Leurs L J, Buth J, Harris P L, Blankensteijn J D
EUROSTAR Data Registry Center, Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands.
Eur J Vasc Endovasc Surg. 2007 Feb;33(2):172-6. doi: 10.1016/j.ejvs.2006.09.011. Epub 2006 Nov 9.
Patients with abdominal aortic aneurysm (AAA) can be treated by transfemoral endovascular intervention and by conventional open surgery. Level-one evidence of the safety and efficacy of one treatment mode over the other is only provided by a randomised controlled trial (RCT). Results reported by voluntary registries are considered less valid than data from RCTs. On the other hand the outcome of a RCT may not be generalisable to the common practice because of vigorous selection of patients and institutions.
The outcomes reported by the Dutch Randomized Endovascular Aneurysm Management (DREAM) trial were compared with the results of the EURopean collaborators on Stent-graft techniques for AAA Repair (EUROSTAR) registry.
To obtain comparable study groups with regard to risk factors equal proportions of ASA I, II and III patients as observed in the endovascular arm of the DREAMtrial were selected at random from the EUROSTAR-registry. All patients had an aneurysm of at least 50mm. Only patients, who had been enrolled into the registry from 1999, were selected to avoid the influence of first generation endografts which are not longer in use. Patient characteristics and outcomes of endovascular AAA repair (EVAR) of EUROSTAR and DREAM-trial participants were compared. Differences in early findings between study groups were assessed by Chi-Square tests for discrete variables and by Wilcoxon rank sum tests for continuous variables. Follow-up variables were analysed by Kaplan-Meier and Cox proportional hazard models.
Data of 177 patients of the DREAM trial with randomization to EVAR and 856 patients selected in the EUROSTAR-registry were compared. Baseline characteristics were comparable between the EUROSTAR-cohort and EVAR-arm of the DREAM-trial. The 36-month survival-rate was 87.6% for EVAR-arm in the DREAM-trial similar to the 86.8% found in this EUROSTAR-study population. The freedom of secondary procedures reached after 3 years 85.7%, and 86.9% in the DREAM and EUROSTAR-cohort, respectively.
We found comparable characteristics and outcomes between patients of comparable risk class of the EUROSTAR-registry and the EVAR-cohort of the DREAM-trial. This demonstrates the following: first, the EUROSTAR-data provide reliable information, and further comparisons of registry data with patients treated by conventional AAA surgery may be justified. Secondly, the various outcomes of the randomised DREAM trial appear generalisable, as it agrees with observations in a broad common practice derived database.
腹主动脉瘤（AAA）患者可通过经股动脉血管内介入治疗和传统开放手术进行治疗。只有随机对照试验（RCT）才能提供一种治疗模式相对于另一种治疗模式安全性和有效性的一级证据。自愿登记处报告的结果被认为不如RCT数据有效。另一方面，由于对患者和机构进行了严格筛选，RCT的结果可能无法推广到常规临床实践中。
比较荷兰随机血管内动脉瘤管理（DREAM）试验报告的结果与欧洲AAA修复支架移植物技术协作组（EUROSTAR）登记处的结果。
为了获得在危险因素方面具有可比性的研究组，从EUROSTAR登记处随机选择与DREAM试验血管内治疗组中观察到的ASA I、II和III级患者比例相同的患者。所有患者的动脉瘤直径至少为50mm。仅选择1999年以后登记入册的患者，以避免不再使用的第一代血管内移植物的影响。比较EUROSTAR和DREAM试验参与者的患者特征及血管内AAA修复（EVAR）的结果。研究组之间早期结果的差异通过离散变量的卡方检验和连续变量的Wilcoxon秩和检验进行评估。随访变量通过Kaplan-Meier和Cox比例风险模型进行分析。
比较了DREAM试验中177例随机接受EVAR治疗的患者的数据与EUROSTAR登记处选择的856例患者的数据。EUROSTAR队列与DREAM试验的EVAR组之间的基线特征具有可比性。DREAM试验中EVAR组的36个月生存率为87.6%，与本EUROSTAR研究人群中发现的86.8%相似。3年后DREAM组和EUROSTAR队列的二次手术免做率分别达到85.7%和86.9%。
我们发现EUROSTAR登记处风险类别相当的患者与DREAM试验的EVAR组患者具有相似的特征和结果。这表明：第一，EUROSTAR数据提供了可靠的信息，进一步将登记处数据与接受传统AAA手术治疗的患者进行比较可能是合理的。第二，随机DREAM试验的各种结果似乎具有可推广性，因为它与来自广泛的常规临床实践数据库中的观察结果一致。
