Takeshi Kimura1, Ken Kozuma2, Kengo Tanabe3, Sunao Nakamura4, Masahisa Yamane5, Toshiya Muramatsu6, Shigeru Saito7, Junji Yajima8, Nobuhisa Hagiwara9, Kazuaki Mitsudo10, Jeffrey J Popma11, Patrick W Serruys12, Yoshinobu Onuma13, Shihwa Ying14, Sherry Cao14, Peter Staehr14, Wai-Fung Cheong14, Hajime Kusano14, Gregg W Stone15. 1. Department of Cardiovascular Medicine, Kyoto University Hospital, 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan taketaka@kuhp.kyoto-u.ac.jp. 2. Teikyo University Hospital, Tokyo, Japan. 3. Division of Cardiology, Cardiac Intensive Care Unit, Mitsui Memorial Hospital, Tokyo, Japan. 4. Center of Cardiovascular Medicine, Shin-Tokyo Hospital, Matsudo, Japan. 5. Saitama Sekishinkai Hospital, Sayama, Japan. 6. Saiseikai Yokohama Tobu Hospital, Yokohama, Japan. 7. Division of Cardiology and Catheterization Laboratories, Shonan Kamakura General Hospital, Kamakura, Japan. 8. Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan. 9. Tokyo Women's Medical University Hospital, Tokyo, Japan. 10. Center of Cardiology, Kurashiki Central Hospital, Kurashiki, Japan. 11. Beth Israel Deaconess Medical Center, Boston, MA, USA. 12. Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands Imperial College, London, UK. 13. Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands. 14. Abbott Vascular, Santa Clara, CA, USA. 15. Columbia University Medical Center, New York-Presbyterian Hospital, and the Cardiovascular Research Foundation, New York, NY, USA.
Abstract
AIMS: Theoretically, bioresorbable vascular scaffolds (BVSs) may provide superior long-term results compared with permanent metallic drug-eluting stents (DESs). However, whether BVSs are as safe and effective as metallic DESs prior to complete bioresorption is unknown. METHODS AND RESULTS: ABSORB Japan was a single-blind, multicentre, active-controlled, randomized trial designed to support regulatory approval of the Absorb BVS in Japan. Eligible patients with one or two de novo lesions in different epicardial vessels were randomized at 38 Japanese sites in a 2:1 ratio to Absorb BVS vs. cobalt-chromium everolimus-eluting stents (CoCr-EESs). The primary endpoint was target lesion failure [TLF: a composite of cardiac death, myocardial infarction attributable to target vessel, or ischaemia-driven target lesion revascularization (ID-TLR)] at 12 months, powered for non-inferiority. The major secondary endpoint was angiographic in-segment late lumen loss (LLL) at 13 months. A total of 400 patients were randomized to BVSs (266 patients and 275 lesions) or CoCr-EESs (134 patients and 137 lesions). TLF through 12 months was 4.2% with BVSs and 3.8% with CoCr-EESs [difference (upper one-sided 95% confidence limit) = 0.39% (3.95%); Pnon-inferiority < 0.0001]. Definite/probable stent/scaffold thrombosis at 12 months occurred in 1.5% of the patients with both devices (P = 1.0), and ID-TLR for restenosis was infrequent (1.1% with BVSs and 1.5% with CoCr-EESs, P = 1.0). With 96.0% angiographic follow-up, in-segment LLL at 13 months was 0.13 ± 0.30 mm with BVSs and 0.12 ± 0.32 mm with CoCr-EESs [difference (upper one-sided 95% confidence limit) = 0.01 (0.07); Pnon-inferiority < 0.0001). CONCLUSION: In the ABSORB Japan randomized trial, 12-month clinical and 13-month angiographic outcomes of BVSs were comparable to CoCr-EESs. CLINICAL REGISTRATION: ClinicalTrials.gov, number NCT01844284. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: Theoretically, bioresorbable vascular scaffolds (BVSs) may provide superior long-term results compared with permanent metallic drug-eluting stents (DESs). However, whether BVSs are as safe and effective as metallic DESs prior to complete bioresorption is unknown. METHODS AND RESULTS: ABSORB Japan was a single-blind, multicentre, active-controlled, randomized trial designed to support regulatory approval of the Absorb BVS in Japan. Eligible patients with one or two de novo lesions in different epicardial vessels were randomized at 38 Japanese sites in a 2:1 ratio to Absorb BVS vs. cobalt-chromium everolimus-eluting stents (CoCr-EESs). The primary endpoint was target lesion failure [TLF: a composite of cardiac death, myocardial infarction attributable to target vessel, or ischaemia-driven target lesion revascularization (ID-TLR)] at 12 months, powered for non-inferiority. The major secondary endpoint was angiographic in-segment late lumen loss (LLL) at 13 months. A total of 400 patients were randomized to BVSs (266 patients and 275 lesions) or CoCr-EESs (134 patients and 137 lesions). TLF through 12 months was 4.2% with BVSs and 3.8% with CoCr-EESs [difference (upper one-sided 95% confidence limit) = 0.39% (3.95%); Pnon-inferiority < 0.0001]. Definite/probable stent/scaffold thrombosis at 12 months occurred in 1.5% of the patients with both devices (P = 1.0), and ID-TLR for restenosis was infrequent (1.1% with BVSs and 1.5% with CoCr-EESs, P = 1.0). With 96.0% angiographic follow-up, in-segment LLL at 13 months was 0.13 ± 0.30 mm with BVSs and 0.12 ± 0.32 mm with CoCr-EESs [difference (upper one-sided 95% confidence limit) = 0.01 (0.07); Pnon-inferiority < 0.0001). CONCLUSION: In the ABSORB Japan randomized trial, 12-month clinical and 13-month angiographic outcomes of BVSs were comparable to CoCr-EESs. CLINICAL REGISTRATION: ClinicalTrials.gov, number NCT01844284. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Gregg W Stone; Takeshi Kimura; Runlin Gao; Dean J Kereiakes; Stephen G Ellis; Yoshinobu Onuma; Bernard Chevalier; Charles Simonton; Ovidiu Dressler; Aaron Crowley; Ziad A Ali; Patrick W Serruys Journal: JAMA Cardiol Date: 2019-12-01 Impact factor: 14.676