Name of the Study: Randomised comparison of Abluminus DES+ sirolimus-eluting stents versus everolimus-eluting stents in coronary artery disease patients with diabetes mellitus global: the ABILITY diabetes global study

Published in congress: EuroPCR 2024

Dr. Mustafa Karanfil

Introduction:
Diabetes mellitus (DM), affecting 40% of coronary artery disease (CAD) patients, creates a prothrombotic and proinflammatory environment, thereby increasing the risk of ischemic complications. Patients with DM who undergo percutaneous coronary intervention (PCI) experience higher rates of major adverse cardiac events (MACE) and repeat revascularization. New-generation drug-eluting stents (DES) have replaced bare metal stents (BMS) and first-generation DES, but information on long-term clinical outcomes in diabetic patients is limited. Abluminus DES is a new stent designed for diabetic patients, with a thin-strut, cobalt-chromium structure releasing sirolimus.

Objectives:
This study aims to test the efficacy and safety of Abluminus DES compared to XIENCE stent, which releases everolimus, in diabetic patients with minimal exclusion criteria applied.

Methods:
A prospective, multicenter, multinational, randomized, open-label, 2-arm study was conducted, including type 1 and 2 DM patients with stable CAD or NSTE-ACS and excluding STEMI, cardiogenic shock, PCI for in-stent restenosis, or PCI for bypass grafts. The first co-primary endpoint was non-inferiority for target lesion revascularization (TLR) with an event rate of 7.5% and a non-inferiority margin of 3%. The second co-primary endpoint was non-inferiority for target lesion failure (TLF), including TLR, target vessel-related MI, and cardiovascular death, with an event rate of 9% and a non-inferiority margin of 3%.

Results:
A total of 3050 patients were randomized, with 1514 patients in the Abluminus DES arm and 1520 patients in the XIENCE DES arm included in the intention-to-treat (ITT) analysis. There were no differences in demographic, clinical, diabetic, or procedural characteristics between the groups. At 1 year, the rate of TLR was 2.14% in the XIENCE arm and 4.78% in the Abluminus arm, with a treatment difference of 2.64% (95% CI: 1.28-4.00), hazard ratio (95% CI): 2.27 (1.48-3.50), and a P-value for non-inferiority of 0.409. At 1 year, the rate of TLF was 6.25% in the XIENCE arm and 9.66% in the Abluminus arm, with a treatment difference of 3.41% (95% CI: 1.52-5.40), hazard ratio (95% CI): 1.58 (1.21-2.06), and a P-value for non-inferiority of 0.658.

Conclusion:
The open-label design of the study, along with the novel implantation mechanism and long inflation time (45 seconds) of the Abluminus stent, as well as operators' unfamiliarity with it, and the unexpectedly low event rates in the control group may have influenced the results.

Comments:
The ABILITY DIABETES-GLOBAL study is the largest, head-to-head, randomized clinical trial comparing the new Abluminus DES to the XIENCE everolimus-eluting stent in moderate-risk diabetic patients undergoing PCI. Both stent platforms were safe and effective, and the clinical performance of Abluminus DES was in line with current-generation drug-eluting stents. Non-inferiority was not met for the two co-primary endpoints. However, these results may be due to lower than expected event rates in the control group. A 2-year follow-up is planned, and long-term results will provide further clarity on whether Abluminus DES implantation is associated with better clinical outcomes in diabetic patients.