Novel completed biodegradable polymer sirolimus-eluting stent versus durable polymer sirolimus-eluting stent in de novo lesions: nine-month angiographic and three-year clinical outcomes of HOPE trial.

Fei Yuan; Xin Chen; Xiantao Song; Dongqi Wang; Zheng Zhang; Weimin LI; Zhanquan LI; Hui LI; Xinyi Chen; Yong Huo; Lefeng Wang; Caiyi LU; Qinghua LU; Bo XU; Wei LI; Shuzheng Lyu; Null

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Novel completed biodegradable polymer sirolimus-eluting stent versus durable polymer sirolimus-eluting stent in de novo lesions: nine-month angiographic and three-year clinical outcomes of HOPE trial.

Author: Fei YUAN ¹ ; Xin CHEN ¹ ; Xiantao SONG ¹ ; Dongqi WANG ² ; Zheng ZHANG ³ ; Weimin LI ⁴ ; Zhanquan LI ⁵ ; Hui LI ⁶ ; Xinyi CHEN ⁷ ; Yong HUO ⁸ ; Lefeng WANG ⁹ ; Caiyi LU ¹⁰ ; Qinghua LU ¹¹ ; Bo XU ¹² ; Wei LI ¹³ ; Shuzheng LYU ¹⁴ ; null
Author Information

1. Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China.
2. Department of Cardiology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi 710061, China.
3. Department of Cardiology, First Affiliated Hospital of Lanzhou University, Lanzhou, Gansu 730000, China.
4. Department of Cardiology, First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang 150001, China.
5. Department of Cardiology, People's Hospital of Liaoning Province, Shenyang, Liaoning 110016, China.
6. Department of Cardiology, General Hospital of Daqing Oilfield, Daqing, Heilongjiang 163411, China.
7. Department of Cardiology, People's Hospital of Shaanxi Province, Xi'an, Shaanxi 710068, China.
8. Department of Cardiology, Peking University First Hospital, Beijing 100044, China.
9. Department of Cardiology, Chao-yang Hospital, Capital Medical University, Being 100020, China.
10. Department of Cardiology, Chinese People's Liberation Army General Hospital, Beijing 100853, China.
11. Department of Cardiology, Second Hospital of Shandong University, Jinan, Shandong 250033, China.
12. Cardiac Catheterization Laboratory, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100037, China.
13. National Center for Cardiovascular Diseases of China, Beijing 100037, China.
14. Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing 100029, China. Email: shuzheng@medmail.com.cn.
Publication Type:Journal Article
MeSH: Adult; Aged; Angiography; Coronary Artery Disease; surgery; Coronary Restenosis; prevention & control; Drug-Eluting Stents; Humans; Middle Aged; Percutaneous Coronary Intervention; Polymers; chemistry; therapeutic use; Sirolimus; therapeutic use; Titanium; chemistry; Treatment Outcome; Young Adult
From: Chinese Medical Journal 2014;127(14):2561-2566
CountryChina
Language:English
Abstract:
BACKGROUNDDrug-eluting stents (DES) with durable polymer have significantly reduced restenosis and target vessel revascularization compared with bare metal stents. Durable polymer has been linked with persistent inflammation of vessel wall and delayed endothelial healing that may increase the risk of late and very late stent thrombosis. This study sought to evaluate the efficacy and safety of HELIOS completed biodegradable polymer sirolimus-eluting stent (SES) in de novo coronary lesions.
METHODSTotally, 287 patients with one or two de novo coronary lesions (lesion length ≤ 38 mm and reference vessel diameter 2.5-4.0 mm) were enrolled in the HOPE study, a prospective, multicenter, randomized, non-inferiority trial. Patients were randomized to treatment either with HELIOS completed biodegradable polymer SES (n = 142) or PARTNER durable polymer SES (n = 145). The primary endpoint was angiographic in-stent late lumen loss (LLL) at 9-month follow-up. The secondary endpoint included stent thrombosis and major adverse cardiac events including cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR).
RESULTSThe 9-month in-stent LLL in the HELIOS group was similar to the PARTNER group, (0.16 ± 0.22) mm vs. (0.19 ± 0.30) mm (P = 0.28). The difference and 95% confidence interval were -0.03 (-0.09, 0.04), and the P value for non-inferiority <0.01. Major adverse cardiovascular event (MACE) occurred in 7.9% vs. 8.2%, MI in 2.4% vs. 3.0%, TLR in 5.5% vs. 3.0%, and stent thrombosis in 0 vs. 1.5%; and events were comparable between the HELIOS group and PARTNER group at three-year follow-up (all P > 0.05). The three-year cardiac death was lower in the HELIOS group, but with no significant difference, 0 vs. 3.0% (P = 0.12).
CONCLUSIONSIn the HOPE trial, the novel completed biodegradable polymer SES HELIOS was non-inferior to the durable polymer SES PARTNER with respect to nine-month in-stent LLL in de novo coronary lesions. The incidence of other clinical endpoints was low for both of the stents in three-year follow-up.