Quality of life after PCI vs CABG among patients with diabetes and multivessel coronary artery disease: a randomized clinical trial.
Quality of life after PCI vs CABG among patients with diabetes and multivessel coronary artery disease: a randomized clinical trial.
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DOI：
10.1001/jama.2013.279208
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发表时间：
2013-10-16
影响因子：
120.7
通讯作者：
Cohen, David J.
中科院分区：
文献类型：
--
作者：
Abdallah, Mouin S.;Wang, Kaijun;Magnuson, Elizabeth A.;Spertus, John A.;Farkouh, Michael E.;Fuster, Valentin;Cohen, David J.
FREEDOM 试验表明，在患有糖尿病 (DM) 和多支冠状动脉疾病 (CAD) 的患者中，与使用药物洗脱支架的经皮冠状动脉介入治疗 (DES-PCI) 相比，冠状动脉旁路移植术 (CABG) 手术可降低死亡率和心肌梗死率，但中风风险较高。从患者的角度评估健康状况是否有好处尚不清楚。比较 CABG 与 DES-PCI 对 DM 和多支 CAD 患者健康状况的影响。 2005 年至 2010 年间，来自 18 个国家的 1900 名患有 DM 和多支血管 CAD 的患者被随机接受 CABG (n=947) 或 DES-PCI (n=953) 作为初始治疗策略。其中，共有 1880 名患者接受了基线健康状况评估（935 名患者接受了 CABG，945 名患者接受了 DES-PCI），并构成了主要分析样本。采用 CABG 或 DES-PCI 进行初始血运重建。使用西雅图心绞痛问卷 (SAQ) 的心绞痛频率 (AF)、身体限制 (PL) 和生活质量 (QOL) 领域在基线、1、6 和 12 个月以及此后每年评估健康状况。对于每个量表，分数范围从 0 到 100，其中分数越高代表健康状况越好。使用纵向混合效应模型评估 CABG 与 DES-PCI 的效果。基线时，CABG 组 SAQ-AF、SAQ-PL 和 SAQ-QOL 分量表的平均（±标准差）得分为 70.9±25.1、67.3±24.4 和 47.8±25.0，DES-PCI 组分别为 71.4±24.7、69.9±23.2 和 49.2±25.7。 2 年随访时，CABG 后平均评分为 96.0±11.9、87.8±18.7 和 82.2±18.9，DES-PCI 后平均评分为 94.7±14.3、86.0±19.3 和 80.4±19.6，CABG 在每个领域的益处显着更大（平均治疗益处 1.3 [95% CI 0.3 至 2.2]， 4.4 [95% CI 2.7 至 分别为 6.1] 和 2.2 [95% CI 0.7 至 3.8] 点；每次比较 p<0.01）。超过 2 年，两种血运重建策略之间没有一致的差异。对于患有糖尿病和多支血管 CAD 的患者，CABG 提供的中期健康状况和生活质量比 DES-PCI 稍好——主要是在初次治疗后 6 个月到 2 年内。然而，获益的幅度很小，可能没有临床意义。 NCT00086450。
The FREEDOM trial demonstrated that among patients with diabetes mellitus (DM) and multivessel coronary artery disease (CAD), coronary artery bypass graft (CABG) surgery results in lower rates of death and MI but a higher risk of stroke as compared with percutaneous coronary intervention using drug-eluting stents (DES-PCI). Whether there are benefits in terms of health status as assessed from the patient's perspective is unknown. To compare the impact of CABG vs. DES-PCI on health status among patients with DM and multivessel CAD. Between 2005 and 2010, 1900 patients from 18 countries with DM and multivessel CAD were randomized to undergo either CABG (n=947) or DES-PCI (n=953) as an initial treatment strategy. Of these, a total of 1880 patients had baseline health status assessed (935 CABG, 945 DES-PCI) and comprised the primary analytic sample. Initial revascularization with CABG or DES-PCI. Health status was assessed using the angina frequency (AF), physical limitations (PL), and quality of life (QOL) domains of the Seattle Angina Questionnaire (SAQ) at baseline, 1, 6, and 12 months, and annually thereafter. For each scale, scores range from 0 to 100 where higher scores represent better health. The effect of CABG vs. DES-PCI was evaluated using longitudinal mixed effect models. At baseline, mean (± standard deviation) scores were 70.9±25.1, 67.3±24.4 and 47.8±25.0 for the SAQ-AF, SAQ-PL and SAQ-QOL subscales for the CABG group and 71.4±24.7, 69.9±23.2 and 49.2±25.7 for the DES-PCI group. At 2 year follow up, mean scores were 96.0±11.9, 87.8±18.7 and 82.2±18.9 after CABG and 94.7±14.3, 86.0±19.3 and 80.4±19.6 after DES-PCI with significantly greater benefit of CABG on each domain (mean treatment benefit 1.3 [95% CI 0.3 to 2.2], 4.4 [95% CI 2.7 to 6.1], and 2.2 [95% CI 0.7 to 3.8] points, respectively; p<0.01 for each comparison). Beyond 2 years, there were no consistent differences between the 2 revascularization strategies. For patients with diabetes and multivessel CAD, CABG provides slightly better intermediate term health status and quality of life than DES-PCI—mainly between 6 months and 2 years after initial treatment. However, the magnitude of benefit is small and may not be clinically meaningful. NCT00086450.
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