Author + information
- Kozo Okada1,
- Yasuhiro Honda2,
- Hideki Kitahara2,
- M. Brooke Hollak3,
- Paul G. Yock2,
- Hajime Kusano4,
- Wai-Fung Cheong5,
- Krishna Sudhir4,
- Peter J. Fitzgerald2 and
- Takeshi Kimura6
- 1Stanford University School of Medicine, Division of Cardiovascular Medicine, Stanford Cardiovascular Institute, Stanford, California, United States
- 2Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, California, United States
- 3Stanford University School of Medicine, Division of Cardiovascular Medicine, Stanford, California, United States
- 4Abbott Vascular, Santa Clara, California, United States
- 5Abbott Vascular, Los Altos, California, United States
- 6Kyoto University Hospital, Kyoto, Japan
This study aimed to evaluate influence of calcified plaque (CP) on device expansion after bioresorbable vascular scaffold (BVS) implantation, compared with everolimus-eluting stents (EES).
In the ABSORB Japan trial, volumetric IVUS was performed at post-procedure in 146 lesions (98 Absorb BVS: 48 EES, 2:1 randomization). Device expansion was evaluated as a ratio of average device area (%volume expansion) or minimum device area (%area expansion) to mean reference lumen area. CP score was calculated by grading the measured calcium angle as 0 to 4 (for 0°, <90°, 90-180°, 180-270° and >270°, respectively) for the entire device segment analyzed at 1-mm intervals. Device sizing was evaluated by [nominal device diameter - mean reference diameter] classified as undersized (≤-0.25 mm), properly sized (-0.25 to 0.25 mm) and oversized (>0.25 mm).
Overall, BVS had smaller device expansion than EES, which was particularly prominent in high CP-score (HCP) lesions (CP score ≥ median). In the EES arm, HCP lesions were post-dilated more frequently with a non-compliant balloon (87.5% vs. 45.5%, p<0.01) at higher dilation pressure (18±4 vs. 15±4 mmHg, p<0.05) than non-HCP lesions. In contrast, the BVS arm showed no procedural difference between the HCP and non-HCP lesions; thus, the post-dilation pressure was significantly lower in BVS than in EES for the treatment of HCP lesions (15±4 vs. 18±4 mmHg, p=0.02). In both BVS and EES, oversized device selection was associated with good device expansion even in HCP lesions (BVS p=0.01, EES p=0.01).
In ABSORB Japan, significantly smaller device expansion in calcified lesions observed in the BVS arm may, in part, be attributable to procedural differences between the 2 devices. Further studies are warranted to clarify appropriate optimization strategy for BVS in this lesion subset.
CORONARY: Bioresorbable Vascular Scaffolds