Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial

Abstract Aim Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells...

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Published in	European heart journal Vol. 43; no. 13; pp. 1320 - 1330
Main Authors	Romaguera, Rafael, Salinas, Pablo, Gomez-Lara, Josep, Brugaletta, Salvatore, Gómez-Menchero, Antonio, Romero, Miguel A, García-Blas, Sergio, Ocaranza, Raymundo, Bordes, Pascual, Kockar, Marcelo Jiménez, Salvatella, Neus, Jiménez-Díaz, Victor A, Alameda, Mar, Trillo, Ramiro, Lee, Dae Hyun, Martín, Pedro, López-Benito, María, Freites, Alfonso, Pascual-Tejerina, Virginia, Hernández-Hernández, Felipe, Blanco, Bruno García del, Mohandes, Mohsen, Bosa, Francisco, Pinar, Eduardo, Roura, Gerard, Comin-Colet, Josep, Fernández-Ortiz, Antonio, Macaya, Carlos, Rossello, Xavier, Sabate, Manel, Pocock, Stuart J, Gómez-Hospital, Joan A
Format	Journal Article
Language	English
Published	England Oxford University Press 31.03.2022
Subjects	Coronary Artery Disease - etiology Coronary Artery Disease - therapy Diabetes Mellitus Drug-Eluting Stents Fast Track Clinical Research Humans Percutaneous Coronary Intervention - methods Prosthesis Design Sirolimus - analogs & derivatives Sirolimus - therapeutic use Treatment Outcome Percutaneous coronary intervention Randomized trial Diabetes mellitus Drug-eluting stents
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ISSN	0195-668X 1522-9645 1522-9645
DOI	10.1093/eurheartj/ehab790

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Abstract	Abstract Aim Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. Methods and results We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44–0.96; Pnon-inferiority < 0.001; Psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46–0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. Conclusion In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome. Clinical trial registration ClinicalTrials.gov: NCT03321032. Graphical Abstract Graphical Abstract In the SUGAR trial, 1175 patients with diabetes mellitus and coronary artery disease were randomly assigned to receive Cre8 EVO or Resolute Onyx stents. Patients allocated to Cre8 EVO stents had a reduced risk of target lesion failure at 1-year follow-up.
AbstractList	Abstract Aim Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. Methods and results We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44–0.96; Pnon-inferiority < 0.001; Psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46–0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. Conclusion In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome. Clinical trial registration ClinicalTrials.gov: NCT03321032. Graphical Abstract Graphical Abstract In the SUGAR trial, 1175 patients with diabetes mellitus and coronary artery disease were randomly assigned to receive Cre8 EVO or Resolute Onyx stents. Patients allocated to Cre8 EVO stents had a reduced risk of target lesion failure at 1-year follow-up. Graphical Abstract In the SUGAR trial, 1175 patients with diabetes mellitus and coronary artery disease were randomly assigned to receive Cre8 EVO or Resolute Onyx stents. Patients allocated to Cre8 EVO stents had a reduced risk of target lesion failure at 1-year follow-up. Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44-0.96; Pnon-inferiority < 0.001; Psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46-0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome. ClinicalTrials.gov: NCT03321032. Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes.AIMPatients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes.We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44-0.96; Pnon-inferiority < 0.001; Psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46-0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups.METHODS AND RESULTSWe did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44-0.96; Pnon-inferiority < 0.001; Psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46-0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups.In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome.CONCLUSIONIn patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome.ClinicalTrials.gov: NCT03321032.CLINICAL TRIAL REGISTRATIONClinicalTrials.gov: NCT03321032.
Author	Gomez-Lara, Josep Rossello, Xavier Gómez-Menchero, Antonio Bosa, Francisco Alameda, Mar Lee, Dae Hyun López-Benito, María Pinar, Eduardo Sabate, Manel Salvatella, Neus Mohandes, Mohsen Fernández-Ortiz, Antonio Macaya, Carlos Kockar, Marcelo Jiménez Romero, Miguel A Ocaranza, Raymundo Romaguera, Rafael Bordes, Pascual Pocock, Stuart J García-Blas, Sergio Jiménez-Díaz, Victor A Trillo, Ramiro Roura, Gerard Martín, Pedro Freites, Alfonso Hernández-Hernández, Felipe Blanco, Bruno García del Salinas, Pablo Comin-Colet, Josep Brugaletta, Salvatore Gómez-Hospital, Joan A Pascual-Tejerina, Virginia
AuthorAffiliation	22 Hospital Joan XXIII de Tarragona , Tarragona, Spain 11 Hospital del Mar , Barcelona, Spain 10 Hospital de la Santa Creu i Sant Pau , Barcelona, Spain 4 Hospital Juan Ramón Jiménez , Huelva, Spain 14 Hospital de Santiago , Santiago de Compostela, Spain 15 Hospital Marqués de Valdecilla , Santander, Spain 7 Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV) 17 Hospital Universitario de León , León, Spain 18 Hospital San Juan , Alicante, Spain 23 Hospital Universitario de Canarias , Tenerife, Spain 16 Hospital Doctor Negrín , Gran Canaria, Spain 25 Centro Nacional de Investigaciones Cardiovaculares (CNIC) , Madrid, Spain 13 Hospital Universitario Son Espases—IDISBA , Mallorca, Spain 1 Hospital de Bellvitge—IDIBELL, University of Barcelona , Barcelona, Spain 19 Hospital Virgen de la Salud , Toledo, Spain 26 Department of Medical Statistics, London School of Hygiene & Tropical Medicine , London, UK 8 Hospital Lucus Augusti , Lugo, Spain 5 Hospital Reina Sofía , Córdoba, S
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BackLink	https://www.ncbi.nlm.nih.gov/pubmed/34735004$$D View this record in MEDLINE/PubMed
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ContentType	Journal Article
Contributor	Gracida, Montserrat Ortega-Paz, Luis Fuentes, Lara Castillo-Poyo, Rocío Jiménez-Quevedo, Pilar Salazar, Carlos H Ferreiro, José L Muntané-Carol, Guillem de Prado, Armando Pérez Teruel, Luis de la Torre Hernández, José M Cequier, Angel Sanchis, Juan Ojeda, Soledad
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Copyright	The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology. 2021 The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.
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Keywords	Percutaneous coronary intervention Randomized trial Diabetes mellitus Drug-eluting stents
Language	English
License	This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com https://creativecommons.org/licenses/by-nc/4.0 The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.
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Notes	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 The list of SUGAR trial collaborators is available in the Acknowledgements section. Rafael Romaguera, Pablo Salinas contributed equally to this work.
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Snippet	Abstract Aim Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between... Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most... Graphical Abstract In the SUGAR trial, 1175 patients with diabetes mellitus and coronary artery disease were randomly assigned to receive Cre8 EVO or Resolute...
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SubjectTerms	Coronary Artery Disease - etiology Coronary Artery Disease - therapy Diabetes Mellitus Drug-Eluting Stents Fast Track Clinical Research Humans Percutaneous Coronary Intervention - methods Prosthesis Design Sirolimus - analogs & derivatives Sirolimus - therapeutic use Treatment Outcome
Title	Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial
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