Puskas John D, Williams Willis H, Mahoney Elizabeth M, Huber Philip R, Block Peter C, Duke Peggy G, Staples James R, Glas Katherine E, Marshall J Jeffrey, Leimbach Mark E, McCall Susan A, Petersen Rebecca J, Bailey Dianne E, Weintraub William S, Guyton Robert A
Division of Cardiothoracic Surgery,Emory University School of Medicine and Emory Center for Outcomes Research, Atlanta, Ga, USA.
JAMA. 2004 Apr 21;291(15):1841-9. doi: 10.1001/jama.291.15.1841.
Previous trials of off-pump coronary artery bypass (OPCAB) have enrolled selected patients and have not rigorously evaluated long-term graft patency. A preliminary report showed OPCAB achieved improved inhospital outcomes, similar completeness of revascularization, and shorter lengths of stay compared with conventional coronary artery bypass grafting (CABG).
To assess graft patency, clinical and quality-of-life outcomes, and cost among patients while in the hospital and at 1-year follow-up.
DESIGN, SETTING, AND PATIENTS: Randomized controlled trial of patients unselected for coronary anatomy, ventricular function, or comorbidities between March 10, 2000, and August 20, 2001, at a US academic center. A total of 200 patients were enrolled; 3 patients were withdrawn after randomization for mitral valve repair or replacement. Follow-up was complete for 197 patients at 30 days; 185 at 1 year.
One surgical session consisting of elective OPCAB or CABG with cardiopulmonary bypass. The surgeon had extensive experience performing off-pump surgery; patients were subsequently managed by blinded protocols.
Coronary angiography documented graft patency prior to hospital discharge and at 1 year; health-related quality of life; and cost of the index and subsequent hospitalization(s).
Graft patency was similar for OPCAB and conventional CABG with cardiopulmonary bypass at 30 days (absolute difference, 1.3%; 95% confidence interval [CI], -0.66% to 3.31%; P =.19) and at 1 year (absolute difference, -2.2%; 95% CI, -6.1% to 1.7%; P =.27). Rates of death, stroke, myocardial infarction, angina, and reintervention were similar at 30 days and 1 year. There were no significant differences in health-related quality of life. Mean total hospitalization cost per patient at hospital discharge was 2272 dollars (95% CI, 755 dollars-3732 dollars) less for OPCAB (P =.002) and 1955 dollars (95% CI, -766 dollars to 4727 dollars) less at 1 year (P =.08).
In this randomized single-surgeon trial among unselected patients with angiographic follow-up, OPCAB achieved similar graft patency in the hospital and at 1 year. Cardiac outcomes and health-related quality of life at 30 days and 1 year were similar and patients incurred a lower cost. OPCAB may provide complete revascularization that is durable and cost-effective.
先前非体外循环冠状动脉搭桥术(OPCAB)的试验纳入的是经过挑选的患者,且未对长期移植物通畅情况进行严格评估。一份初步报告显示,与传统冠状动脉搭桥术(CABG)相比,OPCAB改善了住院结局,血管重建的完整性相似,住院时间更短。
评估患者在住院期间及1年随访时的移植物通畅情况、临床和生活质量结局以及费用。
设计、地点和患者:2000年3月10日至2001年8月20日在美国一家学术中心对未根据冠状动脉解剖结构、心室功能或合并症进行挑选的患者进行随机对照试验。共纳入200例患者;3例患者在随机分组后因二尖瓣修复或置换退出。197例患者在30天完成随访;185例在1年完成随访。
一次手术,包括择期OPCAB或体外循环下的CABG。外科医生有丰富的非体外循环手术经验;患者随后按照盲法方案进行管理。
冠状动脉造影记录出院前和1年时的移植物通畅情况;健康相关生活质量;以及首次及后续住院的费用。
OPCAB与传统体外循环CABG在30天时的移植物通畅情况相似(绝对差异为1.3%;95%置信区间[CI],-0.66%至3.31%;P = 0.19),在1年时也相似(绝对差异为-2.2%;95% CI,-6.1%至1.7%;P = 0.27)。30天和1年时的死亡、中风、心肌梗死、心绞痛和再次干预发生率相似。健康相关生活质量无显著差异。OPCAB组患者出院时平均总住院费用比CABG组少2272美元(95% CI,755美元至3732美元)(P = 0.002),1年时少1955美元(95% CI,-766美元至4727美元)(P = 0.08)。
在这项对未挑选患者进行血管造影随访的随机单外科医生试验中,OPCAB在住院期间及1年时的移植物通畅情况相似。30天和1年时的心脏结局和健康相关生活质量相似,且患者费用更低。OPCAB可能提供持久且具有成本效益的完全血管重建。