Intravascular ultrasound predictors of long-term outcomes following ABSORB bioresorbable scaffold implantation: A pooled analysis of the ABSORB III and ABSORB Japan trials. Issue 3 (September 2021)

• Record Type: Journal Article
• Authors: Nishi, Takeshi; Okada, Kozo; Kitahara, Hideki; Kameda, Ryo; Ikutomi, Masayasu; Imura, Shinji; Hollak, M. Brooke; Yock, Paul G.; Popma, Jeffrey J.; Kusano, Hajime; Cheong, Wai-Fung; Sudhir, Krishnankutty; Fitzgerald, Peter J.; Ellis, Stephen G.; Kereiakes, Dean J.; Stone, Gregg W.; Honda, Yasuhiro; Kimura, Takeshi
• Is Part Of: Journal of cardiology. Volume 78:Issue 3(2021)
• Page Start: 224
• Page End: 229
• Publication Date: 2021-09
• Subjects: Intravascular ultrasound -- Bioresorbable vascular scaffold -- Drug-eluting stent; Cardiology -- Periodicals; 616.12
• DOI: 10.1016/j.jjcc.2021.03.005
• Languages: English
• ISSNs: 0914-5087

Abstract

Highlights: A pooled analysis of the intravascular ultrasound (IVUS) cohorts in the ABSORB III and Japan trials. The IVUS predictors of clinical outcomes following ABSORB bioresorbable vascular scaffolds were investigated. Nonuniform device expansion and residual plaque are related to adverse events. A future study is warranted to investigate the role of IVUS in bioresorbable scaffolds implantation. Abstract: Background: The long-term prognostic impact of IVUS findings following Absorb BVS implantation remains uncertain. This study aimed to identify the IVUS predictors of long-term clinical outcomes following ABSORB bioresorbable vascular scaffold (BVS) implantation from the pooled IVUS substudy cohorts of the ABSORB III and Japan trials. Methods: A total of 298 lesions in 286 patients were enrolled with 2:1 randomization to ABSORB BVS vs. cobalt-chromium everolimus-eluting stents. This sub-analysis included 168 lesions of 160 patients in the Absorb arm whose post-procedural quantitative IVUS were available. The primary endpoint of this analysis was device-oriented composite endpoint (DOCE) of target lesion failure, including cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization. The median follow-up duration was 4.9 [3.1–5.0] years. Results: During follow-up, DOCE occurred in 10.1% of lesions treated with Absorb BVS. Among several post-procedural IVUS indices associated with DOCE, non-uniform device expansion (defined as uniformity index = minimum / maximum device area) (hazard ratio 0.47 per 0.1 increase [95%CI 0.28 to 0.77]; p = 0.003) and residual reference plaque burden (hazard ratio 4.01 per 10% increase [95%CI 1.50 to 10.77]; p = 0.006) were identified as independent predictors of DOCE by Cox multivariable analysis. Conclusions: Nonuniform device expansion and substantial untreated residual plaque in reference segments were associated with long-term adverse events following BVS implantation. Baseline imaging to identify the appropriate device landing zone and procedural imaging to achieve uniform device expansion if possible (e.g. through post-dilatation) may improve clinical outcomes of BVS implantation. Clinical trial registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01751906 (ABSORB III); NCT01844284 (ABSORB Japan).