Comparison of One-stop Hybrid Revascularization Versus Off-pump Coronary Artery Bypass for the Treatment of Multi-vessel Disease
Comparison of "One-stop" Hybrid Coronary Revascularization Versus Off-pump Coronary Artery Bypass for the Treatment of Multi-vessel Coronary Artery Disease
研究概览
地位
条件
详细说明
- With the development of specialized devices and experience, off-pump coronary artery bypass (OPCAB) has been a well-established less invasive technique for coronary revascularization. Compared with conventional on-pump coronary artery bypass grafting (CABG), OPCAB avoids the use of cardiopulmonary bypass and cardioplegic arrest, and is associated with decreased morbidity, shorter length of stay in ICU and hospital, and less perioperative complications, especially in elderly patients with severe comorbidities. "One-stop" (also named simultaneous) hybrid coronary revascularization is also a novel, safe and feasible minimally invasive approach in selected patients with multivessel coronary artery disease (CAD). It allows surgical and interventional procedures to be performed consecutively in the "one-stop" hybrid operating suite, an enhanced operating room equipped with radiographic capability, wherein the left intramammary artery (LIMA) is placed on the left anterior descending artery (LAD) by minimally invasive procedure, immediately followed by percutaneous coronary intervention/stenting on the non-LAD lesions. However, few studies are now available on the outcomes of coronary revascularization between the new hybrid strategy with conventional OPCAB. This study is a single center randomized clinical trial to compare 1-year clinical outcomes of "one-stop" hybrid coronary revascularization with OPCAB in selected patients with multivessel CAD with suitable coronary anatomy.
Sample size:
- We examined the results of SYNTAX trial and of our institution published previously. The 1-year MACCE rate (the primary endpoint) is estimated as being 13% for OPCAB. The sample calculated for this trial is 400 patients.
Design/Methodology:
- Trial design: A single center randomized clinical trial comparing "one-stop" hybrid procedure versus conventional OPCAB in 400 patients with suitable anatomy who need revascularization.
Intervention: Patients will be randomized to undergo either "one-stop" hybrid procedure or conventional OPCAB.
- Randomization: Patients will be evaluated by both a cardiac surgeon and an interventional cardiologist. After obtaining informed written consent, patients will be randomized to receive "one-stop" hybrid procedure or conventional OPCAB. An expertise-based randomization will be used.
The data adjudicators will be blinded to the study. Due to the nature of this study, the operating surgeons, cardiologists, anesthetists, other operative room staff, and ICU staff will not be blind in this study.
Study intervention:
- Candidates will be randomized to receive "one-stop" hybrid procedure or conventional OPCAB.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Beijing
-
Beijing、Beijing、中国、100037
- 招聘中
- China National Center for Cardiovascular Diseases, Cardiovascular Institute & Fuwai Hospital
-
接触：
- Shengshou Hu, M.D.
- 电话号码：0086-010-8839-8359
- 邮箱：shengshouhu@yahoo.com
-
接触：
- Zhe Zheng, M.D.
- 电话号码：0086-010-8839-8359
- 邮箱：zhengzhefuwai@tom.com
-
首席研究员：
- Shengshou Hu, M.D.
-
首席研究员：
- Yuejin Yang, M.D.
-
Beijing、Beijing、中国、100037
- 招聘中
- Institute of cardiovascular diseases & Fuwai hospital
-
接触：
- Shengshou Hu, M.D.
- 电话号码：0086-10-8839-8359
- 邮箱：shengshouhu@yahoo.com
-
接触：
- Zhe Zheng, M.D.
- 电话号码：0086-10-8839-8359
- 邮箱：zhengzhefuwai@tom.com
-
首席研究员：
- Shengshou Hu, M.D.
-
首席研究员：
- Yuejin Yang, M.D.
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Two- or three-vessel disease, left main disease, or LM equivalent with 2 or 3-vessel disease (left anterior descending [LAD], left circumflex [LCX], right coronary artery [RCA] territory);
- LAD diseases not suitable for PCI [i.e. chronic totally occlusion (CTO), severe calcification or/and angulated lesions, bifurcation or trifurcation lesions];
- Angiographic characteristics of non-LAD lesion(s) amiable to PCI;
- Chronic stable or unstable angina pectoris of CCS 2 or greater (symptoms of angina and/or objective evidence of myocardial ischemia);
- Evaluated by both cardiac surgeon and cardiologist together.
Exclusion Criteria:
- Need for emergent CABG;
- Prior CABG;
- Prior PCI with stenting within 6 months of study entry;
- Stroke with 6 months of study entry;
- Overt congestive heart failure;
- Need for a concomitant operation (i.e. valve repair or replacement, Maze surgery);
- Hemodynamic instability;
- Situations in which complete revascularization is not possible served;
- Allergy to radiographic contrast, aspirin or clopidogrel.
- Contradictions to PCI: Occluded coronary vessels, PVD, Unable to achieve access, Fresh thrombus, Vessels <1.5mm; Intolerance to aspirin or both clopidogrel and ticlopidine;
- Cannot undergo either CABG or PCI/DES because of a coexisting medical condition
- History of significant bleeding; Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：One-stop hybrid revasularization
|
MIDCAB with no associated or concomitant surgical procedures, using partial ministernotomy, without cardiopulmonary bypass (CPB) and cardioplegia.
其他名称：
PCI with drug eluting stents (DES) performed by cardiologists on the non-LAD lesions in the same operating suite immediately following MIDCAB. Device: Polymer-based Sirolimus-Eluting Stents (SES).
其他名称：
|
|
有源比较器：Off-pump coronary artery bypass
|
Procedure: coronary artery bypass without cardiopulmonary Coronary artery bypass surgery with no associated or concomitant surgical procedures, using full median sternotomy, without cardiopulmonary bypass (CPB) and cardioplegia.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
主要不良心脏或脑血管事件 (MACCE) 的复合，包括死亡、心肌梗塞、中风和/或再次血运重建。
大体时间：1年
|
1年
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
总体 MACCE 率。
大体时间：手术后 30 天和入组后 2 年
|
手术后 30 天和入组后 2 年
|
|
心脏死亡。
大体时间：手术后 30 天，入组后 1 年和 2 年
|
手术后 30 天，入组后 1 年和 2 年
|
|
记录在案的心肌梗塞。
大体时间：手术后 30 天，入组后 1 年和 2 年
|
手术后 30 天，入组后 1 年和 2 年
|
|
靶病变血运重建。
大体时间：手术后 30 天，入组后 1 年和 2 年
|
手术后 30 天，入组后 1 年和 2 年
|
|
心绞痛复发。
大体时间：入学后 1 年和 2 年
|
入学后 1 年和 2 年
|
|
成本效益分析。
大体时间：入学后 1 年和 2 年
|
入学后 1 年和 2 年
|
|
生活质量。
大体时间：入学后 6 个月、1 年和 2 年
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入学后 6 个月、1 年和 2 年
|
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再住院。
大体时间：入学后 6 个月、1 年和 2 年
|
入学后 6 个月、1 年和 2 年
|
合作者和调查者
调查人员
- 研究主任：Shengshou Hu, M.D.、China National Center for Cardiovascular Diseases
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 20091216
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