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强化他汀治疗与冠状动脉旁路手术后早期移植物闭塞:积极降脂抑制静脉移植物事件随机临床试验。

Intensive versus moderate statin therapy and early graft occlusion after coronary bypass surgery: The Aggressive Cholesterol Therapy to Inhibit Vein Graft Events randomized clinical trial.

机构信息

Lynn Heart and Vascular Institute, Boca Raton Regional Hospital, and Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, Fla.

Lynn Heart and Vascular Institute, Boca Raton Regional Hospital, and Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton, Fla.

出版信息

J Thorac Cardiovasc Surg. 2019 Jan;157(1):151-161.e1. doi: 10.1016/j.jtcvs.2018.05.123. Epub 2018 Jul 21.

DOI:10.1016/j.jtcvs.2018.05.123
PMID:30122341
Abstract

OBJECTIVE

Statins prevent saphenous vein graft (SVG) disease and improve outcomes after coronary artery bypass graft surgery. However, the optimal postoperative statin dose remains unclear. The Aggressive Cholesterol Therapy to Inhibit Vein Graft Events trial was undertaken to evaluate whether early postoperative high-dose statin therapy reduces SVG occlusion compared with conventional moderate-dose therapy.

METHODS

In this pilot, multicenter, double-blind randomized trial, 173 patients who had coronary artery bypass graft surgery with SVG were randomized to receive 10 mg or 80 mg atorvastatin daily for 1 year. The primary outcome was SVG occlusion at 1 year. Secondary outcomes were SVG stenosis and major adverse cardiovascular events.

RESULTS

During trial enrollment, patients randomized to 80 mg atorvastatin achieved significantly lower low-density lipoprotein cholesterol levels (P < .00001). One-year graft assessment was performed in 145 patients (83.8%). The primary outcome, SVG occlusion at 1 year, did not significantly differ between the 2 groups (12.9% vs 11.4% for 10 mg atorvastatin vs 80 mg atorvastatin; P = .85). The incidence of vein graft stenosis also did not significantly differ between the groups (P = .54). However, there was a trend toward fewer patients developing vein graft disease (either occlusion or stenosis) in the 80 mg atorvastatin group (29.2% vs 19.2%, 10 mg atorvastatin vs 80 mg atorvastatin; P = .18). Freedom from major adverse cardiovascular events at 1 year was similar between the groups (P = .27).

CONCLUSIONS

Compared with 10 mg atorvastatin, 80 mg atorvastatin did not significantly reduce vein graft occlusion 1 year after coronary artery bypass graft surgery in this pilot trial.

摘要

目的

他汀类药物可预防隐静脉桥(SVG)疾病并改善冠状动脉旁路移植术后的结局。然而,最佳的术后他汀类药物剂量仍不清楚。强化降脂抑制静脉桥事件试验(Aggressive Cholesterol Therapy to Inhibit Vein Graft Events trial)旨在评估与常规中等剂量治疗相比,术后早期高剂量他汀类药物治疗是否可降低 SVG 闭塞的发生率。

方法

在这项先导性、多中心、双盲随机试验中,173 例接受冠状动脉旁路移植术并使用 SVG 的患者被随机分配接受每天 10mg 或 80mg 阿托伐他汀治疗 1 年。主要结局为 1 年时的 SVG 闭塞。次要结局为 SVG 狭窄和主要不良心血管事件。

结果

在试验入组期间,随机接受 80mg 阿托伐他汀的患者低密度脂蛋白胆固醇水平显著降低(P<0.00001)。145 例患者(83.8%)完成了 1 年的移植评估。主要结局即 1 年时的 SVG 闭塞在两组间无显著差异(10mg 阿托伐他汀组为 12.9%,80mg 阿托伐他汀组为 11.4%;P=0.85)。两组间静脉桥狭窄的发生率也无显著差异(P=0.54)。然而,80mg 阿托伐他汀组中发生静脉桥疾病(闭塞或狭窄)的患者比例呈下降趋势(29.2% vs 19.2%,10mg 阿托伐他汀 vs 80mg 阿托伐他汀;P=0.18)。两组 1 年时主要不良心血管事件的发生率无显著差异(P=0.27)。

结论

与 10mg 阿托伐他汀相比,在这项先导性试验中,80mg 阿托伐他汀在冠状动脉旁路移植术后 1 年并未显著降低静脉桥闭塞的发生率。

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