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Safety and Efficacy of Biodegradable Polymer-Coated Sirolimus-Eluting Stents in "Real-World" Practice

18-Month Clinical and 9-Month Angiographic Outcomes

Yaling Han, MD^_*,_*, Quanmin Jing, MD^_*, Bo Xu, MBBS, Lixia Yang, MD, Huiliang Liu, MD, Xiaoming Shang, MD^||, Tieming Jiang, MD^¶, Zhanquan Li, MD^#, Hua Zhang, MD^_**, Hui Li, MD, Jian Qiu, MD, Yingfeng Liu, MD, Yi Li, MD^_*, Xuezhi Chen, MD^_*, Runlin Gao, MD for the CREATE (Multi-Center Registry of Excel Biodegradable Polymer Drug-Eluting Stents) Investigators

^_* Shenyang Northern Hospital, Shenyang, China
Cardiovascular Institute and Fuwai Hospital, Beijing, China
Kunming General Hospital of Chengdu Military Region, Kunming, China
General Hospital of Armed Police Forces, Beijing, China
^|| Tangshan Gongren Hospital, Tangshan, China
^¶ Affiliated Hospital of Chinese People's Armed Police Forces Medical College, Tianjin, China
^# The People's Hospital of Liaoning Province, Shenyang, China
^_** Shanxi Provincial Corps Hospital of Chinese People's Armed Police Forces, Xi'an, China
Daqing Oilfields General Hospital, Daqing, China
Guangzhou Army General Hospital, Guangzhou, China
Zhujiang Hospital of Southern Medical University, Guangzhou, China

^_* Reprint requests and correspondence: Dr. Yaling Han, Department of Cardiology, Shenyang Northern Hospital, Shenyang 110016, China (Email: hanyaling.nh{at}gmail.com).

Objectives: This study sought to evaluate the safety and efficacy of a biodegradable polymer-coated sirolimus-eluting stent (Excel, JW Medical System, Weihai, China) with 6-month dual antiplatelet therapy in daily practice.

Background: It has been hypothesized that persistent presence of polymer may compromise the safety of drug-eluting stents, and that therefore biodegradable polymer coatings might reduce late adverse events.

Methods: Between June and November 2006, 2,077 patients, exclusively treated with Excel stents at 59 centers from 4 countries, were enrolled in this prospective, multicenter registry. Recommended antiplatelet regimen included clopidogrel and aspirin for 6 months followed by chronic aspirin therapy.

Results: The average duration of clopidogrel treatment was 199.8 ± 52.7 days and 80.5% of discharged patients discontinued clopidogrel at 6 months. The cumulative rates of major adverse cardiac events were 0.9% at 30 days, 2.7% at 1 year, and 3.1% at 18 months. Overall rate of stent thrombosis was 0.87% at 18 months. The rates of acute, subacute, late, and very late stent thrombosis were 0.1%, 0.38%, 0.34%, and 0.05%, respectively. Angiographic follow-up, performed in 974 (31.6%) lesions from 653 patients (31.7%), revealed a mean in-stent late lumen loss of 0.21 ± 0.39 mm. Binary restenosis rates were 3.8% in-stent and 6.7% in-segment.

Conclusions: This multicenter registry documents satisfactory safety and efficacy profiles, as evidenced by low rates of major adverse cardiac events and stent thrombosis up to 18 months, for the Excel biodegradable polymer-based sirolimus-eluting stent when used with 6 months of dual antiplatelet therapy in a "real-world" setting. (Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent [CREATE]; NCT00331578)

Key Words: drug-eluting stents • sirolimus • biodegradable polymer • coronary heart disease

Abbreviations and Acronyms   DES = drug-eluting stent(s)   MACE = major adverse cardiac event(s)   MI = myocardial infarction   PLA = polylactic acid   SES = sirolimus-eluting stent(s)   TLR = target lesion revascularization

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