Abstract 13565: A hs-CRP Level But Not Coronary Plaque Regression or Change in Plaque Composition Could Predict Future Cardiovascular Events in Statin-Treated Patients with Coronary Artery Disease -The Extended TRUTH Study-
Background: The TRUTH study was a prospective, open-labeled, randomized and multicenter trial to evaluate the effects of 8-month treatment with pitavastatin (aggressive lipid-lowering) versus pravastatin (moderate lipid-lowering) on coronary artery plaque composition using virtual histology (VH)-intravascular ultrasound (IVUS). This study demonstrated that both statins therapy altered coronary artery plaque composition by significantly decreasing the fibro-fatty component and increasing the dense-calcium component. However, impacts of plaque regression or change in plaque composition on clinical outcomes have not been established. Hypothesis: We assessed the hypothesis that plaque regression or change in plaque composition determined by VH-IVUS predicts long-term clinical outcomes.
Methods: Among 164 patients who participated in the TRUTH trial, 119 patients with analyzable IVUS data both at enrollment and at 8-month follow-up were enrolled and observed for at least 2 years. The primary endpoint was defined as a composite of the following events: cardiovascular death, nonfatal myocardial infarction, nonfatal cerebral infarction, unstable angina and ischemic-driven revascularization except target lesion revascularization.
Results: The frequency of primary endpoint was 10.3% (6/58) in the pitavastatin group and 16.4% (10/61) in the pravastatin group during the follow-up period (mean 41.9±9.4 months). Cumulative event-free survival was not different between the two groups (Log-rank test, p=0.28). Furthermore, plaque regression, negative remodeling, and change in plaque composition were not different between with and without event group while serum hs-CRP level with event group was significantly higher (1.4 vs. 0.6 mg/L, p=0.01) than that without event group. The events rates gradually increase with increasing in hs-CRP level (8.8% in hs-CRP <1.0 mg/L, 20.5% in hs-CRP ≥1.0 mg/L, and 29.4% in hs-CRP ≥3.0 mg/L).
Conclusions: Coronary artery plaque regression, negative remodeling and change in plaque composition during statin therapy did not predict future cardiovascular events. Rather, serum hs-CRP level could serve as a predictor for cardiovascular events.
- © 2012 by American Heart Association, Inc.