PCI vs. CABG in UPLM-ISR

NCT ID: NCT04968977

Last Updated: 2021-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

305 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-01-01

Study Completion Date

2021-06-01

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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UPLM-ISR

PCI vs. CABG

Intervention Type PROCEDURE

PCI vs. CABG

Interventions

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PCI vs. CABG

PCI vs. CABG

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Silesia

OTHER

Sponsor Role lead

Responsible Party

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Wojciech Wańha

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fabrizio D'Ascenzo

Turin, , Italy

Site Status

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

Bialystok, , Poland

Site Status

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

Gdansk, , Poland

Site Status

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

Katowice, , Poland

Site Status

Jacek Legutko

Krakow, , Poland

Site Status

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

Krakow, , Poland

Site Status

Miedziowe Centrum Zdrowia S.A.

Lubin, , Poland

Site Status

Marek Grygier

Poznan, , Poland

Site Status

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

Warsaw, , Poland

Site Status

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

Wroclaw, , Poland

Site Status

Third Department of Cardiology, Medical University of Katowice

Zabrze, , Poland

Site Status

Countries

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Italy Poland

References

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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.

Reference Type DERIVED
PMID: 35615559 (View on PubMed)

Other Identifiers

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05

Identifier Type: -

Identifier Source: org_study_id

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