Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial
Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial
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DOI：
10.1016/s0140-6736(04)16979-1
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发表时间：
2004-09-04
期刊：
影响因子：
168.9
通讯作者：
Thompson, SG
中科院分区：
文献类型：
--
作者：
Greenhalgh, RM;Brown, LC;Thompson, SG
背景腹主动脉瘤腔内修复术（EVAR）是一种在解剖结构合适时治疗腹主动脉瘤（AAA）患者的新技术。关于腔内修复术与传统开放手术相比如何存在不确定性。腹主动脉瘤腔内修复术试验1是煽动比较这些治疗的患者判断适合开放AAA repair.Methods之间，1999年和2003年，1082名择期（非急诊）患者随机接受腹主动脉瘤腔内修复术（n=543）或开放AAA修复术（n=539）。在41家精通腹主动脉瘤腔内修复术技术的英国医院招募了年龄至少60岁、动脉瘤直径5.5 cm或以上、适合开放手术修复（麻醉和医学上足够好）的患者参加研究。主要结果是全因死亡率，这些结果将于2005年公布。这里提出的主要分析是手术死亡率意向治疗和二次分析是在每协议patients.Findings患者（983名男性，99名女性）的平均年龄为74岁（SD 6）和平均AAA直径为6.5厘米（SD 1）。1047例（97%）患者接受了AAA修复术，1008例（93%）患者接受了分配的治疗。30-腹主动脉瘤腔内修复术组的日死亡率为1.7%（9/531），而开放修复术组为4.7%（24/516）（比值比0.35 [95% CI 0.16-0.77]，p=0.009）。根据符合方案分析，腹主动脉瘤腔内修复术的30天死亡率为1.6%（8/512），而开放修复术为4.6%（23/496）（0.33 [0.15-0.74]，p=0.007）。二次介入在腹主动脉瘤腔内修复术患者中更常见（9.8% vs 5.8%，p=0.02）。解释在大型AAA患者中，腹主动脉瘤腔内修复术治疗与开放性修复术相比，30天手术死亡率降低了三分之二。临床实践的任何变化都应等待持久性和长期结果。
Background Endovascular aneurysm repair (EVAR) is a new technology to treat patients with abdominal aortic aneurysm (AAA) when the anatomy is suitable. Uncertainty exists about how endovascular repair compares with conventional open surgery. EVAR trial 1 was instigated to compare these treatments in patients judged fit for open AAA repair.Methods Between 1999 and 2003, 1082 elective (non-emergency) patients were randomised to receive either EVAR (n=543) or open AAA repair (n=539). Patients aged at least 60 years with aneurysms of diameter 5.5 cm or more, who were fit enough for open surgical repair (anaesthetically and medically well enough for the procedure), were recruited for the study at 41 British hospitals proficient in the EVAR technique. The primary outcome measure is all-cause mortality and these results will be released in 2005. The primary analysis presented here is operative mortality by intention to treat and a secondary analysis was done in per-protocol patients.Findings Patients (983 men, 99 women) had a mean age of 74 years (SD 6) and mean AAA diameter of 6.5 cm (SD 1). 1047 (97%) patients underwent AAA repair and 1008 (93%) received their allocated treatment. 30-day mortality in the EVAR group was 1.7% (9/531) versus 4.7% (24/516) in the open repair group (odds ratio 0.35 [95% CI 0.16-0.77], p=0.009). By per-protocol analysis, 30-day mortality for EVAR was 1.6% (8/512) versus 4.6% (23/496) for open repair (0.33 [0.15-0.74], p=0.007). Secondary interventions were more common in patients allocated EVAR (9.8% vs 5.8%, p=0.02).Interpretation In patients with large AAAs, treatment by EVAR reduced the 30-day operative mortality by two-thirds compared with open repair. Any change in clinical practice should await durability and longer term results.