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

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.

[Prognostic evaluation of patients with systolic dysfunction: functional and echocardiographic evaluation]. / Valoración pronóstica de los pacientes con disfunción sistólica: estudio funcional y ecocardiográfico.

INTRODUCTION AND OBJECTIVES: Multiple clinical and echocardiographic parameters have been shown to have prognostic value in cases of left ventricular dysfunction. The purpose of this paper was to evaluate the relative predictive power of such parameters. METHODS: Ninety-one patients with systolic dysfunction were prospectively studied. Functional status was evaluated using the New York Heart Association classification and the 6-minute walking test. Other clinical and biochemical parameters were assessed, and an anatomic and functional echocardiographic study was performed. RESULTS: Mean follow-up was 16.5 months (SD: 6.95). Eighteen patients died and two underwent heart transplantation (cardiac death 22%). Multiple regression analysis showed that the only independent predictor of death was functional status. Functional classes I and II showed a 16-month mortality rate of 10%, class III 40% and class IV 83%. The mortality rate was 67% for patients who walked < 300 meters and 0% for those who reached > 500 meters. When echocardiographic results were analyzed separately, the only independent predictors of outcome were left atrial diameter and the E wave deceleration time. Deceleration times < 100 ms or atrial diameters > 5 cm were associated with a mortality rate of 46%. The correlation between E wave deceleration time and the walking test was r = 0.55, p < 0.0001. CONCLUSIONS: Functional status is the main predictor of outcome in patients with systolic dysfunction, whether assessed subjectively or estimated objectively by a walking test. Among echo-Doppler parameters, the deceleration time of the E wave and left atrial diameter gave similar prognostic information, although with less statistical significance. They can confirm or substitute the prognosis obtained by the functional classification.