Department of Cardiology, Bern University Hospital, Bern, Switzerland.
Department of Cardiology, Bern University Hospital, Bern, Switzerland.
JACC Cardiovasc Interv. 2016 Jul 25;9(14):1473-83. doi: 10.1016/j.jcin.2016.04.027.
The aim of this study was to compare clinical outcomes in relation to the duration of triple antithrombotic therapy (TAT) among patients with indications for oral anticoagulation undergoing percutaneous coronary intervention (PCI).
TAT is recommended for patients undergoing PCI with a firm indication for oral anticoagulation. Duration of TAT may influence outcomes, but the optimal period of TAT remains uncertain.
Between 2009 and 2013, 8,772 consecutive patients undergoing PCI for stable coronary artery disease or acute coronary syndrome were prospectively included in the Bern PCI Registry (NCT02241291). Of 568 patients with indications for oral anticoagulation, 245 (43%) were discharged on a regimen of 1-month TAT and 323 (57%) on a regimen >1-month TAT (mean 5.1 ± 3.3 months, median 3 months). The primary endpoint was a composite of cardiac death, myocardial infarction, stroke, definite stent thrombosis, or TIMI (Thrombolysis in Myocardial Infarction) major bleeding within 1 year.
Patients on 1-month compared with >1-month TAT were more commonly women, with stable coronary artery disease, had higher HAS-BLED scores, and less frequently received drug-eluting stents. In multivariate analyses, the primary endpoint did not differ between groups (adjusted hazard ratio: 1.07; 95% confidence interval: 0.56 to 2.06; p = 0.84). Results were consistent in stratified analyses in relation to clinical presentation with acute coronary syndrome (38%) and PCI with drug-eluting stents (79%) (p for interaction = 0.18 and 0.95, respectively). There were no differences in the secondary bleeding endpoint, Bleeding Academic Research Consortium ≥3 bleeding (adjusted hazard ratio: 0.62; 95% confidence interval: 0.21 to 1.80; p = 0.37) and the secondary composite ischemic endpoint (cardiac death, myocardial infarction, stroke, or definite stent thrombosis) (adjusted hazard ratio: 1.12; 95% confidence interval: 0.55 to 2.29; p = 0.76).
One-month TAT, used preferentially in patients with higher estimated bleeding risk in this observational study, was associated with similar net clinical outcomes compared with longer TAT durations throughout 1 year following PCI.
本研究旨在比较经皮冠状动脉介入治疗（PCI）患者中具有抗凝指征的三联抗栓治疗（TAT）持续时间与临床结局的关系。
对于具有抗凝指征且行 PCI 的患者，推荐使用 TAT。TAT 的持续时间可能会影响结局，但 TAT 的最佳持续时间仍不确定。
2009 年至 2013 年，前瞻性纳入了 8772 例因稳定型冠状动脉疾病或急性冠状动脉综合征而行 PCI 的连续患者，纳入了伯尔尼 PCI 注册研究（NCT02241291）。在 568 例具有抗凝指征的患者中，245 例（43%）出院时接受 1 个月 TAT 治疗，323 例（57%）接受＞1 个月 TAT 治疗（平均 5.1±3.3 个月，中位数 3 个月）。主要终点为 1 年内发生心脏死亡、心肌梗死、卒、确定的支架血栓形成或 TIMI（心肌梗死溶栓治疗）大出血的复合终点。
与接受＞1 个月 TAT 的患者相比，接受 1 个月 TAT 的患者更常见于女性、患有稳定型冠状动脉疾病、HAS-BLED 评分更高，且较少接受药物洗脱支架治疗。多变量分析显示，两组之间主要终点无差异（调整后的危险比：1.07；95%置信区间：0.56 至 2.06；p=0.84）。在急性冠状动脉综合征（38%）和药物洗脱支架 PCI（79%）的分层分析中，结果一致（交互作用 p 值分别为 0.18 和 0.95）。在次要出血终点、BARC≥3 级出血（调整后的危险比：0.62；95%置信区间：0.21 至 1.80；p=0.37）和次要复合缺血终点（心脏死亡、心肌梗死、卒或确定的支架血栓形成）方面，两组之间无差异（调整后的危险比：1.12；95%置信区间：0.55 至 2.29；p=0.76）。
在这项观察性研究中，优先在估计出血风险较高的患者中使用 1 个月 TAT，与 1 年 PCI 后更长的 TAT 持续时间相比，其净临床结局相似。
