Author + information
- Received July 19, 2017
- Revision received November 26, 2017
- Accepted November 28, 2017
- Published online April 2, 2018.
- Kozo Okada, MDa,
- Yasuhiro Honda, MDa,∗ (, )
- Hideki Kitahara, MDa,
- Kyuhachi Otagiri, MDa,
- Shigemitsu Tanaka, MDa,
- M. Brooke Hollak, RNa,
- Paul G. Yock, MDa,
- Jeffrey J. Popma, MDb,
- Hajime Kusano, PhDc,
- Wai-Fung Cheong, PhDc,
- Krishnankutty Sudhir, MD, PhDa,c,
- Peter J. Fitzgerald, MD, PhDa,
- Takeshi Kimura, MDd,
- on behalf of the ABSORB Japan Investigators
- aDivision of Cardiovascular Medicine, Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, California
- bDepartment of Internal Medicine, Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts
- cClinical Science and Medical Affairs, Abbott Vascular, Santa Clara, California
- dDepartment of Cardiovascular Medicine, Kyoto University Hospital, Kyoto, Japan
- ↵∗Address for correspondence:
Dr. Yasuhiro Honda, Division of Cardiovascular Medicine, Stanford University School of Medicine, 300 Pasteur Drive, Room H3554, Stanford, California 94305-5637.
Objectives The aim of this study was to characterize post-procedural intravascular ultrasound (IVUS) findings in the ABSORB Japan trial, specifically stratified by the size of target coronary arteries.
Background Despite overall noninferiority confirmed in recent randomized trials comparing bioresorbable vascular scaffolds (BVS) (Absorb BVS) and cobalt-chromium everolimus-eluting metallic stents (CoCr-EES), higher event rates of Absorb BVS have been reported with suboptimal deployment, especially in small coronary arteries.
Methods In the ABSORB Japan trial, 150 patients (2:1 randomization) were scheduled in the IVUS cohort. Small vessel was defined as mean reference lumen diameter <2.75 mm. Tapered-vessel lesions were defined as tapering index (proximal/distal reference lumen diameter) ≥1.2.
Results Overall, IVUS revealed that the Absorb BVS arm had smaller device expansion than the CoCr-EES arm did, which was particularly prominent in small- and tapered-vessel lesions. Higher tapering index was also associated with higher rates of incomplete strut apposition in Absorb BVS, but not in CoCr-EES. With respect to procedural techniques, small-vessel lesions were treated more frequently with noncompliant balloons at post-dilatation but using significantly lower pressure in the Absorb BVS arm. In contrast, tapered-vessel lesions were post-dilated at equivalent pressure but with significantly smaller balloon catheters in the Absorb BVS arm, compared with the CoCr-EES arm.
Conclusions The significantly smaller device expansion especially in small vessels may account for the poorer outcomes of Absorb BVS in this lesion type. Appropriate optimization strategy, possibly different between polymeric and metallic devices, needs to be established for bioresorbable scaffold technology. (AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 Absorb™ BVS) in Japanese Population [ABSORB JAPAN]; NCT01844284)
The ABSORB Japan trial was funded by Abbott Vascular, Santa Clara, California. Drs. Yock, Fitzgerald, and Kimura have received institutional research grant support from Abbott Vascular. Drs. Kusano, Cheong, and Sudhir are employees of Abbott Vascular. Dr. Popma has received institutional grant support from Boston Scientific, Medtronic, and Abbott Vascular; and has served on the advisory board for Boston Scientific and Abbott Vascular. Dr. Kimura has served on the advisory board for Abbott Vascular and Abbott Vascular Japan. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received July 19, 2017.
- Revision received November 26, 2017.
- Accepted November 28, 2017.
- 2018 American College of Cardiology Foundation
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