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

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)

Postepy Kardiol Interwencyjnej. 2022 Mar;18(1):14-26. doi: 10.5114/aic.2022.115631. Epub 2022 Apr 22.

Authors

Rafał Januszek¹, Jacek Bil², Natasza Gilis-Malinowska³, Bartłomiej Staszczak¹, Tomasz Figatowski³, Marek Milewski⁴, Maksymilian Mielczarek³, Łukasz Dylewski⁴, Maciej Wybraniec⁵, Brunon Tomasiewicz⁶, Piotr Kübler⁶, Tomasz Walczak^{6

7}, Bruno Hrymniak⁷, Piotr Desperak⁸, Piotr Niezgoda⁹, Rafał Wolny¹⁰, Magdalena Chudzik¹¹, Grzegorz Smolka⁴, Dariusz Ciećwierz³, Krzysztof Reczuch⁶, Marcin Gruchała³, Jacek Kubica⁹, Robert J Gil², Elvin Kedhi^{4

12}, Fabrizio D'Ascenzo¹³, Robert Balan¹⁴, Artur Pawlik¹, Łukasz Kuźma¹⁵, Sławomir Dobrzycki¹⁵, Damian Hudziak¹⁶, Stanisław Bartuś¹, Mariusz Gąsior⁸, Andrzej Ochała⁴, Adam Witkowski¹⁰, Miłosz Jaguszewski³, Wojciech Wojakowski⁴, Wojciech Wańha⁴

Affiliations

¹ Department of Cardiology and Cardiovascular Interventions, University Hospital, Krakow, Poland.
² Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, Poland.
³ First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland.
⁴ Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland.
⁵ First Department of Cardiology, School of Medicine in Katowice, Medical University of Silesia, Katowice, Poland.
⁶ Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University, Poland.
⁷ Department of Cardiology, 4 Military Hospital, Wroclaw, Poland.
⁸ Third Department of Cardiology, Medical University of Katowice, Zabrze, Poland.
⁹ Cardiovascular Institute, Nicolaus Copernicus University, Bydgoszcz, Poland.
¹⁰ Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland.
¹¹ Medical University of Warsaw, Warsaw, Poland.
¹² AZ Sint Jan Brugge, Belgium.
¹³ Division of Cardiology, Department of Internal Medicine, Città della Salute e della Scienza, University of Turin, Turin, Italy.
¹⁴ Department of Cardiac Surgery, Klinikum Passau, Passau, Germany.
¹⁵ Department of Invasive Cardiology, Medical University of Bialystok, Białystok, Poland.
¹⁶ Department of Cardiac Surgery, Medical University of Silesia, Katowice, Poland.

Abstract

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