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Biomarker-based strategy assesses likely benefit of ezetimibe added to statin therapy post-ACS
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A biomarker-based approach may effectively identify a gradient of risk among post-ACS patients who would most benefit from the addition of ezetimibe to statin therapy.
According to a secondary analysis of the IMPROVE-IT trial published in the Journal of the American College of Cardiology, researchers found that a multi-marker approach using established CV biomarkers to evaluate risk for recurrent CV events in post-ACS patients and clinical benefit showed a pattern of greater absolute risk reduction in CV death, MI and stroke when ezetimibe was added to statin therapy in patients at greater risk on the basis of biomarker levels.
Results of the IMPROVE-IT trial were previously reported by Cardiology Today. the new prespecified nested analysis included 7,195 patients stabilized after ACS and within 1 month after randomization in the overall IMPROVE-IT trial (mean age, 63 years; 25% women, 29.5% with diabetes).
Levels of the following biomarkers were assessed following randomization in IMPROVE-IT: high-sensitivity troponin T, N-terminal pro-B-type natriuretic peptide, growth-differentiation factor-15 and high-sensitivity C-reactive protein. Patients with at least 3 elevated biomarkers were classified as high-risk (n = 1,437), 1 to 2 elevated biomarkers as intermediate risk (n = 3,842) and no elevated biomarkers as low risk (n = 1,916).
The researchers reported an independent association between elevated levels of each biomarker with greater risk for CV death, MI and stroke and CV death and HF (P < .001 for each). High-risk patients with three or more positive biomarkers yielded an absolute risk difference of –7.3% with addition of ezetimibe (95% CI, 13.8-0.8%; P = .02), while the absolute risk difference was –4.4% in the intermediate-risk group (95% CI, 9.7-0.8). The group with no elevated biomarkers did not appear to benefit from the addition of ezetimibe, according to the results.
“[A] multi-marker approach using established cardiac biomarkers identified higher-risk patients who derived a correspondingly high benefit from the addition of ezetimibe to simvastatin therapy,” Arman Qamar, MD, MPH, with the TIMI Study Group, division of cardiovascular medicine, Brigham and Women’s Hospital and Harvard Medical School, and colleagues wrote. “Therapeutic decision making with biomarkers offers the potential to personalize secondary preventive therapy in patients with [stable ischemic heart disease].”
The researchers recommended that future studies examine the role of a biomarker-based strategy to guide patient selection for other treatment options. – by Scott Buzby
Disclosures: Qamar reports he receives institutional grant support from Daiichi-Sankyo and has received fees for educational activities from the American College of Cardiology, Society for Cardiovascular Angiography and Interventions, Pfizer, Medscape, and Clinical Exercise Physiology Association. Please see the study for all other authors’ relevant financial disclosures.
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C. Noel Bairey Merz, MD, FACC, FAHA, FESC
These results reiterate the relatively low efficacy of ezetimibe for risk reduction and clarify that the benefit appears to be in those ACS patients at relatively higher risk identified by biomarkers. Notably, this is 1,437 of 7,195, or 20%, of the ACS population, traditionally considered all at “high risk.” Because ACS is relatively less common than stable ischemic heart disease, these results suggest that a minority of a minority population would benefit compared with all patients with ischemic heart disease.
Also, because most patients with ischemic heart disease live longer than the 3 to 5 years of study follow-up, these results may underestimate the lifetime risk reduction of ezetimibe added to statin when taken for more than 5 years.
Stratifying the results by sex would be useful, as women more often have elevated BNP and less often troponin I in the setting of ACS, and this difference is prognostically useful.
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