Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.
EuroIntervention. 2017 Mar 20;12(16):2009-2017. doi: 10.4244/EIJ-D-16-00884.
The aim of the study was to compare outcomes in unfractionated heparin (UFH) and bivalirudin-treated patients undergoing primary percutaneous coronary intervention (PPCI).
This observational study contained 20,612 PPCI patients treated with either UFH monotherapy or bivalirudin with or without concomitant UFH. Patients with oral anticoagulant or glycoprotein IIb/IIIa inhibitor (GPI) treatment were excluded. The primary outcome measure was definite early stent thrombosis (ST) that occurred at low and similar rates in UFH only and bivalirudin-treated patients: 0.9% vs. 0.8% (adjusted hazard ratio [HR] 1.08, 95% confidence interval [CI]: 0.7-1.65). All-cause death at 30 days occurred in 6.9% vs. 5.4% of patients (adjusted HR 1.23, 95% CI: 1.05-1.44) and within 365 days in 12.1% vs. 8.9% (adjusted HR 1.34, 95% CI: 1.19-1.52) in the two groups, respectively. The incidence of major bleeding within 30 days was 0.8% vs. 0.6% (adjusted HR 1.54, 95% CI: 0.97-2.45). The incidence of reinfarction within 365 days and stroke within 30 days was similar between groups.
In this large, nationwide observational study we found low and similar rates of early ST in UFH only and bivalirudin-treated patients undergoing primary PCI. Mortality was higher in UFH compared with bivalirudin-treated patients.
本研究旨在比较未分级肝素（UFH）和比伐卢定治疗行直接经皮冠状动脉介入治疗（PPCI）的患者的结局。
本观察性研究纳入 20612 例行 PPCI 治疗的患者，其中接受 UFH 单药治疗或比伐卢定治疗，或 UFH 联合比伐卢定治疗。排除接受口服抗凝药或糖蛋白 IIb/IIIa 抑制剂（GPI）治疗的患者。主要结局测量指标为低且相似的 UFH 单药治疗和比伐卢定治疗患者的明确早期支架血栓形成（ST）发生率：0.9%比 0.8%（校正后危险比 [HR] 1.08，95%置信区间 [CI]：0.7-1.65）。30 天全因死亡率分别为 6.9%和 5.4%（校正后 HR 1.23，95%CI：1.05-1.44），365 天全因死亡率分别为 12.1%和 8.9%（校正后 HR 1.34，95%CI：1.19-1.52）。两组患者 30 天内大出血发生率分别为 0.8%和 0.6%（校正后 HR 1.54，95%CI：0.97-2.45）。两组患者 365 天内再梗死发生率和 30 天内卒中发生率相似。
在这项大型全国性观察性研究中，我们发现 UFH 单药治疗和比伐卢定治疗行直接经皮冠状动脉介入治疗的患者早期 ST 发生率较低且相似。与比伐卢定治疗的患者相比，UFH 治疗的患者死亡率更高。
