BACKGROUND:In 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. METHODS:ABILITY 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. FINDINGS:Between 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; pnon-inferiority=0·44) and target lesion failure (137 [9·7%, 8·4-11·5] vs 89 [6·2%, 5·3-7·8]; 3·5%, 1·5-5·5; pnon-inferiority=0·68). For both endpoints, the lower bound of the 95% CI for the absolute risk difference excluded zero. Target-vessel myocardial infarction occurred more frequently in the Abluminus DES+ SES group (73 of 1421 patients [Kaplan-Meier estimate 5·2%, 95% CI 4·1-6·5] vs 44 of 1446 patients [3·1%, 2·4-4·3]) but there were no significant differences in cardiovascular death (41 of 1421 patients [2·9%, 2·1-3·9] vs 30 of 1446 patients [2·1%, 1·5-3·0]) and all-cause death (52 of 1421 patients [3·7%, 2·8-4·8] vs 48 of 1446 patients [3·3%, 2·5-4·4]). Results were consistent at 24 months in the intention-to-treat analysis, however no significant differences were observed between the two groups in landmark analyses between 12 and 24 months. INTERPRETATION:In 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. FUNDING:Concept Medical.

OBJECTIVES:Intravascular imaging (IVI) with percutaneous coronary intervention (PCI) in the United States has historically been low, but there have been recent increases. However, how IVI use has changed at an operator level and the characteristics of operators who adopted IVI vs those who did not are unknown. METHODS:Using Medicare Provider Utilization and Payment data, the authors identified PCI operators in 2019 and 2023 who performed at least 30 PCI annually. IVI use was categorized as low/none (IVI to PCI ratio [IPR]: 0.0-0.30), intermediate (IPR: 0.31-0.70), and high (IPR: ≥0.71). Regression models identified provider characteristics associated with IVI adoption. RESULTS:In 2019, 3385 operators performed at least 30 PCI. IVI use in 2019 was low/none among 77.8% operators, intermediate in 15.7%, and high in 6.4%. In 2023, 2289 operators performed at least 30 PCI. IVI use in 2023 was low/none among 48.8% operators, intermediate in 21.8%, and high in 29.3%. Among 1671 operators active in both years, 30.9% of prior low/none users adopted IVI. Only 12.2% of intermediate or high IVI users had a reduction in IVI use. Newer high-volume operators showed high IVI use (51.1%). Non-adoption of IVI was associated with earlier graduation year, smaller hospitals, Southern region, and higher procedural volume, while gender, practice focus, teaching status of affiliated hospital, and hospital affiliation changes were not significant. CONCLUSIONS:IVI use has increased nationally but adoption remains uneven, with structural and generational factors driving persistent disparities and highlighting the need for targeted implementation strategies.

Automated artificial intelligence (AI)-based assessment of atherosclerosis burden applied to coronary computed tomography angiography (CCTA) can optimize image processing times, standardize interpretation, and minimize inter-observer variability. We investigated the diagnostic utility of AI-based CCTA quantification (AI-QCT) of coronary atherosclerosis in coronary segments co-registered with intravascular ultrasound (IVUS) of diseased and non-diseased segments. Patients who underwent CCTA and IVUS in the INVICTUS registry (ClinicalTrials.gov: NCT04066062) were enrolled. Images were analyzed by independent core laboratories blinded to each modality’s findings. Vessel external elastic membrane (EEM), lumen, plaque volumes, plaque burden, and percent atheroma volume (PAV) were quantified in whole co-registered segments and subsegments containing non-calcified and low-attenuation plaques. A calcium index was calculated for the whole co-registered segment. A total of 108 vessels from 85 patients were included. Pearson’s correlation demonstrated strong associations between AI-QCT and IVUS in quantifying the EEM volume (r = 0.899), lumen volume (r = 0.943), and plaque volume (r = 0.833), length-normalized PAV (r = 0.851), and calcium index (r = 0.960) in the whole-segment analysis. Strong correlations were seen for vessel, lumen, and plaque volumes in non-calcified (Pearson’s coefficient: 0.95, 0.97, and 0.83, respectively) and low-attenuation (Pearson’s coefficient: 0.90, 0.86, and 0.86, respectively) plaque segments. The minimum lumen area was 0.61 ± 1.18 mm2 (95

Background: Coronary microvascular function assessment with invasive Doppler-derived coronary flow reserve (CFR) has challenges related to Doppler signal quality, limiting clinical adoption. We investigated whether the use of ultrasound microbubble contrast agents can improve coronary flow signals and reduce measurement variability during invasive CFR measurement. Methods: Participants underwent assessment of coronary flow velocity using a Doppler sensor-tipped coronary wire. Baseline signal quality was determined by expert clinicians, and signals were categorized into good or poor quality. Doppler quality was then assessed at predetermined time periods after administration of SonoVue (Bracco): baseline, first pass, and subsequent discrete 20-second time periods, following this up to 260 seconds after first pass. For each time period, several parameters were assessed: signal-to-noise ratio, Doppler envelope quality (analyzed by a previously validated artificial intelligence–based score), and the coefficient of variation of tracked flow velocity. Results: Fifteen cases were included. In the group with poor quality baseline Doppler signal (N = 10), signal-to-noise ratio, Doppler envelope quality score, and coefficient of variation significantly improved with microbubble contrast (signal-to-noise ratio: P < .05 for all periods after first pass; Doppler envelope quality score: P < .05 for all periods; coefficient of variation: P < .05 for all periods). In the group with a good quality baseline Doppler signal (N = 5), there were no changes in these parameters. Microbubble administration did not cause significant coronary hyperemia (P = .875 when compared to baseline). Conclusions: Ultrasound microbubble contrast agents can enhance Doppler signal quality during invasive CFR measurements. These agents could be used to improve the reliability of flow measurements in clinical practice and facilitate the adoption of coronary microvascular assessment.