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Performance evaluation of biodegradable polymer sirolimus and ascorbic acid eluting stent systems.

Won-Il Jo¹, Ji-Hyun Youn¹, So-Young Kang¹

¹CG Bio Co. Ltd, Seoul, Korea.

Journal of Materials Science. Materials in Medicine

|October 29, 2022

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This study compared four drug-eluting stents (DES), finding D+Storm® DES superior in foreshortening and recoil. A clinical trial confirmed D+Storm® DES safety with no major adverse cardiovascular events in 201 patients.

Area of Science:

Cardiovascular Medicine
Biomaterials Science
Medical Device Engineering

Background:

Drug-eluting stents (DES) are crucial in treating coronary artery disease.
Biodegradable polymer stents offer potential advantages over traditional metallic stents.
Evaluating mechanical properties and clinical safety is essential for new DES technologies.

Purpose of the Study:

To evaluate the performance of biodegradable polymer sirolimus and ascorbic acid eluting stent systems against four commercially available drug-eluting stents (DES).
To characterize mechanical properties including dimension, foreshortening, recoil, radial force, and trackability.
To assess the safety and efficacy of a novel DES through registry experiments.

Main Methods:

Mechanical testing was performed to evaluate dimensions, foreshortening, recoil, radial force, crossing profile, folding shape, trackability, and dislodgement force.

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A post-marketing clinical study was conducted in real-world settings.

Registry data from 201 patients with 1-month follow-up were analyzed for safety outcomes.

Main Results:

D+Storm® DES demonstrated superior performance with 1.3% foreshortening and 3.70% recoil compared to other tested DES.
The ongoing clinical study of D+Storm® DES enrolled 201 patients, with no major adverse cardiovascular events (MACE) reported after 1-month follow-up.
Initial findings suggest D+Storm® DES is safe in a clinical setting, with further assessment planned for 300 patients.

Conclusions:

Objective evaluation and comparison of mechanical responses of four commercially available DES were reported.
While mechanical features showed minor differences, understanding these can aid in selecting the most suitable stent for specific clinical situations.
The D+Storm® DES exhibits promising safety and performance, warranting continued clinical evaluation.