BACKGROUND: The safety and efficacy of a China-made polymer-free @entity1311 -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 @entity1 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 @entity299 (MACE) including @entity75 revascularization (TLR), the combined incidence of @entity204 , and non-fatal @entity583 ; the second endpoint was the incidence of stent @entity715 . RESULTS: Overall, 1376 lesions were treated successfully with 1713 Yinyi stents, and 1019 (98.7%) @entity1 received dual antiplatelet therapy for at least 12 months. At 3 years, a total of 13 (1.33%) @entity1 had suffered @entity204 . The incidence of non-fatal @entity583 and TLR was 9 (0.92%) and 58 (5.92%) among the @entity1 . Stent @entity715 occurred in 13 (1.33%) @entity1 , and the rate of @entity4207 ( @entity4207 ) definite or probable stent @entity715 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.

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

@entity1 :: ('9606', 'Species') :: ['patients'] @entity75 :: ('MESH:D001927', 'Disease') :: ['target lesion'] @entity1311 :: ('MESH:D017239', 'Chemical') :: ['paclitaxel'] @entity4207 :: ('MESH:D007859', 'Disease') :: ['ARC', 'Academic Research Consortium'] @entity299 :: ('MESH:D006331', 'Disease') :: ['cardiac events'] @entity583 :: ('MESH:D009203', 'Disease') :: ['myocardial infarction'] @entity204 :: ('MESH:D003643', 'Disease') :: ['cardiac death'] @entity715 :: ('MESH:D013927', 'Disease') :: ['thrombosis']
@entity1311 :: (MESH:D017239,Chemical) :: ['Paclitaxel']
