Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Korea; Graduate School of Public Health, Yonsei University, Seoul, Korea.
J Am Coll Cardiol. 2023 Aug 1;82(5):401-410. doi: 10.1016/j.jacc.2023.05.042.
The RACING (randomized comparison of efficacy and safety of lipid-lowering with statin monotherapy versus statin/ezetimibe combination for high-risk cardiovascular diseases) trial examined the effects of combination therapy with moderate-intensity statin and ezetimibe in patients with atherosclerotic cardiovascular disease compared with high-intensity statin monotherapy.
This observational study was conducted to evaluate the impact of 2 treatment strategies used in the RACING trial in clinical practice.
After stabilized inverse probability of treatment weighting, a total of 72,050 patients who were prescribed rosuvastatin after drug-eluting stent implantation were identified from a nationwide cohort database: 10,794 patients with rosuvastatin 10 mg plus ezetimibe 10 mg (combination lipid-lowering therapy) and 61,256 patients with rosuvastatin 20 mg monotherapy. The primary endpoint was the 3-year composite event of cardiovascular death, myocardial infarction, coronary artery revascularization, hospitalization for heart failure treatment, or nonfatal stroke in accordance with the RACING trial.
Combination lipid-lowering therapy was associated with a lower occurrence of the primary endpoint (11.6% vs 15.2% for those with high-intensity statin monotherapy; HR: 0.75; 95% CI: 0.70-0.79; P < 0.001). Compared with high-intensity statin monotherapy, combination lipid-lowering therapy was associated with fewer discontinuations of statin (6.5% vs 7.6%; HR: 0.85; 95% CI: 0.78-0.94: P < 0.001) and a lower occurrence of new-onset diabetes requiring medication (7.7% vs 9.6%; HR: 0.80; 95% CI: 0.72-0.88; P < 0.001).
In clinical practice, combination lipid-lowering therapy with ezetimibe and moderate-intensity statin was associated with favorable clinical outcomes and drug compliance in patients treated with drug-eluting stent implantation. (CONNECT DES Registry; NCT04715594).
RACING（随机比较降脂疗效和安全性的研究，比较了他汀类药物单药治疗与他汀类药物/依折麦布联合治疗高危心血管疾病的效果）试验研究了与高强度他汀类药物单药治疗相比，中强度他汀类药物和依折麦布联合治疗在动脉粥样硬化性心血管疾病患者中的效果。
本观察性研究旨在评估 RACING 试验中使用的 2 种治疗策略在临床实践中的影响。
对全国队列数据库中经药物洗脱支架植入后的患者，使用逆概率治疗加权法进行稳定后，共纳入 72050 例接受瑞舒伐他汀治疗的患者：10794 例瑞舒伐他汀 10mg 联合依折麦布 10mg（联合降脂治疗），61256 例瑞舒伐他汀 20mg 单药治疗。主要终点是根据 RACING 试验，3 年复合心血管死亡、心肌梗死、冠状动脉血运重建、因心力衰竭住院治疗或非致死性卒中事件。
联合降脂治疗降低了主要终点的发生率（高强度他汀类药物单药治疗组为 15.2%，联合降脂治疗组为 11.6%；HR：0.75；95%CI：0.70-0.79；P<0.001）。与高强度他汀类药物单药治疗相比，联合降脂治疗的他汀类药物停药率更低（6.5%比 7.6%；HR：0.85；95%CI：0.78-0.94；P<0.001），新诊断需要药物治疗的糖尿病发生率更低（7.7%比 9.6%；HR：0.80；95%CI：0.72-0.88；P<0.001）。
在临床实践中，依折麦布联合中强度他汀类药物的联合降脂治疗与药物洗脱支架植入后患者的良好临床结局和药物依从性相关。（CONNECT DES 登记研究；NCT04715594）。
