NYU Grossman School of Medicine, New York, NY (J.S.H., R.A., H.R.R., S.B., Y.X., S.M., M.C., A.C., J.D.N., J.S.B., A.B.T.).
Duke Clinical Research Institute, Durham, NC (S.M.O., R.D.L., D.B.M.).
Circulation. 2023 Jan 3;147(1):8-19. doi: 10.1161/CIRCULATIONAHA.122.062714. Epub 2022 Nov 6.
The ISCHEMIA trial (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches) compared an initial invasive versus an initial conservative management strategy for patients with chronic coronary disease and moderate or severe ischemia, with no major difference in most outcomes during a median of 3.2 years. Extended follow-up for mortality is ongoing.
ISCHEMIA participants were randomized to an initial invasive strategy added to guideline-directed medical therapy or a conservative strategy. Patients with moderate or severe ischemia, ejection fraction ≥35%, and no recent acute coronary syndromes were included. Those with an unacceptable level of angina were excluded. Extended follow-up for vital status is being conducted by sites or through central death index search. Data obtained through December 2021 are included in this interim report. We analyzed all-cause, cardiovascular, and noncardiovascular mortality by randomized strategy, using nonparametric cumulative incidence estimators, Cox regression models, and Bayesian methods. Undetermined deaths were classified as cardiovascular as prespecified in the trial protocol.
Baseline characteristics for 5179 original ISCHEMIA trial participants included median age 65 years, 23% women, 16% Hispanic, 4% Black, 42% with diabetes, and median ejection fraction 0.60. A total of 557 deaths accrued during a median follow-up of 5.7 years, with 268 of these added in the extended follow-up phase. This included a total of 343 cardiovascular deaths, 192 noncardiovascular deaths, and 22 unclassified deaths. All-cause mortality was not different between randomized treatment groups (7-year rate, 12.7% in invasive strategy, 13.4% in conservative strategy; adjusted hazard ratio, 1.00 [95% CI, 0.85-1.18]). There was a lower 7-year rate cardiovascular mortality (6.4% versus 8.6%; adjusted hazard ratio, 0.78 [95% CI, 0.63-0.96]) with an initial invasive strategy but a higher 7-year rate of noncardiovascular mortality (5.6% versus 4.4%; adjusted hazard ratio, 1.44 [95% CI, 1.08-1.91]) compared with the conservative strategy. No heterogeneity of treatment effect was evident in prespecified subgroups, including multivessel coronary disease.
There was no difference in all-cause mortality with an initial invasive strategy compared with an initial conservative strategy, but there was lower risk of cardiovascular mortality and higher risk of noncardiovascular mortality with an initial invasive strategy during a median follow-up of 5.7 years.
URL: https://www.
gov; Unique identifier: NCT04894877.
ISCHEMIA 试验（国际比较健康效果研究，比较药物和介入治疗策略）比较了慢性冠状动脉疾病合并中度或重度缺血患者的初始侵入性策略与初始保守性策略，在中位 3.2 年的随访期间，大多数结局无显著差异。目前正在进行死亡率的扩展随访。
ISCHEMIA 参与者被随机分配到初始侵入性策略加指南指导的药物治疗或保守策略。纳入有中度或重度缺血、射血分数≥35%且近期无急性冠状动脉综合征的患者。排除有无法接受的心绞痛水平的患者。通过现场或通过中心死亡索引搜索对生存状态进行扩展随访。此中期报告包括截至 2021 年 12 月的数据。我们通过非参数累积发生率估计、Cox 回归模型和贝叶斯方法，按随机策略分析全因、心血管和非心血管死亡率。按照试验方案，无法确定的死亡被归类为心血管死亡。
5179 名原始 ISCHEMIA 试验参与者的基线特征包括中位年龄 65 岁，23%为女性，16%为西班牙裔，4%为黑人，42%患有糖尿病，中位射血分数为 0.60。在中位随访 5.7 年期间共发生 557 例死亡，其中 268 例发生在扩展随访阶段。其中包括 343 例心血管死亡、192 例非心血管死亡和 22 例未分类死亡。随机治疗组之间全因死亡率无差异（7 年发生率，侵入性策略组为 12.7%，保守性策略组为 13.4%；调整后的危险比为 1.00 [95%CI，0.85-1.18]）。初始侵入性策略可降低 7 年心血管死亡率（6.4%比 8.6%；调整后的危险比为 0.78 [95%CI，0.63-0.96]），但会增加 7 年非心血管死亡率（5.6%比 4.4%；调整后的危险比为 1.44 [95%CI，1.08-1.91]）。在预先指定的亚组中，包括多血管冠状动脉疾病，没有证据表明治疗效果存在异质性。
与初始保守策略相比，初始侵入性策略并未降低全因死亡率，但在中位 5.7 年的随访中，初始侵入性策略可降低心血管死亡率，增加非心血管死亡率。
网址：https://www.
gov；独特标识符：NCT04894877。
