TY - JOUR
T1 - Incidence of late-acquired stent malapposition of drug eluting stents with second generation permanent and biodegradable polymer coatings-A prospective, randomized comparison using optical coherence tomography
AU - Roth, Christian
AU - Gangl, Clemens
AU - Dalos, Daniel
AU - Delle-Karth, Georg
AU - Neunteufl, Thomas
AU - Berger, Rudolf
N1 - Publisher Copyright:
© 2018 Wiley Periodicals, Inc.
PY - 2018/12
Y1 - 2018/12
N2 - 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.
AB - 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.
KW - Absorbable Implants/adverse effects
KW - Aged
KW - Coronary Angiography/methods
KW - Coronary Artery Disease/diagnostic imaging
KW - Coronary Vessels/diagnostic imaging
KW - Drug-Eluting Stents/adverse effects
KW - Everolimus/administration & dosage
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Incidence
KW - Male
KW - Middle Aged
KW - Neointima
KW - Percutaneous Coronary Intervention/adverse effects
KW - Polymers/adverse effects
KW - Postoperative Complications/epidemiology
KW - Prospective Studies
KW - Prosthesis Design/adverse effects
KW - Prosthesis Failure/adverse effects
KW - Sirolimus/administration & dosage
KW - Tomography, Optical Coherence/methods
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=85057323420&partnerID=8YFLogxK
U2 - 10.1111/joic.12572
DO - 10.1111/joic.12572
M3 - Journal article
C2 - 30479028
SN - 0896-4327
VL - 31
SP - 780
EP - 791
JO - Journal of Interventional Cardiology
JF - Journal of Interventional Cardiology
IS - 6
ER -