Clinical Research Unit, Division of Cardiothoracic Surgery, Emory University School of Medicine, Emory University Hospital Midtown, Atlanta, Georgia 30308, USA.
Ann Thorac Surg. 2011 Jun;91(6):1836-42; discussion 1842-3. doi: 10.1016/j.athoracsur.2010.12.043.
The Surgical Management of Arterial Revascularization Therapies trial was conceived to rigorously compare completeness of revascularization, clinical outcomes and resource utilization in unselected patients referred for elective, primary coronary artery bypass grafting randomly assigned to undergo off-pump (OPCAB) or conventional on-pump coronary artery bypass grafting using cardiopulmonary bypass (CPB). The goal of this follow-up study was to compare long-term survival, graft patency, myocardial ischemia, and clinical outcomes among survivors who volunteered to return for clinical evaluation and imaging studies.
Two hundred unselected patients with multivessel coronary artery disease were randomly assigned to OPCAB or CPB coronary artery bypass grafting between March 2000 and August 2001. All-cause mortality was determined by individual patient contact and referencing the Social Security Death Master File. Of 140 survivors, 87 volunteered to return after a minimum of 6.8 years (maximum, 8.4 years; mean, 7.5 years) for assessment of graft patency (computed tomographic angiography) and myocardial ischemia (cardiac positron emission tomography and 12-lead electrocardiogram). Age at follow-up ranged from 38 to 90 years (mean, 68 years).
There were 26 deaths from all causes among OPCAB patients and 31 among CPB patients as of March 30, 2009. Graft patency was similar between groups among 622 grafts assessed by angiography before hospital discharge (99% OPCAB versus 97.7% CPB; p=0.22, Fisher's exact test), among 511 grafts assessed by angiography at 1 year (93.6% OPCAB versus 95.8% CPB; p=0.33), and among 190 grafts assessed by computed tomographic angiography at late follow-up (76% OPCAB versus 83.5% CPB; p=0.44). Twelve of 34 OPCAB (35.3%) and 16 of 39 CPB patients (41.0%) had any ischemia on positron emission tomography scanning (p=0.62). Four OPCAB patients (11.8%) and 9 CPB patients (23.1%) had an ischemic region in excess of 10% of myocardium (p=0.21). At late follow-up, recurrent angina had occurred in 11 of 43 (25.6%) OPCAB patients and 5 of 44 (11.4%) CPB patients (p=0.09). Percutaneous reintervention had been performed at the discretion of blinded local cardiologists in 1 of 43 (2.3%) OPCAB patients and 1 of 44 (2.3%) CPB patients (p=1.0). No patient in either group has undergone repeat CABG.
In this randomized trial, off-pump and on-pump coronary artery bypass grafting were associated with similar early and late graft patency, incidence of recurrent or residual myocardial ischemia, need for reintervention, and long-term survival.
动脉血运重建治疗的外科管理试验是为了严格比较在随机分配接受择期、原发性冠状动脉旁路移植术的患者中，完全血运重建、临床结果和资源利用情况，这些患者未经选择，随机分为接受非体外循环（OPCAB）或常规体外循环（CPB）冠状动脉旁路移植术。本随访研究的目的是比较存活患者的长期生存、移植物通畅、心肌缺血和临床结果，这些患者自愿返回进行临床评估和影像学研究。
2000 年 3 月至 2001 年 8 月，200 例多支冠状动脉疾病患者被随机分配接受 OPCAB 或 CPB 冠状动脉旁路移植术。通过个体患者联系和参考社会安全死亡主文件确定全因死亡率。140 例存活患者中，87 例在至少 6.8 年（最长 8.4 年；平均 7.5 年）后自愿返回，进行移植物通畅性（计算机断层血管造影）和心肌缺血（心脏正电子发射断层扫描和 12 导联心电图）评估。随访时年龄为 38 至 90 岁（平均 68 岁）。
截至 2009 年 3 月 30 日，OPCAB 组有 26 例患者死于各种原因，CPB 组有 31 例患者死于各种原因。出院前通过血管造影评估的 622 个移植物中（OPCAB 为 99%，CPB 为 97.7%；p=0.22，Fisher 确切检验）、1 年时通过血管造影评估的 511 个移植物中（OPCAB 为 93.6%，CPB 为 95.8%；p=0.33）和晚期通过计算机断层血管造影评估的 190 个移植物中（OPCAB 为 76%，CPB 为 83.5%；p=0.44），移植物通畅性相似。34 例 OPCAB 患者中有 12 例（35.3%）和 39 例 CPB 患者中有 16 例（41.0%）在正电子发射断层扫描检查时有任何程度的缺血（p=0.62）。4 例 OPCAB 患者（11.8%）和 9 例 CPB 患者（23.1%）有超过 10%的心肌缺血（p=0.21）。在晚期随访中，43 例 OPCAB 患者中有 11 例（25.6%）和 44 例 CPB 患者中有 5 例（11.4%）出现复发性心绞痛（p=0.09）。根据当地盲法心脏病专家的判断，在 43 例 OPCAB 患者中有 1 例（2.3%）和 44 例 CPB 患者中有 1 例（2.3%）进行了经皮再介入治疗（p=1.0）。两组均无患者再次接受冠状动脉旁路移植术。
在这项随机试验中，非体外循环和体外循环冠状动脉旁路移植术与相似的早期和晚期移植物通畅、复发性或残留心肌缺血、需要再介入以及长期生存相关。
