Skip to main content
OpenTrials
Completed

NCT Number: NCT04968977

PCI vs. CABG in UPLM-ISR

Left main (LM) coronary artery disease is associated with high morbidity and mortality owing to the large myocardial territory at risk for ischemia. Evidence from randomized controlled trials supports that percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for LM disease is an acceptable treatment strategy compared with coronary artery bypass graft surgery in patients with low or intermediate anatomic complexity. However in-stent restenosis (ISR) after DES in LM disease is still occurring with an incidence of 9,7%. Studies comparing the percutaneous coronary intervention with coronary artery bypass grafting (CABG) in the treatment of in-stent restenosis in unprotected left main have been scarce. While surgical revascularization is considered to be the standard treatment for this kind of stent failure, owing to a high risk of perioperative morbidity and mortality, the restoration of flow with PCI may be a reliable alternative. Additionally, it is not clear whether re-PCI is safe in these patients. Therefore, the purpose of the present study was to compare long-term outcomes following PCI or CABG for UPLM-ISR disease.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

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

Patients were divided into two separate cohorts for the analyses. The data included consecutive patients with ≥50% diameter UPLM-ISR, with or without multivessel coronary artery disease. Patients with an equivalent of UPLM-ISR: left main distal bifurcation disease, within the proximal 5 mm of the left anterior descending artery (LAD) or left circumflex artery (LCx) ostium (in the absence of significant angiographic stenosis in the left main coronary artery), were eligible. Patients who had protected LM-ISR, defined as the occurrence of at least one patent arterial or venous graft to the left coronary artery, other concomitant non-CABG procedure during surgery, were excluded.

Treatment and study plan

PCI vs. CABG

Procedure

PCI vs. CABG

Primary outcomes

  1. MACCE

    Time frame: 4 years

Secondary outcomes

  1. cardiac death

    Time frame: 4 years

  2. myocardial infarction

    Time frame: 4 years

  3. target vessel revascularization

    Time frame: 4 years

  4. stroke

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study title

Long-term Outcomes Following Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting for Treating In-stent Restenosis in Unprotected Left Main Coronary Artery: Multicenter LM-DRAGON Registry

Acronym: LM-DRAGON

Important dates

Study start
2001
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2021
Registry last updated
Jul 20, 2021

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.

Published trials that share one or more normalized conditions with this study.