冠心病患者经皮冠状动脉介入术后长期接受双联抗血小板治疗的出血和输血事件及其影响因素

Bleeding and blood transfusion events and their influencing factors in patients with coronary heart disease receiving long-term dual antiplatelet therapy after percutaneous coronary intervention

目的探讨接受经皮冠脉介入术(PCI)后采取长期双联抗血小板治疗(DAPT)冠心病患者的出血和输血事件及其影响因素。方法选择2021年5月至2023年4月于空军军医大学第一附属医院确诊为冠心病并行PCI,术后对其规律采取DAPT(口服阿司匹林+替格瑞洛,或阿司匹林+氯吡格雷)方案治疗的4516例患者为研究对象。患者年龄为(59.4±7.2)岁,男、女性患者分别为3557和959例。根据PCI后采取DAPT方案治疗1年内是否发生严重出血事件,将这4516例患者分为严重出血组(n=48)和非严重出血组(n=4468);根据是否接受输血治疗,将其分为输血组(n=71)和未输血组(n=4445)。采用回顾性研究方法,收集患者PCI前基线,PCI后采取DAPT方案治疗1年内,出血、输血及生存相关临床资料。采用单因素分析法筛选可能影响PCI后采取DAPT方案治疗1年内患者严重出血和输血的因素后,将有统计学意义的临床资料纳入多因素非条件logistic回归分析,进一步筛选独立影响因素。根据临床资料的类型和分布,单因素分析采用独立样本t检验、χ^(2)检验或Fisher确切概率法。本研究遵循的程序符合空军军医大学第一附属医院人体试验委员会制定的标准,经过该伦理委员会批准(批准文号:KY-20210465-2)。结果对本研究4516例冠心病患者PCI后采取DAPT方案治疗1年内出血及输血相关临床资料的调查结果如下。①患者出血、严重出血、胃肠出血、脑出血发生率分别为10.2%(460/4516)、1.1%(48/4516)、0.9%(40/4516)和0.2%(8/4516)。输血组71例患者中,皮肤黏膜、胃肠、脑出血者分别为23例(0.5%,23/4516),40例(0.9%,40/4516)和8例(0.2%,8/4516)。②与非严重出血组患者比较,严重出血组患者的年龄较大[(65.7±11.1)岁比(59.5±7.2)岁],基线血红蛋白(Hb)值较低[(134.5±23.1)g/L比(143.9±16.7)g/L],并且差异均有统计学意义(t=5.91、-3.85,均P<0.001)。多因素非条件logistic回顾分析结果显示,年龄为冠心病患者PCI后采取DAPT方案治疗1年内发生严重出血的独立危险因素(OR=1.122,95%CI:1.079~1.166,P<0.001),基线Hb值为独立保护因素(OR=0.967,95%CI:0.950~0.984,P<0.001)。③与未输血组患者比较,输血组患者的年龄较高[(66.6±10.1)岁比(59.4±7.2)岁]、美国麻醉医师协会(ASA)分级较高[ASAⅢ级患者占比:40.8%(29/71)比16.1%(715/4445)]、PCI时间较长[手术时间>120 min患者占比:54.9%(39/71)比33.1%(1470/4445)]、基线Hb值较低[(103.5±13.6)g/L比(123.9±16.7)g/L],并且差异均有统计学意义(t=8.34,P<0.001;χ^(2)=31.13,P<0.001;χ^(2)=22.14,P<0.001;t=-9.27,P<0.001)。多因素非条件logistic回归分析结果显示,年龄(OR=1.136,95%CI:1.099~1.174,P<0.001),ASA分级(OR=2.852,95%CI:1.679~4.847,P<0.001),PCI时间(OR=1.461,95%CI:1.098~1.943,P=0.009)为冠心病患者PCI后采取DAPT方案治疗1年内接受输血治疗独立危险因素,基线Hb值为独立保护因素(OR=0.938,95%CI:0.923~0.952,P<0.001)。结论对冠心病患者PCI后采取DAPT方案治疗1年内的出血和输血发生风险较高,包括胃肠和脑出血等严重出血事件。患者年龄为患者PCI后采取DAPT 1年内严重出血和输血的危险因素,而基线Hb值为独立保护因素。

ObjectiveTo explore bleeding and blood transfusion events and their influencing factors in patients with coronary heart disease who received long-term dual antiplatelet therapy(DAPT)after percutaneous coronary intervention(PCI).MethodsFrom May 2021 to April 2023,a total of 4516 patients who were diagnosed with coronary heart disease and underwent PCI at the First Affiliated Hospital of Air Force Military Medical University and regularly received DAPT(oral aspirin+ticagrelor,or aspirin+clopidogrel)after surgery were selected as research subjects.The age of these patients was(59.4±7.2)years old,and there were 3557 male and 959 female patients.According to whether occurred severe bleeding within 1 year after PCI with DAPT,these 4516 patients were divided into severe bleeding group(n=48)and non-severe bleeding group(n=4468);according to whether they received blood transfusion,they were divided into blood transfusion group(n=71)and non-blood transfusion group(n=4445).A retrospective study method was used to collect patients′clinical data related to baseline data before PCI,bleeding,blood transfusion,and survival within 1 year of receiving DAPT after PCI.After screening for factors that might influence severe bleeding and blood transfusion in patients receiving DAPT within 1 year after PCI using univariate analysis,statistically significant clinical data were further included in multifactorial unconditional logistic regression analysis to screen for independent influence factors.Depending on the type and distribution of clinical data,univariate analysis was performed using the independent samples t-test,chi-square test,or the Fisher exact probabilities.The procedures followed in this study were in accordance with the standards established by the Committee of Investigation in Human Beings of First Affiliated Hospital of Air Force Military Medical University,and this study was approved by the committee(Approval No.KY-20210465-2).ResultsThe results of investigation on clinical data related to bleeding and blood transfusion in 4516 patients with coronary heart disease who received DAPT within 1 year after PCI were as follows.①The incidences of bleeding,severe bleeding,gastrointestinal bleeding,and cerebral hemorrhage were 10.2%(460/4516),1.1%(48/4516),0.9%(40/4516),and 0.2%(8/4516),respectively.Among 71 patients in blood transfusion group,there were 23 patients(0.5%,23/4516),40 patients(0.9%,40/4516),8 patients(0.2%,8/4516)occurred skin and mucosal bleeding,gastrointestinal bleeding,and cerebral bleeding,respectively.②Compared with patients in non-severe bleeding group,patients in severe bleeding group were older[(65.7±11.1)years vs(59.5±7.2)years]and had lower baseline hemoglobin(Hb)values[(134.5±23.1)g/L vs(143.9±16.7)g/L],and the differences were all statistically significant(t=5.91,-3.85,both P<0.001).The results of multivariate unconditional logistic retrospective analysis showed that age was an independent risk factor for severe bleeding within 1 year DAPT after PCI in patients with coronary heart disease(OR=1.122,95%CI:1.079-1.166,P<0.001),and baseline Hb value was an independent protective factor(OR=0.967,95%CI:0.950-0.984,P<0.001).③Compared with patients in non-blood transfusion group,patients in blood transfusion group were older[(66.6±10.1)years vs(59.4±7.2)years],had higher American Society of Anesthesiologists(ASA)grade[proportion of ASA gradeⅢpatients:40.8%(29/71)vs 16.1%(715/4445)],and had longer PCI operation time[proportion of patients with operation time>120 min:54.9%(39/71)vs 33.1%(1470/4445)],and lower baseline Hb value[(103.5±13.6)g/L vs(123.9±16.7)g/L],and the differences were all statistically significant(t=8.34,P<0.001;χ^(2)=31.13,P<0.001;χ^(2)=22.14,P<0.001;t=-9.27,P<0.001).The results of multivariate unconditional logistic regression analysis showed that age(OR=1.136,95%CI:1.099-1.174,P<0.001),ASA grade(OR=2.852,95%CI:1.679-4.847,P<0.001),and PCI operation time(OR=1.461,95%CI:1.098-1.943,P=0.009)were independent risk factors for blood transfusion within 1 year DAPT after PCI in patients with coronary heart disease,and baseline Hb value was an independent protective factor(OR=0.938,95%CI:0.923-0.952,P<0.001).ConclusionsPatients with coronary heart disease who received DAPT within 1 year after PCI have a higher risk of bleeding and blood transfusion,including severe bleeding events such as gastrointestinal and cerebral bleeding.Patient age is an independent risk factor for severe bleeding and blood transfusion within 1 year received DAPT after PCI,while baseline Hb value is an independent protective factor.