The DESyne BDS Plus Randomized Clinical Trial (RCT) is a prospective, multicenter, single-blind study. The RCT is evaluating the safety, effectiveness, and performance of the world’s first triple-drug site-specific antithrombotic therapy (TRx). The trial compares the DESyne BDS Plus to the DESyne X2 Drug-Eluting Coronary Stent System in the treatment of de novo native coronary artery lesions.
Data collection continued through three years.
target lesion failure at 36 months for DESyne BDS Plus with TRx (p=0.016)
VS.
target lesion failure at 36 months for control DES
The 36-month results from DESyne BDS Plus RCT demonstrated the safety and effectiveness of site specific anti-thrombotic drug therapy:
The DESyne BDS Plus stent demonstrated competitive performance compared to contemporary drug-eluting stents across key clinical endpoints.
These results support the effectiveness of triple-drug site-specific antithrombotic therapy (TRx) in maintaining vessel patency and reducing restenosis.
Note: *, Median (interquartile range). #, Subject has two target lesions with OCT analysis on one target lesion only. †, L=29 at MLA and L=30 at MCS and MSA
The trial includes 202 patients across 14 sites in Europe, New Zealand, and Brazil. An imaging subset of 58 patients had angiographic and optical coherence tomography (OCT) assessment completed in the first six months.
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Drug-eluting stents (DES) are designed to keep coronary arteries open after PCI by releasing antiproliferative drugs that reduce neointimal hyperplasia and restenosis.
They have become the standard of care because they:
However, DES still require adjunctive systemic antithrombotic therapy to manage the risk of clot formation at the stent site.
While DES are highly effective at reducing restenosis, they do not directly address thrombosis at the site of the implant. This creates a reliance on systemic therapies such as dual antiplatelet therapy (DAPT), which can:
As a result, there is growing interest in approaches that can address both restenosis and thrombosis more precisely.
Site-specific antithrombotic therapy delivers anticoagulant drugs directly at the stent implantation site, rather than relying solely on systemic circulation.
The DESyne BDS Plus system incorporates:
This approach is designed to:
In the DESyne BDS Plus RCT, pharmacokinetic data showed subtherapeutic systemic levels with maintained local therapeutic effect, highlighting this targeted approach.
Imaging plays a critical role in both procedural planning and outcome assessment.
Angiography provides:
Optical Coherence Tomography (OCT) provides:
In the DESyne BDS Plus RCT, an imaging subset underwent angiographic and OCT assessment to better understand device performance and vessel response.
Systemic antithrombotic therapies can increase the risk of:
By delivering therapy directly at the site of coronary artery disease, site-specific approaches aim to:
PMN 2505 Rev A
PMN 1777 Rev A
