Abluminus DES+ fails to meet noninferiority versus everolimus stent in diabetes

medwireNews: The ABILITY Diabetes Global study has failed to show noninferiority of a sirolimus-eluting stent (SES) specifically designed for patients with diabetes undergoing percutaneous coronary intervention compared with an everolimus-eluting stent (EES).

The findings, published in The Lancet, showed higher rates of ischemia-driven target-lesion revascularization and target lesion failure in the first year with the Abluminus DES+ SES (Concept Medical, Tampa, Florida, USA) than with the XIENCE durable polymer EES (Abbott, Santa Clara, California, USA).

The researchers explain that the Abluminus DES+ is a thin-strut, cobalt–chromium platform that “incorporates a biodegradable polymer with sirolimus release, along with a coating on the exposed parts of the delivery balloon.” They say that this combined approach “is intended to augment drug delivery to areas prone to in-stent restenosis, a process that is more aggressive in patients with diabetes.”

While extended follow-up to 24 months showed similar findings to those at 12 months, landmark analyses from 12 to 24 months conversely showed that “the excess risk with the Abluminus DES+ was confined to the first year and outcomes thereafter were similar, excluding a persistent hazard,” note Roxana Mehran (Icahn School of Medicine at Mount Sinai, New York, USA) and colleagues.

A total of 3032 adults with type 1 or 2 diabetes undergoing PCI for at least one de novo coronary lesion due to chronic coronary syndrome or ST-elevation acute coronary syndrome at 74 sites in 16 countries were enrolled in the trial. The majority (92%) of participants had type 2 diabetes, with a median glycated hemaglobin of 7.6% (60 mmol/mol). Just over a third (35.1%) were receiving insulin and 71.8% were receiving sensitizers, predominantly metformin. The patients had a median age of 68 years and 71% were men.

The stents were implanted as intended with no restrictions. The only recommendation was an extended balloon inflation time of 45 seconds with the SES “to facilitate drug transfer,” say the researchers. This was the median inflation time for this group, compared with 24 seconds with the EES.

Nearly all the patients received dual antiplatelet therapy after the procedure in line with clinical guidelines, most commonly with aspirin and clopidogrel.

At 12 months, 4.8% of 1421 patients who were randomly assigned to receive the SES and did so according to the study protocol experienced the coprimary endpoint of ischemia-driven target-lesion revascularization, compared with 2.1% of 1446 counterparts who instead received the EES. This equated to an absolute risk difference of 2.7%, which was not significantly different to the noninferiority margin of 2.8%, meaning noninferiority could not be shown.  

The rates for the other primary endpoint of target lesion failure were 9.7% and 6.2%, respectively, giving an absolute difference of 3.5%, which again was not significantly different to the noninferior margin of 3.0%.

For both endpoints, the lower bound of the 95% confidence interval for the absolute risk difference was above 0, the team reports, favoring the EES.

There was also a significantly higher rate of the composite endpoint of cardiovascular death or target-vessel myocardial infarction among patients in the SES group than the EES group, at 5.2% versus 3.1%, but there were no significant differences in cardiovascular death alone and all-cause death.

The study authors conclude: “The absence of an incremental benefit with the Abluminus DES+ highlights the ongoing unmet need for innovation in stent technology and adjunctive therapies to reduce residual ischaemic risk in patients with diabetes and coronary artery disease requiring percutaneous coronary intervention.”

They suggest that “[n]ew technologies, such as drug-coated balloons, might provide an alternative strategy for selected lesions by avoiding stent implantation, potentially reducing the burden of neointimal proliferation and late adverse events.”

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Lancet 2026; 407: 227–236