Paravastu Sharath Chandra Vikram, Jayarajasingam Rubaraj, Cottam Rachel, Palfreyman Simon J, Michaels Jonathan A, Thomas Steven M
Academic Vascular Unit, The University of Sheffield, Regent Court, 30 Regent Street, Sheffield, UK, S1 4DA.
Cochrane Database Syst Rev. 2014 Jan 23;2014(1):CD004178. doi: 10.1002/14651858.CD004178.pub2.
An abnormal dilatation of the abdominal aorta is referred to as an abdominal aortic aneurysm (AAA). Due to the risk of rupture, surgical repair is offered electively to individuals with aneurysms greater than 5.5 cm in size. Traditionally, conventional open surgical repair (OSR) was considered the first choice approach. However, over the past two decades endovascular aneurysm repair (EVAR) has gained popularity as a treatment option. This article intends to review the role of EVAR in the management of elective AAA.
To assess the effectiveness of EVAR versus conventional OSR in individuals with AAA considered fit for surgery, and EVAR versus best medical care in those considered unfit for surgery. This was determined by the effect on short, intermediate and long-term mortality, endograft related complications, re-intervention rates and major complications.
The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Specialised Register (January 2013) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2012, Issue 12). The TSC also searched trial databases for details of ongoing or unpublished studies.
Prospective randomised controlled trials (RCTs) comparing EVAR with OSR in individuals with AAA considered fit for surgery. and comparing EVAR with best medical care in individuals considered unfit for surgery. We excluded studies with inadequate data or using an inadequate randomisation technique.
Three reviewers independently evaluated trials for appropriateness for inclusion and extracted data using pro forma designed by the Cochrane PVD Group. We assessed the quality of trials using The Cochrane Collaboration's 'Risk of bias' tool. We entered collected data in to Review Manager (version 5.2.3) for analysis. Where direct comparisons could be made, we determined odds ratios (OR). We tested studies for heterogeneity and, when present, we used a random-effects model; otherwise we used a fixed-effect model. We tabulated data that could not be collated.
Four high-quality trials comparing EVAR with OSR (n = 2790) and one high-quality trial comparing EVAR with no intervention (n = 404) fulfilled the inclusion criteria. In individuals considered fit for surgery, a pooled analysis, including 1362 individuals randomised to EVAR and 1361 randomised to OSR, found short-term mortality (including 30-day or inhospital mortality, excluding deaths prior to intervention) with EVAR to be significantly lower than with OSR (1.4% versus 4.2%, OR 0.33, 95% confidence interval (CI) 0.20 to 0.55; P < 0.0001). Using intention-to-treat analysis (ITT) there was no significant difference in mortality at intermediate follow-up (up to four years from randomisation), with 221 (15.8%) and 237 (17%) deaths in the EVAR (n = 1393) and OSR (n = 1390) groups, respectively (OR 0.92, 95% CI 0.75 to 1.12; P = 0.40). There was also no significant difference in long-term mortality (beyond four years), with 464 (37.3%) deaths in the EVAR and 470 (37.8%) deaths in the OSR group (OR 0.98, 95% CI 0.83 to 1.15; P = 0.78). Similarly, there was no significant difference in aneurysm-related mortality between groups, either at the intermediate- or long-term follow up.Studies showed that both EVAR and OSR were associated with similar incidences of cardiac deaths (OR 1.14, 95% CI 0.86 to 1.52; P = 0.36) and fatal stroke rate (OR 0.81, 95% CI 0.42 to 1.55; P = 0.52). The long-term reintervention rate was significantly higher in the EVAR group than in the OSR group (OR 1.98, 95% CI 1.12 to 3.51; P = 0.02; I(2) = 85%). Results of the reintervention analysis should be interpreted with caution due to significant heterogeneity. Operative complications, health-related quality of life and sexual dysfunction were generally comparable between the EVAR and OSR groups. However, there was a slightly higher incidence of pulmonary complications in the OSR group compared with the EVAR group (OR 0.36, 95% CI 0.17 to 0.75; P = 0.006).In individuals considered unfit for conventional OSR, the one included trial found no difference between the EVAR and no-intervention groups with regard to all-cause mortality at final follow up, with 21.0 deaths per 100 person-years in the EVAR group and 22.1 deaths per 100 person years in the no-intervention group (adjusted hazard ratio (HR) with EVAR 0.99, 95% CI 0.78 to 1.27; P = 0.97). Aneurysm-related deaths were, however, significantly higher in the no-intervention group than in the EVAR group (adjusted HR 0.53, 95% CI 0.32 to 0.89; P = 0.02). There was no difference in myocardial events (HR 1.07, 95% CI 0.60 to 1.91) between the groups in this study.
AUTHORS' CONCLUSIONS: In individuals considered fit for conventional surgery, EVAR was associated with lower short-term mortality than OSR. However, this benefit from EVAR did not persist at the intermediate- and long-term follow ups. Individuals undergoing EVAR had a higher reintervention rate than those undergoing OSR. Most of the reinterventions undertaken following EVAR, however, were catheter-based interventions associated with low mortality. Operative complications, health-related quality of life and sexual dysfunction were generally comparable between EVAR and OSR. However, there was a slightly higher incidence of pulmonary complications in the OSR group than in the EVAR group.In individuals considered unfit for open surgery, the results of a single trial found no overall short- or long-term benefits of EVAR over no intervention with regard to all-cause mortality, but individuals may differ and individual preferences should always be taken into account.
腹主动脉异常扩张被称为腹主动脉瘤（AAA）。由于存在破裂风险，对于动脉瘤直径大于5.5厘米的患者，通常会择期进行手术修复。传统上，传统开放手术修复（OSR）被视为首选方法。然而，在过去二十年中，血管内动脉瘤修复（EVAR）作为一种治疗选择越来越受欢迎。本文旨在综述EVAR在择期AAA治疗中的作用。
评估在适合手术的AAA患者中，EVAR与传统OSR相比的有效性，以及在不适合手术的患者中，EVAR与最佳药物治疗相比的有效性。这通过对短期、中期和长期死亡率、血管内移植物相关并发症、再次干预率和主要并发症的影响来确定。
Cochrane外周血管疾病组试验搜索协调员（TSC）检索了专业注册库（2013年1月）和Cochrane对照试验中央注册库（CENTRAL）（2012年，第12期）。TSC还检索了试验数据库，以获取正在进行或未发表研究的详细信息。
前瞻性随机对照试验（RCT），比较适合手术的AAA患者中EVAR与OSR，以及不适合手术的患者中EVAR与最佳药物治疗。我们排除了数据不足或使用不充分随机化技术的研究。
三位评审员独立评估试验是否适合纳入，并使用Cochrane PVD组设计的表格提取数据。我们使用Cochrane协作网的“偏倚风险”工具评估试验质量。我们将收集到的数据输入Review Manager（版本5.2.3）进行分析。在可以进行直接比较的情况下，我们确定比值比（OR）。我们对研究进行异质性检验，如有异质性，我们使用随机效应模型；否则我们使用固定效应模型。我们将无法整理的数据制成表格。
四项比较EVAR与OSR的高质量试验（n = 2790）和一项比较EVAR与无干预的高质量试验（n = 404）符合纳入标准。在适合手术的患者中，一项汇总分析包括1362例随机接受EVAR的患者和1361例随机接受OSR的患者，发现EVAR的短期死亡率（包括30天或住院死亡率，不包括干预前死亡）显著低于OSR（1.4%对4.2%，OR 0.33，95%置信区间（CI）0.20至0.55；P < 0.0001）。使用意向性分析（ITT），中期随访（随机分组后长达四年）死亡率无显著差异，EVAR组（n = 1393）有221例（15.8%）死亡，OSR组（n = 1390）有237例（17%）死亡（OR 0.92，95% CI 0.75至1.12；P = 0.40）。长期死亡率（四年后）也无显著差异，EVAR组有464例（37.3%）死亡，OSR组有470例（37.8%）死亡（OR 0.98，95% CI 0.83至1.15；P = 0.78）。同样，在中期或长期随访中，两组之间动脉瘤相关死亡率也无显著差异。研究表明，EVAR和OSR的心脏死亡发生率（OR 1.14，95% CI 0.86至1.52；P = 0.36）和致命性卒中率（OR 0.81，95% CI 0.42至1.55；P = 0.52）相似。EVAR组的长期再次干预率显著高于OSR组（OR 1.98，95% CI 1.12至3.51；P = 0.02；I(2)=85%）。由于显著的异质性，再次干预分析结果应谨慎解释。EVAR组和OSR组的手术并发症、健康相关生活质量和性功能障碍总体相当。然而，OSR组的肺部并发症发生率略高于EVAR组（OR 0.36，95% CI 0.17至0.75；P = 0.006）。在不适合传统OSR的患者中，纳入的一项试验发现，EVAR组和无干预组在最终随访时全因死亡率无差异，EVAR组每100人年有21.0例死亡，无干预组每100人年有22.1例死亡（EVAR调整后危险比（HR）0.99，95% CI 0.78至1.27；P = 0.97）。然而，无干预组的动脉瘤相关死亡显著高于EVAR组（调整后HR 0.53，95% CI 0.32至0.89；P = 0.02）。本研究中两组之间心肌事件无差异（HR 1.07，95% CI 0.60至1.91）。
在适合传统手术的患者中，EVAR与低于OSR的短期死亡率相关。然而，EVAR的这一益处在中期和长期随访中并未持续。接受EVAR的患者再次干预率高于接受OSR的患者。然而，EVAR后进行的大多数再次干预是基于导管的干预，死亡率较低。EVAR组和OSR组的手术并发症、健康相关生活质量和性功能障碍总体相当。然而，OSR组的肺部并发症发生率略高于EVAR组。在不适合开放手术的患者中，一项试验的结果发现，就全因死亡率而言，EVAR与无干预相比没有总体短期或长期益处，但个体可能存在差异，应始终考虑个体偏好。
