PCI vs. CABG in UPLM-ISR

NCT04968977 | Completed DMC

• 1 other identifier: 05
• Study Type: observational
• Target: 305
• Locations: 2 countries
• Sites: 11

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.

Conditions

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

Keywords

unprotected left main; in-stent restenosis; coronary artery bypass graft; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• MACCE

  4 years

Secondary Outcomes (4)

• cardiac death

  4 years

• myocardial infarction

  4 years

• target vessel revascularization

  4 years

• stroke

  4 years

Study Arms (1)

UPLM-ISR

Procedure: PCI vs. CABG

Interventions

PCI vs. CABG PROCEDURE

PCI vs. CABG

UPLM-ISR

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 305 unselected patients were included in the pooled analysis, of whom 203 (66.6%) patients were treated with a PCI and 102 (33.4%) with a CABG.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (11)

Fabrizio D'Ascenzo

Turin, Italy

Location

Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital

Bialystok, Poland

Location

First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland

Gdansk, Poland

Location

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

Katowice, 40-635, Poland

Location

Jacek Legutko

Krakow, Poland

Location

Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland

Krakow, Poland

Location

Miedziowe Centrum Zdrowia S.A.

Lubin, Poland

Location

Marek Grygier

Poznan, Poland

Location

Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration

Warsaw, Poland

Location

Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University

Wroclaw, Poland

Location

Third Department of Cardiology, Medical University of Katowice

Zabrze, Poland

Location

Related Publications (1)

• Wanha W, Bil J, Kolodziejczak M, Kowalowka A, Kowalewski M, Hudziak D, Gocol R, Januszek R, Figatowski T, Milewski M, Tomasiewicz B, Kubler P, Hrymniak B, Desperak P, Kuzma L, Milewski K, Gora B, Los A, Kulczycki J, Wlodarczak A, Skorupski W, Grygier M, Lesiak M, D'Ascenzo F, Andres M, Kleczynski P, Litwinowicz R, Borin A, Smolka G, Reczuch K, Gruchala M, Gil RJ, Jaguszewski M, Bartus K, Suwalski P, Dobrzycki S, Dudek D, Bartus S, Ga Sior M, Ochala A, Lansky AJ, Deja M, Legutko J, Kedhi E, Wojakowski W. Percutaneous Coronary Intervention vs. Coronary Artery Bypass Grafting for Treating In-Stent Restenosis in Unprotected-Left Main: LM-DRAGON-Registry. Front Cardiovasc Med. 2022 Apr 29;9:849971. doi: 10.3389/fcvm.2022.849971. eCollection 2022.

  PMID: 35615559 DERIVED

MeSH Terms

Conditions

Coronary Restenosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Stenosis; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 20, 2021
• Study Start: January 1, 2001
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

PL (10); IT (1)