Percutaneous Coronary Intervention Versus Coronary Bypass Surgery in United States Veterans With Diabetes
Percutaneous Coronary Intervention Versus Coronary Bypass Surgery in United States Veterans With Diabetes
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DOI：
10.1016/j.jacc.2012.11.044
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发表时间：
2013-02-26
影响因子：
24
通讯作者：
Reda, Domenic
中科院分区：
文献类型：
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作者：
Kamalesh, Masoor;Sharp, Thomas G.;Reda, Domenic
目的本研究旨在确定糖尿病合并严重冠状动脉疾病患者的最佳冠状动脉血运重建策略。背景尽管大型试验、数据库和荟萃分析的亚组分析发现，糖尿病合并复杂冠状动脉疾病患者在接受手术治疗时生存率更高，一项随机试验，在高血压糖尿病患者中比较药物洗脱支架和手术干预的效果。危险性冠状动脉疾病尚未报道。方法在一项前瞻性、多中心研究中，198例符合条件的糖尿病伴严重冠状动脉疾病患者被随机分配接受冠状动脉旁路移植术（CABG）（n = 97）或经皮冠状动脉介入治疗（PCI），洗脱支架（n = 101），并随访至少2年。主要结局指标是非致死性心肌梗死或死亡的复合指标。次要结局指标包括全因死亡率，心源性死亡率，非致命性心肌梗死，stroke.Results研究被停止，因为招募缓慢后，只招募了25%的预期样本量，使其严重不足的主要复合终点死亡加非致命性心肌梗死（危害比：0.89，95%置信区间：0.47至1.71）。然而，在平均2年的随访期后，CABG的全因死亡率为5.0%，PCI为21（风险比：0.30; 95%置信区间：0.11至0.80），而非致命性心肌梗死的风险为15%的冠状动脉旁路移植术和6.2%的PCI（危险比：3.32; 95%可信区间：1.07 ~ 10.30）结论：本研究的主要终点严重不足，因此无法得出关于CABG和PCI的比较有效性的确切结论。主要终点的组成部分存在有趣的差异。然而，置信区间非常大，结果必须被视为假设生成。（糖尿病患者的冠状动脉血运重建; NCT 00326196）（美国科尔心脏病学杂志2013;61：808-16）（C）2013年，美国心脏病学会基金会
Objectives This study sought to determine the optimal coronary revascularization strategy in patients with diabetes with severe coronary disease.Background Although subgroup analyses from large trials, databases, and meta-analyses have found better survival for patients with diabetes with complex coronary artery disease when treated with surgery, a randomized trial comparing interventions exclusively with drug-eluting stents and surgery in patients with diabetes with high-risk coronary artery disease has not yet been reported.Methods In a prospective, multicenter study, 198 eligible patients with diabetes with severe coronary artery disease were randomly assigned to either coronary artery bypass grafting (CABG) (n = 97) or percutaneous coronary intervention (PCI) with drug-eluting stents (n = 101) and followed for at least 2 years. The primary outcome measure was a composite of nonfatal myocardial infarction or death. Secondary outcome measures included all-cause mortality, cardiac mortality, nonfatal myocardial infarction, and stroke.Results The study was stopped because of slow recruitment after enrolling only 25% of the intended sample size, leaving it severely underpowered for the primary composite endpoint of death plus nonfatal myocardial infarction (hazard ratio: 0.89; 95% confidence interval: 0.47 to 1.71). However, after a mean follow-up period of 2 years, all-cause mortality was 5.0% for CABG and 21% for PCI (hazard ratio: 0.30; 95% confidence interval: 0.11 to 0.80), while the risk for nonfatal myocardial infarction was 15% for CABG and 6.2% for PCI (hazard ratio: 3.32; 95% confidence interval: 1.07 to 10.30).Conclusions This study was severely underpowered for its primary endpoint, and therefore no firm conclusions about the comparative effectiveness of CABG and PCI are possible. There were interesting differences in the components of the primary endpoint. However, the confidence intervals are very large, and the findings must be viewed as hypothesis generating only. (Coronary Artery Revascularization in Diabetes; NCT00326196) (J Am Coll Cardiol 2013;61:808-16) (C) 2013 by the American College of Cardiology Foundation