The Abluminus DES+ sirolimus-eluting stent (SES) exhibited higher rates of ischemia-driven target-lesion revascularization (ID-TLR) and target-lesion failure (TLF) at 12 months in patients with diabetes undergoing PCI compared to the XIENCE everolimus-eluting stent (EES), according to findings from the ABILITY Diabetes Global trial recently published in The Lancet.

Alexandre Abizaid, MD, PhD, FACC, Roxana Mehran, MD, FACC, et al., included 3,032 trial participants from 74 sites in 16 countries (median age 68 years; 29% female), randomized to either Abluminus DES+ SES or XIENCE EES between June 12, 2020, and Sept. 9, 2022. Primary endpoints were ID-TLR (2.8% noninferiority margin) and TLF (3% margin) at 12 months post PCI.

Results showed that the Abluminus DES+ SES did not meet the criteria for noninferiority for both endpoints compared to the XIENCE EES (ID-TLR: 67 of 1,421 patients [Kaplan-Meier estimate 4.8%, 95% CI 3.9-6.2] vs. 30 of 1,446 [2.1%, 95% CI 1.6-3.2]; absolute risk difference 2.7%, 95% CI 1.3-4.1; P_{noninferiority} = 0.44; TLF: 137 [9.7%, 8.4-11.5] vs. 89 [6.2%, 5.3-7.8]; 3.5%, 1.5-5.5; P_{noninferiority} = 0.68).

Abizaid, Mehran and colleagues note a greater incidence of target-vessel myocardial infarction in the Abluminus DES+ SES group (73 of 1,421 patients [Kaplan-Meier estimate 5.2%, 95% CI 4.1-6.5] vs. 44 of 1,446 [3.1%, 2.4-4.3]). No significant difference was found in cardiovascular death and all-cause death.

Additionally, the authors write that "at 2 years, differences between the stents were no longer statistically significant…Landmark analyses from 12 months to 24 months showed parallel event curves, indicating that the excess risk with the Abluminus DES+ was confined to the first year and outcomes thereafter were similar, excluding a persistent hazard."