Abluminus DES+ sirolimus-eluting stent versus everolimus-eluting stent in patients with diabetes and coronary artery disease (ABILITY Diabetes Global): results from a multicentre, randomised controlled trial.

backgroundIn patients with coronary artery disease, diabetes increases the risk of restenosis and adverse cardiovascular events after percutaneous coronary intervention (PCI). The Abluminus DES+ is a thin-strut cobalt-chromium sirolimus-eluting stent (SES) with abluminal and balloon-surface coating intended to enhance drug delivery to the vessel wall. We aimed to compare the efficacy and safety of the Abluminus DES+ SES versus the XIENCE durable-polymer everolimus-eluting stent (EES) in patients with diabetes undergoing PCI.

methodsABILITY Diabetes Global was a multicentre, prospective, open-label, randomised controlled trial conducted at 74 sites in 16 countries. Adults (aged ≥18 years) with type 1 or type 2 diabetes undergoing PCI for at least one de novo coronary lesion due to chronic coronary syndrome or non-ST-elevation acute coronary syndrome were eligible. Patients were randomly assigned (1:1) to the Abluminus DES+ SES or the XIENCE EES. Randomisation was stratified by site using a secure web-based system with concealed allocation and randomly varying block sizes (4, 6, and 8). Operators were unmasked to allocation; staff performing clinical follow-up and the independent clinical events committee were masked. For the Abluminus DES+ SES, a balloon inflation time of at least 45 s was recommended to facilitate drug transfer; dual antiplatelet therapy was prescribed to all patients according to clinical guidelines and local practice. The primary hypothesis of the study was the non-inferiority of the Abluminus DES+ SES compared with the XIENCE EES for the two coprimary endpoints at 12 months (in the per-protocol population): ischaemia-driven target-lesion revascularisation (2·8% non-inferiority margin) and target-lesion failure (3·0% margin), defined as a composite of cardiovascular death, target-vessel myocardial infarction, or ischaemia-driven target-lesion revascularisation. Time-to-event analyses were conducted with Kaplan-Meier estimates and Cox proportional hazards models. This trial is registered with ClinicalTrials.gov (NCT04236609) and is complete.

findingsBetween June 12, 2020, and Sept 9, 2022, 3032 patients were randomly assigned to the Abluminus DES+ SES (n=1514) or XIENCE EES (n=1518). 2931 (96·7%) of 3032 patients completed follow-up to death or 24-month follow-up. Median age was 68·0 years (IQR 60-74). 879 (29·0%) of 3032 patients were female and 2153 (71·0%) were male. At 12 months, in the per-protocol analysis, the Abluminus DES+ SES did not meet the criteria for non-inferiority for ischaemia-driven target-lesion revascularisation compared with XIENCE EES (67 of 1421 patients [Kaplan-Meier estimate 4·8%, 95% CI 3·9-6·2] vs 30 of 1446 [2·1%, 95% CI 1·6-3·2]; absolute risk difference 2·7%, 95% CI 1·3-4·1; p

interpretationIn patients with diabetes undergoing PCI, the Abluminus DES+ SES was not non-inferior to the XIENCE EES, resulting in higher rates of ischaemia-driven target-lesion revascularisation and target lesion failure at 12-month follow-up. Event rates between 12 and 24 months were similar between groups. These findings highlight the persistent challenge of optimising outcomes in patients with diabetes and underscore the need for continued innovation in stent design and adjunctive pharmacotherapy to reduce residual ischaemic risk in this population.

fundingConcept Medical.