Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Key Laboratory of Coronary Heart Disease Prevention, Guangdong General Hospital, Guangdong Academic of Medical Sciences, Guangzhou, China.
Department of Cardiology, The Second People's Hospital of Nanhai District, Guangdong General Hospital's Nanhai Hospital, Foshan, China.
JAMA Intern Med. 2019 Feb 1;179(2):186-194. doi: 10.1001/jamainternmed.2018.5953.
The association of parenteral anticoagulation therapy with improved outcomes in patients with non-ST-segment elevation acute coronary syndrome was previously established. This benefit has not been evaluated in the era of dual antiplatelet therapy and percutaneous coronary intervention.
To evaluate the association between parenteral anticoagulation therapy and clinical outcomes in patients with non-ST-segment elevation acute coronary syndrome undergoing percutaneous coronary intervention.
DESIGN, SETTING, AND PARTICIPANTS: This cohort study included 8197 adults who underwent percutaneous coronary intervention for non-ST-segment elevation acute coronary syndrome from January 1, 2010, to December 31, 2014, at 5 medical centers in China. Patients receiving parenteral anticoagulation therapy only after percutaneous coronary intervention were excluded.
Parenteral anticoagulation therapy.
The primary outcome was in-hospital all-cause death and in-hospital major bleeding as defined by the Bleeding Academic Research Consortium definition (grades 3-5).
Of 6804 patients who met the final criteria, 5104 (75.0%) were male, with a mean (SD) age of 64.2 (10.4) years. The incidence of in-hospital death was not significantly different between the patients who received and did not receive parenteral anticoagulation therapy (0.3% vs 0.1%; P = .13) (adjusted odds ratio, 1.27; 95% CI, 0.38-4.27; P = .70). A similar result was found for myocardial infarction (0.3% vs 0.3%; P = .82) (adjusted odds ratio, 0.77; 95% CI, 0.29-2.07; P = .61). In-hospital major bleeding was more frequent in the parenteral anticoagulation group (2.5% vs 1.0%; P < .001) (adjusted odds ratio, 1.94; 95% CI, 1.24-3.03; P = .004). At a median (interquartile range) follow-up of 2.96 years (1.93-4.46 years), all-cause death was not significantly different between the 2 groups (adjusted hazards ratio, 0.87; 95% CI, 0.71-1.07; P = .19), but the incidence of major bleeding was higher in the parenteral anticoagulation group (adjusted hazards ratio, 1.43; 95% CI, 1.01-2.02; P = .04). The propensity score analysis confirmed these primary analyses.
In the patients undergoing percutaneous coronary intervention for non-ST-segment elevation acute coronary syndrome, parenteral anticoagulation therapy was not associated with a lower risk of all-cause death or myocardial infarction but was significantly associated with a higher risk of major bleeding. These findings raise important safety questions about the current practice of routine parenteral anticoagulation therapy while we await randomized trials of this practice.
先前已经证实，非 ST 段抬高型急性冠状动脉综合征患者接受静脉抗凝治疗与改善结局相关。但在双联抗血小板治疗和经皮冠状动脉介入治疗时代，尚未对此获益进行评估。
评估非 ST 段抬高型急性冠状动脉综合征患者行经皮冠状动脉介入治疗时接受静脉抗凝治疗与临床结局之间的关联。
设计、地点和参与者：这项队列研究纳入了 2010 年 1 月 1 日至 2014 年 12 月 31 日在中国 5 家医疗中心接受非 ST 段抬高型急性冠状动脉综合征经皮冠状动脉介入治疗的 8197 例成年人。排除仅在经皮冠状动脉介入治疗后接受静脉抗凝治疗的患者。
静脉抗凝治疗。
主要结局为院内全因死亡和根据 Bleeding Academic Research Consortium 定义（3-5 级）定义的院内大出血。
在符合最终标准的 6804 例患者中，5104 例（75.0%）为男性，平均（SD）年龄为 64.2（10.4）岁。接受和未接受静脉抗凝治疗的患者院内死亡发生率无显著差异（0.3% vs 0.1%；P = .13）（调整后比值比，1.27；95% CI，0.38-4.27；P = .70）。心肌梗死也呈现相似结果（0.3% vs 0.3%；P = .82）（调整后比值比，0.77；95% CI，0.29-2.07；P = .61）。静脉抗凝组院内大出血更为常见（2.5% vs 1.0%；P < .001）（调整后比值比，1.94；95% CI，1.24-3.03；P = .004）。在中位（四分位间距）随访 2.96 年（1.93-4.46 年）期间，两组间全因死亡无显著差异（调整后风险比，0.87；95% CI，0.71-1.07；P = .19），但静脉抗凝组大出血发生率较高（调整后风险比，1.43；95% CI，1.01-2.02；P = .04）。倾向评分分析证实了这些主要分析结果。
在接受非 ST 段抬高型急性冠状动脉综合征经皮冠状动脉介入治疗的患者中，静脉抗凝治疗与较低的全因死亡或心肌梗死风险无关，但与大出血风险显著增加相关。这些发现对目前常规静脉抗凝治疗实践提出了重要的安全性问题，我们仍在等待对此类治疗的随机试验。
