Effect of Statin Treatment on Modifying Plaque Composition: A Double-Blind, Randomized Study

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• 作者：Seung-Jung Park ; MD ; PhD^a ; ^{sjpark@amc.seoul.kr" class="auth_mail" title="E-mail the corresponding author} ; Soo-Jin Kang ; MD ; PhD^a ; Jung-Min Ahn ; MD^a ; Mineok Chang ; MD^a ; Sung-Cheol Yun ; PhD^b ; Jae Hyung Roh ; MD^a ; Pil Hyung Lee ; MD^a ; Hyun Woo Park ; MD^a ; Sung-Han Yoon ; MD^a ; Duk-Woo Park ; MD ; PhD^a ; Seung-Whan Lee ; MD ; PhD^a ; Young-Hak Kim ; MD ; PhD^a ; Cheol Whan Lee ; MD ; PhD^a ; Gary S. Mintz ; MD^c ; Ki Hoon Han ; MD ; PhD^a ; Seong-Wook Park ; MD ; PhD^a
• 关键词：atherosclerosis ; hydroxymethylglutaryl-CoA reductase inhibitors ; intravascular ultrasound
• 刊名：Journal of the American College of Cardiology
• 出版年：2016
• 出版时间：19 April 2016
• 年：2016
• 卷：67
• 期：15
• 页码：1772-1783
• 全文大小：1290 K

文摘

How statins alter the natural course of coronary atherosclerosis with compositional changes remains unclear.

Objectives

This study aimed to determine the effect of statin therapy on modifying plaque composition.

Methods

The STABLE (Statin and Atheroma Vulnerability Evaluation) prospective, single-center, double-blind, randomized study evaluated the effect of statins on functionally insignificant coronary stenoses. We randomly assigned 312 patients with a virtual histology (VH) intravascular ultrasound–defined fibroatheroma-containing index lesion to rosuvastatin 40 mg versus 10 mg (2:1 ratio). In 225 (72%) patients, grayscale- and VH-intravascular ultrasound were completed at baseline and 12 months. The primary endpoint was the change in VH-defined percent compositional volume within the target segment from baseline to follow-up in the per-protocol analysis set.

Results

Percent necrotic core (NC) volume within the target segment significantly decreased from 21.3 ± 6.8% to 18.0 ± 7.5% during 1-year follow-up, whereas the percent fibrofatty volume increased (11.7 ± 5.8% vs. 14.8 ± 9.3%; all p < 0.001). Percent fibrous (59.4 ± 7.8% vs. 59.2 ± 8.6%) and dense calcium (7.6 ± 5.1% vs. 7.8 ± 5.6%) volumes were unchanged. Frequencies of VH (55% vs. 29%) decreased significantly. Normalized total (202.9 ± 72.3 mm³ vs. 188.5 ± 67.8 mm³; p = 0.001) and percent (51.4 ± 8.3% vs. 50.4 ± 8.8%; p = 0.018) atheroma volumes decreased. Independent predictors of percent NC volume change were body mass index (β = 0.37; 95% confidence interval [CI]: 0.05 to 0.70), high sensitivity C-reactive protein (β = −3.16; 95% CI: −5.64 to −0.69), and baseline percent NC volume (β = −0.44; 95% CI: −0.68 to −0.19; all p < 0.05). VH-defined percent compositional volume changes in the rosuvastatin 40- and 10-mg groups were similar.

Conclusions

Rosuvastatin reduced NC and plaque volume and decreased thin-cap fibroatheroma rate. There were no significant differences between high- versus moderate-intensity rosuvastatin. (Statin and Atheroma Vulnerability Evaluation [STABLE]; NCT00997880)