Treatment of in-stent restenosis with ultrathin-strut versus thin-strut drug-eluting stents or drug-eluting balloons: a multicentre registry

Ovidio De Filippo¹^,², MD; Wojciech Wańha³, MD; Tiziana Sanavia⁴, PhD; Rafal Januszek⁵, MD; Federico Giacobbe¹^,², MD; Gianluca Campo⁶, MD; Tineke H. Pinxterhuis⁷^,⁸, MD; Davide Capodanno⁹, MD; Brunon Tomasiewicz¹⁰, MD; Mario Iannaccone¹¹, MD; Attilio Leone¹², MD; Rafał Wolny¹³, MD; Francesco Bruno¹^,², MD; Giuseppe Patti¹⁴, MD; Giuseppe Musumeci¹⁵, MD; Gaetano Liccardo¹⁶, MD; Roberto Verardi¹⁷, MD; Sergio Raposeiras Roubin¹⁸, MD; Giuseppe Tarantini¹⁹, MD; Łukasz Kuźma²⁰, MD; Leor Perl²¹, MD; Andrea Gagnor²², MD; Krzysztof Reczuch²³, MD; Federico Conrotto¹, MD; Domenico Tuttolomondo²⁴, MD; Eline H. Ploumen⁷^,⁸, MD; Piotr Niezgoda²⁵, MD; Serena Caglioni⁶, MD; Pierluigi Omedè¹, MD; Antonio Greco⁹, MD; Jacek Kubica²⁵, MD; Robert J. Gil²⁶, MD; Raffaele Piccolo¹², MD; Ran Kornowski²¹, MD; Jacek Bil²⁶, MD; Arianna Morena¹^,², MD; Paolo Zocca⁷, MD; Mauro Pennone¹, MD; Mariusz Gąsior²⁷, MD; Miłosz Jaguszewski²⁸, MD; Clemens Von Birgelen⁷, MD; Piero Fariselli⁴, PhD; Gaetano M. De Ferrari¹^,², MD; Wojciech Wojakowski³, MD; Fabrizio D’Ascenzo¹^,², MD

1. Division of Cardiology, Cardiovascular and Thoracic Department, “Citta della Salute e della Scienza” Hospital, Turin, Italy; 2. Department of Medical Sciences, University of Turin, Turin, Italy; 3. Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland; 4. Computational Biomedicine Unit, Department of Medical Sciences, University of Turin, Turin, Italy; 5. Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland; 6. Cardiology Unit, Azienda Ospedaliero Universitaria Di Ferrara, Ferrara, Italy; 7. Department of Cardiology, Thorax Centrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; 8. Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands; 9. Division of Cardiology, Azienda Ospedaliero Universitaria Policlinico “G. Rodolico-San Marco”, University of Catania, Catania, Italy; 10. Institute of Heart Diseases, Wroclaw University Hospital, Wroclaw, Poland; 11. Division of Cardiology, Ospedale San Giovanni Bosco, Turin, Italy; 12. Department of Advanced Biomedical Sciences, Division of Cardiology, University of Naples Federico II, Naples, Italy; 13. Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland; 14. Department of Translational Medicine, Maggiore della Carità Hospital, University of Eastern Piedmont, Novara, Italy; 15. Cardiology Department, Azienda Ospedaliera Ordine Mauriziano Umberto I, Turin, Italy; 16. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy; 17. Division of Cardiology, Ospedale Maggiore Carlo Alberto Pizzardi, Bologna, Italy; 18. Cardiology Department, University Hospital Alvaro Cunqueiro, Galicia Sur Health Research Institute (IISGS), Pontevedra, Spain; 19. Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua Medical School, Padova, Italy; 20. Department of Invasive Cardiology, Medical University of Białystok, Białystok, Poland; 21. Cardiology Department, Beilinson Hospital, Rabin Medical Center, Petah Tikva, Israel; 22. Division of Cardiology, Ospedale Maria Vittoria, Torino, Italy; 23. Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland; 24. Cardiology Unit, University Hospital of Parma, Parma, Italy; 25. Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland; 26. Department of Invasive Cardiology, Centre of Postgraduate Medical Education, State Medical Institute of the Ministry of Interior and Administration, Warsaw, Poland; 27. Third Department of Cardiology, Medical University of Silesia, Zabrze, Poland; 28. First Department of Cardiology, Medical University of Gdańsk, Gdańsk, Poland

Abstract

Background: Limited data exist on ultrathin-strut drug-eluting stent (ultrathin DES) performance in DES in-stent restenosis (ISR).

Aims: We aimed to assess the efficacy and safety of ultrathin DES compared to thin-strut DES and drug-eluting balloons (DEB) for DES-ISR.

Methods: Patients from the DEB Dragon (ClinicalTrials.gov: NCT04415216) and ULTRA registries (ClinicalTrials.gov: NCT05205148) were divided into ultrathin DES, thin-strut DES, or DEB groups for DES-ISR treatment. Both propensity score matching (PSM) and inverse probability weighting (IPW) were considered to adjust the distribution of patients in each class. Cox regression was applied to the following main endpoints: device-oriented composite endpoints (DOCE; including cardiac death, target lesion revascularisation [TLR] and target vessel myocardial infarction), TLR and target vessel revascularisation (TVR).

Results: A total of 269, 541, and 557 patients received an ultrathin DES, thin-strut DES, and DEB, respectively. After 3 years of follow-up, in the IPW-adjusted overall cohort, ultrathin DES were associated with a significantly reduced risk of DOCE compared to DEBs (hazard ratio [HR] 0.353, 95% confidence interval [CI]: 0.194-0.642; p<0.001), as well as thin-strut DES (HR 0.645, 95% CI: 0.457-0.911; p=0.013). Compared to DEBs, ultrathin DES also reduced the risks of both TLR (HR 0.184, 95% CI: 0.081-0.417; p<0.001) and TVR (HR 0.188, 95% CI: 0.093-0.379; p<0.001), while thin-strut DES did not (TLR: HR 0.686, 95% CI: 0.407-1.157; p=0.157; TVR: HR 0.706, 95% CI: 0.453-1.101; p=0.124). For diffuse ISR patients, ultrathin DES reduced the risk of DOCE (HR 0.364, 95% CI: 0.188-0.705; p=0.003), as did thin-strut DES (HR 0.602, 95% CI: 0.367-0.987; p=0.044), while a reduction of TLR (HR 0.220, 95% CI: 0.091-0.531; p<0.001) and TVR (HR 0.241, 95% CI: 0.113-0.513; p<0.001) was achieved only by ultrathin DES.

Conclusions: Ultrathin DES were associated with reduced DOCE, TLR and TVR risks in diffuse ISR compared to DEBs.

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