Approximately half of all women with symptomatic ischemia who undergo coronary angiography are found to have non-obstructive coronary artery disease ((ischemia and non-obstructive coronary artery disease, INOCA), which is associated with a high rate of major adverse cardiovascular events (MACE) and a reduction in quality of life (QoL). Previous studies have suggested that intensive medical therapy (IMT) with high-intensity statins, angiotensin-converting enzyme inhibitors (ACE inhibitors), or angiotensin II receptor blockers (ARBs) at the maximum tolerated doses could be beneficial.
This pragmatic study evaluated whether IMT could reduce the occurrence of MACE compared to the standard care over a five-year follow-up. Researchers expected a 20-% reduction in the incidence of events. The study was designed as a randomized, blinded, multicenter trial in symptomatic women with suspected INOCA.
Secondary endpoints included quality of life (QoL), time to return to work, healthcare utilization, angina, cardiovascular death, and a five-year win-ratio analysis.
A total of 2476 patients were randomized. The average patient age was 64.2 years. INOCA was diagnosed in 45.5% of cases through coronary computed tomography (CT); in the rest of cases, diagnosis was established through angiography. Additionally, 21.5% of participants had diabetes, and their mean LDL-C level was 93 mg/dL.
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When evaluating the primary endpoint of MACE-free survival probability, IMT showed no significant differences compared to the standard treatment (hazard ratio [HR] 1.13; 95% confidence interval [CI] 0.94–1.37; p=0.20). These findings were confirmed in a sensitivity analysis (HR 0.74; 95% CI 0.35–1.56; p=0.43).
Researchers noted some study limitations, such as recruitment during the COVID-19 pandemic and a lower-risk profile among patients diagnosed using coronary CT.
Conclusion
Intensive treatment with higher doses of medical therapy did not reduce the incidence of the primary composite endpoint proposed by researchers.
Presented by Eileen Handberg en Late-Breaking Clinical Trials, ACC 25, March 29, Chicago, EE.UU.
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