OBJECTIVES AND BACKGROUND: Polymer coatings of drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malapposition (LASM) with the risk of stent thrombosis. This study evaluated, if biodegradable polymer (BP) reduces the incidence of LASM compared to permanent polymer (PP) after treatment with newer generation DES.
METHODS AND RESULTS: Fifty patients with 59 lesions were randomized (2:1) to elective treatment with second generation PP-DES (n = 32, 39 stents), either Everolimus-eluting or Zotarolimus-eluting stents, or with BP-DES (Biolimus-eluting stents [BES]; n = 18, 20 stents) and underwent optical coherence tomography directly after implantation and after 1 year. After implantation acute stent malappositions (ASM) were documented in 30 stents (51%) distributed to 22 stents treated with PP-DES (56%) and 8 with BP-DES (40%; n.s.). After 1 year, late stent malappositions (LSM) were detected in 14 stents (24 %); ASM persisted (APSM) in 9 stents after one year (7 PP-DES-18%, 2 BES-10%), whereas ASM resolved in 21 stents. In addition, LASM was documented in nine stents including five stents without and four stents with additional APSM. All LASM were located in PP-DES (n = 9; 23%), none in BP-DES (P = 0.022). Compared to the reference lumen area, in-stent lumen area of stents without LASM was smaller due to neointimal hyperplasia (P = 0.021), whereas in-stent lumen area at maximum LASM of stents with LASM was larger due to positive remodeling (P = 0.002).
CONCLUSIONS: In conclusion the use of BP-DES reduced the occurrence of LASM due to positive remodeling compared to second generation PP-DES.
- Absorbable Implants/adverse effects
- Coronary Angiography/methods
- Coronary Artery Disease/diagnostic imaging
- Coronary Vessels/diagnostic imaging
- Drug-Eluting Stents/adverse effects
- Everolimus/administration & dosage
- Follow-Up Studies
- Middle Aged
- Percutaneous Coronary Intervention/adverse effects
- Polymers/adverse effects
- Postoperative Complications/epidemiology
- Prospective Studies
- Prosthesis Design/adverse effects
- Prosthesis Failure/adverse effects
- Sirolimus/administration & dosage
- Tomography, Optical Coherence/methods
- Treatment Outcome