Implementing a CABG Program Based on Extensive Bilateral Internal Thoracic Artery Use in the Canary Islands: an Inverse Probability of Treatment Weighted Analysis of Survival, Stroke and Sternal Wound Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 666
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
Coronary artery bypass grafting (CABG) remains the preferred revascularization strategy for patients with complex multivessel coronary artery disease. The left internal thoracic artery is universally accepted as the standard conduit for grafting the left anterior descending artery, but the long-term clinical benefit and safety of bilateral internal thoracic artery (BITA) grafting compared with single internal thoracic artery (SITA) grafting remain debated.
This retrospective cohort study compares long-term outcomes after BITA versus SITA grafting in consecutive adult patients undergoing first-time isolated CABG with at least two coronary grafts between May 1, 2017 and October 31, 2025 at Hospital Universitario de Gran Canaria Dr. Negrin. The primary endpoint is all-cause mortality during follow-up. Secondary outcomes include cardiovascular mortality, non-cardiovascular mortality, deep sternal wound infection, stroke, myocardial infarction, repeat coronary revascularization, and major adverse cardiovascular events (MACE).
Treatment groups will be balanced using stabilized inverse probability of treatment weighting derived from a multivariable propensity score model including clinically relevant baseline variables. Long-term outcomes will be analyzed using weighted Kaplan-Meier survival curves and Cox proportional hazards regression.
详细描述
Background and scientific rationale:
Coronary artery disease remains a leading cause of mortality worldwide. Coronary artery bypass grafting is recommended as a preferred revascularization strategy for selected patients with complex multivessel coronary artery disease and left main coronary artery disease because of durable long-term clinical benefits.
Although the left internal thoracic artery graft to the left anterior descending artery has superior long-term patency and survival compared with venous conduits, routine use of bilateral internal thoracic arteries remains limited. Observational studies have suggested improved long-term survival following BITA grafting, whereas randomized evidence has not consistently demonstrated a statistically significant survival advantage in intention-to-treat analyses. Concerns regarding deep sternal wound infection, particularly in patients with diabetes mellitus, obesity, and chronic pulmonary disease, have also limited wider adoption.
Study hypothesis:
The use of bilateral internal thoracic artery grafting is associated with improved long-term survival compared with single internal thoracic artery grafting without increasing the adjusted risk of deep sternal wound infection. Any survival benefit may be primarily explained by a reduction in cardiovascular mortality rather than non-cardiovascular mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age 18 years or older.
- •First-time isolated coronary artery bypass grafting.
- •At least two coronary artery grafts performed.
- •Surgery performed between May 1, 2017 and October 31,
- •Complete information regarding surgical grafting strategy.
- •Available follow-up.
排除标准
- •Previous coronary artery bypass grafting.
- •Single coronary artery graft only.
- •Concomitant cardiac surgical procedures.
- •Missing information regarding arterial grafting strategy.
- •Missing follow-up data.
- •Missing essential baseline variables preventing propensity score estimation.
研究组 & 干预措施
Bilateral Internal Thoracic Artery Grafting (BITA)
Patients receiving bilateral internal thoracic artery grafts as part of the myocardial revascularization procedure. Additional radial artery or saphenous vein grafts could be used whenever required to achieve complete revascularization.
Single Internal Thoracic Artery Grafting (SITA)
Patients receiving one internal thoracic artery together with additional saphenous vein and/or radial artery grafts according to surgeon preference.
结局指标
主要结局
All-cause mortality
时间窗: From coronary artery bypass graft surgery until death or last available clinical follow-up, with maximum follow-up through October 31, 2025. (107 months)
Death from any cause occurring after coronary artery bypass graft surgery.
次要结局
- Cardiovascular mortality(From surgery until death or last available follow-up, with maximum follow-up through October 31, 2025. (107 months))
- Non-cardiovascular mortality(From surgery until death or last available follow-up, with maximum follow-up through October 31, 2025. (107 months))
- Deep sternal wound infection(Postoperative period through available follow-up. (107 months))
- Stroke(From surgery until last available clinical follow-up, with maximum follow-up through October 31, 2025. (107 months))
- Myocardial infarction(From surgery until last available clinical follow-up, with maximum follow-up through October 31, 2025. (107 months))
- Repeat coronary revascularization(From surgery until last available clinical follow-up, with maximum follow-up through October 31, 2025. (107 months))
- Major adverse cardiovascular events(From surgery until last available clinical follow-up, with maximum follow-up through October 31, 2025. (107 months))
研究者
Jose Ignacio Juárez Del Río
Ignacio Juarez del Rio, MD
Hospital Universitario Gran Canaria Doctor Negrín