NCT04968977

PCI vs. CABG in UPLM-ISR

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 305 (actual)
• Sponsor: Medical University of Silesia · Academic / Other
• Sex: —
• Age: —
• Healthy volunteers: —

Summary

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.

Conditions

• Restenosis, Coronary
• Left Main Coronary Artery Disease
• PTCA Left Main Artery Complications

Interventions

Type	Name	Description
PROCEDURE	PCI vs. CABG	PCI vs. CABG

Timeline

• Start date: 2001-01-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2021-07-20
• Last updated: 2021-07-20

Locations

11 sites across 2 countries: Italy, Poland