Sirolimus Eluting Balloons for Patients with Acute Coronary Syndrome – Evidence from the SELUTION DeNovo Trial
Presenter
Andy Ladwiniec, MD, University Hospitals of Leicester NHS Trust, Leicester, United Kingdom
Christian Spaulding1, Etienne Puymirat1, Andy Ladwiniec, MD2, Matthieu Godin3, Thomas Schmitz4, Axel Linke5, Simon Eccleshall6, Nick Curzen, Ph.D.7, Michael Dickinson8, Gioel Gabrio Secco9 and Clemens Steinwender10, (1)European Hospital Georges Pompidou, Paris, France, (2)University Hospitals of Leicester NHS Trust, Leicester, United Kingdom, (3)Clinique Saint-Hilaire, Rouen, France, (4)Department of Cardiology, Elisabeth Krankenhaus Essen, Essen, Germany, (5)Department of Internal Medicine and Cardiology Herat Center, University Clinic, University of Technology Dresden, Dresden, Germany, (6)Department of Cardiology, Norfolk and Norwich University Hospital & Honorary Associate Professor, University of East Anglia, Norwich Research Park, Norwich, United Kingdom, (7)University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom, (8)UMC Utrecht, Utrecht, Netherlands, (9)Ospedale Civile Santi Antonio e Biagio e Cesare Arrigo, Alessandria, Italy, (10)Kepler Universitätsklinikum GmbH, Linz, Austria
Keywords: Acute Coronary Syndromes (ACS), Coronary, Drug-coated Balloon (DCB) and Drug-eluting Stent (DES)
Background
: Current Percutaneous Coronary Intervention (PCI) for patients presenting with Acute Coronary Syndrome (ACS) is based on the implantation of Drug Eluting Stents (DES), but these may be associated with specific adverse events over a prolonged follow-up. Use of Drug Coated Balloons (DCB) may help decrease the occurrence of DES-associated problems but the evidence concerning their use for ACS patients is limited. The SELUTION DeNovo trial enrolled 3323 patients undergoing PCI and randomized them 1:1 to a strategy of either SELUTION SLR Sirolimus Eluting Balloon (SEB) with provisional stenting or systematic DES implantation. STEMI was an exclusion criterion. 1089/3323 patients (32.7%) presented with NSTEMI or unstable angina. The one-year results for the overall trial population have been reported, and non-inferiority of the SEB approach was achieved with a Target Vessel Failure (TVF) of 5.3% for the SEB arm vs. 4.4% for the DES arm.
Methods
: A prespecified SELUTION DeNovo sub-study in patients with NSTEMI or unstable angina assessed the one-year rate of TVF, a composite of cardiac death, Target-Vessel related Myocardial Infarction (TV-MI) and clinically-driven Target Vessel Revascularization (cd-TVR).
Results
: | | SEB arm | DES arm |
| Number of patients | 553 | 529 |
| Age | 65.9+10.3 | 65.4+11.4 |
| Female sex | 153/553 (27.7%) | 136/529 (25.7%) |
| NSTEMI presentation | 404/553 (73.1%) | 384/529 (72.6%) |
| Unstable angina presentation | 149(553 (26.9%) | 145/529 (27.4%) |
| Multi-lesion procedure | 157/553 (28.4%) | 144/529 (27.2%) |
| Bail-out stenting/lesion | 138/750 (18.4%) | na |
| Bail-out stenting/patient | 116/553 (21%) | na |
| TVF | 29/553 (5.3%) | 26/529 (4.9%) |
| Cardiac death | 3/553 (0.6%) | 4/529 (0.8%) |
| TV- MI | 17/553 (3.1%) | 15/529 (2.8%) |
| cd-TVR | 17/553 (3.1%) | 14/529 (2.7%) |
Conclusions
: At one year the rates of TVF and its components were all low and similar in both groups. This supports the use of a SEB strategy with minimal stenting as a safe and effective alternative to systematic DES implantation for patients presenting with unstable angina or NSTEMI. Potential benefits of minimal stenting will require longer term follow-up to become apparent.