ABILITY DIABETES-GLOBAL, a randomised controlled head-to-head trial comparing safety and efficacy of percutaneous coronary intervention with the sirolimus-eluting Abluminus DES+ (Concept Medical) to Xience (Abbott) in patients with diabetes mellitus has completed enrolment
The prospective, randomised, open-label, two-arm parallel-group trial has enrolled 3,050 diabetic patients, and is being steered by chairperson Roxana Mehran (Icahn School of Medicine at Mount Sinai, New York, USA) and medical director Marie-Claude Morice (Institut Hospitalier Jacques Cartier, Massy, France), and alongside principal investigators Alexandre Abizaid (Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil), Antonio Colombo (Centro Cuore Columbus, Milan, Italy) and Shigeru Saito (Shonan Kamakura General Hospital, Kamakura, Japan).
The primary endpoints of the trial are target lesion failure (TLF), a composite of cardiac death, myocardial infarction (MI) or ischaemia-driven target lesion revascularisation (TLR) powered for non-inferiority and ischaemia-driven TLR at one-year follow-up powered for non-inferiority and sequential superiority for diabetic patients.
“In the face of the pandemic, the completion of enrolment of the ABILITY DM study marks an important milestone in the largest ever prospective randomised clinical trial in patients with diabetes mellitus. This signifies a crucial juncture in providing real-time and current evidence with Abluminus DES+ (with drug-coated balloon) technology pitched against the best-in-class drug-eluting stent,” Mehran was quoted as saying in a press release.
“I would like to thank all the site investigators, operators, technicians, and study coordinators, the Cardiovascular European Research Center (CERC), and Mount Sinai and Icahn School of Medicine who played a stellar role in achieving this,” added Morice. “In particular the CERC and Mount Sinai research team who conducted the trial so well at such a complex time; their commitment is unique and will contribute to the success of the trial, a potentially significant improvement for diabetic patients with cardiovascular disease.”
Abluminus DES+ which has regulatory approvals in Europe and other countries, uses a proprietary Envisolution technology to provide homogenous drug delivery by coating the stent surface and exposed parts of the balloon and on the edges of the balloon. In clinical studies conducted at other centers Abluminus DES+ has proven effective in managing patients with diabetes mellitus.