Elixir Medical’s DESyne BDS Plus RCT 12-Month Data Presented

May 24, 2024—Elixir Medical recently announced 12-month clinical data from the DESyne BDS Plus randomized controlled trial (RCT).

The prospective, multicenter, single-blind study is evaluating the safety, effectiveness, and performance of the company’s DESyne BDS Plus—a triple drug-eluting coronary implant with site-specific antithrombotic therapeutic coating (TRx)—compared with a contemporary, durable polymer drug-eluting stent (DES; DESyne X2; Elixir) in the treatment of de novo native coronary artery lesions.

The DESyne BDS Plus RCT is composed of 202 patients enrolled at 14 sites in Europe, New Zealand, and Brazil. An imaging subset of 58 patients had angiographic and optical coherence tomography assessment completed in the first 6 months. Data collection will continue through 3 years, advised the company.

The data were presented at a late-breaking clinical session during the EuroPCR 2024 conference which was held May 14-17 in Paris, France.

According to Elixir Medical, the 12-month clinical results demonstrated safety and efficacy of DESyne BDS Plus compared to the contemporary DES. The target lesion failure (TLF) rate was for the device was significantly lower (2.1% vs 9.3%; P = .03). Patients treated with DESyne BDS Plus showed no definite or probable stent thrombosis, cardiovascular death, or target vessel myocardial infarction.

The company noted that previously presented data found that the study met its primary endpoint of TLF at day 3 or at hospital discharge, whichever came first (0.0% vs 5.0%; P < .001 for noninferiority).

In its press release, Elixir Medical stated that the three drugs in the device’s TRx bioresorbable coating are two anticoagulants (rivaroxaban and argatroban) and an antiproliferative mTOR inhibitor (sirolimus) designed for delivery of a site-specific antithrombotic therapeutic. The coronary implant with the TRx therapeutic is designed to reduce thrombotic risk while eliminating the negative side effect of bleeding associated with oral antithrombotic use and to help address the challenge of logistically managing ischemic and bleeding risk in at-risk percutaneous coronary intervention patients.

Alexandre Abizaid, MD, an interventional cardiologist at Instituto do Coração in Sao Paulo, Brazil, discussed the study in Elixir Medical’s press release.

“The current standard of care of combining oral antithrombotic therapies continues to pose serious challenges, especially in patients who are at high thrombotic risk and high bleeding risk, as managing the tradeoff between ischemic and bleeding risks is logistically unsustainable for health care providers and often results in delay of essential treatment decisions,” commented Dr. Abizaid. “These exciting results from the DESyne BDS Plus RCT demonstrate the sustained superiority in safety and efficacy of DESyne BDS Plus compared to a standard of care DES and underscore the potential for site-specific antithrombotic therapeutic (TRx) as a promising solution that effectively addresses the compromises we have to make between bleeding and thrombosis when using systemic drug therapies.”