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Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD (WARRIOR): a randomised controlled trial
Carl J Pepine1, Eileen Handberg1, Rhonda Cooper-DeHoff2
1Division of Cardiology, Department of Medicine, University of Florida, Gainesville, Florida, USA.
Insights
Intensive medical treatment did not reduce major ischemic events in women with suspected angina without obstructive coronary artery disease. Further research is needed due to the high burden of angina hospitalizations and poor quality of life in this population.
Area of Science:
- Cardiology
- Women's Health
- Clinical Trials
Background:
- Many women experience angina due to suspected ischemia but have no obstructive coronary artery disease (ANOCA/INOCA).
- This condition significantly impacts quality of life and healthcare resource utilization.
Purpose of the Study:
- To evaluate if intensive medical treatment (IMT) reduces major ischemic events in women with suspected ANOCA/INOCA.
- To compare IMT (high-intensity statin, ACE inhibitor/ARB, aspirin) against usual care (UC).
Main Methods:
- A randomized, prospective, blinded-outcomes evaluation study.
- Conducted across 71 sites in the USA involving 2476 women.
- Primary outcome: composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and hospitalization for angina or heart failure (MACE).
Main Results:
- At 2.5 years, no significant difference in MACE between IMT and UC groups (HR=1.13; p=0.20).
- Hospitalizations for angina were the primary driver of MACE.
- Sensitivity analysis suggested a potential benefit of IMT, but with limited statistical power (HR=0.74; p=0.43).
Conclusions:
- Intensive medical treatment did not improve outcomes in women with suspected ANOCA/INOCA.
- The high burden of angina hospitalizations and reduced quality of life warrants further investigation.
- Limited study power prevents definitive conclusions about the potential efficacy of IMT.
Importance:
Women with angina due to suspected ischaemia referred for coronary angiography often have no obstructive coronary artery disease (ANOCA/INOCA).
Objective:
To determine if intensive medical treatment (IMT) reduces major ischaemic events (major adverse cardiovascular event, MACE) among women with suspected ANOCA/INOCA.
Design:
Randomised, prospective, blinded-outcomes evaluation.
Setting:
71 sites in the USA.
Participants:
2476 women with suspected ANOCA/INOCA.
Interventions:
IMT-high intensity statin, ACE inhibitor (ACEi) or angiotensin receptor blocker (ARB) and aspirin versus usual care (UC).
Main Outcomes And Measures:
Primary: all cause death, myocardial infarction, stroke/transient ischaemic attack, hospitalisation for angina or heart failure (MACE). Secondary: components of the primary, quality of life and win ratio.
Results:
Recruitment was lower than planned (n=2476), yielding an aged population (mean, 64 years) with well-controlled blood pressure and low-density lipoprotein cholesterol at baseline, and relatively high rates of statin and ACEI/ARB use. At 2.5 years, 421 events occurred (221 in IMT, 200 in UC) with no difference in the primary outcome (HR=1.13 (95% CI 0.94 to 1.37) for IMT vs UC, p=0.20) or secondary outcomes. Hospitalisations for angina were the dominant contributor to MACE. Sensitivity analysis of contamination provided an estimated HR for IMT versus UC of 0.74 95% CI (0.352 to 1.558), p=0.43.
Conclusions And Relevance:
Among women with suspected ANOCA/INOCA, outcomes were dominated by chest pain and IMT did not improve outcomes, although limited power precludes concluding that it may not be helpful. The findings support the need for more investigation in this population with high burden of angina hospitalisation, health resource consumption and poor quality of life.
Trial Registration Number:
NCT03417388.
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