Nerlekar Nitesh, Vasanthakumar Sheran A, Whitmore Kristyn, Soh Cheng Hwee, Chan Jasmine, Goel Vinay, Ryan Jacqueline, Jones Catherine, Stanton Tony, Mitchell Geoffrey, Tonkin Andrew, Watts Gerald F, Nicholls Stephen J, Marwick Thomas H
Baker Heart and Diabetes Research Institute, Melbourne, Victoria, Australia.
Victorian Heart Hospital, Melbourne, Victoria, Australia.
JAMA. 2025 Apr 22;333(16):1403-1412. doi: 10.1001/jama.2025.0584.
Coronary artery calcium (CAC) scoring provides prognostic information, especially in patients at intermediate risk for coronary artery disease (CAD). However, the benefit of combining CAC score with a primary prevention strategy has not been tested in a randomized trial.
To assess whether combining the CAC score with a prevention strategy can be used to limit plaque progression in intermediate-risk patients with a family history of premature CAD.
DESIGN, SETTING, AND PARTICIPANTS: Prospective, randomized, open-blinded end point clinical trial in 7 hospitals across Australia (between 2013 and 2020; the last date of follow-up was June 5, 2021). Asymptomatic people aged 40 to 70 years with a first-degree relative with CAD onset at younger than 60 years old or second-degree relative with onset at younger than 50 years old were recruited from the community.
Intermediate-risk participants underwent CAC scoring. Those with a CAC score greater than 0 but less than 400 underwent coronary computed tomography angiography (CCTA) and were randomized to CAC score-informed prevention or usual care.
Follow-up CCTA was obtained at 3 years, with plaque volume measured by an independent core laboratory. The primary outcome was total plaque volume, with further analysis for calcified and noncalcified plaque volume.
This study included 365 participants (mean [SD] age, 58 [6] years; 57.5% male); 179 in the CAC score-informed and 186 in the usual care groups. Compared with usual care, the CAC score-informed group showed a sustained reduction in total (mean [SD], -3 [31] mg/dL vs -56 [38] mg/dL; P < .001) and LDL (mean [SD], -2 [31] vs -51 [36] mg/dL; P < .001) cholesterol levels at 3 years, which was associated with a reduction in pooled cohort equation risk calculation (mean [SD], 2.1% [2.9%] vs 0.5% [2.9%]; P < .001). Plaque progression was greater in usual care than CAC score-informed participants for total plaque volume (mean [SD], 24.9 [37.7] mm3 vs 15.4 [30.9] mm3; P = .009), noncalcified plaque volume (mean [SD], 15.7 [32.2] mm3 vs 5.6 [28.5] mm3; P = .002), and fibrofatty and necrotic core plaque volume (mean [SD], 4.5 [25.8] mm3 vs -0.8 [12.6] mm3; P = .02). These plaque volume changes were independent of other risk factors including baseline plaque volume, blood pressure, and lipid profile.
The combination of CAC score with a primary prevention strategy in intermediate-risk patients with a family history of CAD was associated with reduction of atherogenic lipids and slower plaque progression compared with usual care. These data support the use of CAC score to assist intensive preventive strategies in intermediate-risk patients.
anzctr.org.au Identifier: ACTRN12614001294640.
冠状动脉钙化（CAC）评分可提供预后信息，尤其是在冠状动脉疾病（CAD）中度风险患者中。然而，将CAC评分与一级预防策略相结合的益处尚未在随机试验中得到验证。
评估将CAC评分与预防策略相结合是否可用于限制有早发CAD家族史的中度风险患者的斑块进展。
设计、地点和参与者：在澳大利亚7家医院进行的前瞻性、随机、开放盲法终点临床试验（2013年至2020年期间；最后随访日期为2021年6月5日）。从社区招募年龄在40至70岁之间、有CAD发病年龄小于60岁的一级亲属或发病年龄小于50岁的二级亲属的无症状人群。
中度风险参与者接受CAC评分。CAC评分大于0但小于400的参与者接受冠状动脉计算机断层扫描血管造影（CCTA），并随机分为基于CAC评分的预防组或常规治疗组。
在3年时进行随访CCTA，由独立核心实验室测量斑块体积。主要结局是总斑块体积，并对钙化和非钙化斑块体积进行进一步分析。
本研究纳入365名参与者（平均[标准差]年龄，58[6]岁；57.5%为男性）；基于CAC评分的预防组179名，常规治疗组186名。与常规治疗相比，基于CAC评分的预防组在3年时总胆固醇（平均[标准差]，-3[31]mg/dL对-56[38]mg/dL；P<.001）和低密度脂蛋白胆固醇（平均[标准差]，-2[31]对-51[36]mg/dL；P<.001）水平持续降低，这与汇总队列方程风险计算的降低相关（平均[标准差]，2.1%[2.9%]对0.5%[2.9%]；P<.001）。常规治疗组的斑块进展在总斑块体积（平均[标准差]，24.9[37.7]mm³对15.4[30.9]mm³；P=.009）、非钙化斑块体积（平均[标准差]，15.7[32.2]mm³对5.6[28.5]mm³；P=.002）以及纤维脂肪和坏死核心斑块体积（平均[标准差]，4.5[25.8]mm³对-0.8[12.6]mm³；P=.02）方面均大于基于CAC评分的预防组参与者。这些斑块体积变化独立于其他风险因素，包括基线斑块体积、血压和血脂谱。
与常规治疗相比，在有CAD家族史的中度风险患者中，将CAC评分与一级预防策略相结合与致动脉粥样硬化脂质的降低和斑块进展减缓相关。这些数据支持使用CAC评分来辅助中度风险患者的强化预防策略。
anzctr.org.au标识符：ACTRN12614001294640。
