Trial reportEuropean heart journal2022
Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial.
Trial report in European heart journal, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03321032 (Second-generation drUg-elutinG Stents in diAbetes), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Second-generation drUg-elutinG Stents in diAbetes: a Randomized Trial (the SUGAR Trial)
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.
- Polymer-free stents for percutaneous coronary intervention in diabetic patients: a systematic review and meta-analysis.Future cardiology · 2024Pooled it
- One-year outcomes of polymer-free amphilimus-eluting stents versus durable polymer zotarolimus-eluting stents in patients with diabetes mellitus: a meta-analysis.Cardiovascular diabetology · 2022Pooled it
- Polymer-free versus biodegradable-polymer drug-eluting stent in patients undergoing percutaneous coronary intervention: an assessor-blind, non-inferiority, randomised controlled trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025Trial
- Device innovation or systemic risk management?-rethinking priorities in diabetic percutaneous coronary intervention.Cardiovascular diagnosis and therapy · 2026Article
- Nanocarrier SIroliMus-coated balloon-based percutaneous coronary intervention (PCI) versus drug-eluting stent (DES)-onLy PCI in patients with diabetes mellitus.Cardiovascular diabetology · 2026Observational
- Advances in Technology and Technique in Percutaneous Coronary Intervention: A Clinical Review.Internal medicine (Tokyo, Japan) · 2026Review
- Role of Polymer-Free Drug-Eluting Stents in Insulin-Dependent Diabetic Patients Undergoing Percutaneous Coronary Intervention: An Observational Study.Journal of personalized medicine · 2025Article
- Contemporary Percutaneous Coronary Intervention in Diabetic Patients.Reviews in cardiovascular medicine · 2025Review
- Impact of Diabetes on Long-Term Outcomes of Percutaneous Coronary Intervention for Coronary Bifurcation Lesions.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025Observational
- Observational
- Advances in Clinical Cardiology 2022: A Summary of Key Clinical Trials.Advances in therapy · 2023Review
- Stent Thrombosis and Restenosis with Contemporary Drug-Eluting Stents: Predictors and Current Evidence.Journal of clinical medicine · 2023Review
- Polymer Free Amphilimus Drug Eluting Stent for Infrapopliteal Arterial Disease in Patients with Critical Limb Ischemia: A New Device in the Armamentarium.Medicina (Kaunas, Lithuania) · 2022Review
- Impact of Diabetes on 10-Year Outcomes Following ST-Segment-Elevation Myocardial Infarction: Insights From the EXAMINATION-EXTEND Trial.Journal of the American Heart Association · 2022Article
- Advances in Clinical Cardiology 2021: A Summary of Key Clinical Trials.Advances in therapy · 2022Review
- The year in cardiovascular medicine 2021: interventional cardiology.European heart journal · 2022Article
- Bifurcation strategies using second-generation drug-eluting stents on clinical outcomes in diabetic patients.Frontiers in cardiovascular medicine · 2022Article
- Predictive Value of Plasma Big Endothelin-1 in Adverse Events of Patients With Coronary Artery Restenosis and Diabetes Mellitus: Beyond Traditional and Angiographic Risk Factors.Frontiers in cardiovascular medicine · 2022Article
Corrections and comments
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Authors and funding
33 authors at 20 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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. 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.
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. CLINICAL
trial registrationClinicalTrials.gov: NCT03321032.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.