Clinical trial NCT04415216: DEB vs Thin-DES in DES-ISR: Long Term Outcomes (DEB Dragon Registry)
Official title: Long-term Outcomes Following Drug Eluting Balloon Versus Thin Struts Drug Eluting Stents for Treating In-stent Restenosis: Propensity Score-matched Analysis(DEB-Dragon Registry).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: In Stent Restenosis
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
Collaborators: name: Wojciech Wojakowski
First posted: 2020-06-04
Enrollment: 1369
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with DES-ISR who were treated with either paclitaxel-DEB or thin-DES

Brief summary: Data regarding the usefulness of percutaneous coronary intervention (PCI) with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR) in every day clinical practice is scarce. We aimed to evaluate comparing the efficacy and safety profile of DEB and thin-DES in DES-ISR.


Eligibility criteria: Inclusion Criteria:

• All consecutive patients with DES-ISR who were treated with either paclitaxel-DEB or thin-DES.

Exclusion Criteria:

* PCI with DES struts thickness \>100μm
* PCI with DEB and thin-DES in the same procedure
* PCI of other vascular territories during the same procedure
* PCI in saphenous vain graft or internal mammary artery

Primary outcomes:
measure: TLR
timeFrame: 3 years
Secondary outcomes:
measure: DOCE
timeFrame: 3 years
measure: TVR
timeFrame: 3 years
measure: TV-MI
timeFrame: 3 years
measure: cardiac death
timeFrame: 3 years
measure: myocardial infarction
timeFrame: 3 years
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Department of Invasive Cardiology, Medical University of Bialystok
city: Bydgoszcz
country: Poland
facility: Cardiovascular Institute, Nicolaus Copernicus University, Bydgoszcz, Poland
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: Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
city: Warszawa
country: Poland
facility: Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland
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, Januszek R, Gilis-Malinowska N, Figatowski T, Milewski M, Pawlik A, Staszczak B, Wybraniec M, Tomasiewicz B, Kubler P, Kuliczkowski W, Walczak T, Hrymniak B, Desperak P, Mielczarek M, Ciecwierz D, Niezgoda P, Wolny R, Chudzik M, Kuzma L, Kralisz P, Kedhi E, D'Ascenzo F, Hudziak D, Kowalowka A, Smolka G, Reczuch K, Gruchala M, Kubica J, Gil RJ, Dobrzycki S, Dudek D, Bartus S, Gasior M, Ochala A, Witkowski A, Jaguszewski M, Wojakowski W. Long-Term Outcomes Following Drug-Eluting Balloons Versus Thin-Strut Drug-Eluting Stents for Treatment of In-Stent Restenosis (DEB-Dragon-Registry). Circ Cardiovasc Interv. 2021 Sep;14(9):e010868. doi: 10.1161/CIRCINTERVENTIONS.121.010868. Epub 2021 Sep 3.