Novel Supreme Drug-Eluting Stents With Early Synchronized Antiproliferative Drug Delivery to Inhibit Smooth Muscle Cell Proliferation After Drug-Eluting Stents Implantation in Coronary Artery Disease: Results of the PIONEER III Randomized Clinical Trial.

Autor: Lansky AJ; Division of Cardiology, Yale School of Medicine, New Haven, CT (A.J.L., A.B., Y.H., C.P., A.M.).; Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London and Barts Heart Centre, London, United Kingdom (A.J.L., A.B., A.M.)., Kereiakes DJ; Christ Hospital Heart and Vascular Center, Cincinnati, OH (D.J.K.)., Baumbach A; Division of Cardiology, Yale School of Medicine, New Haven, CT (A.J.L., A.B., Y.H., C.P., A.M.).; Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London and Barts Heart Centre, London, United Kingdom (A.J.L., A.B., A.M.)., Windecker S; Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Switzerland (S.W.)., Hussain Y; Division of Cardiology, Yale School of Medicine, New Haven, CT (A.J.L., A.B., Y.H., C.P., A.M.)., Pietras C; Division of Cardiology, Yale School of Medicine, New Haven, CT (A.J.L., A.B., Y.H., C.P., A.M.)., Dressler O; Cardiovascular Research Foundation, New York, NY (O.D., O.I., M.B.L.)., Issever O; Cardiovascular Research Foundation, New York, NY (O.D., O.I., M.B.L.)., Curtis M; University of Calgary, Alberta, Canada (M.C.)., Bertolet B; Cardiology Associates of North Mississippi, Tupelo (B.B.)., Zidar JP; North Carolina Heart and Vascular, University of North Carolina, Raleigh (J.P.Z.)., Smits PC; Maasstad Ziekenhuis, Rotterdam, The Netherlands (P.C.S.)., Alfonso Jiménez Díaz V; Hospital Álvaro Cunqueiro, Vigo, Spain (V.A.J.D.)., McLaurin B; Armed Health Medical Center, Anderson, SC (B.M.)., Hofma S; Medisch Centrum Leeuwarden, Hartcentrum Friesland, Leeuwarden, The etherlands (S.H.)., Cequier Á; Bellvitge Hospital, University of Barcelona, IDIBELL, Spain (A.C.)., Dib N; Mercy Gilbert Medical Center, Gilbert, AZ (N.D.)., Benit E; Jessa Ziekenhuis, Campus Virga Jesse, Hasselt, Belgium (E.B.)., Mathur A; Division of Cardiology, Yale School of Medicine, New Haven, CT (A.J.L., A.B., Y.H., C.P., A.M.).; Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London and Barts Heart Centre, London, United Kingdom (A.J.L., A.B., A.M.)., Brogno D; College of Physicians and Surgeons, Columbia University, New York, NY (D.B., M.B.L.)., Berland J; Clinique Saint-Hilaire, Rouen, France (J.B.)., Wykrzykowska J; Academic Medical Center, University of Amsterdam, The Netherlands (J.W.).; Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands (J.W.)., Piegari G; Penn State Health Medical Group-Berks Cardiologists, Wyomissing, PA (G.P.)., Brugaletta S; Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Spain (S.B.)., Saito S; Shonan Kamakura General Hospital, Kamakura, Japan (S.S.)., Leon MB; Cardiovascular Research Foundation, New York, NY (O.D., O.I., M.B.L.).; College of Physicians and Surgeons, Columbia University, New York, NY (D.B., M.B.L.).
Jazyk: angličtina
Zdroj: Circulation [Circulation] 2021 Jun; Vol. 143 (22), pp. 2143-2154. Date of Electronic Publication: 2021 Apr 06.
DOI: 10.1161/CIRCULATIONAHA.120.052482
Abstrakt: Background: Accelerated endothelial healing after targeted antiproliferative drug delivery may limit the long-term inflammatory response of drug-eluting stents (DESs). The novel Supreme DES is designed to synchronize early drug delivery within 4 to 6 weeks of implantation, leaving behind a prohealing permanent base layer. Whether the Supreme DES is safe and effective in the short term and can improve long-term clinical outcomes is not known.
Methods: In an international, 2:1 randomized, single-blind trial, we compared treatment with Supreme DES to durable polymer everolimus-eluting stents (DP-EES) in patients with acute and chronic coronary syndromes. The primary end point was target lesion failure-a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. The trial was designed to demonstrate noninferiority (margin of 3.58%) of the Supreme DES at 12 months compared with DP-EES (URL: https://www.clinicaltrials.gov; Unique identifier: NCT03168776).
Results: From October 2017 to July 2019, a total of 1629 patients were randomly assigned (2:1) to the Supreme DES (N=1086) or DP-EES (N=543). At 12 months, target lesion failure occurred in 57 of 1057 patients (5.4%) in the Supreme DES group and in 27 of 532 patients (5.1%) in the DP-EES group (absolute risk difference, 0.32% [95% CI, -1.87 to 2.5]; P non inferiority =0.002]. There were no significant differences in rates of device success, clinically driven target lesion revascularization, or stent thrombosis at 12 months, and the safety composite of cardiovascular death and target vessel myocardial infarction was 3.5% versus 4.6% (hazard ratio, 0.76 [95% CI, 0.46-1.25]) with Supreme DES compared with DP-EES, although rates of combined clinically and non-clinically driven target lesion revascularization at 12 months were higher with Supreme DES.
Conclusions: Among patients with acute and chronic coronary syndromes undergoing percutaneous coronary intervention, the Supreme DES proved to be noninferior to the standard DP-EES. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03168776.
Databáze: MEDLINE
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