Improvement of Coronary Artery Obstructions by Intensive Cholesterol Reduction

Functional Improvement of Coronary Artery Narrowing by Cholesterol Reduction With a PCSK9 Antibody (FITTER)

In a large number of patients who are hospitalised for a heart attack, there is more than one diseased coronary artery vessel. The most severe coronary artery the obstruction is normally treated by angioplasty, but the optimal treatment approach for other obstructions is not fully established. Studies suggest that a heart attack increases the risk for a second heart attack, by destabilising the other coronary artery obstructions due to an inflammatory response. Recent evidence suggests that intensive lowering of “bad” cholesterol directly after a heart attack occurs could improve these other coronary artery obstructions.

The newly established partnership between Radboudumc, Amgen b.v., and Infraredx inc. will make it possible to investigate the effect of early intensive cholesterol reduction on the inflammatory response after a heart attack, the composition of the other obstructions and the functional implications of these obstructions. More efficient treatment of coronary artery obstructions could save approximately € 8000,00 in healthcare costs of additional angioplasty per patient with approximately 20.000 heart attacks each year in the Netherlands. Besides direct healthcare related costs societal impact should be positive with more rapid participation in society and especially return to work.

The FITTER study will provide valuable information on the contribution of inflammation and cholesterol particles on destabilisation of non-infarct coronary obstructions potentially responsible for a second heart attack. This study will be performed in multiple Dutch medical centers. Patients who are hospitalised with an heart attack and who have multiple coronary artery obstructions will be treated with either Evolocumab, or placebo. The expectation is that this treatment will reduce the inflammatory response, stabilise coronary artery obstructions and will improve the flow in these arteries. This will benefit health, but also reduce total health care costs.

Summary
While the infarct related coronary artery is direct opened by angioplasty, obstructions in other vessels might remain. In this study the effect of a PCSK9 Antibody will be investigated, a new and effective cholesterol-lowering agent on these lesions in an attempted to reduce the need for additional angioplasty within 3 months.
Technology Readiness Level (TRL)
6 - 8
Time period
30 months
Partners
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