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腹主动脉瘤开放手术与血管内治疗的长期结果:基于重构事件发生时间数据的系统评价和荟萃分析

Long-Term Outcomes of Open Versus Endovascular Treatment for Abdominal Aortic Aneurysm: Systematic Review and Meta-Analysis With Reconstructed Time-to-Event Data.

作者信息

Loufopoulos Georgios, Tasoudis Panagiotis, Koudounas Georgios, Zoupas Ioannis, Madouros Nikolaos, Sá Michel Pompeu, Karkos Christos D, Giannopoulos Stefanos, Tassiopoulos Apostolos K

机构信息

Cardiothoracic and Vascular Surgery Working Group, Society of Junior Doctors, Athens, Greece.

Department of Surgery, Saint-Imier Hospital, Saint-Imier, Switzerland.

出版信息

J Endovasc Ther. 2023 Oct 19:15266028231204805. doi: 10.1177/15266028231204805.

Abstract

BACKGROUND

The advent of endovascular techniques has revolutionized the care of patients with uncomplicated abdominal aortic aneurysms. This analysis compares the overall survival and the freedom from reintervention rate between open surgical repair (OSR) and endovascular repair (EVAR) in patients undergoing elective abdominal aortic aneurysm (AAA) repair.

METHODS

PubMed, Scopus, and Cochrane databases were searched for studies including patients who underwent either OSR or EVAR for uncomplicated AAA. All randomized controlled trials and propensity-score-matched cohort studies reporting on the outcomes of interest were considered eligible for inclusion. The systematic search of the literature was performed by 2 independent investigators in accordance with the recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. We conducted 1-stage and 2-stage meta-analyses with Kaplan-Meier-derived time-to-event data and meta-analysis with a random-effects model.

RESULTS

Thirteen studies met our eligibility criteria, incorporating 13 409 and 13 450 patients in the OSR and EVAR arms, respectively. Patients who underwent open repair had improved overall survival rates compared with those who underwent EVAR (hazard ratio [HR]=0.93, 95% confidence interval [CI]=0.88-0.98, p=0.004) during a mean follow-up of 53.8 (SD=29.8) months and this was validated by the 2-stage meta-analysis (HR=0.89, 95% CI=0.8-0.99, p=0.03, I=62.25%). Splitting timepoint analysis suggested that EVAR offers better survival outcome compared with OSR in the first 11 months following elective intervention (HR=1.37, 95% CI=1.22-1.54, p<0.0001), while OSR offers a significant survival advantage after the 11-month timepoint and up to 180 months (HR=0.84, 95% CI=0.8-0.89, p<0.0001). Similarly, freedom from reintervention was found to be significantly better in EVAR patients (HR=1.28, 95% CI=1.14-1.44, p<0.0001) within the first 30 days. After the first month postrepair, however, OSR demonstrated higher freedom-from-reintervention rates compared with EVAR that remained significant for up to 168 months during follow-up (HR=0.73, 95% CI=0.66-0.79, p<0.0001).

CONCLUSIONS

Despite the first-year survival advantage of EVAR in patients undergoing elective AAA repair, OSR was associated with a late survival benefit and decreased risk for reintervention in long-term follow-up.

CLINICAL IMPACT

Open surgical repair for uncomplicated abdominal aortic aneurysm offers better long-term outcomes in terms of survival and freedom from reintervention rate compared to the endovascular approach but in the first year it carries a higher risk of mortality. The novelty of our study lies that instead of comparing study-level effect estimates, we analyzed reconstructed individual patient-level data. This offered us the opportunity to perform our analyses with mathematically robust and flexible survival models, which was proved to be crucial since there was evidence of different hazard over time. Our findings underline the need for additional investigation to clarify the significance of open surgical repair when compared to the latest endovascular devices and techniques within the evolving era of minimally invasive procedures.

摘要

背景

血管内技术的出现彻底改变了单纯性腹主动脉瘤患者的治疗方式。本分析比较了接受择期腹主动脉瘤(AAA)修复的患者中,开放手术修复(OSR)和血管内修复(EVAR)之间的总生存率和再次干预率。

方法

检索PubMed、Scopus和Cochrane数据库,查找纳入接受OSR或EVAR治疗单纯性AAA患者的研究。所有报告感兴趣结局的随机对照试验和倾向评分匹配队列研究均被视为符合纳入标准。由2名独立研究人员按照系统评价和Meta分析的首选报告项目(PRISMA)声明的建议进行文献系统检索。我们使用Kaplan-Meier法推导的事件发生时间数据进行1阶段和2阶段Meta分析,并采用随机效应模型进行Meta分析。

结果

13项研究符合我们的纳入标准,OSR组和EVAR组分别纳入13409例和13450例患者。在平均53.8(标准差=29.8)个月的随访期间,接受开放修复的患者总生存率高于接受EVAR的患者(风险比[HR]=0.93,95%置信区间[CI]=0.88-0.98,p=0.004),2阶段Meta分析验证了这一结果(HR=0.89,95%CI=0.8-0.99,p=0.03,I²=62.25%)。时间点拆分分析表明,在择期干预后的前11个月,与OSR相比,EVAR的生存结局更好(HR=1.37,95%CI=1.22-1.54,p<0.0001),而在11个月时间点之后直至180个月,OSR具有显著的生存优势(HR=0.84,95%CI=0.8-0.89,p<0.0001)。同样,在术后前30天内,EVAR患者的再次干预率显著更低(HR=1.28,95%CI=1.14-1.44,p<0.0001)。然而,在修复后第一个月之后,与EVAR相比,OSR的再次干预率更高,在随访期间长达168个月仍具有显著性(HR=0.73,95%CI=0.66-0.79,p<0.0001)。

结论

尽管在接受择期AAA修复的患者中,EVAR在第一年具有生存优势,但在长期随访中,OSR具有晚期生存获益且再次干预风险降低。

临床意义

与血管内方法相比,单纯性腹主动脉瘤的开放手术修复在生存和再次干预率方面提供了更好的长期结局,但在第一年它具有更高的死亡风险。我们研究的新颖之处在于,我们不是比较研究水平的效应估计值,而是分析了重建的个体患者水平数据。这使我们有机会使用数学上稳健且灵活的生存模型进行分析,这被证明是至关重要的,因为有证据表明随时间推移风险不同。我们的研究结果强调,在微创程序不断发展的时代,与最新的血管内装置和技术相比,需要进行更多研究以阐明开放手术修复的意义。

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