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Randomized Controlled Trial
. 2022 Mar 31;43(13):1320-1330.
doi: 10.1093/eurheartj/ehab790.

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

Rafael Romaguera  1 , Pablo Salinas  2 , Josep Gomez-Lara  1 , Salvatore Brugaletta  3 , Antonio Gómez-Menchero  4 , Miguel A Romero  5 , Sergio García-Blas  6   7 , Raymundo Ocaranza  8 , Pascual Bordes  9 , Marcelo Jiménez Kockar  10 , Neus Salvatella  11 , Victor A Jiménez-Díaz  12 , Mar Alameda  13 , Ramiro Trillo  14 , Dae Hyun Lee  15 , Pedro Martín  16 , María López-Benito  17 , Alfonso Freites  18 , Virginia Pascual-Tejerina  19 , Felipe Hernández-Hernández  20 , Bruno García Del Blanco  21 , Mohsen Mohandes  22 , Francisco Bosa  23 , Eduardo Pinar  24 , Gerard Roura  1 , Josep Comin-Colet  1 , Antonio Fernández-Ortiz  2 , Carlos Macaya  2 , Xavier Rossello  13   25   26 , Manel Sabate  3 , Stuart J Pocock  25 , Joan A Gómez-Hospital  1 ; SUGAR trial investigators
Collaborators, Affiliations
Randomized Controlled Trial

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

Rafael Romaguera et al. Eur Heart J. .

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.

Keywords: Diabetes mellitus; Drug-eluting stents; Percutaneous coronary intervention; Randomized trial.

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Figures

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.
Figure 1
Figure 1
Trial flowchart.
Figure 2
Figure 2
Primary endpoint and its components. Time-to-event curves are shown for patients in the intention-to-treat population who were randomly assigned to receive Cre8 EVO stents or Resolute Onyx stents. CI, confidence interval; HR, hazard ratio; MI, myocardial infarction.
Figure 3
Figure 3
Prespecified subgroup analyses of the primary endpoint. AMI, acute myocardial infarction; HbA1c, glycated haemoglobin; LDL, low-density lipoprotein cholesterol; SGLT2i, sodium-glucose cotransporter 2 inhibitors; STEMI, ST-elevation myocardial infarction.
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References

    1. Saeedi P, Petersohn I, Salpea P et al.; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: results from the International Diabetes Federation Diabetes Atlas, 9(th) edition. Diabetes Res Clin Pract 2019;157:107843. - PubMed
    1. Inohara T, Kohsaka S, Spertus JA et al. Comparative trends in percutaneous coronary intervention in Japan and the United States, 2013 to 2017. J Am Coll Cardiol 2020;76:1328–1340. - PubMed
    1. Farkouh ME, Domanski M, Sleeper LA et al.; FREEDOM Trial Investigators. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med 2012;367:2375–2384. - PubMed
    1. Kaul U, Bangalore S, Seth A et al.; TUXEDO-India Investigators. Paclitaxel-eluting versus everolimus-eluting coronary stents in diabetes. N Engl J Med 2015;373:1709–1719. - PubMed
    1. Bavishi C, Chugh Y, Kimura T et al. Biodegradable polymer drug-eluting stent vs. contemporary durable polymer drug-eluting stents in patients with diabetes: a meta-analysis of randomized controlled trials. Eur Heart J Qual Care Clin Outcomes 2020;6:81–88. - PubMed

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