Cardiovascular Clinical Research Center, New York University School of Medicine, New York, New York.
Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.
JAMA Cardiol. 2019 Mar 1;4(3):273-286. doi: 10.1001/jamacardio.2019.0014.
It is unknown whether coronary revascularization, when added to optimal medical therapy, improves prognosis in patients with stable ischemic heart disease (SIHD) at increased risk of cardiovascular events owing to moderate or severe ischemia.
To describe baseline characteristics of participants enrolled and randomized in the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) trial and to evaluate whether qualification by stress imaging or nonimaging exercise tolerance test (ETT) influenced risk profiles.
DESIGN, SETTING, AND PARTICIPANTS: The ISCHEMIA trial recruited patients with SIHD with moderate or severe ischemia on stress testing. Blinded coronary computed tomography angiography was performed in most participants and reviewed by a core laboratory to exclude left main stenosis of at least 50% or no obstructive coronary artery disease (CAD) (<50% for imaging stress test and <70% for ETT). The study included 341 enrolling sites (320 randomizing) in 38 countries and patients with SIHD and moderate or severe ischemia on stress testing. Data presented were extracted on December 17, 2018.
Enrolled, excluded, and randomized participants' baseline characteristics. No clinical outcomes are reported.
A total of 8518 patients were enrolled, and 5179 were randomized. Common reasons for exclusion were core laboratory determination of insufficient ischemia, unprotected left main stenosis of at least 50%, or no stenosis that met study obstructive CAD criteria on study coronary computed tomography angiography. Randomized participants had a median age of 64 years, with 1168 women (22.6%), 1726 nonwhite participants (33.7%), 748 Hispanic participants (15.5%), 2122 with diabetes (41.0%), and 4643 with a history of angina (89.7%). Among the 3909 participants randomized after stress imaging, core laboratory assessment of ischemia severity (in 3901 participants) was severe in 1748 (44.8%), moderate in 1600 (41.0%), mild in 317 (8.1%) and none or uninterpretable in 236 (6.0%), Among the 1270 participants who were randomized after nonimaging ETT, core laboratory determination of ischemia severity (in 1266 participants) was severe (an eligibility criterion) in 1051 (83.0%), moderate in 101 (8.0%), mild in 34 (2.7%) and none or uninterpretable in 80 (6.3%). Among the 3912 of 5179 randomized participants who underwent coronary computed tomography angiography, 79.0% had multivessel CAD (n = 2679 of 3390) and 86.8% had left anterior descending (LAD) stenosis (n = 3190 of 3677) (proximal in 46.8% [n = 1749 of 3739]). Participants undergoing ETT had greater frequency of 3-vessel CAD, LAD, and proximal LAD stenosis than participants undergoing stress imaging.
The ISCHEMIA trial randomized an SIHD population with moderate or severe ischemia on stress testing, of whom most had multivessel CAD.
ClinicalTrials.gov Identifier: NCT01471522.
对于因中度或重度缺血而处于心血管事件高风险的稳定型缺血性心脏病（SIHD）患者，在最佳药物治疗的基础上增加冠状动脉血运重建是否能改善预后尚不清楚。
描述国际比较有效性研究中比较药物和介入治疗的稳定性缺血性心脏病（ISCHEMIA）试验入组和随机分组患者的基线特征，并评估是否通过应激成像或非成像运动耐量试验（ETT）进行资格筛选会影响风险状况。
设计、地点和参与者：ISCHEMIA 试验招募了在应激试验中存在中度或重度缺血的 SIHD 患者。大多数参与者接受了盲法冠状动脉计算机断层血管造影检查，并由核心实验室进行了审查，以排除至少 50%的左主干狭窄或无阻塞性冠状动脉疾病（CAD）（<50%的影像学应激试验和<70%的 ETT）。该研究包括来自 38 个国家的 341 个入组地点（320 个随机分组）和 SIHD 患者，以及应激试验中存在中度或重度缺血的患者。提取数据的时间为 2018 年 12 月 17 日。
入组、排除和随机分组患者的基线特征。未报告临床结局。
共有 8518 例患者入组，其中 5179 例被随机分组。常见的排除原因是核心实验室确定缺血程度不足、未保护的左主干狭窄至少 50%或研究冠状动脉计算机断层血管造影无符合研究阻塞性 CAD 标准的狭窄。随机分组的患者中位年龄为 64 岁，其中 1168 例为女性（22.6%），1726 例为非白人（33.7%），748 例为西班牙裔（15.5%），2122 例患有糖尿病（41.0%），4643 例有胸痛史（89.7%）。在 3909 例接受应激成像后随机分组的患者中，核心实验室评估的缺血严重程度（在 3901 例患者中）为严重的有 1748 例（44.8%），中度的有 1600 例（41.0%），轻度的有 317 例（8.1%），无或无法解释的有 236 例（6.0%）。在 1270 例接受非成像 ETT 后随机分组的患者中，核心实验室确定的缺血严重程度（在 1266 例患者中）为严重（入选标准）的有 1051 例（83.0%），中度的有 101 例（8.0%），轻度的有 34 例（2.7%），无或无法解释的有 80 例（6.3%）。在 5179 例随机分组的患者中，有 3912 例行冠状动脉计算机断层血管造影检查，其中 79.0%有多支血管 CAD（3390 例中有 2679 例），86.8%有左前降支（LAD）狭窄（3677 例中有 3190 例）（近端 46.8%[3739 例中有 1749 例]）。行 ETT 的患者与行应激成像的患者相比，有更高的三支血管 CAD、LAD 和近端 LAD 狭窄发生率。
ISCHEMIA 试验随机分组的是在应激试验中存在中度或重度缺血的 SIHD 患者，其中大多数患者有多支血管 CAD。
ClinicalTrials.gov 标识符：NCT01471522。
