CTO患者PCI与口服药物治疗疗效比较的荟萃分析

Meta-analysis on efficacy of PCI treatment or conservative treatment among patients with chronic total occlusions

目的比较经皮冠状动脉介入治疗(PCI)和口服药物治疗对冠状动脉慢性完全闭塞(CTO)患者的疗效。方法该研究为荟萃分析。检索Pubmed、Embase和Web of Science数据库,检索时间为建库至2020年5月10日,运用以下检索式进行检索——“chronic total occlusion”和“percutaneous coronary intervention”和“medical therapy”。另外还检索了相关文献的参考文献,以寻找符合研究纳入标准的文献。纳入诊断符合CTO病变诊断标准(包括单支或多支CTO病变)且患者接受了PCI和口服药治疗或单独以口服药治疗作为初始治疗策略的随机对照试验(RCT)或队列研究。终点事件包括全因死亡、心原性死亡、再发心肌梗死(心梗)、再次血运重建、主要不良心血管事件(MACE)和卒中。采用随机效应模型计算合并效应量风险比(RR)和95%置信区间(95%CI),并分别对RCT及队列研究进行亚组分析。结果最终纳入文献16篇,其中12篇为队列研究,4篇为RCT,共计患者12223例。共14项研究(RCT 4篇,队列研究10篇)报道了PCI和/或口服药物治疗后CTO患者全因死亡的情况,结果示与口服药物治疗组比较,PCI组患者全因死亡风险更低(RR=0.45,95%CI 0.39~0.53,P<0.001);亚组分析结果示,队列研究中PCI组患者全因死亡风险更低(RR=0.44,95%CI 0.38~0.52,P<0.001),而RCT中二者风险相当(P=0.27)。共13项研究(RCT 3篇,队列研究10篇)报道了接受PCI和/或口服药物治疗后CTO患者心原性死亡的情况,结果示与口服药物治疗组比较,PCI组患者心原性死亡风险更低(RR=0.44,95%CI 0.35~0.55,P<0.001);亚组分析结果示,队列研究中PCI组患者心原性死亡风险更低(RR=0.43,95%CI 0.34~0.54,P<0.001),而RCT中二者风险相当(P=0.25)。共14项研究(RCT 4篇,队列研究10篇)报道了接受PCI和/或口服药物治疗后CTO患者再发心梗的情况,结果示与口服药物治疗组比较,PCI组患者再发心梗风险更低(RR=0.62,95%CI 0.44~0.88,P=0.007);亚组分析结果示,队列研究中PCI组患者再发心梗风险更低(RR=0.56,95%CI 0.40~0.78,P=0.0005),而RCT中二者风险相当(P=0.17)。共14项研究(RCT 4篇,队列研究10篇)报道了PCI和/或口服药物治疗后CTO患者再次血运重建的情况,结果示与口服药物治疗组比较,PCI组患者再次血运重建的风险相当(P=0.91);亚组分析结果示,无论在队列研究还是在RCT中二者再次血运重建的风险均相当(P分别为0.60和0.41)。共11项研究(RCT 3篇,队列研究8篇)报道了PCI和/或口服药物治疗后CTO患者发生MACE的情况,结果示与口服药物治疗组比较,PCI组患者发生MACE风险更低(RR=0.74,95%CI 0.59~0.93,P=0.03);亚组分析结果示,队列研究中PCI组患者发生MACE的风险更低(RR=0.72,95%CI 0.56~0.93,P=0.01),而RCT中二者风险相当(P=0.8)。共6项研究(RCT 2篇,队列研究4篇)报道了PCI和/或口服药物治疗后CTO患者发生卒中的情况,结果显示二者卒中风险相当(RR=0.62,95%CI 0.32~1.20,P=0.15);亚组分析结果显示,无论在队列研究还是RCT中二者卒中风险均相当(P值分别为0.48和0.32)。结论与口服药物治疗比较,采用PCI治疗CTO患者疗效可能更好。

Objective To compare the efficacy between percutaneous coronary intervention(PCI)and conservative medication treatment in chronic total occlusions(CTO)patients.Methods It was a meta-analysis.Articles on drug therapy and PCI for complete coronary artery occlusion were retrieved from Pubmed,Embase and Web of Science databases.The search time was from the database construction to May 10,2020,and the following search criteria were used for the search"chronic total occlusion""percutaneous coronary intervention"and"medical therapy".References from searched literatures were also searched to identify more eligible studies.Randomized controlled trials(RCT)and cohort studies comparing efficacy of PCI versus oral medication as well as medication as initial therapy option for CTO patients with single or multiple lesions were included.The primary endpoints included all-cause death,cardiac death,recurrent myocardial infarction,re-revascularization,major adverse cardiac events(MACE)and stroke.Data were analyzed with ReviewManager5.3.0 software.Pooled effect size RR and 95%CI were calculated by randomization effect model.Heterogeneity was evaluated by I2.Bege test was used to evaluate publication bias.Subgroup analyses were performed for RCT and cohort studies.Results A total of 1079 articles were retrieved and 16 studies(RCT=4,cohort study=12)were included with 12223 patients.Fourteen publications(RCT=4,cohort study=10)reported all-cause death post PCI and/or drug therapy.Results showed that risk of all-cause death was significantly lower in PCI group than in drug therapy group(RR=0.45,95%CI 0.39-0.53,P<0.001);subgroup analysis showed that risk of all-cause death was significantly lower in PCI group than in drug therapy group from cohort studies(RR=0.44,95%CI 0.38-0.52,P<0.001),but comparable in RCT(P=0.27).Thirteen studies(RCT=3,cohort study=10)reported cardiac death post PCI and/or drug therapy.Results showed that risk of cardiac death was significantly lower in PCI group than in drug therapy group(RR=0.44,95%CI 0.35-0.55,P<0.001);subgroup analysis showed that risk of cardiac death was significantly lower in PCI group than in drug therapy group in cohort studies(RR=0.43,95%CI 0.34-0.54,P<0.001),but not in RCT(P=0.25).Fourteen publications(RCT=4,cohort study=10)reported recurrent myocardial infarction post PCI and/or drug therapy.Results showed that risk of recurrent myocardial infarction was significantly lower in PCI group than in drug therapy group(RR=0.62,95%CI 0.44-0.88,P=0.007);subgroup analysis showed that risk of recurrent myocardial infarction was significantly lower in PCI group than in drug therapy group from cohort studies(RR=0.56,95%CI 0.40-0.78,P=0.0005),but comparable in RCT(P=0.17).Fourteen publications(RCT=4,cohort study=10)reported re-revascularization post PCI and/or drug therapy.Results showed that risk of re-revascularization was comparable between PCI group and drug therapy group(P=0.91);subgroup analysis showed that risk of re-revascularization was comparable between PCI group and drug therapy group both in cohort study and RCT(P=0.60 and 0.41,respectively).Eleven publications(RCT=3,cohort study=8)reported MACE post PCI and/or drug therapy.Results showed that risk of MACE was significantly lower in PCI group than in drug therapy group(RR=0.74,95%CI 0.59-0.93,P=0.03);subgroup analysis showed that risk of MACE was significantly lower in PCI group than in drug therapy group in cohort studies(RR=0.72,95%CI 0.56-0.93,P=0.01),but not in RCT(P=0.8).Six publications(RCT=2,cohort study=4)reported stroke post PCI and/or drug therapy.Results showed that risk of stroke was comparable between PCI and drug therapy groups(RR=0.62,95%CI 0.32-1.20,P=0.15);subgroup analysis showed that risk of stroke was comparable between PCI and drug therapy groups both in cohort studies and RCT(P=0.48 and 0.32,respectively).Conclusion Compared with oral drug therapy,PCI may have better efficacy for CTO patients based on results from this cohort study.