Long-term outcomes following drug-eluting balloon or thin-strut drug-eluting stents for treatment of in-stent restenosis stratified by duration of dual antiplatelet therapy (DEB-Dragon Registry)

Rafał Januszek; Jacek Bil; Natasza Gilis-Malinowska; Bartłomiej Staszczak; Tomasz Figatowski; Marek Milewski; Maksymilian Mielczarek; Łukasz Dylewski; Maciej Wybraniec; Brunon Tomasiewicz; Piotr Kübler; Tomasz Walczak; Bruno Hrymniak; Piotr Desperak; Piotr Niezgoda; Rafał Wolny; Magdalena Chudzik; Grzegorz Smolka; Dariusz Ciećwierz; Krzysztof Reczuch; Marcin Gruchała; Jacek Kubica; Robert J. Gil; Elvin Kedhi; Fabrizio D’Ascenzo; Robert Balan; Artur Pawlik; Łukasz Kuźma; Sławomir Dobrzycki; Damian Hudziak; Stanisław Bartuś; Mariusz Gąsior; Andrzej Ochała; Adam Witkowski; Miłosz Jaguszewski; Wojciech Wojakowski; Wojciech Wańha

doi:10.5114/aic.2022.115631

eISSN: 1897-4295
ISSN: 1734-9338

Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej

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abstract:

Original paper

Long-term outcomes following drug-eluting balloon or thin-strut drug-eluting stents for treatment of in-stent restenosis stratified by duration of dual antiplatelet therapy (DEB-Dragon Registry)

Rafał Januszek

¹

,

Jacek Bil

²

,

Natasza Gilis-Malinowska

³

,

Bartłomiej Staszczak

¹

,

Tomasz Figatowski

³

,

Marek Milewski

⁴

,

Maksymilian Mielczarek

³

,

Łukasz Dylewski

⁴

,

Maciej Wybraniec

⁵

,

Brunon Tomasiewicz

⁶

,

Piotr Kübler

⁶

,

Tomasz Walczak

^{6, 7}

,

Bruno Hrymniak

⁷

,

Piotr Desperak

⁸

,

Piotr Niezgoda

⁹

,

Rafał Wolny

¹⁰

,

Magdalena Chudzik

¹¹

,

Grzegorz Smolka

⁴

,

Dariusz Ciećwierz

³

,

Krzysztof Reczuch

⁶

,

Marcin Gruchała

³

,

Jacek Kubica

⁹

,

Robert J. Gil

²

,

Elvin Kedhi

^{4, 12}

,

Fabrizio D’Ascenzo

¹³

,

Robert Balan

¹⁴

,

Artur Pawlik

¹

,

Łukasz Kuźma

¹⁵

,

Sławomir Dobrzycki

¹⁵

,

Damian Hudziak

¹⁶

,

Stanisław Bartuś

¹

,

Mariusz Gąsior

⁸

,

Andrzej Ochała

⁴

,

Adam Witkowski

¹⁰

,

Miłosz Jaguszewski

³

,

Wojciech Wojakowski

⁴

,

Wojciech Wańha

⁴

Department of Cardiology and Cardiovascular Interventions, University Hospital, Krakow, Poland
Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland
First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
First Department of Cardiology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland
Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University, Poland
Department of Cardiology, 4th Military Hospital, Wroclaw, Poland
Third Department of Cardiology, Medical University of Katowice, Zabrze, Poland
Cardiovascular Institute, Nicolaus Copernicus University, Bydgoszcz, Poland
Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland
Medical University of Warsaw, Warsaw, Poland
AZ Sint Jan Brugge, Belgium
Division of Cardiology, Department of Internal Medicine, Città della Salute e della Scienza, University of Turin, Turin, Italy
Department of Cardiac Surgery, Klinikum Passau, Passau, Germany
Department of Invasive Cardiology, Medical University of Bialystok, Białystok, Poland
Department of Cardiac Surgery, Medical University of Silesia, Katowice, Poland

Adv Interv Cardiol 2022; 18, 1 (67): 14–26

DOI: https://doi.org/10.5114/aic.2022.115631

Online publish date: 2022/04/22

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AMA

Januszek R, Bil J, Gilis-Malinowska N, et al. Long-term outcomes following drug-eluting balloon or thin-strut drug-eluting stents for treatment of in-stent restenosis stratified by duration of dual antiplatelet therapy (DEB-Dragon Registry). Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2022;18(1):14-26. doi:10.5114/aic.2022.115631.

APA

Januszek, R., Bil, J., Gilis-Malinowska, N., Staszczak, B., Figatowski, T.,  & Milewski, M. et al. (2022). Long-term outcomes following drug-eluting balloon or thin-strut drug-eluting stents for treatment of in-stent restenosis stratified by duration of dual antiplatelet therapy (DEB-Dragon Registry). Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, 18(1), 14-26. https://doi.org/10.5114/aic.2022.115631

Chicago

Januszek, Rafał, Jacek Bil, Natasza Gilis-Malinowska, Bartłomiej Staszczak, Tomasz Figatowski, Marek Milewski,  and Maksymilian Mielczarek et al. 2022. "Long-term outcomes following drug-eluting balloon or thin-strut drug-eluting stents for treatment of in-stent restenosis stratified by duration of dual antiplatelet therapy (DEB-Dragon Registry)". Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej 18 (1): 14-26. doi:10.5114/aic.2022.115631.

Harvard

Januszek, R., Bil, J., Gilis-Malinowska, N., Staszczak, B., Figatowski, T., Milewski, M., Mielczarek, M., Dylewski, Ł., Wybraniec, M., Tomasiewicz, B., Kübler, P., Walczak, T., Hrymniak, B., Desperak, P., Niezgoda, P., Wolny, R., Chudzik, M., Smolka, G., Ciećwierz, D., Reczuch, K., Gruchała, M., Kubica, J., Gil, R., Kedhi, E., D’Ascenzo, F., Balan, R., Pawlik, A., Kuźma, Ł., Dobrzycki, S., Hudziak, D., Bartuś, S., Gąsior, M., Ochała, A., Witkowski, A., Jaguszewski, M., Wojakowski, W.,  and Wańha, W. (2022). Long-term outcomes following drug-eluting balloon or thin-strut drug-eluting stents for treatment of in-stent restenosis stratified by duration of dual antiplatelet therapy (DEB-Dragon Registry). Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, 18(1), pp.14-26. https://doi.org/10.5114/aic.2022.115631

MLA

Januszek, Rafał et al. "Long-term outcomes following drug-eluting balloon or thin-strut drug-eluting stents for treatment of in-stent restenosis stratified by duration of dual antiplatelet therapy (DEB-Dragon Registry)." Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej, vol. 18, no. 1, 2022, pp. 14-26. doi:10.5114/aic.2022.115631.

Vancouver

Januszek R, Bil J, Gilis-Malinowska N, Staszczak B, Figatowski T, Milewski M et al. Long-term outcomes following drug-eluting balloon or thin-strut drug-eluting stents for treatment of in-stent restenosis stratified by duration of dual antiplatelet therapy (DEB-Dragon Registry). Advances in Interventional Cardiology/Postępy w Kardiologii Interwencyjnej. 2022;18(1):14-26. doi:10.5114/aic.2022.115631.

Introduction
Data regarding the duration of dual antiplatelet therapy (DAPT) in patients with drug-eluting stent restenosis (DES-ISR) treated with percutaneous coronary intervention (PCI) and drug-eluting balloons (DEB) or DES are not unambiguous.

Aim
To evaluate the relationship between long-term outcomes and the length of DAPT in patients treated with PCI due to DES-ISR with DEB or DES.

Material and methods
Overall, a total of 1,367 consecutive patients with DES-ISR, who underwent PCI with DEB or DES between 2008 and 2019 entered the study. The mean length of the follow-up was 1,298.7 ±794 days. We assessed study endpoints according to the duration of DAPT (≤ 3 vs. > 3 and ≤ 6 vs. > 6 months) before and after propensity score matching (PSM): stroke, target lesion revascularisation (TLR), target vessel revascularisation (TVR), myocardial infarction (MI), death and device oriented composite endpoints (DOCE). Kaplan-Meier estimates were created to differentiate long-term outcomes.

Results
Pairwise contrast analysis considering type of PCI (DES vs. DEB) and duration of DAPT (≤ 6 vs. > 6 months) before PSM revealed superiority of DES + DAPT > 6 months vs. DEB + DAPT > 6 months for DOCE (p < 0.001), TVR (p = 0.02) and TLR (p = 0.01). Also, DES+DAPT ≤ 6 months was found to be superior compared to DEB + DAPT ≤ 6 months for DOCE (p < 0.001), TVR (p = 0.02) and TLR (p = 0.01). Kaplan-Meier estimate analysis confirmed that DAPT > 6 months is related to a higher stroke rate (p = 0.01) when compared to ≤ 6 months.

Conclusions
Treatment with DAPT in patients with DES-ISR is related to better long-term outcomes in the case of PCI with DES than DEB. DAPT > 6 months is related to the greater rate of strokes, independently of the type of treatment (DES and DEB) than DAPT ≤ 6 months.

keywords:

Long-term outcomes following drug-eluting balloon or thin-strut drug-eluting stents for treatment of in-stent restenosis stratified by duration of dual antiplatelet therapy (DEB-Dragon Registry)

drug-eluting balloon(s), drug-eluting stent(s), in-stent restenosis, duration of dual antiplatelet therapy, long-term outcomes