Lei Song1, Bo Xu2, Yundai Chen3, Yujie Zhou4, Shaobin Jia5, Zhixiong Zhong6, Xi Su7, Yitong Ma8, Qi Zhang9, Jian Liu10, Yang Wang11, Changdong Guan12, Ming Zheng13, Shubin Qiao1, Runlin Gao14. 1. Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China. 2. National Clinical Research Center for Cardiovascular Diseases, Beijing, China; Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: bxu@citmd.com. 3. Department of Cardiology, Chinese People's Liberation Army General Hospital, Beijing, China. 4. Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. 5. Department of Cardiology, General Hospital of Ningxia Medical University, Yinchuan, China. 6. Department of Cardiology, Meizhou People's Hospital, Meizhou, China. 7. Department of Cardiology, Wuhan Asian Heart Hospital, Wuhan, China. 8. Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, Urumqi, China. 9. Department of Cardiology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China. 10. Department of Cardiology, Peking University People's Hospital, Beijing, China. 11. Medical Research and Biometrics Center, National Center for Cardiovascular Diseases, Beijing, China. 12. Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. 13. Shanghai MicroPort Medical (Group), Shanghai, China. 14. Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China. Electronic address: gaorunlin@citmd.com.
Abstract
OBJECTIVES: The aim of the present study was to evaluate the safety and efficacy of thinner strut Firesorb (100/125 μm) sirolimus-eluting bioresorbable scaffolds (BRS) versus cobalt-chromium everolimus-eluting stents (CoCr-EES) in patients with coronary artery disease. BACKGROUND: First-generation thicker strut BRS were associated with unexpected device-related adverse outcomes at long-term follow-up. METHODS: Eligible patients with 1 or 2 de novo noncomplex coronary lesions were randomized to the Firesorb BRS group or CoCr-EES group in a 1:1 ratio. The primary endpoint was 1-year angiographic in-segment late loss (LL), powered for noninferiority testing. The key secondary endpoint was the 1-year proportion of covered struts assessed on optical coherence tomography, powered for noninferiority and subsequent superiority testing. RESULTS: A total of 433 participants from 28 Chinese centers were randomized to the Firesorb BRS group (n = 215) or CoCr-EES group (n = 218). Patient-level 1-year in-segment LL was 0.17 ± 0.27 mm in the Firesorb BRS group and 0.18 ± 0.37 mm in the CoCr-EES group (difference -0.01 mm; 95% confidence interval [CI]: -0.07 to 0.06; pnoninferiority < 0.0001) in the intention-to-treat population and was 0.17 ± 0.27 mm in the Firesorb BRS group and 0.19 ± 0.37 mm in the CoCr-EES group (difference -0.005 mm; 95% CI: -0.07 to 0.06; pnoninferiority < 0.0001) in the per-protocol set. The proportion of covered struts was 99.3% in the Firesorb BRS group and 98.8% in the CoCr-EES group (difference 0.8%; 95% CI: -0.5% to 2.1%; pnoninferiority < 0.0001; psuperiority = 0.21). One-year clinical outcomes were similar between groups. CONCLUSIONS: The thinner strut Firesorb BRS was noninferior to the CoCr-EES for the primary endpoint of 1-year angiographic in-segment LL and the key secondary endpoint of 1-year proportion of covered struts by optical coherence tomography. (A Trial of Firesorb in Patients With Coronary Artery Disease: FUTURE-II [FUTURE-II]; NCT02890160).
OBJECTIVES: The aim of the present study was to evaluate the safety and efficacy of thinner strut Firesorb (100/125 μm) sirolimus-eluting bioresorbable scaffolds (BRS) versus cobalt-chromium everolimus-eluting stents (CoCr-EES) in patients with coronary artery disease. BACKGROUND: First-generation thicker strut BRS were associated with unexpected device-related adverse outcomes at long-term follow-up. METHODS: Eligible patients with 1 or 2 de novo noncomplex coronary lesions were randomized to the Firesorb BRS group or CoCr-EES group in a 1:1 ratio. The primary endpoint was 1-year angiographic in-segment late loss (LL), powered for noninferiority testing. The key secondary endpoint was the 1-year proportion of covered struts assessed on optical coherence tomography, powered for noninferiority and subsequent superiority testing. RESULTS: A total of 433 participants from 28 Chinese centers were randomized to the Firesorb BRS group (n = 215) or CoCr-EES group (n = 218). Patient-level 1-year in-segment LL was 0.17 ± 0.27 mm in the Firesorb BRS group and 0.18 ± 0.37 mm in the CoCr-EES group (difference -0.01 mm; 95% confidence interval [CI]: -0.07 to 0.06; pnoninferiority < 0.0001) in the intention-to-treat population and was 0.17 ± 0.27 mm in the Firesorb BRS group and 0.19 ± 0.37 mm in the CoCr-EES group (difference -0.005 mm; 95% CI: -0.07 to 0.06; pnoninferiority < 0.0001) in the per-protocol set. The proportion of covered struts was 99.3% in the Firesorb BRS group and 98.8% in the CoCr-EES group (difference 0.8%; 95% CI: -0.5% to 2.1%; pnoninferiority < 0.0001; psuperiority = 0.21). One-year clinical outcomes were similar between groups. CONCLUSIONS: The thinner strut Firesorb BRS was noninferior to the CoCr-EES for the primary endpoint of 1-year angiographic in-segment LL and the key secondary endpoint of 1-year proportion of covered struts by optical coherence tomography. (A Trial of Firesorb in Patients With Coronary Artery Disease: FUTURE-II [FUTURE-II]; NCT02890160).
Authors: Ben Hoddy; Naveed Ahmed; Kadem Al-Lamee; Nial Bullett; Nick Curzen; Neil W Bressloff Journal: Cardiovasc Eng Technol Date: 2022-07-11 Impact factor: 2.305