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Journal Article Ahead of print 16 citations

PubMed: 42290366 DOI: 10.1161/CIRCULATIONAHA.126.079033

Sirolimus-Eluting Balloon With Provisional Stenting Versus Systematic Drug-Eluting Stent Implantation to Treat De Novo Coronary Lesions: A Randomized, Open-Label, Noninferiority Trial.

Circulation

Authors: Christian Spaulding, Florian Krackhardt, Kris Bogaerts, Eltigani Abdelaal, Fernando Alfonso, Carlo Briguori, Leonhard Bruch, Nicholas Cruden, Alexander W Den Hartog, Philippe Garot, Mathieu Godin, David Hildick-Smith, Thomas Johnson, Andrew Ladwiniec, Axel Linke, Clint Anthony Maart, Kambis Mashayekhi, Pascal Meier, Ludovic Meunier, Kenneth Morgan, Peter O'Kane, Etienne Puymirat, Tuomas T Rissanen, Manel Sabaté, Thomas Schmitz, Gabor G Toth, Jasper Trevelyan, Piotr Wanczura, Wiemer Marcus, Joanna J Wykrzykowska, Philip Urban, Simon Eccleshall

Affiliations

  • Department of Cardiology, European Hospital Georges Pompidou, Assistance Publique Hôpitaux de Paris, Paris-Cité University, INSERM Centre d'investigation Clinique 1414, France (C.S. E.P.).
  • Berlin Institute of Health at Charité Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Charité Campus Virchow-Klinikum, Germany (F.K).
  • Department of Public Health and Primary Care, I-BioStat, KU Leuven, Belgium (K.B.).
  • UHasselt, I-BioStat, Belgium (K.B.).
  • Manchester Heart Institute, Manchester University NHS Foundation Trust, UK (E.A.).
  • Cardiology Department, Hospital Universitario de La Princesa/Universidad Autonoma de Madrid IIS-IP, CIBER-CV, Spain (F.A.).
  • Mediterranea Cardiocentro, Naples, Italy (C.B.).
  • BG Klinikum Unfallkrankenhaus Department of Internal Medicine/Cardiology, Berlin, Germany (L.B.).
  • Royal Infirmary of Edinburgh, UK (N.C.).
  • Department of Cardiology, Amsterdam University Medical Center, Netherlands (A.W.D.H.).
  • Institut Cardiovasculaire Paris Sud Hôpital Jacques Cartier Ramsay-Santé, Massy, France (P.G.).
  • Clinique Saint Hillaire, Rouen, France (M.G.).
  • Sussex Cardiac Centre University Hospitals Sussex, Brighton, UK (D.H.-S.).
  • Bristol Heart Institute, Translational Health Sciences, University of Bristol, Bristol Royal Infirmary University, UK (T.J.).
  • Department of Internal Medicine and Cardiology, Herat Center, University Clinic, University of Technology Dresden, Germany (A.L.).
  • Department of Cardiovascular Sciences, University of Leicester, National Institute for Health and Care Research Leicester Biomedical Research Center, British Heart Foundation Centre of Research Excellence, Glenfield Hospital, UK (A.L.).
  • Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich Medical School, University of East Anglia, UK (C.A.M, S.E.).
  • Department of Internal Medicine and Cardiology, Heart Center Lahr, Germany (K.M.).
  • Service de Cardiologie, Fribourg Hospitals HFR, Switzerland (P.M.).
  • Cardiology Department, Centre Hospitalier La Rochelle, France (L.M.).
  • Northern General Hospital, Sheffield, UK (K.P.M.).
  • Dorset Heart Centre, University Hospitals Dorset, Royal Bournemouth Hospital, UK (P.O.).
  • Heart Center, North Karelia Central Hospital, Siunsote, University of Eastern Finland, Kuopio (T.T.R.).
  • Interventional Cardiology Department, Cardiovascular Institute, Hospital Clinic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain (M.S.).
  • University of Barcelona, CIBER-CV, Spain (M.S.).
  • Department of Cardiology, Elisabeth Krankenhaus Essen, Germany (T.S.).
  • Division of Cardiology, University Heart Center Graz, Medical University Graz, Germany (G.G.T.).
  • Worcestershire Acute Hospital NHS Trust, UK (J.T.).
  • Department of Cardiology, Collegium Medicum, University of Rzeszow, Poland (P.W.).
  • Johannes Wesling Universitätsklinik, Minden, Germany (M.W.).
  • Department of Cardiology, University Medical Center Groningen, Netherlands (J.W.).
  • Cardiovascular Department, Hôpital de la Tour, Geneva, Switzerland (P.U.).

Abstract

BACKGROUND

Implantation of drug eluting stents (DESs) is currently the default approach for percutaneous coronary interventions, but long-term adverse events still exist. An approach with minimal stenting deserves to be assessed in a randomized trial. We studied a novel sirolimus-eluting balloon (SEB) that elutes sirolimus over a 90-day period using a biodegradable polymer microreservoir technology.

METHODS

In a multicenter, open-label, randomized trial, we compared an SEB-based strategy with provisional DES with one of systematic DES for de novo lesions in coronary arteries between 2 and 5 mm in diameter. Subjects were randomized 1:1 before percutaneous coronary intervention. The primary end point was target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization. It was tested for noninferiority at 1 year with the use of an absolute margin equal to 50% of the combined event rate at a significance level of 0.025. The primary analysis population included all randomized subjects with completed or attempted percutaneous revascularization, analyzed according to the intention-to-treat principle. A sensitivity analysis was performed on the per-protocol population.

RESULTS

Between August 27, 2021, and July 29, 2024, 3323 participants were randomized and treated in 62 sites. Among 1661 participants in the SEB strategy group, bailout stenting was performed in 343 (20.7%). Target vessel failure 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 2.38%]; 1-sided P=0.02 for noninferiority with a 2.44% noninferiority margin). Clinically driven target vessel revascularization occurred more frequently in the SEB strategy group (3.3% versus 2.1%; risk difference, 1.22% [95% CI, 0.11%-2.33%). Safety events, including lesion thrombosis, were low and similar in both groups. Although the results of the per-protocol population (3194 participants, 96%) did not confirm noninferiority (upper boundary of the 95% CI, 2.63; P=0.04), they were similar to the intention-to-treat results in both magnitude and direction.

CONCLUSIONS

At 1 year, in the primary intention-to-treat analysis population, a strategy of percutaneous coronary intervention with SEB and provisional DES was noninferior to the systematic use of DES for the primary end point of target vessel failure. The per-protocol population sensitivity analysis did not confirm noninferiority. Clinically driven target vessel revascularization occurred more frequently in the SEB strategy group. At 5 years, target vessel failure will be tested again for noninferiority and for superiority if noninferiority is achieved.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT04859985.

MeSH

Stents, Drug-Eluting Stents, Coronary Artery Disease, Pharmaceutical Preparations, Cardiovascular System, Angioplasty, Percutaneous Coronary Intervention, Sirolimus, Wounds And Injuries, Blood Circulation, Recipient Vessels