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CABG edges PCI in quality-of-life measures for diabetes patients 改善糖尿病患者生活质量:CABG优于PCI  

2013-10-17 12:05:35|  分类: 心血管科 |  标签: |举报 |字号 订阅

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By: MARY ANN MOON, Cardiology News Digital Network


For diabetic patients who have multivessel coronary artery disease, bypass surgery provides slightly better quality of life and cardiovascular-related health status than does stenting for roughly 2 years, according to a substudy of the FREEDOM trial reported online Oct. 15 in JAMA.


Beyond 2 years, there are no significant differences between the two approaches regarding health status and quality of life in this patient group, said Dr. Mouin S. Abdallah of St. Luke’s Mid America Heart Institute, Kansas City, Mo., and his associates.


Both revascularization strategies yield substantial and sustained improvements for patients who have concomitant multivessel coronary artery disease (CAD) and diabetes, but coronary artery bypass graft surgery generally is preferred because it has a small but significant edge in reducing morbidity and mortality, is less expensive, and produces markedly more durable results. However, the risk of stroke is higher with CABG, and it requires a longer recovery period because it is more invasive, "which may be particularly relevant to patients who are more concerned about quality rather than duration of life," the investigators noted.


"For such patients, our study provides reassurance that there are not major differences in long-term health status and quality of life between the two treatment strategies," they said.


Dr. Abdallah and his colleagues performed a prospective substudy of quality-of-life issues alongside the FREEDOM (Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease) clinical trial. In FREEDOM, 1,900 patients from 18 countries were randomly assigned to undergo either CABG or percutaneous coronary intervention with drug-eluting stents during 2005-2010.


For their substudy, Dr. Abdallah and his associates assessed 935 participants who were assigned to CABG and 945 assigned to PCI. The mean patient age was 63 years, and 72% were men. Median follow-up was 44-47 months.


Patients in both study groups reported substantial and long-lasting improvements in cardiovascular-specific health status, as measured by the Seattle Angina Questionnaire and the Rose Dyspnea Scale. Scores on these instruments improved markedly within 1 month of both procedures and remained high throughout follow-up.


Patients in the PCI group showed more rapid improvement following the procedure, "but these benefits were transient and largely restricted to the first month of follow-up," the researchers said.


"Between 6 months and 2 years, health status was slightly better with CABG across a range of cardiac-specific domains including angina relief, physical function, and overall quality of life. Beyond 2 years, there were no consistent differences in any health status or quality-of-life domains between the CABG and PCI strategies," they reported (JAMA 2013;310:1581-90).


For example, the proportion of angina-free patients was slightly but significantly greater with CABG than with PCI at 6 months (83.7% vs. 78.1%) and at 12 months (83.5% vs. 79.5%), but was not significantly different thereafter.


Similarly, measures of physical limitations imposed by CAD were "modestly" higher with CABG than with PCI for 3 years after the procedure, but there were no significant between-group differences after year 3.


And dyspnea improved faster after PCI than after CABG, but by 6 months this difference had disappeared. By 1 year, the proportion of patients who reported moderate dyspnea was only 9% in both groups, and that proportion stayed fairly steady at 10%-12% in both groups for the remainder of follow-up.


The findings were similar in a sensitivity analysis and in a further analysis restricted only to patients who had reported daily or weekly angina at baseline.


In the FREEDOM trial, CABG showed a clear benefit over PCI for the composite endpoint of death, myocardial infarction, or stroke in patients with concomitant multivessel CAD and diabetes. CABG also afforded slightly better angina relief, especially in patients who had the most severe angina at baseline.


Moreover, patients in the PCI group were more likely to require continuing antianginal medication and twice as likely to undergo repeat revascularization procedures than those in the CABG group.


However, the study findings demonstrate that PCI is clearly beneficial for patients who want to avoid the acute risks of CABG surgery, and is an excellent alternative for those who want a less invasive treatment, Dr. Abdallah and his associates said.


This study was supported by the National Heart, Lung, and Blood Institute. Cordis and Boston Scientific provided the drug-eluting stents, Eli Lilly provided abciximab and research funds, and Sanofi-Aventis and Bristol-Myers Squibb provided clopidogrel. Dr. Abdallah reported no relevant financial conflicts of interest; his associates reported numerous ties to industry sources.



《美国医学会杂志》(JAMA)10月15日在线发表的FREEDOM试验的分支研究结果显示,在合并多支冠状动脉疾病的糖尿病患者中,与支架术组相比,旁路手术组的生活质量和心血管相关健康状态稍佳且这一获益持续约2年。2年后,两组在健康状态和生活质量方面无显著差异(JAMA 2013;310:1581-90)。


在这项前瞻性分支研究中,堪萨斯城圣卢克美国中部心脏协会的Mouin S. Abdallah医生及其同事评估了935例接受冠状动脉旁路移植术(CABG)的患者和945例接受经皮冠状动脉介入治疗(PCI)的患者。患者平均年龄为63岁,72%为男性。中位随访时间为44~47个月。


西雅图心绞痛问卷和Rose呼吸困难量表测定结果显示,两组患者的心血管特异性健康状态均获得显著且持续的改善。这些量表的评分在两种手术进行后1个月内显著改善,并且整个随访期间的评分均保持较高。PCI组患者在术后改善更快,但这些获益为短暂性且主要限于随访第1个月。


在6个月至2年内,CABG组各个心脏特异性领域(包括心绞痛缓解、躯体功能和总体生活质量)的健康状态稍佳。2年后,CABG组和PCI组在任何健康状态或生活质量领域方面无差异。例如,6个月(83.7% vs. 78.1%) 和12个月时(83.5% vs. 79.5%)CABG组无心绞痛的患者比例稍高PCI组,差异具有显著性,但此后差异不显著。同样,CABG组术后3年内的冠状动脉疾病所致躯体受限指标轻微高于PCI组,但3年后两组间无显著差异。


PCI后呼吸困难改善的速度快于CABG后,但6个月时这一差异消失。1年时,两组中报告中度呼吸困难的患者比例均仅为9%,并且剩余随访时间内两组的这一比例稳定维持在10%~12%。


敏感性分析和对仅限于基线报告每日或每周心绞痛的患者进行的进一步分析也得出相似结果。


研究者表示,两种血运重建策略均可使合并多支冠状动脉疾病的糖尿病患者获得显著且持续的改善,但一般首选CABG,因为其在降低发病率和死亡率方面具有轻微但显著的优势,并且比较便宜,产生的效果明显更持久。然而,CABG的卒中风险较高,并且因其侵入性较高,需要的恢复时间较长,这对于更关注生活质量而非生命长度的患者而言更具有相关性。上述研究表明,对于此类患者,两种治疗策略在远期健康状态和生活质量方面无重要差异。


该研究获美国国立心肺和血液研究所支持。Cordis和Boston Scientific公司提供药物洗脱支架,礼来公司提供阿昔单抗和研究基金,赛诺菲安万特和百时美施贵宝公司提供氯吡格雷。Abdallah医生声明无相关经济利益冲突,其同事与药企存在诸多联系。

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