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Restenosis, CoronaryLM-DRAGONNCT04968977

PCI vs. CABG in UPLM-ISR

An observational study of Restenosis, Coronary and Left Main Coronary Artery Disease, run by Medical University of Silesia at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Any age
What is being tested?
PCI vs. CABG
Type of treatment
Surgery or procedure
How many people
305 participants
Where
11 sitesin 2 countries
Study dates
1 Jan 2001to 1 Jun 2021
How long will I take part?
4 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Child, Adult, Older adult

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.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

Poland10 sites

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

    Bialystok

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

    Gdansk

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

    Katowice, 40-635

  • Jacek Legutko

    Krakow

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

    Krakow

  • Miedziowe Centrum Zdrowia S.A.

    Lubin

  • Marek Grygier

    Poznan

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

    Warsaw

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

    Wroclaw

  • Third Department of Cardiology, Medical University of Katowice

    Zabrze

Other trials in Poland

Italy1 site

  • Fabrizio D'Ascenzo

    Turin

Other trials in Italy

About this study

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

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.

Being tested
PCI vs. CABG
Keywords
unprotected left main, in-stent restenosis, coronary artery bypass graft, percutaneous coronary intervention
Medical subject headings
Coronary Restenosis, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCI vs. CABGProcedure or surgery

    PCI vs. CABG

Study groups in NCT04968977
Study groupRoleWhat they receive
UPLM-ISRNot described
Receives: Procedure: PCI vs. CABG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MACCE

    Measured: 4 years

Secondary outcomes (4)

  1. cardiac death

    Measured: 4 years

  2. myocardial infarction

    Measured: 4 years

  3. target vessel revascularization

    Measured: 4 years

  4. stroke

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2021
  2. Study start1 Jan 2001
  3. Primary completion1 Jun 2021
  4. Study completion1 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
305 participants (actual)
Target duration
4 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04968977
Sponsor's protocol ID
05
Acronym
LM-DRAGON
Status last verified
Jul 2021
First submitted
9 Jul 2021
Last updated
20 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The data that support the findings of this study are available from the corresponding author upon reasonable request.

Publications

  • 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.

    PubMed 35615559

Questions about this trial

What is this clinical trial studying?

An observational study of Restenosis, Coronary and Left Main Coronary Artery Disease, run by Medical University of Silesia at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Poland, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACCE (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04968977, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.

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