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Completed

NCT Number: NCT07373678

CABG Versus PCI in Patients With Isolated LAD Chronic Total Occlusion

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sefa SURAL

Mersin, 33010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Coronary artery bypass grafting

Procedure

Coronary artery bypass graft surgery performed as part of routine clinical care prior to study inclusion.

Percutaneous coronary intervention

Procedure

Percutaneous coronary intervention performed as part of routine clinical care prior to study inclusion.

Primary outcomes

  1. Procedural success

    Time frame: perioperatively / periprocedurally

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

Secondary outcomes

  1. Major adverse cardiac events (MACCE) at 3 years

    Time frame: 3 years

    Composite endpoint including all-cause mortality, non-fatal myocardial infarction, cerebrovascular events, and target vessel revascularization within 3 years after the index procedure.

Sponsors and collaborators

Lead sponsor

Mersin Medicalpark Hastanesi

Other

Collaborators

  • Biruni University
  • Jolimont Hospital
  • Mersin Training and Research Hospital
  • Minneapolis Heart Institute
  • Necmettin Erbakan University

Registry information

Official study title

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

Acronym: RITUAL

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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