Department of Cardiovascular and Thoracic Surgery, Montefiore Medical Center, Bronx, New York.
Department of Cardiovascular Surgery, Mount Sinai Morningside, New York, New York.
JAMA Cardiol. 2022 Aug 1;7(8):808-816. doi: 10.1001/jamacardio.2022.1437.
Intimal hyperplasia and subsequent saphenous vein graft failure may have significant adverse clinical effects in patients undergoing coronary artery bypass surgery. External support of saphenous vein grafts has the potential to prevent vein graft dilation and hence slow the rate of intimal hyperplasia and increase long-term vein patency.
To determine efficacy, as measured by intimal hyperplasia, and safety of an external saphenous vein graft support device in patients undergoing a coronary bypass graft procedure.
DESIGN, SETTING, AND PARTICIPANTS: This within-patient randomized, open-label, multicenter study was conducted at 17 Cardiothoracic Surgical Trials Network centers in North America. Between January 2018 and February 2019, 224 patients with multivessel coronary artery disease undergoing isolated bypass surgery were enrolled. For each patient, 1 of 2 vein grafts was randomized to receive external support or no support.
External vein graft support or no support.
The primary efficacy end point was intimal hyperplasia area assessed by intravascular ultrasound at 12 months postrandomization for each study graft. Secondary confirmatory end points were lumen diameter uniformity assessed by angiography and graft failure (≥50% stenosis) by quantitative coronary angiography. Major cardiac and cerebrovascular events were collected through month 12.
Among 224 patients (mean [SD] age, 65.8 [8.3] years; 178 [79.5%] male), 203 (90.6%) were eligible for intravascular ultrasound, of which 85 (41.9%) had at least 1 study graft occluded or severely diseased at 12 months (55 supported, 56 unsupported). After imputation of data missing because of graft occlusion or severe disease, the estimated mean (SE) intimal hyperplasia area was 5.11 (0.16) mm2 in supported grafts and 5.79 (0.20) mm2 in unsupported grafts (P = .07). In a sensitivity analysis of 113 patients with both grafts imaged, the mean intimal hyperplasia area was 4.58 (0.18) mm2 and 5.12 (0.23) mm2 in supported and unsupported grafts, respectively (P = .04). By 12 months, 5 patients (2.2%) died and 16 patients (7.1%) experienced a major cardiac or cerebrovascular event.
The 12-month difference in intimal hyperplasia area between supported and unsupported grafts did not achieve statistical significance. Cumulative mortality and major cardiac or cerebrovascular events rates were similar to those in other randomized coronary artery bypass trials. Further investigation to assess the effect of external graft support devices on long-term graft patency and clinical outcomes is warranted.
ClinicalTrials.gov Identifier: NCT03209609.
在接受冠状动脉旁路移植术的患者中，内膜增生和随后的隐静脉移植物失败可能会产生显著的不良临床影响。隐静脉移植物的外部支撑具有防止静脉移植物扩张的潜力，从而减缓内膜增生的速度，增加长期静脉通畅率。
确定在接受冠状动脉旁路移植术的患者中，一种外部隐静脉移植物支撑装置的疗效，以内膜增生为衡量标准，并评估其安全性。
设计、地点和参与者：这是一项在北美 17 个心胸外科试验网络中心进行的患者内随机、开放标签、多中心研究。2018 年 1 月至 2019 年 2 月期间，纳入了 224 名患有多支冠状动脉疾病且正在接受单纯旁路手术的患者。对于每位患者，其中一条隐静脉移植物被随机分配接受外部支撑或不接受支撑。
外部静脉移植物支撑或不支撑。
主要疗效终点是在随机分组后 12 个月，通过血管内超声评估每个研究移植物的内膜增生面积。次要确认终点是通过血管造影评估管腔直径均匀性和通过定量冠状动脉造影评估移植物失败（≥50%狭窄）。主要心脏和脑血管事件通过 12 个月进行收集。
在 224 名患者（平均[标准差]年龄，65.8[8.3]岁；178[79.5%]为男性）中，有 203 名（90.6%）符合血管内超声检查条件，其中 85 名（41.9%）在 12 个月时有至少 1 个研究移植物闭塞或严重病变（55 个有支撑，56 个无支撑）。在因移植物闭塞或严重疾病而缺失数据的情况下进行插补后，支撑移植物的估计平均（SE）内膜增生面积为 5.11（0.16）mm²，非支撑移植物为 5.79（0.20）mm²（P=0.07）。在 113 名双侧移植物均进行成像的患者的敏感性分析中，支撑和非支撑移植物的平均内膜增生面积分别为 4.58（0.18）mm²和 5.12（0.23）mm²（P=0.04）。12 个月时，5 名患者（2.2%）死亡，16 名患者（7.1%）发生主要心脏或脑血管事件。
支撑和非支撑移植物之间 12 个月的内膜增生面积差异未达到统计学意义。累积死亡率和主要心脏或脑血管事件发生率与其他随机冠状动脉旁路移植试验相似。需要进一步研究评估外部移植物支撑装置对长期移植物通畅率和临床结局的影响。
ClinicalTrials.gov 标识符：NCT03209609。
