Featured ArticleIssueNov 21

Novel Study on CAD-Diabetes PCI

A new study is turning out to be significant for Diabetic patients with coronary disease who continue to be treated sub-optimally with current devices. The Ability Diabetes Global study has enrolled its 1000th patient, which is a significant milestone towards a possible breakthrough in the medical device industry.

ABILITY Diabetes Global is a randomised comparison of Abluminus DES+ Sirolimus-Eluting Stents versus Everolimus-Eluting Stents in Coronary Artery Disease Patients with Diabetes Mellitus Global. Study Design According to Concept Medical a Tampa, Florida-based medical device company with operational offices in The Netherlands, Singapore and Brazil and manufacturing units in India; the study can offer patients with progress in innovation in PCI.

The study is a prospective, multi-centre, multinational, randomised, 2-arm parallel-group study. The idea is to compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy, and safety of Abluminus DES+ sirolimus-eluting stents (SES) versus Everolimus-Eluting Stents (EES). At least 40 per cent of patients are expected to be affected by multivessel coronary artery disease and 30 per cent with the acute coronary syndrome. The principal investigators are Prof Antonio Colombo, Director EMO GVM – Centro Cuore Columbus, Maria Cecila Hospital, Italy; Prof Alexandre Abizaid, Instituto Dante Pazzanese de Cardiologia, Brazil and ProfShigeru Saito, Shonan Kamakura General Hospital, Japan.

Progress So Far
ABILITY Diabetes Global started with the index patient enrolment on 11th June 2020 in Italy (at the peak of the first wave of COVID-19 pandemic) by PI Prof Antonio Colombo and the pace of enrolment since then has been steady and consistent, with a thousand patients being enrolled in just over a year. Despite COVID-19 ravaging the world over, the pace of enrollment is remarkable because the healthcare facilities are occupied with caring for patients hospitalised with COVID-19. Although the COVID-19 crisis still looms over us, Cardiovascular Disease (CVD) remains the number one killer and Diabetes continues to be the key comorbidity and contributor to Coronary Artery Disease (CAD).

ABILITY Diabetes Global is the world’s largest Randomised Controlled Trial (RCT) for CAD patients with diabetes as a comorbidity. This RCT measures the safety and efficacy of the Abluminus DES+ which is specially crafted with the patented Envisolution Technology and has proven to be effective in managing the proliferative CAD lesions seen in DM. With the promising pace of enrolment so far, Concept Medical eagerly looks forward to the completion and results of ABILITY Diabetes Global targeting more than 3000 diabetic patients, across 100 centres, spanning more than 25 countries against the XIENCE EES family (Abbott Cardiovascular). Concept Medical is delighted to be a part of this achievement which is a direct result of the endless support, guidance, and experience of Prof Roxana Mehran (Chairperson), Prof Marie-Claude Morice (Medical Director), Prof Alexandre Abizaid, Prof Antonio Colombo and Prof Shigeru Saito (Principal Investigators), and the entire steering committee. Contributing to this achievement are the sites that showed encouragement in participation with the top enrollers so far being – Instituto Dante Pazzanese, Sao Paulo, razil (Dr Chamié), National Heart Foundation Hospital and Research Institute, Dhaka, Bangladesh (Prof Malik), Herzzentrum Segeberger Kliniken, Bad Segberg, Germany (Dr Allali) and many more. It is the dedication and commitment of all the sites, the site investigator, and technicians for accomplishing this. The credit also extends to Cardiovascular European Research Center (CERC), Mount Sinai and ICAHN School of Medicine for their valuable contribution and constant coordination every day which is of utmost importance.

At this point, when the trial is proceeding with excellent engagement from its investigators, and coordinators. Prof Mehran expresses her enthusiasm, “I am encouraged by the progress we are making on this largest trial in PCI and diabetes and incredibly enthusiastic about the future of what we can offer to these complex patients with progress ininnovation in PCI.”

Prof Marie-Claude Morice, CEO, CERC expresses her thoughts, “The CERC team is pleased to work hand in hand with Mount Sinai and the team. We are extremely proud to achieve this important milestone. This study is significant for diabetic patients with coronary disease who continue to be treated sub-optimally with current devices. The ‘non-COVID’ patients should not be ignored during the pandemic period. Thanks to the highly motivated investigators and study coordinators, we were able to obtain consent from the respective ethics committees which enabled us to enrol 1000 patients at such a fast pace.”

For a company with the vision of Advancing Innovation, the 1000 patient enrolment is a significant milestone towards a possible breakthrough in the medical device industry. Concept Medical looks to progress rapidly and add one more milestone to its credit.

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