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Evaluation in 3 Months Duration of Neointimal Coverage After Zotarolimus-Eluting Stent Implantation by Optical Coherence Tomography

The ENDEAVOR OCT Trial

Jung-Sun Kim, MD, PhD^_*, Ik-Kyung Jang, MD, PhD, Chunyu Fan, MD^_*, Tae Hoon Kim, MD^_*, Jin-Sun Kim, MD^_*, Sang Min Park, MD^_*, Eui-Young Choi, MD, PhD^_*, Sang Hak Lee, MD, PhD^_*, Young-Guk Ko, MD^_*, Donghoon Choi, MD, PhD^_*, Myeong-Ki Hong, MD, PhD^_*, Yangsoo Jang, MD, PhD^_*,_*

^_* Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea
Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts

^_* Reprint requests and correspondence: Dr. Yangsoo Jang, Division of Cardiology, Yonsei Cardiovascular Center, Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu, 120-752 Seoul, South Korea (Email: jangys1212{at}yuhs.ac).

Objectives: We performed this study to investigate the vascular response in early period after zotarolimus-eluting stent (ZES) (Endeavor Sprint, Medtronic CardioVascular, Minneapolis, Minnesota) implantation.

Background: The ZES has different characteristics, with biocompatible polymer and rapid drug-elution, compared with the first-generation drug-eluting stents (DES).

Methods: The ENDEAVOR OCT (Evaluation in 3 Months Duration of Neointimal Coverage after Zotarolimus-Eluting Stent Implantation by Optical Coherence Tomography) trial is a prospective, single-center study evaluating vascular healing patterns with optical coherence tomography (OCT) at 3 months after stent implantation. A total of 31 ZES in 30 patients underwent serial OCT at immediate post-intervention and 3 months. Neointimal growth and malapposition were analyzed at each stent strut of cross-sectional OCT images with 0.5-mm intervals.

Results: The incidence of malapposition at post-intervention and 3 months was 6.0% and 0.2%, respectively. However, late acquired malapposition was not detected at 3 months. Of 31 stents, 27 stents (87.1%) were covered completely with neointima, but the remaining 4 stents had 2 (0.8%), 4 (0.9%), 4 (1.2%), and 6 (1.4%) uncovered struts. Overall mean percentage of covered stent struts was 99.9 ± 0.4%. This finding was consistent among groups with acute coronary syndrome and stable angina pectoris (99.9 ± 0.3% vs. 99.9 ± 0.4%, p = 0.92). Intracoronary thrombus was documented in 1 stent (3.2%) among 31 stents.

Conclusions: Most of the stent struts were covered with neointima, and late acquired malapposition was not found at 3 months after ZES implantation. Therefore, the current study demonstrated that ZES might have a favorable in vivo vascular response at 3 months after stent implantation. (Evaluation of Zotarolimus Eluting Stent at 3 Months Using Optical Coherence Tomography [ENDEAVOR OCT]; NCT00815139)

Key Words: drug-eluting stent • optical coherence • tomography • zotarolimus

Abbreviations and Acronyms   ACS = acute coronary syndrome   DAT = dual antiplatelet therapy   DES = drug-eluting stent(s)   IVUS = intravascular ultrasound   LST = late stent thrombosis   MI = myocardial infarction   NIH = neointimal hyperplasia   OCT = optical coherence tomography   PCI = percutaneous coronary intervention   RVD = reference vessel diameter   SAP = stable angina pectoris   SES = sirolimus-eluting stents(s)   ZES = zotarolimus-eluting stent(s)

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