Related Experiment Video
Updated: Sep 2, 2025
Novel Percutaneous Approach for Deployment of 3D Printed Coronary Stenosis Implants in Swine Models of Ischemic Heart Disease
Published on: February 18, 2020
Incidence and natural history of coronary evagination after implanted biodegradable polymer sirolimus-eluting stent
Keiko Tsuji1, Masaru Ishida1, Tomonori Itoh1
1Division of Cardiology, Department of Internal Medicine, Iwate Medical University, 2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate 028-3695, Japan.
Insights
Coronary evagination (CE) after biodegradable polymer sirolimus-eluting stent (BP-SES) implantation is common initially but typically resolves within 12 months. This suggests the safety of biodegradable polymer coatings on drug-eluting stents (DES).
Area of Science:
- Interventional Cardiology
- Biomaterials Science
- Medical Imaging
Background:
- First-generation drug-eluting stent (DES) coronary evagination (CE) is established.
- CE after biodegradable polymer sirolimus-eluting stent (BP-SES) implantation remains unevaluated.
Purpose of the Study:
- To assess the incidence and natural history of CE following BP-SES implantation.
- To evaluate the safety and feasibility of biodegradable polymer coatings on DES.
Main Methods:
- A multicenter registry evaluated stable coronary lesions treated with Ultimaster BP-SES.
- Serial optical frequency domain imaging (OFDI) assessed CE at 0-1-12 or 0-3-12 months.
- CE was defined by specific depth and length criteria between apposed struts.
Main Results:
- CE was observed in 42.6% and 24.5% of lesions at 1 and 3 months, respectively.
- Most CEs resolved by 12 months, with minimal residual area and decreased malapposed stent area.
- CEs primarily originated from acute stent malapposition or coronary dissection.
Conclusions:
- CE after BP-SES is occasionally observed in stable lesions but generally resolves within 12 months.
- No late-acquired stent malapposition was noted.
- Findings support the safety and feasibility of biodegradable polymer coatings in DES.
Aims:
The incidence and temporal change in coronary evagination (CE) after first-generation drug-eluting stent implantation is well established, whereas that after biodegradable polymer sirolimus-eluting stent (BP-SES) implantation has not yet been evaluated. The aim of this study is to assess the incidence and natural history of CE after BP-SES implantation.
Methods And Results:
In this multicenter registry, stable coronary lesions treated by Ultimaster BP-SES were evaluated by serial optical frequency domain imaging (OFDI) (at 0-1-12 or 0-3-12 months) and the incidence of CE was assessed. Coronary evagination was defined as the presence of an outward bulge in luminal vessel contour between apposed struts according to the following criteria: (i) evagination depth ≥10% of nominal stent diameter and (ii) evagination length ≥3.0 mm. Optical frequency domain imaging was obtained in 98, 47, 49, and 87 lesions at 0, 1, 3, and 12 months, respectively. Coronary evagination was observed in 20 (42.6%) and 12 (24.5%) lesions at 1 and 3 months, respectively, and all but one CE had resolved at 12 months. At 12 months, the mean CE area was almost zero and the mean malapposed stent area was also decreased. Comparison of the serial OFDI images indicated that CEs originated mostly from acute stent malapposition or coronary dissection behind the implanted stent.
Conclusions:
In stable lesions, CE was occasionally observed with Ultimaster BP-SES at 1-3 months but mostly resolved within 12 months, without late-acquired stent malapposition. These findings suggest the safety and feasibility of biodegradable polymer coating on DES.
