Early vascular healing with rapid breakdown biodegradable polymer sirolimus-eluting versus durable polymer everolimus-eluting stents assessed by optical coherence tomography.
BACKGROUND
Differences in early arterial healing patterns after stent implantation between biodegradable and durable polymer based new generation drug-eluting stents are not well understood. The aim of this study was to compare the healing patterns of a novel rapid breakdown (≤8 weeks) biodegradable polymer sirolimus-eluting stent (BP-SES) with a durable polymer everolimus-eluting stent (EES) using intravascular optical coherence tomography (OCT) at 4 months.


METHODS
A total of 20 patients were randomly assigned to stenting with BP-SES (n=11) or EES (n=9). Overall intravascular imaging was available for 15 (75%) patients. The primary endpoint was the difference in rate of uncovered struts between BP-SES and EES. To account for strut-level clustering, the results in both treatment groups were compared using a generalized linear mixed model approach.


RESULTS
Regarding the primary endpoint, BP-SES as compared to EES showed similar rates of uncovered struts (37 [6.8%] versus 167 [17.5%], odds ratio (OR) 0.45 (95% CI 0.09-2.24), p=0.33). There were no malapposed struts in BP-SES group and 14 malapposed struts in EES group (p=0.97). No difference in percent neointimal volume (14.1±8.2% vs. 11.4±6.4%, p=0.56) was observed.


CONCLUSIONS
Although rapid-breakdown BP-SES as compared to EES showed signs of improved early tissue coverage, after adjustment for strut-level clustering these differences were not statistically significant. No differences in ability to suppress neointimal hyperplasia after stent implantation between 2 stents were observed.
Deutsches Herzzentrum, Technische Universität, München, Germany. tomohisa@dhm.mhn.de
Tomohisa
T
Tada
Robert A
RA
Byrne
Tibor
T
Schuster
Rezarta
R
Cuni
Hironori
H
Kitabata
Klaus
K
Tiroch
Alfred
A
Dirninger
Franz
F
Gratze
Klaus
K
Kaspar
Gerald
G
Zenker
Michael
M
Joner
Albert
A
Schömig
Adnan
A
Kastrati
D020341:Absorbable Implants; D000368:Aged; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003331:Coronary Vessels / Q000473:pathology*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D005858:Germany; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D058426:Neointima; D016017:Odds Ratio; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D010865:Pilot Projects; D011108:Polymers; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014945:Wound Healing
D002317:Cardiovascular Agents; D011108:Polymers; D000068338:Everolimus; D020123:Sirolimus