EuroPCR 2024: Elixir Medical's 12-Month Data Shows Enhanced Safety and Efficacy of Site-Specific Antithrombotic vs DES

Elixir Medical, a company known for its innovative treatment technologies for cardiovascular and peripheral diseases, has recently shared promising 12-month clinical data from its DESyne BDS Plus Randomized Controlled Trial (RCT). This study assesses the DESyne BDS Plus, a unique triple drug-eluting coronary implant, comparing its performance to that of a conventional, durable polymer drug-eluting stent (DES). The findings, which were revealed at the EuroPCR 2024 conference in Paris, indicated that DESyne BDS Plus significantly lowered the risk of target lesion failure (TLF) over a 12-month period when compared to standard DES.

Dr. Alexandre Abizaid, an interventional cardiologist from Instituto do Coração (InCor) in Sao Paulo, Brazil, highlighted the persistent challenges in managing ischemic and thrombotic risks with traditional oral antithrombotic therapies. He noted that the DESyne BDS Plus RCT results emphasize the device's superiority in safety and efficacy over conventional DES. This breakthrough showcases the potential of site-specific antithrombotic therapeutic (TRx) as an innovative solution to the longstanding issue of balancing bleeding and thrombotic risks associated with systemic drug therapies.

The study's 12-month clinical outcomes demonstrated a significantly lower TLF rate of 2.1% for DESyne BDS Plus, compared to 9.3% for contemporary DES. Importantly, there were no instances of definite or probable stent thrombosis, cardiovascular death, or target vessel myocardial infarction (TV-MI) in patients treated with DESyne BDS Plus. Previous data also confirmed that the primary endpoint of the study was met, with a TLF rate of 0.0% for DESyne BDS Plus patients at day three or hospital discharge, versus 5.0% for those treated with conventional DES.

The DESyne BDS Plus system utilizes a bioresorbable coating that contains three drugs: rivaroxaban and argatroban (both anticoagulants), and sirolimus (an antiproliferative mTOR inhibitor). This design aims to deliver site-specific antithrombotic therapy, reducing thrombotic risk while avoiding the bleeding complications typically associated with oral antithrombotics. This targeted approach helps in managing ischemic and bleeding risks more effectively, particularly in patients undergoing percutaneous coronary intervention (PCI).

Motasim Sirhan, CEO of Elixir Medical, expressed his enthusiasm about the significant 12-month clinical outcomes of the TRx platform. He emphasized that site-specific antithrombotic therapy offers a more effective strategy for addressing ischemic risk without the bleeding risks linked to oral antithrombotic treatments.

Coronary artery disease remains the leading cause of death among men and women across most racial and ethnic groups in the U.S. While PCI has improved mortality rates, the procedure is still associated with risks, including stent thrombosis, which can lead to severe myocardial infarction and poor outcomes. Managing ischemic and thrombotic risks requires strict medication adherence, yet only about 60% of patients follow their prescribed cardiovascular treatments. This non-adherence can lead to a significant increase in the risk of cardiovascular events or mortality. Furthermore, a notable percentage of patients undergo non-cardiac surgery within six months of PCI, necessitating careful management of thrombotic and bleeding risks by healthcare providers.

The DESyne BDS Plus Randomized Clinical Trial is a prospective, multicenter, single-blind study that involves 202 patients across 14 sites in Europe, New Zealand, and Brazil. The trial evaluates the safety, efficacy, and performance of the DESyne BDS Plus Triple Drug-Eluting Coronary Implant in treating de novo native coronary artery lesions. An imaging subset of 58 patients underwent angiographic and optical coherence tomography (OCT) assessments within the first six months. Data collection will continue for up to three years to provide comprehensive long-term results.

Elixir Medical, based in Milpitas, California, is committed to developing disruptive platforms to treat coronary and peripheral artery diseases, aiming to deliver improved clinical outcomes for millions of patients worldwide.