PCI vs. CABG in UPLM-ISR

Left Main Coronary Artery Disease Clinical Trial

— LM-DRAGON  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04968977
• Other study ID #: 05
• Status: Completed
• Start date: January 1, 2001
• Est. completion date: June 1, 2021

Study information

• Verified date: July 2021
• Source: Medical University of Silesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• PCI vs. CABG
PCI vs. CABG

Locations

Country	Name	City	State
Italy	Fabrizio D'Ascenzo	Turin
Poland	Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital	Bialystok
Poland	First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland	Gdansk
Poland	Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland	Katowice
Poland	Jacek Legutko	Kraków
Poland	Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland	Kraków
Poland	Miedziowe Centrum Zdrowia S.A.	Lubin
Poland	Marek Grygier	Poznan
Poland	Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration	Warszawa
Poland	Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University	Wroclaw
Poland	Third Department of Cardiology, Medical University of Katowice	Zabrze

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Countries where clinical trial is conducted

Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACCE		4 years
Secondary	cardiac death		4 years
Secondary	myocardial infarction		4 years
Secondary	target vessel revascularization		4 years
Secondary	stroke		4 years