Rationale and design of the Women's Ischemia Trial to Reduce Events in Nonobstructive CAD (WARRIOR) trial
Rationale and design of the Women's Ischemia Trial to Reduce Events in Nonobstructive CAD (WARRIOR) trial
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DOI：
10.1016/j.ahj.2021.03.011
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发表时间：
2021-04-21
影响因子：
4.8
通讯作者：
Pepine, Carl J.
中科院分区：
文献类型：
--
作者：
Handberg, Eileen M.;Merz, C. Noel Bairey;Pepine, Carl J.
在所有有心绞痛症状和/或缺血体征且无阻塞性冠状动脉疾病（INOCA）的女性中，约有一半接受冠状动脉造影的女性发生主要不良心脏事件（MACE）、生活质量差和资源消耗的风险升高。然而，指南的重点是症状管理，而临床实践通常只提倡保证。INOCA受试者的初步研究表明，强化药物治疗（IMT），包括高强度他汀类药物和血管紧张素转换酶抑制剂（ACE-I）或受体阻滞剂（ARB）的益处，为限制MACE的随机实用试验提供了理论基础。在大约70个美国研究中心的4，422名有症状的INOCA女性患者（NCT 03417388）中，对IMT与常规治疗（UC）的实用策略进行盲法结局评价（PROBE设计）。假设在2.5年随访时，与UC相比，IMT将使首次发生MACE的主要结局降低20%。次要结局包括3年随访期间的生活质量、恢复“职责”/工作的时间、医疗保健利用、心绞痛、心血管死亡和个体主要结局组成部分。本研究利用基于网络的数据采集、电子同意书、单一IRB和集中药房将策略药物直接分发到患者家中，以减少研究中心和患者负担。一个生物储存库将收集血液样本，以评估潜在的mechanism.Conclusions本试验的结果将提供必要的重要数据，告知指导方针，如何最好地管理这个不断增长的和具有挑战性的妇女人口与INOCA。
Background Approximately half of all women with anginal symptoms and/or signs of ischemia and no obstructive coronary artery disease (INOCA) referred for coronary angiography have elevated risk for major adverse cardiac events (MACE), poor quality of life and resource consumption. Yet, guidelines focus on symptom management while clinical practice typically advocates only reassurance. Pilot studies of INOCA subjects suggest benefit with intensive medical therapy (IMT) that includes high-intensity statins and angiotensin converting enzyme inhibitors (ACE-I) or receptor blockers (ARB) to provide the rationale for a randomized pragmatic trial to limit MACE.Methods The Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD is a multicenter, prospective, random-ized, blinded outcome evaluation (PROBE design) of a pragmatic strategy of IMT vs usual care (UC) in 4,422 symptomatic women with INOCA (NCT 03417388) in approximately 70 United States sites. The hypothesis is that IMT will reduce the primary outcome of first occurrence of MACE by 20% vs. UC at similar to 2.5 year followup. Secondary outcomes include quality of life, time to return to "duty"/work, healthcare utilization, angina, cardiovascular death and individual primary outcome components over 3 years follow-up. The study utilizes web-based data capture, e-consents, single IRB and centralized pharmacy distribution of strategy medications directly to patients' homes to reduce site and patient burden. A biorepository will collect blood samples to assess potential mechanisms.Conclusions The results of this trial will provide important data necessary to inform guidelines regarding how best to manage this growing and challenging population of women with INOCA.