Neutral effect of intensive medical therapy in women with INOCA

ACC.25 – Among women with suspected INOCA, an intensive medical therapy strategy did not reduce the risk of MACE at 5 years compared with usual care.

This summary is based on the presentation of Eileen Handberg, PhD (Gainesville, FL, USA) at the ACC.25 Scientific Session - Primary And Secondary Outcomes Of The Women’s Ischemia Trial To Reduce Events In Non Obstructive Coronary Artery Disease.

Introduction and methods

Approximately half of the women who undergo coronary angiography for suspected ischemia have ischemia with no obstructive coronary artery disease (INOCA). Women with INOCA have an elevated MACE risk and poor quality of life (QoL). The WARRIOR trial evaluated whether intensive medical therapy (IMT) versus usual care (UC) reduces the risk of MACE in women with suspected INOCA at 5-year follow-up.

The WARRIOR (Women’s Ischemia Trial To Reduce Events In Non Obstructive Coronary Artery Disease) trial was a multicenter, prospective, randomized, blinded outcome evaluation trial that randomized 2476 symptomatic women with suspected INOCA (as assessed with invasive coronary angiography (n=1353) or coronary tomographic angiography (n=1123)) to IMT (n=1239) or UC (n=1237) and patients were followed every 6 months. The IMT strategy consisted of high-intensity statin, maximally tolerated dose ACE inhibitor or ARB and low dose aspirin. The COVID-19 pandemic negatively impacted enrollment.

The primary outcome was MACE, a composite of all-cause mortality, nonfatal MI, nonfatal stroke or hospitalization for worsening angina or HF. Secondary outcomes included the individual components of the primary outcome.

Main results

• At 5 years, there was no difference in the primary outcome between the IMT group and the UC group (HR: 1.13; 95%CI: 0.94–1.37; P=0.20).
• MACE occurred in 369 patients in the IMT group and in 354 patients in the UC group after 5 year follow-up. The majority of these events were hospitalization for angina (305 vs. 298 events).
• There was no difference in any of the individual components of MACE between the two treatment groups.

Conclusion

In the pragmatic WARRIOR trial among women with suspected INOCA, treatment with an IMT strategy did not reduce the risk MACE compared with UC. “This trial was a neutral trial and should not be considered a negative trial,” said Eileen Handberg. “Rather, [there was] insufficient adherence and power to test the primary hypothesis. This should not be interpreted as endorsing discontinuation of statin or ACEI or ARB medications among women with CV risk factors.”

- Our reporting is based on the information provided at the ACC.25 Scientific Session -