Concept Medical Completes Enrollment in the ABILITY DIABETES-GLOBAL RCT

September 28, 2022—Concept Medical Inc. announced the completion of enrollment in the ABILITY DIABETES-GLOBAL randomized controlled trial (RCT) comparing the company’s sirolimus drug-eluting stent (DES), Abluminus DES+, with the Xience family of DES (Abbott) for percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM).

According to the company, the prospective, open-label, two-arm parallel-group RCT has enrolled 3,050 patients. More about the trial is available here on the company’s website.

The study’s primary endpoints are:

• Target lesion failure (a composite of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization [TLR]) powered for noninferiority
• Ischemia-driven TLR at 1-year follow-up powered for noninferiority and sequential superiority for patients with diabetes

The Abluminus DES+ (with a drug-coated balloon [DCB]) uses Concept Medical’s Envisolution technology to provide homogenous drug delivery by coating the stent surface and exposed parts of the balloon as well as the edges of the balloon. Abluminus DES+ has regulatory approvals in Europe and other countries, advised the company.

The ABILITY DIABETES-GLOBAL RCT steering committee is chaired by Roxana Mehran, MD. Marie-Claude Morice serves as Medical Director. The Principal Investigators are Alexandre Abizaid, MD; Antonio Colombo, MD; and Shigeru Saito, MD.

In Concept Medical’s press release, Dr. Mehran commented, “In the face of the pandemic, the completion of enrollment of the ABILITY DM study marks an important milestone in the largest ever prospective RCT in patients with DM. This signifies a crucial juncture in providing real-time and current evidence with Abluminus DES+ (with DCB) technology pitched against the best-in-class DES.”

Dr. Mehran is Professor of Medicine, Cardiology, and Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai, and Director of the Center for Interventional Cardiovascular Research and Clinical Trials at Mount Sinai in New York, New York.

Dr. Colombo added, “We completed enrollment of a landmark trial: the first trial comparing two different DES in 3,050 diabetics. The results will be a benchmark for any new or old PCI technology.”

Dr. Morice, who is CEO of the Cardiovascular European Research Centre (CERC), based in Massy, France, stated, “I would like to thank all the site investigators, operators, technicians, and study coordinators, the CERC, and Mount Sinai and Icahn School of Medicine, who played a stellar role in achieving this—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.”

Dr. Abizaid, who has widely used the product, also stated, “I would like to congratulate Concept Medical and all the investigators for completing the largest randomized trial in PCI for diabetic patients. This 3,000-patient trial tested a novel DES technology called Abluminus, which is the combination of a sirolimus-eluting stent crimped on a DCB. This is certainly a landmark study in the modern era of complex coronary intervention.”

Concept Medical noted that other major centers contributing to completing study enrollment included Instituto Dante Pazzanese de Cardiologia in São Paulo, Brazil, led by Daniel Chamié, MD; the National Heart Foundation Hospital & Research Center in Dhaka, Bangladesh, led by Fazila Malik, MD; and OLVG Hospital in Amsterdam, The Netherlands, led by Maarten Vink, MD.