SELUTION DeNovo Trial: Expanding Horizons for Drug Eluting Balloons

F. Krackhardt (Berlin)¹, S. Eccleshall (Norwich)², M. Wiemer (Minden)³, K. A. Mashayekhi (Lahr/Schwarzwald)⁴, T. Schmitz (Essen)⁵, F. Rahimi Nedjat (Bad Krozingen)⁶, F. J. Brunner (Hamburg)⁷, A. Linke (Dresden)⁸, M. Halbach (Köln)⁹, L. Bruch (Berlin)¹⁰, D. Bongiovanni (Augsburg)¹¹, J. Schofer (Hamburg)¹², M. Andrassy (Bruchsal)¹³, R. Birkemeyer (Ulm)¹⁴, P. Urban (Meyrin - Genf)¹⁵, C. Spaulding (Paris)^16
1Deutsches Herzzentrum der Charite (DHZC) Klinik für Kardiologie, Angiologie und Intensivmedizin | CBF Berlin, Deutschland; ²Norfolk and Norwich University Hospitals NHS Foundation Trust Cardiology Norwich, Großbritannien; ³Johannes Wesling Klinikum Minden Klinik für Kardiologie und Internistische Intensivmedizin Minden, Deutschland; ⁴MediClin Herzzentrum Lahr/Baden Innere Medizin und Kardiologie Lahr/Schwarzwald, Deutschland; ⁵Elisabeth-Krankenhaus Essen GmbH Klinik für Kardiologie und Angiologie Essen, Deutschland; ⁶Universitäts-Herzzentrum Freiburg / Bad Krozingen Bad Krozingen, Deutschland; ⁷Universitäres Herz- und Gefäßzentrum Hamburg Klinik für Kardiologie Hamburg, Deutschland; ⁸Herzzentrum Dresden GmbH an der TU Dresden Klinik für Innere Medizin und Kardiologie Dresden, Deutschland; ⁹Herzzentrum der Universität zu Köln Klinik III für Innere Medizin Köln, Deutschland; ¹⁰Unfallkrankenhaus Berlin Klinik f. Innere Medizin / Kardiologie Berlin, Deutschland; ¹¹Universitätsklinikum Augsburg I. Medizinische Klinik Augsburg, Deutschland; ¹²Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer Hamburg, Deutschland; ¹³Fürst-Stirum-Klinik Bruchsal Medizinische Klinik II Bruchsal, Deutschland; ¹⁴Cardiologicum Herzklinik Ulm MVZ Ulm, Deutschland; ¹⁵Hopital de la Tour Meyrin - Genf, Schweiz; ¹⁶European Hospital Georges Pompidou, Assistance Publique–Hôpitaux de Paris, Paris Cité University, Sudden Cardiac Death Expert Center, Paris, France Department of Cardiology Paris, Frankreich

Introduction: Implantation of drug eluting stents (DES) is the current default approach for most percutaneous coronary interventions (PCI). DES are permanent foreign bodies associated with both acute and long-term adverse events. An alternative approach with minimal stenting is therefore appealing. We studied SELUTION SLR DEB (Cordis), a sirolimus-eluting balloon (SEB) that elutes sirolimus into the vessel wall over a 90-day period using a polymer micro-reservoir technology.
Methods: In an all-comer multi-centre, open-label, randomised trial, we compared a SELUTION DEB-based strategy with provisional DES to one of systematic DES for de novo lesions in coronary arteries between 2 and 5 mm in diameter. Subjects were randomised 1:1 prior to PCI. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction and clinically driven target vessel revascularisation. It was tested for non-inferiority at one year, using a margin equal to 50% of the combined event rate at a significance level of 0.025. This study is registered with ClinicalTrials.gov, NCT04859985 and extended follow-up is ongoing.
Findings: Between August 27, 2021, and July 29, 2024, 3323 participants were randomised and treated in 62 sites. 842 (25.3%) were female. Among 1661 participants in the SEB strategy group, 343 (20.7%) received one or more DES. TVF occurred over 365 days in 88 (5.3%) and 73 (4.4%) participants in the SEB and the systematic DES strategy groups, respectively (risk difference 0.91%; 95% CI –0.55% to 2.3,8%; p=0.02 for non-inferiority using a non-inferiority margin of 2.44%).
Conclusion: SELUTION DeNovo is a large investigator driven, pragmatic strategy trial that randomized patients before lesion preparation. At one year, a strategy of PCI with SEB and provisional DES was non-inferior to the systematic use of DES for the primary endpoint of TVF. There were no acute or late safety concerns: SELUTION DEB strategy had low rates of cardiac death, lesion thrombosis and target-vessel myocardial infarction similar to DES. 80% of participants treated with the SELUTION DEB did not require a stent.