Importance Traditional time-to-event analyses rate events occurring early as more important than later events, even if later events are more severe, eg, death. Days alive out of hospital (DAOH) adds a patient-focused perspective beyond trial end points.

Objective To compare DAOH between invasive management and conservative management, including invasive protocol–assigned stays, in the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) randomized clinical trial.

Design, Setting, and Participants In this prespecified analysis of the ISCHEMIA trial, DAOH was compared between 5179 patients with stable coronary disease and moderate or severe ischemia randomized to invasive management or conservative management. Participants were recruited from 320 sites in 37 countries. Stays included overnight stays in hospital or extended care facility (skilled nursing facility, rehabilitation, or nursing home). DAOH was separately analyzed excluding invasive protocol–assigned procedures. Data were collected from July 2012 to June 2019, and data were analyzed from July 2020 to April 2021.

Interventions Invasive management with angiography and revascularization if feasible or conservative management, with both groups receiving optimal medical therapy.

Main Outcomes and Measures The hypothesis was formulated before data lock in July 2020. The primary end point was mean DAOH per patient between randomization and 4 years. Initial stays for invasive protocol–assigned procedures were prespecified to be excluded.

Results Of 5179 included patients, 1168 (22.6%) were female, and the median (interquartile range) age was 64 (58-70) years. The average DAOH was higher in the conservative management group compared with the invasive management group at 1 month (30.8 vs 28.4 days; P < .001), 1 year (362.2 vs 355.9 days; P < .001), and 2 years (718.4 vs 712.1 days; P = .001). At 4 years, the 2 groups’ DAOH were not significantly different (1415.0 vs 1412.2 days; P = .65). In the invasive management group, 2434 of 4002 stays (60.8%) were for protocol-assigned procedures. There were no clear differences at any time point in DAOH when protocol-assigned procedures were excluded from the invasive management group. There were more hospital and extended care stays in the invasive management vs conservative management group during follow-up (4002 vs 1897; P < .001). Excluding protocol-assigned procedures, there were fewer stays in the invasive vs conservative group (1568 vs 1897; P = .001). Cardiovascular stays following the initial assigned procedures were lower in the invasive management group (685 of 4002 [17.1%] vs 1095 of 1897 [57.8%]; P < .001) due to decreased spontaneous myocardial infarction stays (65 [1.6%] vs 123 [6.5%]; P < .001) and unstable angina stays (119 [3.0%] vs 216 [11.4%]; P < .001).

Conclusions and Relevance DAOH was higher for patients in the conservative management group in the first 2 years but not different at 4 years. DAOH was decreased early in the invasive management group due to protocol-assigned procedures. Hospital stays for myocardial infarction and unstable angina during follow-up were lower in the invasive management group. DAOH provides a patient-focused metric that can be used by clinicians and patients in shared decision-making for management of stable coronary artery disease.

Trial Registration ClinicalTrials.gov Identifier: NCT01471522

重要性 传统的事件发生时间分析认为早期发生的事件比后来发生的事件更重要，即使后来发生的事件更为严重，例如死亡。出院存活天数 (DAOH) 在试验终点之外增加了以患者为中心的视角。

目的 在医疗和侵入性方法的健康有效性比较国际研究 (ISCHEMIA) 随机临床试验中，比较侵入性治疗和保守治疗之间的 DAOH，包括侵入性方案指定的住院时间。

设计、设置和参与者 在 ISCHEMIA 试验的这项预先指定的分析中，对 5179 名患有稳定性冠心病和中度或重度缺血的患者进行了 DAOH 比较，这些患者随机接受侵入性治疗或保守治疗。参与者是从 37 个国家的 320 个地点招募的。住宿包括在医院或长期护理机构（专业护理机构、康复机构或疗养院）过夜。单独分析 DAOH，排除侵入性方案指定程序。数据收集时间为2012年7月至2019年6月，数据分析时间为2020年7月至2021年4月。

干预措施 如果可行的话，采用血管造影和血运重建的侵入性治疗或保守治疗，两组均接受最佳的药物治疗。

主要结果和措施 该假设是在 2020 年 7 月数据锁定之前制定的。主要终点是随机分组至 4 年期间每位患者的平均 DAOH。侵入性方案指定程序的初始停留时间被预先指定为排除在外。

结果 5179 例纳入患者中，1168 例（22.6%）为女性，中位（四分位距）年龄为 64（58-70）岁。与侵入性治疗组相比，保守治疗组在 1 个月（30.8 天 vs 28.4 天； P  < .001）、1 年（362.2 天 vs 355.9 天；P  < .001）和 2 年（718.4 天）时的平均 DAOH 较高。vs 712.1 天；P  = .001)。4 年时，两组的 DAOH 无显着差异（1415.0 天 vs 1412.2 天；P  = .65）。在侵入性治疗组中，4002 次住院中有 2434 次 (60.8%) 进行了方案指定的手术。当方案指定的程序被排除在侵入性管理组之外时，DAOH 在任何时间点都没有明显差异。随访期间，与保守治疗组相比，侵入性治疗组的住院时间和延长护理时间更长（4002 例 vs 1897 例；P  < .001）。排除方案指定的手术，侵入性组与保守性组的住院时间较少（1568 例 vs 1897 例；P  = .001）。 由于自发性心肌梗死住院时间减少（65 人 [1.6%] 比 1897 人中的 1095 人 [57.8%]；侵入性治疗组中初始指定手术后的心血管住院时间较低（4002 人中的 685 人 [17.1%] 与 1897 人中的 1095 人 [57.8%]；P < .001 ） 123 [6.5%]；P  < .001）和不稳定型心绞痛持续时间（119 [3.0%] vs 216 [11.4%]；P  < .001）。

结论和相关性 保守 治疗组患者的 DAOH 在前 2 年较高，但在第 4 年没有差异。由于方案指定的程序，侵入性治疗组早期的 DAOH 有所减少。侵入性治疗组随访期间因心肌梗塞和不稳定心绞痛住院的时间较低。DAOH 提供了一种以患者为中心的指标，临床医生和患者可以使用该指标来共同决策，以管理稳定的冠状动脉疾病。

试验注册 ClinicalTrials.gov 标识符：NCT01471522