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临床试验/NCT07373678
NCT07373678已完成不适用

Coronary Artery Bypass Surgery Versus Percutaneous Coronary Intervention in Patients With Isolated Chronic Total Occlusion of the Left Anterior Descending Artery: The RITUAL Study

Mersin Medicalpark Hastanesi1 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2025年9月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
302
试验地点
1
主要终点
Procedural success

研究概览

简要总结

The aim of this study is to compare coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) in the treatment of isolated chronic total occlusion (CTO) of the left anterior descending (LAD) artery in terms of short- and mid-term clinical outcomes, myocardial revascularization success, and complication rates.

详细描述

Chronic total occlusion (CTO) represents one of the most challenging subgroups of coronary artery disease and is closely associated with adverse cardiovascular outcomes. Previous studies have demonstrated that patients with CTO experience a higher incidence of major adverse cardiovascular events compared with patients without CTO but with significant coronary artery disease (CAD), even after adjustment for demographic characteristics, clinical parameters, and disease severity. Among these patients, those with unrevascularized CTO constitute the highest-risk group, whereas successful revascularization has been shown to reduce the risk to a level comparable to that of patients without CTO but with significant CAD.

Among CTOs, isolated total occlusion of the left anterior descending (LAD) artery has particular clinical importance due to its critical role in myocardial perfusion. Two main revascularization strategies are currently used in the treatment of isolated LAD CTO: percutaneous coronary intervention (PCI) and single-vessel coronary artery bypass grafting (CABG). In surgical revascularization, the left internal mammary artery (LIMA) is most commonly used, although saphenous vein grafts may be preferred in selected cases.

However, direct comparative data between these two treatment strategies in this specific patient population remain extremely limited. In particular, differences between CTO-PCI and single-vessel CABG with respect to revascularization success, in-hospital events, and early post-discharge outcomes have not been systematically evaluated. In the present study, within the framework of the RITUAL study, the outcomes of CTO-PCI and CABG surgery were compared in patients with isolated LAD CTO.

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

入选标准

  • Age 18 years or older at the time of the index procedure.
  • Diagnosis of isolated chronic total occlusion (CTO) of the left anterior descending (LAD) coronary artery.
  • Isolated LAD CTO defined as a de novo or in-stent total occlusion confined to the LAD artery, without significant coronary artery disease (defined as ≥50% stenosis) in other major epicardial coronary arteries, including the left circumflex (LCx), right coronary artery (RCA), or major side branches.
  • No prior percutaneous coronary intervention (PCI) performed in non-LAD coronary arteries.
  • Patients who underwent coronary revascularization with either coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) for isolated LAD CTO.

排除标准

  • History of malignancy or active malignant disease at the time of the index procedure.
  • Prior coronary artery bypass grafting (CABG) or prior percutaneous coronary intervention (PCI) performed in non-LAD coronary arteries.
  • Presentation with ST-segment elevation myocardial infarction (STEMI).
  • Discontinuation of prescribed medical therapy by patient preference within one year after the index procedure.
  • Presence of multiple chronic total occlusions (CTOs) involving more than one coronary artery.
  • Significant side branch disease of the LAD requiring two bypass grafts.
  • Performance of crossover stenting from the LAD into the left main coronary artery during LAD CTO-PCI.
  • Treatment of LAD CTO with drug-eluting balloon (DEB) angioplasty without stent implantation.
  • Left ventricular ejection fraction (LVEF) less than 30%.
  • Presence of severe valvular heart disease (e.g., severe aortic or mitral stenosis or regurgitation).
  • Incomplete angiographic or clinical follow-up data.
  • Use of mechanical circulatory support devices due to advanced heart failure, including intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), or left ventricular assist device (LVAD).

研究组 & 干预措施

Coronary Artery Bypass Grafting (CABG)

Patients with isolated chronic total occlusion of the left anterior descending artery who underwent coronary artery bypass graft surgery.

干预措施: Coronary Artery Bypass Grafting (Procedure)

Percutaneous Coronary Intervention (PCI)

Patients with isolated chronic total occlusion of the left anterior descending artery who underwent percutaneous coronary intervention.

干预措施: Percutaneous Coronary Intervention (Procedure)

结局指标

主要结局

Procedural success

时间窗: perioperatively / periprocedurally

Successful completion of coronary revascularization of the left anterior descending artery without in-hospital major adverse cardiac events.

次要结局

  • Major adverse cardiac events (MACCE) at 3 years(3 years)

研究者

发起方
Mersin Medicalpark Hastanesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sefa Sural

Assistant Professor of Cardiology

Mersin Medicalpark Hastanesi

研究点 (1)

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