The UK endovascular aneurysm repair (EVAR) trials: Design, methodology and progress
The UK endovascular aneurysm repair (EVAR) trials: Design, methodology and progress
复制标题
DOI：
10.1016/j.ejvs.2003.12.019
复制
发表时间：
2004-04-01
影响因子：
5.7
通讯作者：
Greenhalgh, RM
中科院分区：
文献类型：
--
作者：
Brown, LC;Epstein, D;Greenhalgh, RM
目标.腹主动脉瘤腔内修复术（EVAR）试验旨在评估腹主动脉瘤腔内修复术治疗AAA的有效性，包括死亡率、生活质量、耐久性和成本效益。设计。评估年龄至少60岁、计算机断层扫描（CT）显示AAA直径至少5.5 cm的男性和女性患者腹主动脉瘤腔内修复术的解剖结构适用性。合适的患者可进入腹主动脉瘤腔内修复术试验1（如果他们被认为适合传统开放修复术）或腹主动脉瘤腔内修复术试验2（如果他们被认为不适合）。腹主动脉瘤腔内修复术1将患者随机分配至腹主动脉瘤腔内修复术或开放修复术，腹主动脉瘤腔内修复术2将患者随机分配至腹主动脉瘤腔内修复术联合最佳药物治疗或单独最佳药物治疗。腹主动脉瘤腔内修复术试验1和2的目标招募量分别为900例和280例患者。进展。招募于1999年9月开始，目前有40个英国中心参与试验。在腹主动脉瘤腔内修复术试验1中，截至2003年10月随机分配了1037例患者，超过了每月目标。腹主动脉瘤腔内修复术试验2也达到了每月目标，共有319名患者接受了随机化。当招募于2003年12月结束时，患者需要从手术开始至少随访1年。预计将于2005年年中公布这两项审判的全部结果。
Objectives. The endovascular aneurysm repair (EVAR) trials aim to assess the efficacy of EVAR in the treatment of AAA in terms of mortality, quality of life, durability and cost-effectiveness.Design. Male and female patients aged at least 60 years with an AAA diameter measuring at least 5.5 cm on a computed tomography (CT) scan are assessed for anatomical suitability for EVAR. Suitable patients are offered entry either into EVAR Trial 1 if they arc considered fit for conventional open repair or EVAR Trial 2 if they are considered unfit. EVAR 1 randomly allocates patients to EVAR or open repair and EVAR 2 randomly allocates patients to EVAR with best medical treatment or best medical treatment alone. Target recruitment for EVAR Trials 1 and 2 is 900 and 280 patients, respectively.Progress. Recruitment began in September 1999 and there are currently 40 UK centres participating in the trials. Monthly targets are being exceeded in EVAR Trial 1 with 1037 patients randomised by October 2003. EVAR Trial 2 is also meeting monthly targets with a total of 319 patients randomised. When recruitment closes in December 2003 patients will need to be followed for at least 1 year from their operation. Publication of full results for both trials is expected in mid 2005.