Department of Medicine, Veterans Affairs (VA) Medical Center, Minneapolis, Minnesota.
Center of Innovation for Complex Chronic Healthcare, VA Medical Center, Hines, Illinois.
JAMA Surg. 2016 Dec 1;151(12):1139-1144. doi: 10.1001/jamasurg.2016.2783.
Because of the similarity in clinical outcomes after elective open and endovascular repair of abdominal aortic aneurysm (AAA), cost may be an important factor in choosing a procedure.
To compare total and AAA-related use of health care services, costs, and cost-effectiveness between groups randomized to open or endovascular repair.
DESIGN, SETTING, AND PARTICIPANTS: This unblinded randomized clinical trial enrolled 881 patients undergoing planned elective repair of AAA who were candidates for open and endovascular repair procedures. Patients were randomized from October 15, 2002, to April 15, 2008, at 42 Veterans Affairs medical centers. Follow-up was completed on October 15, 2011, and data were analyzed from April 15, 2013, to April 15, 2016, based on intention to treat.
Mean total and AAA-related health care cost per life-year and per quality-adjusted life-year (QALY).
A total of 881 patients (876 men [99.4%]; 5 women [0.6%]; mean [SD] age, 70 [7.8] years) were included in the analysis. After a mean of 5.2 years of follow-up, mean life-years were 4.89 in the endovascular group and 4.84 in the open repair group (P = .68), and mean QALYs were 3.72 in the endovascular group and 3.70 in the open repair group (P = .82). Total mean health care costs did not differ significantly between the 2 groups (endovascular group, $142 745; open repair group, $153 533; difference, -$10 788; 95% CI, -$29 796 to $5825; P = .25). Costs related to AAA, including the initial repair, constituted nearly 40% of total costs and did not differ significantly between the 2 groups (endovascular group, $57 501; open repair group, $57 893; difference, -$393; 95% CI, -$12 071 to $7928; P = .94). Lower costs due to shorter hospitalization for initial endovascular repair were offset by increased costs from AAA-related secondary procedures and imaging studies. The probability of endovascular repair being less costly and more effective was 56.8% when effectiveness was measured in life-years and 55.4% when effectiveness was measured in QALYs for total costs and 31.3% and 34.3%, respectively, for AAA-related costs.
In this multicenter randomized clinical trial with follow-up to 9 years, survival, quality of life, costs, and cost-effectiveness did not differ between elective open and endovascular repair of AAA.
clinicaltrials.gov Identifier: NCT00094575.
由于择期开放和血管内修复腹主动脉瘤（AAA）后的临床结局相似，成本可能是选择手术的一个重要因素。
比较开放和血管内修复组之间总医疗服务和 AAA 相关的使用情况、成本和成本效益。
设计、设置和参与者：这项非盲随机临床试验纳入了 881 名计划择期修复 AAA 的患者，这些患者适合开放和血管内修复手术。2002 年 10 月 15 日至 2008 年 4 月 15 日期间，在 42 家退伍军人事务医疗中心对患者进行随机分组。2011 年 10 月 15 日完成随访，基于意向治疗分析于 2013 年 4 月 15 日至 2016 年 4 月 15 日进行数据分析。
每例生命年和每例质量调整生命年（QALY）的平均总医疗成本和 AAA 相关医疗成本。
共有 881 例患者（876 例男性[99.4%]；5 例女性[0.6%]；平均[标准差]年龄为 70[7.8]岁）纳入分析。平均随访 5.2 年后，血管内组的平均寿命为 4.89 年，开放修复组为 4.84 年（P = .68），血管内组的平均 QALY 为 3.72 年，开放修复组为 3.70 年（P = .82）。两组间总医疗成本无显著差异（血管内组 142745 美元；开放修复组 153533 美元；差异-10788 美元；95%CI，-29796 美元至 5825 美元；P = .25）。与 AAA 相关的成本（包括初次修复）占总成本的近 40%，两组间无显著差异（血管内组 57501 美元；开放修复组 57893 美元；差异-393 美元；95%CI，-12071 美元至 7928 美元；P = .94）。初次血管内修复住院时间较短导致成本降低，但 AAA 相关二次手术和影像学检查导致成本增加。以生命年衡量，血管内修复更具成本效益的概率为 56.8%，以 QALY 衡量，概率为 55.4%，总成本的概率分别为 31.3%和 34.3%，AAA 相关成本的概率分别为 31.3%和 34.3%。
在这项多中心随机临床试验中，对 881 例患者进行了 9 年的随访，择期开放和血管内修复 AAA 的生存、生活质量、成本和成本效益无差异。
clinicaltrials.gov 标识符：NCT00094575。
