Objective: To observe the safety and impact of short-term anticoagulant therapy on prognosis after selective percutaneous coronary intervention (PCI) in patients with coronary artery disease. Methods: From January 2013 to December 2013, 9 769 consecutive patients underwent selective PCI in Fuwai Hospital were retrospectively included in this study. Patients were divided into two groups, including non-post-PCI anticoagulant therapy group and low-dose and short-time post-PCI anticoagulant therapy group (enoxaparin 0.4 ml/12 h or fondaparinux 2.5 mg/day by subcutaneous injection for 2-3 days after PCI). All patients were evaluated at 30 days, 180 days and 12 months for major adverse coronary and cerebral events (MACCE) including all-cause death, myocardial infarction, revascularization and stroke as well as in-stent thrombosis and bleeding events. Data from 1 755 pairs of patients were analysis after propensity score matching. The clinical outcomes were compared between groups by using Kaplan-Meier survival analysis before and after propensity score matching. Multivariable Cox analysis was used to define the impact and determinants of post-PCI anticoagulation on clinical outcomes. Results: one thousand seven hundred and fifty-five (18.0%) patients didn't receive post-PCI anticoagulation and 8 014 (82.0%) patients received post-PCI anticoagulation, 5 666 (58.0%) patients received enoxaparin and 2 348 (24.0%) patients received fondaparinux. Patients were younger and incidence of female patients was less, incidence of renal dysfunction and acute coronary syndrome were higher in low-dose and short-time post-PCI anticoagulant therapy group than in non-post-PCI anticoagulation group (all P<0.05). Similarly, patients with post-PCI anticoagulation were associated with more left main coronary artery lesion and branch lesion (P<0.05). Post-PCI anticoagulation patients were associated with less trans-femoral process, more drug-eluting stents implantation and less simple balloon dilatation (all P<0.05). Nine thousand seven hundred and seventeen (99.5%) patients completed 2 years follow up. Post-PCI anticoagulation patients had significantly lower 30-day all-cause death (0.05% (4 cases) vs. 0.46% (8 cases), P<0.001) and stroke (0 vs. 0.11% (2 cases), P=0.003), lower 180-day all-cause death (0.17% (14 cases) vs. 0.57% (10 cases), P=0.002), revascularization (2.07% (166 cases) vs. 3.71% (65 cases), P<0.001) and MACCE (3.49% (280 cases) vs. 5.47% (96 cases), P<0.001), lower 2-year revascularization (7.61% (610 cases) vs. 12.84% (225 cases), P<0.001) and MACCE (10.92 (875 cases) vs. 16.01% (281 cases), P<0.001). Multivariable Cox regression analysis showed that post-PCI anticoagulant therapy was an independent protective factor of 30-day (HR=0.17, 95%CI 0.05-0.62, P=0.007), 180-day all-cause death (HR=0.37, 95%CI 0.16-0.87, P=0.023) and MACCE (HR=0.74, 95%CI 0.58-0.94, P=0.013), 2-year MACCE (HR=0.71, 95%CI 0.62-0.81, P<0.001). After propensity score matching, post-PCI anticoagulation therapy remained as an independent protective factor of 30-day all-cause death (HR=0.11, 95%CI 0.01-0.92, P=0.042) and 2-year MACCE (HR=0.81, 95%CI 0.68-0.96, P=0.015). Conclusions: Low-dose and short-time post-PCI anticoagulant therapy may decrease 30-day all-cause death, 180-day all-cause death and MACCE and 2-year MACCE, and meanwhile this option does not increase bleeding risk in patients underwent selective PCI.
目的: 探讨冠心病患者择期经皮冠状动脉介入术(PCI)后抗凝治疗的有效性、安全性及其对预后的影响。 方法: 回顾性连续纳入2013年1至12月在阜外医院行择期PCI治疗的9 769例患者。根据术后是否抗凝治疗分为2组,抗凝组术后给予短期较低剂量的常规抗凝治疗(依诺肝素0.4 ml 1次/12 h或磺达肝癸钠2.5 mg 1次/d皮下注射,至术后2~3 d),进行30、180 d及2年的随访,记录全因死亡、心肌梗死、血运重建、卒中、支架内血栓、出血及主要心脑血管不良事件(MACCE,包括:死亡、心肌梗死、血运重建及卒中)发生情况。采用倾向性评分匹配出1 755对患者,Kaplan-Meier生存分析比较匹配前后组间的远期预后差别。同时采用多因素Cox回归分析术后抗凝治疗对预后的影响。 结果: 1 755(18.0%)例患者未接受术后抗凝治疗,8 014(82.0%)例接受了术后抗凝治疗,其中5 666(58.0%)例接受依诺肝素抗凝,2 348(24.0%)例接受磺达肝癸钠抗凝治疗。与无抗凝治疗组比较,抗凝治疗组年龄更小,女性比例更低,肾功能不全比例更低,急性冠状动脉综合征比例更高(P均<0.05)。抗凝治疗组左主干病变比例及分支受累比例更高(P均<0.05);经股动脉穿刺途径比例更低,置入药物洗脱支架比例更高,单纯球囊扩张比例更低(P均<0.05)。9 717(99.5%)例患者完成了2年随访。与无抗凝治疗组(1 755例)比较,抗凝治疗组(8 014例)30 d全因死亡率[0.05%(4例)比0.46%(8例),P<0.001]和卒中[0比0.11%(2例),P=0.003]风险较低,180 d全因死亡率[0.17%(14例)比0.57%(10例),P=0.002]、血运重建[2.07%(166例)比3.71%(65例),P<0.001]及MACCE[3.49%(280例)比5.47%(96例),P<0.001]较低,2年血运重建[7.61%(610例)比12.84%(225例),P<0.001]及MACCE(10.92%(875例)比16.01%(281例),P<0.001)较低。Cox回归分析显示,抗凝治疗是30 d全因死亡(HR=0.17,95%CI 0.05~0.62,P=0.007)、180 d全因死亡(HR=0.37,95%CI 0.16~0.87,P=0.023)和MACCE(HR=0.74,95%CI 0.58~0.94,P=0.013)及2年MACCE(HR=0.71,95%CI 0.62~0.81,P<0.001)的独立保护因素。经过倾向性评分匹配,抗凝治疗仍是30 d全因死亡(HR=0.11,95%CI 0.01~0.92,P=0.042)以及2年MACCE的独立保护因素(HR=0.81,95%CI 0.68~0.96,P=0.015)。 结论: 择期PCI患者,术后给予短期较低剂量的常规抗凝治疗可能有助于降低术后30和180 d的全因死亡、2年的血运重建及MACCE发生风险,而不增加出血风险。.
Keywords: Anticoagulant Therapy; Coronary Artery Disease; Percutaneous coronary intervention; Prognosis.