95% CI, 1.01-8.17; P = .04) but not with heparin plus GPI (0 vs 3 [0.3%]; P = .30).
Despite less procedural complexity, shorter primary percutaneous coronary intervention time was associated with an increased risk of AST in patients treated with bivalirudin but not patients treated with heparin plus GPI, possibly because of the rapid offset of bivalirudin's antithrombotic effect during a window of limited oral antiplatelet action.
clinicaltrials.gov Identifier: NCT00433966.
在接受直接经皮冠状动脉介入治疗（STEMI）的 ST 段抬高型心肌梗死（STEMI）患者中，比伐卢定与减少出血和死亡率相关。然而，当在手术结束时停止使用比伐卢定时，已经注意到急性支架血栓形成（AST）的发生率增加，这可能与这种药物的半衰期较短有关。
评估在使用比伐卢定或肝素加糖蛋白 IIb/IIIa 受体抑制剂（GPI）时，手术持续时间对 AST 的临床影响。
设计、地点和参与者：对 2015 年 3 月 1 日至 2016 年 4 月 30 日期间接受直接经皮冠状动脉介入治疗并接受支架治疗的患者进行了 Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction（HORIZONS-AMI）临床试验的特设分析，并将患者随机分为 1:1 接受比伐卢定或肝素加 GPI。定义为患者到达导管室和患者最后一次血管造影之间的差异。参与者包括 3602 名年龄在 18 岁或以上、接受直接经皮冠状动脉介入治疗且症状发作后 12 小时内出现 STEMI 的患者。
临床事件委员会裁定的明确 AST（发生在经皮冠状动脉介入治疗后 24 小时内）。
在这项分析中包括的患者中，1286 名接受比伐卢定和 1412 名接受肝素加 GPI 的患者确定了手术时间。较短的手术时间定义为持续时间最低四分位数（<45 分钟）。接受较短手术的患者年龄较小，高血压和吸烟者较少。较短的手术程序较不复杂，植入的支架较少，多血管支架较少，血栓较少，无复流较少。与较长的手术相比，比伐卢定与较短的手术时间相关（7[2.1%]vs7[0.7%]；相对风险，2.87；95%置信区间，1.01-8.17；P=0.04），但与肝素加 GPI 无关（0 与 3[0.3%]；P=0.30）。
尽管手术过程的复杂性降低，但接受比伐卢定治疗的患者的主要经皮冠状动脉介入治疗时间较短与 AST 风险增加相关，但接受肝素加 GPI 治疗的患者则没有，这可能是因为比伐卢定的抗血栓作用在口服抗血小板作用有限的窗口期迅速消退。
clinicaltrials.gov 标识符：NCT00433966。
