Left Internal Thoracic Artery Bypass Versus Percutaneous Revascularization in Diabetics:Is Minimally Invasive Left Internal Thoracic Artery Bypass Superior to Percutaneous Revascularization in Diabetic Patients With Isolated LAD Stenosis?
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Successfully enrolled, eligible and consenting patients within the first year of enrollment.
研究概览
简要总结
The purpose of this study is to evaluate whether less invasive bypass surgery using the left chest wall artery is more or less effective than inserting a heart stent in patients with diabetes and a blockage of the main artery at the front of the heart. This will be a clinical trial study where the investigators will test the rate of recruitment into the study, as well as the feasibility of allocating each of the 2 treatments.
详细描述
Purpose/Objectives:
The purpose of this pilot study is to evaluate whether minimally invasive bypass surgery with the left internal thoracic artery (MICS CABG) is more or less effective than percutaneous revascularization with drug eluting stents (PCI/DES) in patients with diabetes and stenosis of the left anterior descending (LAD) artery.
Population:
The investigators will recruit 100 adults with diabetes mellitus (Type 1 or Type 2) and angiographically-confirmed proximal or mid LAD disease, morphologically amenable to either MICS CABG or PCI/DES; outside the context of an acute ST-elevation myocardial infarction, and with indication for revascularization based upon symptoms of worsening angina and/or objective evidence of myocardial ischemia.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female age 18 years or older
- •Diabetes Mellitus (Type 1 or Type 2) undergoing treatment
- •Angiographically confirmed stenosis (≥ 70%) lesion of the proximal LAD (segment 6) or mid LAD (segment 7), with no culprit lesion or stenosis of more than 60% (in a vessel of 1.5 mm or more) in the LCX and RCA territories, and no stenosis equal or more than 50% in the left main artery. Diagonal disease does not constitute an exclusion
- •Angiographic characteristics amenable to both PCI/DES and MICS CABG
- •Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia
- •Willing to comply with all follow-up required study visits
- •Signed and received copy of informed consent
排除标准
- •Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment.
- •Left ventricular ejection fraction less than 20%;
- •Prior CABG surgery.
- •Prior Valve surgery.
- •Prior PCI with stent implantation within 6 months.
- •Previous tuberculosis or trauma to the chest that may have cause adhesions or LITA damage.
- •Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement, as reflected in a Rankin Score >
- •Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during CABG or PCI/DES related anticoagulation.
- •In-stent restenosis in the LAD.
- •Left main stenosis (50% or more).
- •STEMI or Q-wave MI within 72 hours prior to enrollment
- •Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stent).
- •Contraindication to either CABG or PCI/DES because of a coexisting clinical condition.
- •Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.
- •Intolerance or contraindication to aspirin or both clopidogrel and ticagrelor.
- •Dementia with a Mini Mental Status Examination (MMSE) score of <
- •Extra-cardiac illness that is expected to limit survival to less than 5 years.
- •Suspected pregnancy. A pregnancy test (urine or serum) will be administered pre-randomization to all women not clearly menopausal.
- •Concurrent enrollment in another clinical trial.
- •Geographically inaccessible for follow-up visits required by protocol.
研究组 & 干预措施
Minimally Invasive Coronary Bypass
Minimally invasive bypass surgery (MICS CABG) would be conducted to treat the left anterior descending (LAD) artery disease in diabetic patients. This would be a surgical intervention, and differs from the stent procedure arm.
干预措施: Minimally Invasive Coronary Bypass (Procedure)
Percutenous Coronary Intervention
Percutaneous coronary intervention (PCI) with drug eluting stents would be used to treat left anterior descending (LAD) artery disease in diabetic patients. This would be an intervention induced by cardiology, and differs from the surgical intervention arm.
干预措施: Percutenous Coronary Intervention (Procedure)
结局指标
主要结局
Successfully enrolled, eligible and consenting patients within the first year of enrollment.
时间窗: 1 year
To determine the feasibility of the study by successfully recruiting 100 patients within the 1 year recruitment period.
次要结局
- Target Vessel Revasularization (TVR)(2 years)
- Quality of Life (QOL)(2 years)
- All-cause Mortality(2 years)
- Myocardial Infarction (MI)(2 years)
- Stroke(2 years)
研究者
Marc Ruel MD MPH FRCSC
Professor and Chairman, Division of Cardiac Surgery
Ottawa Heart Institute Research Corporation