Author + information
- Received September 9, 2014
- Accepted September 9, 2014
- Published online December 1, 2014.
- Yaling Han, MD, PhD∗∗ (, )
- Bo Xu, MBBS†,
- Quanmin Jing, MD∗,
- Shuzheng Lu, MD‡,
- Lixia Yang, MD§,
- Kai Xu, MD∗,
- Yi Li, MD∗,
- Jing Li, MD∗,
- Changdong Guan, MSc†,
- Ajay J. Kirtane, MD, SM‖,
- Yuejin Yang, MD†,
- I-LOVE-IT 2 Investigators
- ∗General Hospital of Shenyang Military Region, Shenyang, China
- †Fu Wai Hospital, National Center for Cardiovascular Diseases, Beijing, China
- ‡Affiliated Anzhen Hospital of Capital Medical University, Beijing, China
- §Kunming General Hospital of Chengdu Military Region, Kunming, China
- ‖Columbia University Medical Center/New York Presbyterian Hospital, New York, New York
- ↵∗Reprint requests and correspondence:
Dr. Yaling Han, Department of Cardiology, General Hospital of Shenyang Military Region, 83 Wenhua Road, Shenhe District, Shenyang 110016, China.
Objectives The aim of this study was to investigate the hypothesis that a novel biodegradable polymer–coated, cobalt-chromium (CoCr), sirolimus-eluting stent (BP-SES) is noninferior in safety and efficacy outcomes compared with a durable polymer (DP)-SES.
Background No randomized trials have the compared safety and efficacy of BP-SES versus DP-SES on similar CoCr platforms, thereby isolating the effect of the polymer type.
Methods In this prospective, single-blind, randomized trial conducted at 32 Chinese sites, 2,737 patients eligible for coronary stenting were treated with BP- or DP-SES in a 2:1 ratio. The primary endpoint was 12-month target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. Secondary endpoints included TLF components, and definite/probable stent thrombosis.
Results At 12 months, the difference in the primary endpoint of TLF between BP-SES (6.3%) and DP-SES (6.1%) groups was 0.25% (95% confidence interval: −1.67% to 2.17%, p for noninferiority = 0.0002), demonstrating noninferiority of BP-SES to DP-SES. Individual TLF components of cardiac death (0.7% vs. 0.6%, p = 0.62), target vessel myocardial infarction (3.6% vs. 4.3%, p = 0.39), and clinically indicated target lesion revascularization (2.6% vs. 2.2%, p = 0.50) were similar, as were low definite/probable stent thrombosis rates (0.4% vs. 0.6%, p = 0.55).
Conclusions In this large-scale real-world trial, BP-SES was noninferior to DP-SES for 1-year TLF. (Evaluate Safety and Effectiveness of the Tivoli ® DES and the Firebird ® DES for Treatment of Coronary Revascularization; NCT01681381)
The study was sponsored by Essen Technology (Beijing, China) and was also supported by National Key Technology R&D Program in the 12th Five-Year Plan of China (2011BAI11B07) and Key Project of National 12th Five-Year Research Program of China (2012ZX093016-002). All of the authors have reported that they have no relationships relevant to the contents of this paper to disclose. The first 2 authors contributed equally to this work.
- Received September 9, 2014.
- Accepted September 9, 2014.
- American College of Cardiology Foundation