IMPORTANCE The long-term benefits of off-pump ("beating heart") vs on-pump coronary artery bypass grafting (CABG) remain controversial. OBJECTIVE To evaluate the 10-year outcomes and costs of off-pump vs on-pump CABG in the Department of Veterans Affairs (VA) Randomized On/Off Bypass (ROOBY) trial. DESIGN, SETTING, AND PARTICIPANTS From February 27, 2002, to May 7, 2007, 2203 veterans in the ROOBY trial were randomly assigned to off-pump or on-pump CABG procedures at 18 participating VA medical centers. Per protocol, the veterans were observed for 10 years; the 10-year, post-CABG clinical outcomes and costs were assessed via centralized abstraction of electronic medical records combined with merges to VA and non-VA databases. With the use of an intention-to-treat approach, analyses were performed from May 7, 2017, to December 9, 2021. INTERVENTIONS On-pump and off-pump CABG procedures. MAIN OUTCOMES AND MEASURES The 10-year coprimary end points included all-cause death and a composite end point identifying patients who had died or had undergone subsequent revascularization (ie, percutaneous coronary intervention [PCI] or repeated CABG); these 2 end points were measured dichotomously and as time-to-event variables (ie, time to death and time to composite end points). Secondary 10-year end points included PCIs, repeated CABG procedures, changes in cardiac symptoms, and 2018-adjusted VA estimated costs. Changes from baseline to 10 years in post-CABG, clinically relevant cardiac symptoms were evaluated for New York Heart Association functional class, Canadian Cardiovascular Society angina class, and atrial fibrillation. Outcome differences were adjudicated by an end points committee. Given that pre-CABG risks were balanced, the protocol-driven primary and secondary hypotheses directly compared 10-year treatment-related effects. RESULTS A total of 1104 patients (1097 men [99.4%]; mean [SD] age, 63.0 [8.5] years) were enrolled in the off-pump group, and 1099 patients (1092 men [99.5%]; mean [SD] age, 62.5 [8.5] years) were enrolled in the on-pump group. The 10-year death rates were 34.2% (n = 378) for the off-pump group and 31.1% (n = 342) for the on-pump group (relative risk, 1.05; 95% CI, 0.99-1.11; P = .12). The median time to composite end point for the off-pump group (4.6 years; IQR, 1.4-7.5 years) was approximately 4.3 months shorter than that for the on-pump group (5.0 years; IQR, 1.8-7.9 years; P = .03). No significant 10-year treatment-related differences were documented for any other primary or secondary end points. After the removal of conversions, sensitivity analyses reconfirmed these findings. CONCLUSIONS AND RELEVANCE No off-pump CABG advantages were found for 10-year death or revascularization end points; the time to composite end point was lower in the off-pump group than in the on-pump group. For veterans, in the absence of on-pump contraindications, a case cannot be made for supplanting the traditional on-pump CABG technique with an off-pump approach. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01924442.

中文翻译：

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退伍军人事务部非体外循环与体外循环冠状动脉旁路移植术的十年结果：一项随机临床试验。

重要性 非体外循环（“跳动的心脏”）与体外循环冠状动脉旁路移植术 (CABG) 的长期益处仍然存在争议。目的 评估退伍军人事务部 (VA) 随机开/关搭桥 (ROOBY) 试验中停跳与停跳 CABG 的 10 年结果和成本。设计、地点和参与者 从 2002 年 2 月 27 日到 2007 年 5 月 7 日，ROOBY 试验中的 2203 名退伍军人被随机分配到 18 个参与的 VA 医疗中心接受非体外循环或体外循环 CABG 手术。根据协议，退伍军人被观察了 10 年；通过集中提取电子病历并合并 VA 和非 VA 数据库，评估了 CABG 术后 10 年的临床结果和成本。使用意向治疗方法，分析于 2017 年 5 月 7 日至 2021 年 12 月 9 日进行。干预 体外循环和非体外循环 CABG 手术。主要结果和测量 10 年联合主要终点包括全因死亡和确定死亡或接受后续血运重建（即经皮冠状动脉介入治疗 [PCI] 或重复 CABG）的患者的复合终点；这 2 个终点采用二分法测量，并作为事件发生时间变量（即死亡时间和复合终点时间）进行测量。次要 10 年终点包括 PCI、重复 CABG 手术、心脏症状的变化和 2018 年调整后的 VA 估计成本。CABG 后从基线到 10 年的变化、临床相关心脏症状的纽约心脏协会功能分级、加拿大心血管协会心绞痛分级和房颤进行了评估。结果差异由终点委员会裁定。鉴于 CABG 前风险是平衡的，协议驱动的主要和次要假设直接比较了 10 年治疗相关的效果。结果 共有 1104 名患者（1097 名男性 [99.4%]；平均 [SD] 年龄，63.0 [8.5] 岁）被纳入非体外循环组，1099 名患者（1092 名男性 [99.5%]；平均 [SD]年龄，62.5 [8.5] 岁）被纳入体外循环组。停跳组的 10 年死亡率为 34.2% (n = 378)，停跳组为 31.1% (n = 342)（相对风险，1.05；95% CI，0.99-1.11；P = .12). 停跳组至复合终点的中位时间（4.6 年；IQR，1.4-7.5 年）比停跳组（5.0 年；IQR，1.8-7.9 年；P = .03). 对于任何其他主要或次要终点，没有记录到显着的 10 年治疗相关差异。去除转换后，敏感性分析再次证实了这些发现。结论和相关性 对于 10 年死亡或血运重建终点，未发现非体外循环 CABG 优势；非停跳组的复合终点时间短于停跳组。对于退伍军人来说，在没有停跳禁忌症的情况下，不能用停跳方法取代传统的停跳 CABG 技术。试验注册 ClinicalTrials.gov 标识符：NCT01924442。结论和相关性 对于 10 年死亡或血运重建终点，未发现非体外循环 CABG 优势；非停跳组的复合终点时间短于停跳组。对于退伍军人来说，在没有停跳禁忌症的情况下，不能用停跳方法取代传统的停跳 CABG 技术。试验注册 ClinicalTrials.gov 标识符：NCT01924442。结论和相关性 对于 10 年死亡或血运重建终点，未发现非体外循环 CABG 优势；非停跳组的复合终点时间短于停跳组。对于退伍军人来说，在没有停跳禁忌症的情况下，不能用停跳方法取代传统的停跳 CABG 技术。试验注册 ClinicalTrials.gov 标识符：NCT01924442。