EuroPCR - Unveiled the Diab8 randomized trial, the first diabetic DES designed for superiority

Published
Wednesday, May 23, 2018

ALVIMEDICA UNVEILS THE DIAB8 RANDOMIZED STUDY,
THE FIRST AND ONLY DIABETIC DES RANDOMIZED TRIAL DESIGNED FOR SUPERIORITY

  • Diab8 is a 55-center, 3.040-patient randomized controlled trial that pits the performance of Cre8™ EVO, a Polymer-free Amphilimus-eluting stent, against the Everolimus-Eluting stents in the treatment of coronary artery disease in diabetic patients
  • The Diab8 study is designed to establish the superior efficacy of the Cre8™ EVO, the most innovative DES when compared to the current golden standard
  • Diabetes is a major contributor to cardiovascular diseases and is the eleventh common cause of disability worldwide. Today, half a billion people live with diabetes and almost half of them are undiagnosed. According to estimates, the number of people with diabetes may rise up to 629 million in 2045.

Paris, May 23rd 2018 – Alvimedica Medical Technologies, a leading European company in interventional cardiology and innovative stent and catheter producer, officially unveiled today the details of the Diab8 study, the first diabetic Drug-Eluting Stent (DES) randomized trial, during the Annual Meeting of EuroPCR 2018, the World-Leading Course in interventional cardiovascular medicine in Paris, France, May 22-25 2018.

Diab8 is the first diabetic DES study (a 55-center, 3,040-patient randomized controlled trial) that pits the performance of Cre8™ EVO, a Polymer-free Amphilimus-eluting stent, against the Everolimus-Eluting stents in the treatment of coronary artery disease in diabetic patients, in order to prove its superior efficacy at 1 year.

Today, diabetes is a major contributor to cardiovascular diseases and is the eleventh common cause of disability worldwide. According to data from the Diabetes Atlas 2017 of the International Diabetes Federation, half a billion people live with diabetes[1] and the number may rise up to 629 million in 2045. The increased incidence of this disease is mainly due to rising levels of overweight, obesity, physical inactivity and poor diet. The South-East Asia and Western Pacific regions are at the epicenter of the diabetes crisis: China alone has 121 million people with diabetes and India’s diabetes population totals 74 million. Europe follows with its 85 million people suffering from diabetes.

Furthermore, almost half of the people with diabetes are undiagnosed worldwide and this is the reason why it has become urgent to tackle this issue through appropriate screening, diagnosis and cares.

People with diabetes have an increased risk of developing cardiovascular complications such as angina, coronary artery diseases, myocardial infarction and acute coronary syndrome. When undergoing percutaneous coronary intervention, patients with diabetes have poor outcomes compared to the general patient population since they are in fragile conditions, with a major risk of bleeding - stated Antonio Colombo, Professor at IRCCS San Raffaele Hospital, Milan, and principal investigator of the Diab8 trial. “Even though technological development applied to DES has enabled to reach great procedural success, there is still an urgent need to enhance long-term clinical outcomes after coronary revascularization in patients with diabetes. Preliminary data regarding the efficacy of Cre8™ in diabetic patients are very encouraging and through the Diab8 trial we hope we will be able to prove the efficacy of this innovative DES, as it could provide an important milestone for diabetics and their PCI treatment”.

The Cre8™ EVO is a stent tailored to the needs of the diabetic population and it has been developed to ensure the same efficacy that current generation of DES provide to non-diabetic patients. Thanks to its unique features, it can improve clinical outcomes and provide added safety advantages in patients with diabetes compared to all other DES” - said Franco Vallana, Chief Scientific Officer Alvimedica. “We have the opportunity to contribute for a radical change in diabetic PCI clinical outcome and the Diab8 study is designed to establish the superior efficacy of the Cre8™ EVO as the most innovative DES compared to the current golden standard”.

The new stent is designed to provide a controlled elution of the Amphilimus™ formulation through the Abluminal Reservoir Technology, a proprietary polymer-free drug-release system consisting of reservoirs on the stent’s outer surface that control and direct drug release exclusively towards the vessel wall, including complex coronary anatomies and pathologies like those of diabetics.

The Amphilimus™ formulation, a proprietary Sirolimus and Fatty Acids mix, enables enhanced drug tissue permeation and maximize drug bioavailability, utilizing fatty acid transport pathways. This is particularly advantageous in diabetic patients since increased uptake of fatty acid occurs in diabetic cells, increasing device efficacy[2].

Alvimedica's President Leyla Alaton stated: “We firmly believe that patients with diabetes will benefit from this important breakthrough in medical technology. Alvimedica has always been committed to develop innovative approaches and create the highest quality devices and technologies that could answer patients’ unmet needs, by improving their quality of life”.

About Cre8™ EVO

Cre8™ EVO is a highly innovative Drug Eluting Stent (DES) that is designed to face the clinical outcome challenges when treating patients undergoing PCI. Innovation is the only way to further improve current clinical patient outcome. That is what Cre8™ EVO is: a DES born from the most innovative technology to date.

Cre8™ EVO is designed to provide a controlled elution of the Amphilimus™ formulation (a combination of sirolimus and fatty acid) through its Abluminal Reservoir Technology.

The new stent architecture, together with the ground breaking Cre8™ EVO proprietary technology, has been conceived to guarantee effective drug concentration within the vessel wall including complex coronary anatomies and pathologies like those of diabetic patients. The very thin cobalt chromium body, sealed by the Bio Inducer Surface, provides high haemo- and bio-compatibility increasing the rate of strut coverage and thus potentially reducing thrombogenicity.

About Alvimedica

We are a global innovator of unique interventional medical devices, committed to continuing the development and manufacturing of globally recognized and highly innovative product portfolios in both endovascular and interventional cardiology.

We create the highest quality devices and technologies that answer patients’ un-met needs. Our teams are spread all around the world, with our main manufacturing plants in Italy and Turkey.

Our driving passion is to improve the quality of life through innovative technology, creating a better future by investing in both clinical research and product development.

We firmly believe that by working with todays' leading physicians we will create highly effective solutions that meet today’s real unresolved patient needs. This collaboration is fundamental to us as a company, in order to present and discuss new treatment options.

For more information about Alvimedica, please visit: www.alvimedica.com

References

  1. IDF Diabetes Atlas 2017, https://ncdalliance.org/resources/diabetes-atlas-2017-is-now-online
  2. Robert A. Byrne, Eric Eeckhout, Gennaro Sardella, Pieter Stella, Stefan Verheye, PCI in Patients with Diabetes: Role of the Cre8 Drug-eluting Stent, Interventional Cardiology Review, Vol. 12 Spring 2017