Five-year Patency of No-touch Saphenous Vein Grafts in On-pump Versus Clamp-less Off-pump Coronary Artery Bypass Surgery: A Sub-study of a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 主要终点
- Graft patency
研究概览
简要总结
Randomised controlled trials (RCTs) have shown high long-term patency for no-touch saphenous vein grafts (NTSVGs), comparable to the internal thoracic artery in on-pump coronary artery bypass grafting (CABG). RCTs on patency in NTSVGs in off-pump CABG have not been published yet. Orebro University Hospital participated in the CABG Off- or On-pump Revascularization study (CORONARY, ClinicalTrials.gov number, NCT00463294) and included fifty-six patients. Accordingly, this is a sub-study and the aim was to assess the midterm patency in NTSVGs in clamp-less off-pump versus on-pump CABG at five-year follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were eligible if they:
- •provided written informed consent;
- •were >21 years of age;
- •required isolated CABG with median sternotomy;
- •had at least one of the following risk factors:
- •had peripheral vascular disease (previous peripheral bypass, amputation or anklebranchial index <0.90),
- •had cerebrovascular disease (history of stroke, transient ischemic attach or carotid stenosis ≥70%),
- •had renal insufficiency (creatinine above upper limit of normal),
- •were ≥70 years of age, or
- •were between the ages of 60-69 with one of the following: i. had diabetes and taking an oral hypoglycemic agent and/or insulin, ii. required urgent revascularization (i.e., waiting in hospital for revascularization after an acute coronary syndrome), iii. were a recent smoker (within 1 year of randomization), or iv. had left ventricular ejection fraction ≤35%, OR
- •were between the ages of 55-59 with two of the following: i. Diabetes and taking an oral hypoglycemic agent and/or insulin, ii. required urgent revascularization (i.e., waiting in hospital for revascularization after an acute coronary syndrome, iii. were a recent smoker (within 1 year of randomization), or iv. had a left ventricular ejection fraction ≤35%
排除标准
- •Patients were excluded if they:
- •required a concomitant cardiac procedure associated with CABG;
- •had a contraindication to off-pump or on-pump CABG (e.g., calcified aorta, intramuscular left anterior descending artery, calcified coronaries, small target vessels);
- •had a concomitant life-threatening disease likely to limit life expectancy to less than 2 years;
- •were previously enrollment in the CORONARY Trial;
- •required emergency CABG surgery (i.e., immediate revascularization for hemodynamic instability); OR
- •required a redo CABG.
研究组 & 干预措施
On-Pump
Use of extracorporeal circulation
干预措施: The use of extracorporeal circulation (Procedure)
Off-Pump
结局指标
主要结局
Graft patency
时间窗: Five years postoperatively
Graft patency as assessed with computed tomography angiography
次要结局
未报告次要终点
研究者
Ninos Samano M.D.
Consultant in Cardiothoracic Surgery
Örebro County Council