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随机对照 EVAR 试验 1 中腹主动脉瘤开放或血管内修复术后心血管事件和死亡的发生率。

Incidence of cardiovascular events and death after open or endovascular repair of abdominal aortic aneurysm in the randomized EVAR trial 1.

机构信息

Vascular Surgery Research Group, Imperial College, London, UK.

出版信息

Br J Surg. 2011 Jul;98(7):935-42. doi: 10.1002/bjs.7485. Epub 2011 Apr 11.

DOI:10.1002/bjs.7485
PMID:21484775
Abstract

BACKGROUND

The aim was to compare rates of myocardial infarction, stroke and cardiovascular death in patients with a large abdominal aortic aneurysm who had endovascular (EVAR) or open repair to determine whether cardiovascular mortality explains the convergence in survival curves after these procedures.

METHODS

Between 1999 and 2004, 1252 patients were randomized to EVAR or open repair in the UK EVAR trial 1. All patients were followed for death, myocardial infarction or stroke until September 2009. Cox regression was used to compare cardiovascular events and deaths between the randomized groups during different time intervals.

RESULTS

Over 5 years of follow-up, a total of 187 first non-fatal or fatal cardiovascular events (98 myocardial infarctions and 89 strokes) and 256 cardiovascular deaths occurred. Although the endovascular group had a lower cardiovascular event rate than the open repair group (2·6 versus 3·2 per 100 person-years respectively) this was not statistically significant (adjusted hazard ratio (HR) 0·83, 95 per cent confidence interval 0·62 to 1·10; P = 0·199). Overall, there was little difference in cardiovascular mortality between the randomized groups (adjusted HR 1·06, 0·83 to 1·36; P = 0·638), but a non-significant excess of cardiovascular deaths was apparent in the endovascular group during the 6-24-month interval (adjusted HR 1·44, 0·79 to 2·62; P = 0·237).

CONCLUSION

Patients who had EVAR appeared to have a lower subsequent cardiovascular event rate during all time intervals. Cardiovascular mortality was similar between the two groups overall, but more cardiovascular deaths in the EVAR group appeared to contribute to the convergence in all-cause mortality during the first 2 years.

摘要

背景

本研究旨在比较接受血管内(EVAR)或开放修复的大腹主动脉瘤患者的心肌梗死、卒中和心血管死亡发生率,以确定这些治疗后生存曲线趋同是否由心血管死亡率来解释。

方法

在 1999 年至 2004 年间,英国 EVAR 试验 1 中共有 1252 例患者被随机分配至 EVAR 或开放修复组。所有患者均随访至 2009 年 9 月,以记录死亡、心肌梗死或卒中等终点事件。Cox 回归用于比较随机分组患者在不同时间间隔的心血管事件和死亡情况。

结果

在 5 年的随访期间,共发生 187 例首发非致命性或致命性心血管事件(98 例心肌梗死和 89 例卒中等)和 256 例心血管死亡。尽管血管内组的心血管事件发生率低于开放修复组(分别为 2.6 和 3.2/100 人年),但差异无统计学意义(调整后风险比(HR)0.83,95%置信区间 0.62 至 1.10;P = 0.199)。总体而言,两组之间的心血管死亡率差异较小(调整后 HR 1.06,0.83 至 1.36;P = 0.638),但血管内组在 6-24 个月时的心血管死亡似乎有显著增加(调整后 HR 1.44,0.79 至 2.62;P = 0.237)。

结论

接受 EVAR 的患者在所有时间间隔内似乎都有较低的心血管事件发生率。两组之间的心血管死亡率总体上相似,但血管内组的心血管死亡人数似乎更多,这导致了前 2 年内全因死亡率的趋同。

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