Rationale and design of the Women's Ischemia Trial to Reduce Events in Nonobstructive CAD (WARRIOR) trial
Eileen M Handberg1, C Noel Bairey Merz2, Rhonda M Cooper-Dehoff3
1Division of Cardiology, Department of Medicine, University of Florida, Gainesville, FL.
Insights
Intensive medical therapy (IMT) may reduce major adverse cardiac events (MACE) in women with ischemia and no obstructive coronary artery disease (INOCA). This trial compares IMT to usual care to improve outcomes for these patients.
Area of Science:
- Cardiology
- Clinical Trials
- Women's Health
Background:
- Ischemia and no obstructive coronary artery disease (INOCA) affects many women, leading to increased risk of major adverse cardiac events (MACE), reduced quality of life, and high healthcare costs.
- Current guidelines and clinical practice offer limited management strategies for INOCA, often focusing only on symptom management and reassurance.
- Pilot studies suggest that intensive medical therapy (IMT), including high-intensity statins and ACE inhibitors/ARBs, may benefit INOCA patients.
Purpose of the Study:
- To evaluate the effectiveness of a pragmatic strategy of intensive medical therapy (IMT) compared to usual care (UC) in reducing major adverse cardiac events (MACE) in women with INOCA.
- To assess the impact of IMT on secondary outcomes such as quality of life, return to work, healthcare utilization, and angina symptoms.
- To provide data to inform clinical guidelines for managing women diagnosed with INOCA.
Main Methods:
- A multicenter, prospective, randomized, blinded outcome evaluation (PROBE design) trial involving 4,422 symptomatic women with INOCA.
- Participants are randomized to receive either IMT or UC, with a primary outcome of the first occurrence of MACE.
- The study employs efficient data capture methods, including web-based data, e-consents, and centralized medication distribution, to minimize patient and site burden. A biorepository will collect blood samples for mechanistic studies.
Main Results:
- The primary outcome is the reduction of MACE by 20% in the IMT group compared to the UC group at approximately 2.5 years.
- Secondary outcomes will be assessed over 3 years, including quality of life, time to return to work, healthcare utilization, angina frequency, and cardiovascular death.
- The trial aims to establish the efficacy of IMT in a large cohort of women with INOCA.
Conclusions:
- The results of this trial are expected to provide crucial evidence for updating clinical guidelines on INOCA management.
- This research will help determine the optimal therapeutic strategy for this challenging patient population.
- The findings will guide healthcare providers in improving the care and outcomes for women experiencing anginal symptoms with no obstructive coronary artery disease.
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, randomized, blinded outcome evaluation (PROBE design) of a pragmatic strategy of IMT vs usual care (UC) in 4,422 symptomatic women with INOCA (NCT03417388) 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 ∼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.
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