一站式复合冠状动脉血运重建术与冠状动脉旁路移植术及经皮冠状动脉介入治疗冠状动脉多支病变中期疗效的对比研究
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摘要
背景：一站式复合冠状动脉血运重建术(One-stop hybrid coronary revascularization)整合了小切口冠状动脉旁路移植术(Minimal invasive direct coronary artery bypass grafting, MIDCAB)和经皮冠状动脉介入治疗(Percutaneous coronary intervention, PCI)的优点治疗冠状动脉多支病变,以达到微创和完全再血管化治疗的目的。
目的：比较一站式复合技术与冠状动脉旁路移植术(Coronary artery bypass grafting CABG)及PCI治疗冠状动脉多支病变患者的中期临床结果和效费比,探讨一站式复合技术的最佳受益人群。
方法：自2007年6月至2010年12月,共有141例冠状动脉多支病变患者在阜外心血管病医院接受一站式复合冠状动脉血运重建术。同期5797例实施单纯CABG,4294例实施PCI,均为包含前降支在内的冠状动脉多支病变患者,应用倾向性评分(Propensity score)方法从两组病例中各按1：1比例匹配141例患者与一站式复合技术组患者进行配对,分为一站式复合技术组(Hybrid组),CABG组和PCI组。采用欧洲心脏手术风险评分(European system for cardiac operative risk evaluation EuroSCORE),冠状动脉解剖评分(SYNTAX评分)对三组患者进行风险分层。研究终点为患者随访期间的免于主要心脏或脑血管不良事件(Major adverse cardiac and cerebrovascular event, MACCE)发生率,包括全因死亡、心肌梗死、脑血管事件和目标血管再血管化,同时通过比较院内及随访1年后总体治疗费用,探讨三种不同治疗方式的效费比。计量资料采用t检验或者Wilcoxon秩和检验,计数资料采用卡方检验或者Fisher精确检验,等级资料应用Wilcoxon秩和检验。应用Kaplan-meier法进行生存分析。p<0.05认为有统计学差异。
结果：三组患者术前主要临床资料和冠状动脉造影资料没有统计学差异；三组患者均有前降支病变。经过平均3.1年的随访,Hybrid组与CABG组相比MACCE发生率没有显著差异(p=0.25),但与PCI组相比MACCE发生率明显降低(p=0.004)。EuroSCORE分层结果显示：Hybrid组与CABG组及PCI组相比在低危组(p=0.38和p=0.63)和中危组没有显著差异(p=0.87和p=0.2),但在高危组Hybrid组临床效果明显优于CABG组(p=0.02)和PCI治疗组(p=0.01)。SYNTAX分层结果显示Hybrid组与CABG相比在各风险组均没有显著性差异,Hybrid组与PCI相比在低危组和中危组没有差别,但在高危组显著优于PCI(p=0.004)。效费比分析显示Hybrid组院内治疗费用高于CABG组,低于PCI组；但术后1年累计医疗费用明显低于PCI组,和CABG组没有显著性差异。
结论：
1.一站式复合技术在更小的创伤下,获得了与常规CABG相近的中期临床效果,在EuroSCORE高危组,一站式复合技术临床疗效优于常规CABG。
2.一站式复合技术与常规PCI相比,术后MACCE发生率明显降低,在EuroSCORE和SYNTAX评分高危组,一站式复合技术的中期临床效果明显优于PCI。
3.一站式复合技术院内花费高于CABG,中期总体效费比与CABG相似；一站式复合技术院内花费低于PCI,中期总体效费优于PCI。
背景：目前,对于复合技术冠状动脉血运重建术(Hybrid coronary revascularization, HCR)和非体外循环冠状动脉旁路移植术(Off-pump coronary artery bypass grafting, OPCAB)治疗冠状动脉多支病变的临床结果不一致。
目的：本文通过对现有已发表的对比HCR和OPCAB对多支冠脉病变疗效的研究进行荟萃分析,来评价两种治疗方式对多支冠脉病变疗效的安全性和有效性的差异。
方法：全面检索PubMed、EMBASE、Cochrane library等文献数据库及AHA、ACC、 ESC、AATS、EACS历年会议摘要,纳入目前已发表的所有对比药物涂层支架和冠状动脉旁路移植对左主干病变疗效的临床研究。检索年限为1996年4月至2010年12月。对纳入研究的结果进行荟萃分析,观察终点为(1)术后30天死亡、心肌梗死、脑血管事件、再血管化事件；(2)随访1年主要心脑血管不良事件(major adverse cardiac and cerebral events MACCE),包括全因死亡、心肌梗死、脑血管事件、再血管化事件。
结果：共7个研究5695名患者被纳入本研究。复合技术组和非体外冠状动脉旁路移植组术后30天和1年的死亡率没有统计学差异,复合技术组和非体外冠状动脉旁路移植组的比值比(OR)及95%可信区间(95%CI)分别为：30天(OR,0.88；95%CI,0.31-2.55,P=0.82)；1年(OR,0.23；95%CI,0.05-1.06,P=0.06)。复合技术组和非体外冠状动脉旁路移植组MACCE的发生率也相似的,复合技术组和非体外冠状动脉旁路移植组的比值比及95%可信区间分别为：30天(OR,0.65；95%CI,0.33-1.29,P=0.06)1年(OR,0.33；95%CI,0.11-1.01,P=0.052)。
结论：对现有文献进行的荟萃分析显示：复合技术冠状动脉血运重建与非体外循环冠状动脉旁路移植术治疗冠状动脉多支病变的安全性和有效性没有显著性差异。复合技术与非体外循环冠状动脉旁路移植术相比具有更明显的微创优势,但现有的文献中相应的评价不充分。
Background:One stop hybrid coronary revascularization (HCR) combines the best of minimal invasive direct coronary artery bypass grafting (MIDCAB) and percutaneous coronary intervention (PCI) for the treatment of coronary artery multivessel disease, in order to achieve the minimally invasive and completely revascularization treatment.
Objective:We retrospectively analysis the midterm outcomes of one-stop hybrid coronary revascularization compared with coronary artery bypass grafting (CABG) and PCI, and compared the cost-effectiveness between the three groups.
Methods:141patients with multivessel disease underwent one-stop hybrid coronary revascularization at our institution between June2007and December2010. And we identified patients who had undergone CABG (n=141) and PCI (n=141) by propensity-matched method during the same period. Those patients were stratified into three tertiles according to SYNTAX score and EuroSCORE. We compared major adverse cardiac and cerebrovascular events (MACCE include death, myocardial infarction, stroke or target vessel revascularization) and cost-effectiveness during follow-up among the patients. Continuous data are expressed as mean±standard deviation and categoric data as frequency and percentage. Mean values of continuous variables were compared by using the Student t test for variables that were not normal distribution and the Wilcoxon rank sum tests for variables that were not normal distributed. Categoric variables were compared using the chi-square test between groups. The Fisher exact and the Mann-Whitney tests were used when appropriate. Kaplan-Meier methodology was used to calculate actuarial freedom from endpoints. A p value of less than0.05was considered statistically significant.
Results:The clinical and angiographic baseline characteristics were similar between the three groups. According to the results of coronary artery angiography, all patients in three groups have left anterior descending artery disease. At a mean follow-up of3.1years, hybrid was associated with similar rates of MACCE for patients with multivessel disease compared with CABG, but was significantly lower than PCI. The rates of MACCE were similar among patients with low and medium EuroSCOR. But in comparison with CABG and PCI, patients with high EuroSCORE who underwent hybrid had lower rates of MACCE (p=0.02and p=0.01). Hybrid was associated with similar rates of MACCE compared with CABG in each risk tertile of SYNTAX score. Compared with PCI according to SYNTAX score category, hybrid had similar rates of MACCE in low and medium tertile (p=0.34and p=0.13) but significantly lower in high risk tertile (p=0.004). The results of cost-effectiveness showed that treatment costs in hospital of hybrid were higher than CABG, but lower than PCI. At1year, hybrid was associated with lower additional direct costs per patient compared with CABG and PCI.
Conclusions:
1. The outcomes of one stop hybrid procedure were similar with CABG; in EuroSCORE high-risk group, it clinical outcomes were better than conventional CABG.
2. Compared with PCI, one stop hybrid procedure significantly reduced MACCE incidence, and in EuroSCORE and SYNTAX score high-risk group, it's mid-term clinical effect was obviously better.
3. one stop hybrid procedure consumed more resources in hospital than CABG, but the cost-effectiveness were similar in mid-term; one stop hybrid coronary revascularization procedure consumed less resources in hospital and in mid-term than PCI.
Background:The clinical outcomes for multivessel coronary artery disease between hybrid coronary revascularization (HCR) and off-pump coronary artery bypass grafting (OPCAB) are still controversial.
Objective:The present study was to make a meta-analysis of all current available studies which compare HCR with OPCAB for and assess was safety and efficacy between HCR and OPCAB for multivessel coronary disease.
Methods:Electronic databases PubMed、EMBASE、Cochrane library and abstract of AHA、ACC、ESC、AATS、EACS were systematically searched. All researches which compared the clinical outcome between hybrid and OPCAB were included in the present study. The search period varied from April1996to December2010. The endpoint includes (1) death, myocardial infarction, cerebravascular event; target vessel repeated revascularization within30days,(2) MACCE (death,myocardial infarction, cerebravascular event; target vessel repeated revascularization) events during one year follow-up.
Results:Eight studies with5,479patients were finally involved in the present study. The mortality was similar in hybrid and OPCAB groups at30days [odds ratio (95%confidence interval):0.88(0.31-2.55), P=0.82], and one year [0.23(0.05-1.06), P=0.06]. No significant difference was found between hybrid and OPCAB in the risk of MACCE at30days after surgery and during1year's follow up [30days, 1.35(0.33-1.29) P=0.06; one year,0.33(0.11-1.01) P=0.052].
Conclusion:Our meta-analysis demonstrated that there were no significant differences in the safety between hybrid coronary revascularization and off-pump coronary artery bypass grafting in patients with multivessel coronary disease in the one year after intervention.
目的：比较一站式复合技术与冠状动脉旁路移植术(Coronary artery bypass grafting CABG)及PCI治疗冠状动脉多支病变患者的中期临床结果和效费比,探讨一站式复合技术的最佳受益人群。
方法：自2007年6月至2010年12月,共有141例冠状动脉多支病变患者在阜外心血管病医院接受一站式复合冠状动脉血运重建术。同期5797例实施单纯CABG,4294例实施PCI,均为包含前降支在内的冠状动脉多支病变患者,应用倾向性评分(Propensity score)方法从两组病例中各按1：1比例匹配141例患者与一站式复合技术组患者进行配对,分为一站式复合技术组(Hybrid组),CABG组和PCI组。采用欧洲心脏手术风险评分(European system for cardiac operative risk evaluation EuroSCORE),冠状动脉解剖评分(SYNTAX评分)对三组患者进行风险分层。研究终点为患者随访期间的免于主要心脏或脑血管不良事件(Major adverse cardiac and cerebrovascular event, MACCE)发生率,包括全因死亡、心肌梗死、脑血管事件和目标血管再血管化,同时通过比较院内及随访1年后总体治疗费用,探讨三种不同治疗方式的效费比。计量资料采用t检验或者Wilcoxon秩和检验,计数资料采用卡方检验或者Fisher精确检验,等级资料应用Wilcoxon秩和检验。应用Kaplan-meier法进行生存分析。p<0.05认为有统计学差异。
结果：三组患者术前主要临床资料和冠状动脉造影资料没有统计学差异；三组患者均有前降支病变。经过平均3.1年的随访,Hybrid组与CABG组相比MACCE发生率没有显著差异(p=0.25),但与PCI组相比MACCE发生率明显降低(p=0.004)。EuroSCORE分层结果显示：Hybrid组与CABG组及PCI组相比在低危组(p=0.38和p=0.63)和中危组没有显著差异(p=0.87和p=0.2),但在高危组Hybrid组临床效果明显优于CABG组(p=0.02)和PCI治疗组(p=0.01)。SYNTAX分层结果显示Hybrid组与CABG相比在各风险组均没有显著性差异,Hybrid组与PCI相比在低危组和中危组没有差别,但在高危组显著优于PCI(p=0.004)。效费比分析显示Hybrid组院内治疗费用高于CABG组,低于PCI组；但术后1年累计医疗费用明显低于PCI组,和CABG组没有显著性差异。
结论：
1.一站式复合技术在更小的创伤下,获得了与常规CABG相近的中期临床效果,在EuroSCORE高危组,一站式复合技术临床疗效优于常规CABG。
2.一站式复合技术与常规PCI相比,术后MACCE发生率明显降低,在EuroSCORE和SYNTAX评分高危组,一站式复合技术的中期临床效果明显优于PCI。
3.一站式复合技术院内花费高于CABG,中期总体效费比与CABG相似；一站式复合技术院内花费低于PCI,中期总体效费优于PCI。
背景：目前,对于复合技术冠状动脉血运重建术(Hybrid coronary revascularization, HCR)和非体外循环冠状动脉旁路移植术(Off-pump coronary artery bypass grafting, OPCAB)治疗冠状动脉多支病变的临床结果不一致。
目的：本文通过对现有已发表的对比HCR和OPCAB对多支冠脉病变疗效的研究进行荟萃分析,来评价两种治疗方式对多支冠脉病变疗效的安全性和有效性的差异。
方法：全面检索PubMed、EMBASE、Cochrane library等文献数据库及AHA、ACC、 ESC、AATS、EACS历年会议摘要,纳入目前已发表的所有对比药物涂层支架和冠状动脉旁路移植对左主干病变疗效的临床研究。检索年限为1996年4月至2010年12月。对纳入研究的结果进行荟萃分析,观察终点为(1)术后30天死亡、心肌梗死、脑血管事件、再血管化事件；(2)随访1年主要心脑血管不良事件(major adverse cardiac and cerebral events MACCE),包括全因死亡、心肌梗死、脑血管事件、再血管化事件。
结果：共7个研究5695名患者被纳入本研究。复合技术组和非体外冠状动脉旁路移植组术后30天和1年的死亡率没有统计学差异,复合技术组和非体外冠状动脉旁路移植组的比值比(OR)及95%可信区间(95%CI)分别为：30天(OR,0.88；95%CI,0.31-2.55,P=0.82)；1年(OR,0.23；95%CI,0.05-1.06,P=0.06)。复合技术组和非体外冠状动脉旁路移植组MACCE的发生率也相似的,复合技术组和非体外冠状动脉旁路移植组的比值比及95%可信区间分别为：30天(OR,0.65；95%CI,0.33-1.29,P=0.06)1年(OR,0.33；95%CI,0.11-1.01,P=0.052)。
结论：对现有文献进行的荟萃分析显示：复合技术冠状动脉血运重建与非体外循环冠状动脉旁路移植术治疗冠状动脉多支病变的安全性和有效性没有显著性差异。复合技术与非体外循环冠状动脉旁路移植术相比具有更明显的微创优势,但现有的文献中相应的评价不充分。
Background:One stop hybrid coronary revascularization (HCR) combines the best of minimal invasive direct coronary artery bypass grafting (MIDCAB) and percutaneous coronary intervention (PCI) for the treatment of coronary artery multivessel disease, in order to achieve the minimally invasive and completely revascularization treatment.
Objective:We retrospectively analysis the midterm outcomes of one-stop hybrid coronary revascularization compared with coronary artery bypass grafting (CABG) and PCI, and compared the cost-effectiveness between the three groups.
Methods:141patients with multivessel disease underwent one-stop hybrid coronary revascularization at our institution between June2007and December2010. And we identified patients who had undergone CABG (n=141) and PCI (n=141) by propensity-matched method during the same period. Those patients were stratified into three tertiles according to SYNTAX score and EuroSCORE. We compared major adverse cardiac and cerebrovascular events (MACCE include death, myocardial infarction, stroke or target vessel revascularization) and cost-effectiveness during follow-up among the patients. Continuous data are expressed as mean±standard deviation and categoric data as frequency and percentage. Mean values of continuous variables were compared by using the Student t test for variables that were not normal distribution and the Wilcoxon rank sum tests for variables that were not normal distributed. Categoric variables were compared using the chi-square test between groups. The Fisher exact and the Mann-Whitney tests were used when appropriate. Kaplan-Meier methodology was used to calculate actuarial freedom from endpoints. A p value of less than0.05was considered statistically significant.
Results:The clinical and angiographic baseline characteristics were similar between the three groups. According to the results of coronary artery angiography, all patients in three groups have left anterior descending artery disease. At a mean follow-up of3.1years, hybrid was associated with similar rates of MACCE for patients with multivessel disease compared with CABG, but was significantly lower than PCI. The rates of MACCE were similar among patients with low and medium EuroSCOR. But in comparison with CABG and PCI, patients with high EuroSCORE who underwent hybrid had lower rates of MACCE (p=0.02and p=0.01). Hybrid was associated with similar rates of MACCE compared with CABG in each risk tertile of SYNTAX score. Compared with PCI according to SYNTAX score category, hybrid had similar rates of MACCE in low and medium tertile (p=0.34and p=0.13) but significantly lower in high risk tertile (p=0.004). The results of cost-effectiveness showed that treatment costs in hospital of hybrid were higher than CABG, but lower than PCI. At1year, hybrid was associated with lower additional direct costs per patient compared with CABG and PCI.
Conclusions:
1. The outcomes of one stop hybrid procedure were similar with CABG; in EuroSCORE high-risk group, it clinical outcomes were better than conventional CABG.
2. Compared with PCI, one stop hybrid procedure significantly reduced MACCE incidence, and in EuroSCORE and SYNTAX score high-risk group, it's mid-term clinical effect was obviously better.
3. one stop hybrid procedure consumed more resources in hospital than CABG, but the cost-effectiveness were similar in mid-term; one stop hybrid coronary revascularization procedure consumed less resources in hospital and in mid-term than PCI.
Background:The clinical outcomes for multivessel coronary artery disease between hybrid coronary revascularization (HCR) and off-pump coronary artery bypass grafting (OPCAB) are still controversial.
Objective:The present study was to make a meta-analysis of all current available studies which compare HCR with OPCAB for and assess was safety and efficacy between HCR and OPCAB for multivessel coronary disease.
Methods:Electronic databases PubMed、EMBASE、Cochrane library and abstract of AHA、ACC、ESC、AATS、EACS were systematically searched. All researches which compared the clinical outcome between hybrid and OPCAB were included in the present study. The search period varied from April1996to December2010. The endpoint includes (1) death, myocardial infarction, cerebravascular event; target vessel repeated revascularization within30days,(2) MACCE (death,myocardial infarction, cerebravascular event; target vessel repeated revascularization) events during one year follow-up.
Results:Eight studies with5,479patients were finally involved in the present study. The mortality was similar in hybrid and OPCAB groups at30days [odds ratio (95%confidence interval):0.88(0.31-2.55), P=0.82], and one year [0.23(0.05-1.06), P=0.06]. No significant difference was found between hybrid and OPCAB in the risk of MACCE at30days after surgery and during1year's follow up [30days, 1.35(0.33-1.29) P=0.06; one year,0.33(0.11-1.01) P=0.052].
Conclusion:Our meta-analysis demonstrated that there were no significant differences in the safety between hybrid coronary revascularization and off-pump coronary artery bypass grafting in patients with multivessel coronary disease in the one year after intervention.
引文
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