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. 2017 Jan;33(1):28-33.
doi: 10.6515/acs20160131b.

Three-Year Clinical Outcomes of a Polymer-Free Paclitaxel-Eluting Microporous Stent in Real-World Practice: Final Results of the Safety and Efficacy Registry of the Yinyi Stent (SERY-I)

Jinzhou Zhu  1 , Qi Zhang  1 , Lianglong Chen  2 , Chenyun Zhang  3 , Xuchen Zhou  4 , Yong Yuan  5 , Ruiyan Zhang  1
Affiliations

Three-Year Clinical Outcomes of a Polymer-Free Paclitaxel-Eluting Microporous Stent in Real-World Practice: Final Results of the Safety and Efficacy Registry of the Yinyi Stent (SERY-I)

Jinzhou Zhu et al. Acta Cardiol Sin. 2017 Jan.

Abstract

Background: The safety and efficacy of a China-made polymer-free paclitaxel-eluting microporous stent (Yinyi) at 1-year has been previously reported. However, limited evidence exists regarding the long-term performance of this novel drug-eluting stent (DES). This study investigated the 3-year efficacy and safety of the Yinyi stent in the setting of safety and efficacy registry of the Yinyi stent (SERY-I) clinical trial.

Methods: Between June 2008 and August 2009, a total of 1045 patients undergoing percutaneous coronary intervention (PCI) were implanted with ≥ 1 Yinyi stents at 27 medical centers in mainland China. Thereafter, clinical follow-up was performed for a period of 3 years after enrollment. The primary endpoint was the cumulative rate of composite major adverse cardiac events (MACE) including target lesion revascularization (TLR), the combined incidence of cardiac death, and non-fatal myocardial infarction; the second endpoint was the incidence of stent thrombosis.

Results: Overall, 1376 lesions were treated successfully with 1713 Yinyi stents, and 1019 (98.7%) patients received dual antiplatelet therapy for at least 12 months. At 3 years, a total of 13 (1.33%) patients had suffered cardiac death. The incidence of non-fatal myocardial infarction and TLR was 9 (0.92%) and 58 (5.92%) among the patients. Stent thrombosis occurred in 13 (1.33%) patients, and the rate of Academic Research Consortium (ARC) definite or probable stent thrombosis was 0.82%.

Conclusions: Given the limitations that SERY-I was a single arm, nonrandomized study and only telephone follow-up was performed without angiographic analysis, the safety and efficacy of Yinyi stent observed in this extended follow-up Registry needs further verification.

Keywords: Microporous stent; Paclitaxel-eluting stent; Polymer-free; Stent thrombosis.

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Figures

Figure 1
Figure 1
Study flow chart.
Figure 2
Figure 2
Kaplan-Meier estimates of MACE-free survival at 3-year follow-up in studied populations. MACE, major adverse cardiac events.
See this image and copyright information in PMC

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