A triple-drug-eluting coronary implant with a site-specific antithrombotic therapeutic (TRx) coating significantly reduces the risk of target lesion failure (TLF) when compared to a contemporary drug-eluting stent (DES), a new study shows. Data presented at EuroPCR 2024 conference in Paris reveal that Elixir Medical’s DESyne BDS Plus system achieved a significantly lower TLF rate of 2.1% compared to 9.3% for contemporary DES (p=0.03). The 12-month clinical trial also confirmed that no definite or probable stent thrombosis, cardiovascular death, or target vessel myocardial infarction (TV-MI) were observed in the DESyne BDS Plus-treated patients. “These exciting results from the DESyne BDS Plus randomized clinical trial (RCT) demonstrate the sustained superiority in safety and efficacy of DESyne BDS Plus compared to a standard-of-care DES,” said Alexandre Abizaid, MD, PhD, an interventional cardiologist at Instituto do Coração (InCor) in Sao Paulo. “[The trial] underscores the potential for site-specific anti-thrombotic therapeutic (TRx) as a promising solution.” Additional findings Further conclusions drawn from the investigation found the DESyne BDS Plus’ target vessel failure (TVF) rate to be 2.1% vs. 10.3% in the contemporary DES group in complex patients (p=0.017). Pharmacokinetics results showed systemic subtherapeutic levels of the two anticoagulants through 7 days that maintained the therapeutic effect at the site of implant through 6 months. “Twelve-month outcomes continue to support the safety and effectiveness of the site-specific anti-thrombotic therapeutic with DESyne BDS Plus,” said Abizaid, who was presenting during a late-breaking trials session on behalf of the co-principal investigators Stefan Verheye MD, PhD, and Mark Webster, MD. “[The DESyne BDS Plus represents] a promising platform to address the compromise between bleeding and ischemic events when using systemic drugs.” The trial’s results build on previously presented data that found that the study’s primary endpoint was met (p-non-inferiority<0.001); TLF at day 3 or at hospital discharge, whichever came first, which was 0.0% for DESyne BDS Plus treated patients versus 5.0% for patients treated with the contemporary durable polymer DES. Ischemic and bleeding risk Balancing ischemic and bleeding risk with oral anti-thrombotic drugs remains a significant clinical challenge, especially in patients who are at high thrombotic risk (HTR) and high bleeding risk (HBR). Abizaid highlighted that despite shortened dual antiplatelet therapy/single antiplatelet therapy with the latest-generation DES, 3% to 6% of HBR patients experienced Bleeding Academic Research Consortium 3-5 bleeding events at 1 year. Additionally, daily management of patients’ antithrombotic regimen by cardiologists is practically challenging and creates an unsustainable workload burden. DESyne BDS Plus design The success of the DESyne BDS Plus lies in its bioresorbable coating containing two anticoagulants (rivaroxaban and argatroban) and an antiproliferative mechanistic target of rapamycin inhibitor (sirolimus) that are designed for delivery of site-specific antithrombotic therapeutic. Its ability to release three types of drugs is further enhanced its ability to deliver these antithrombotic drugs specifically to the site where the stent is implanted, further improving the safety and effectiveness of the device. “We are thrilled with the statistically significant 12-month clinical outcomes of the TRx platform validating the improved safety and effectiveness of site-specific TRx therapeutic for coronary PCI treatment,” added Motasim Sirhan, the CEO of Elixir Medical in a EuroPCR news release. “Site-specific antithrombotic therapy can be a more effective approach to addressing ischemic risk without the risk and complications of bleeding associated with oral anti-thrombotics.” Study setup The prospective, multicenter, single-blind study included 202 patients across 14 sites in Europe, New Zealand, and Brazil. These patients were then enrolled into the DESyne BDS Plus group (n=100; mean age, years: 63.2±9.9; female: 22 [22%]) and the DESyne X2 group (n=102; mean age, years: 62.7±9.9; female:27 [26%]). The DESyne BDS Plus Pharmacokinetic sub-study (non-randomized), enrolled 11 patients with a follow-up through 7 days and a clinical follow-up through 3 years. An imaging subset of 58 patients had angiographic and optical coherence tomography (OCT) assessment completed in the first 6 months. Data collection will continue through 3 years. The primary endpoint was defined as a TLF at the earlier of 3 days or hospital discharge (non-inferiority). Photo Credit: Screenshot by Jason Wermers/CRTonline.org Photo Caption: Alexandre Abizaid, MD, PhD, right, discusses a study of the DESsyne Plus device with Mirvat Alasnag, MD, during a late-breaking trial session Tuesday at EuroPCR.