TY - JOUR
T1 - 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
AU - Lansky, Alexandra J.
AU - Kereiakes, Dean J.
AU - Baumbach, Andreas
AU - Windecker, Stephan
AU - Hussain, Yasin
AU - Pietras, Cody
AU - Dressler, Ovidiu
AU - Issever, Ozgu
AU - Curtis, Michael
AU - Bertolet, Barry
AU - Zidar, James P.
AU - Smits, Pieter C.
AU - Díaz, Victor Alfonso Jiménez
AU - McLaurin, Brent
AU - Hofma, Sjoerd
AU - Cequier, Ángel
AU - Dib, Nabil
AU - Benit, Edouard
AU - Mathur, Anthony
AU - Brogno, David
AU - Berland, Jacques
AU - Wykrzykowska, Joanna
AU - Piegari, Guy
AU - Brugaletta, Salvatore
AU - PIONEER III Trial Investigators
AU - Saito, Shigeru
AU - Leon, Martin B.
N1 - Publisher Copyright: © 2021 American Heart Association, Inc.
PY - 2021/6
Y1 - 2021/6
N2 - 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]; Pnoninferiority=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.
AB - 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]; Pnoninferiority=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.
KW - Acute coronary syndrome
KW - Drug-eluting stents
KW - Single-blind method
KW - Stents
UR - http://www.scopus.com/inward/record.url?scp=85107065677&partnerID=8YFLogxK
U2 - https://doi.org/10.1161/CIRCULATIONAHA.120.052482
DO - https://doi.org/10.1161/CIRCULATIONAHA.120.052482
M3 - Article
C2 - 33820424
SN - 0009-7322
VL - 143
SP - 2143
EP - 2154
JO - Circulation
JF - Circulation
IS - 22
ER -