Clinical trial NCT04968977: PCI vs. CABG in UPLM-ISR
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 305
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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. 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.

Primary outcomes:
measure: MACCE
timeFrame: 4 years
Secondary outcomes:
measure: cardiac death
timeFrame: 4 years
measure: myocardial infarction
timeFrame: 4 years
measure: target vessel revascularization
timeFrame: 4 years
measure: stroke
timeFrame: 4 years
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Fabrizio D'Ascenzo
city: Białystok
country: Poland
facility: Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital
city: Gdańsk
country: Poland
facility: First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland
city: Katowice
country: Poland
facility: Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
city: Kraków
country: Poland
facility: Jacek Legutko
city: Kraków
country: Poland
facility: Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
city: Lubin
country: Poland
facility: Miedziowe Centrum Zdrowia S.A.
city: Poznań
country: Poland
facility: Marek Grygier
city: Warszawa
country: Poland
facility: Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration
city: Wrocław
country: Poland
facility: Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University
city: Zabrze
country: Poland
facility: Third Department of Cardiology, Medical University of Katowice
Study officials:
References:
citation: 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.