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Intravascular Ultrasound Results From the ENDEAVOR IV Trial

Randomized Comparison Between Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease

Katsuhisa Waseda, MD, PhD^_*, Akiyoshi Miyazawa, MD^_*, Junya Ako, MD, PhD^_*, Takao Hasegawa, MD^_*, Ichizo Tsujino, MD, PhD^_*, Ryota Sakurai, MD, PhD^_*, Paul G. Yock, MD^_*, Yasuhiro Honda, MD^_*, David E. Kandzari, MD, Martin B. Leon, MD, Peter J. Fitzgerald, MD, PhD^_*,_* for the ENDEAVOR IV Trial Investigators

^_* Center for Cardiovascular Technology, Division of Cardiovascular Medicine, Stanford University, Stanford, California
Scripps Green Hospital, La Jolla, California
Columbia University, New York, New York

^_* Reprint requests and correspondence: Dr. Peter J. Fitzgerald, Cardiovascular Medicine, Stanford University, 300 Pasteur Drive, Room H3554, Stanford, California 94305 (Email: crci-cvmed{at}stanford.edu).

Objectives: The aim of this study was to compare the vessel response between zotarolimus-eluting stents (ZES) and paclitaxel-eluting stents (PES) using intravascular ultrasound.

Background: The ENDEAVOR IV (Randomized Comparison of Zotarolimus- and Paclitaxel-Eluting Stents in Patients With Coronary Artery Disease) trial was a randomized controlled study of zotarolimus-eluting, phosphorylcholine-coated, cobalt-alloy stents for the treatment of de novo coronary lesions compared with using PES for the same treatment.

Methods: Data were obtained from patients with serial (baseline and 8-months follow-up) intravascular ultrasound analysis available (n = 198). Volumetric analysis was performed for vessel, lumen, plaque, stent, and neointima. Cross-sectional narrowing (given as percentage) was defined as neointimal area divided by stent area. Neointima-free frame ratio was calculated as the number of frames without intravascular ultrasound-detectable neointima divided by the total number of frames within the stent. Subsegment analysis was performed at every matched 1-mm subsegment throughout the stent.

Results: At follow-up, the ZES group showed significantly greater percentage of neointimal obstruction (16.6 ± 12.0% vs. 9.9 ± 8.9%, p < 0.01) and maximum cross-sectional narrowing (31.8 ± 16.1% vs. 25.2 ± 14.9%, p < 0.01) with smaller minimum lumen area than the PES group did. However, the incidence of maximum cross-sectional narrowing >50% was similar in the 2 groups. Neointima-free frame ratio was significantly lower in the ZES group. In overall analysis, whereas the PES group showed positive remodeling during follow-up (13.7 ± 4.2 mm³/mm to 14.3 ± 4.3 mm³/mm), the ZES group showed no significant difference (12.7 ± 3.6 mm³/mm to 12.9 ± 3.5 mm³/mm). In subsegment analysis, significant focal positive vessel remodeling was observed in 5% of ZES and 25% of PES cases (p < 0.05).

Conclusions: There were different global and focal vessel responses for ZES and PES. Both drug-eluting stents showed a similar incidence of lesions with severe narrowing despite ZES having a moderate increase in neointimal hyperplasia compared with neointimal hyperplasia in PES. There was a relatively lower neointima-free frame ratio in ZES, suggesting a greater extent of neointimal coverage. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269)

Key Words: ultrasound • zotarolimus-eluting stent • coronary artery disease

Abbreviations and Acronyms   CSN = cross-sectional narrowing   DES = drug-eluting stent(s)   ISA = incomplete stent apposition   IVUS = intravascular ultrasound   PES = paclitaxel-eluting stent(s)   VI = volume index   ZES = zotarolimus-eluting stent(s)