PCI vs. CABG in UPLM-ISR

Completed

• Conditions: Left Main Coronary Artery Disease; Restenosis, Coronary; PTCA Left Main Artery Complications
• Interventions: Procedure: PCI vs. CABG

• Registration Number: NCT04968977
• Lead Sponsor: Medical University of Silesia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-19
• Last Update Submitted: 2021-07-19
• Study First Posted: 2021-07-20
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 305

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
UPLM-ISR	PCI vs. CABG	-

Primary Outcome Measures

Name	Time	Method
MACCE	4 years

Secondary Outcome Measures

Name	Time	Method
myocardial infarction	4 years
target vessel revascularization	4 years
stroke	4 years
cardiac death	4 years

Trial Locations

Locations (11)

Marek Grygier; 🇵🇱 Poznań, Poland

Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University; 🇵🇱 Wrocław, Poland

Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland; 🇵🇱 Katowice, Poland

Jacek Legutko; 🇵🇱 Kraków, Poland

Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital; 🇵🇱 Białystok, Poland

Fabrizio D'Ascenzo; 🇮🇹 Turin, Italy

First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland; 🇵🇱 Gdańsk, Poland

Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland; 🇵🇱 Kraków, Poland

Miedziowe Centrum Zdrowia S.A.; 🇵🇱 Lubin, Poland

Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration; 🇵🇱 Warszawa, Poland

Third Department of Cardiology, Medical University of Katowice; 🇵🇱 Zabrze, Poland