Sustained clinical safety and efficacy of a biodegradable-polymer coated sirolimus-eluting stent in “real-world” practice: Three-year outcomes of the CREATE (multi-center registry of EXCEL biodegradable polymer drug eluting stents) study

2011 ◽  
Vol 79 (2) ◽  
pp. 211-216 ◽  
Author(s):  
Yaling Han ◽  
Quanmin Jing ◽  
Yi Li ◽  
Lixia Yang ◽  
Huiliang Liu ◽  
...  
2019 ◽  
Vol 7 (7) ◽  
pp. 1103-1109
Author(s):  
Bhupendra Verma ◽  
Akhilesh Patel ◽  
Deepak Katyal ◽  
Vivek Raj Singh ◽  
Avinash Kumar Singh ◽  
...  

BACKGROUND: The durable polymer drug-eluting stents (DPDES) reduce the risk of repeated target vessel revascularisation (TLR) compared with BMS, but are associated with increased risk of late adverse events. In broadly inclusive populations, the biodegradable-polymer drug-eluting stents (BPDES) have favourable results compared with DPDES in the long term. However, its use in primary angioplasty has not been adequately studied, and data of real-world clinical experience is lacking. AIM: Aim of this study was to assess the safety and efficacy of Yukon Choice PC Elite sirolimus-eluting stent (a novel BPDES) in STEMI patients undergoing primary angioplasty. METHODS: We have presented here one-year clinical follow-up data of the Yukon Choice PC Elite sirolimus-eluting stent in patients undergoing primary angioplasty. A total of 636 patients were enrolled in this single arm, prospective observational study from five centres. RESULTS: This multicentric observational study showed excellent safety and efficacy profile of the novel device at one year follow up. The device-oriented composite endpoint (DOCE) of cardiac death, target-vessel reinfarction, and target-lesion revascularisation (TLR) was 2.7%, and the patient-oriented composite endpoint (POCE) of all-cause death, any myocardial infarction, and any revascularisation was 4.2% at one year. Definite or probable stent thrombosis rate was 0.6%, and no events were recorded beyond 6 months of follow up. CONCLUSIONS: In patients with STEMI undergoing primary angioplasty, the use of Yukon Choice PC Elite (biodegradable polymer sirolimus-eluting stent) has excellent results at one year. It, therefore, represents an attractive alternative to second generation DES in this high-risk population.


2020 ◽  
Vol 50 (4) ◽  
pp. 317 ◽  
Author(s):  
Young Jin Youn ◽  
Sang-Yong Yoo ◽  
Jun-Won Lee ◽  
Sung Gyun Ahn ◽  
Seung-Hwan Lee ◽  
...  

2011 ◽  
Vol 107 (8) ◽  
pp. 59A ◽  
Author(s):  
Seung-Woon Rha ◽  
Kanhaiya L. Poddar ◽  
Meera Kumari ◽  
Byoung Geol Choi ◽  
Yun Kyung Kim ◽  
...  

2017 ◽  
Vol 69 (11) ◽  
pp. 1250
Author(s):  
Joshua Ping Yun Loh ◽  
Rajiv Ananthakrishna ◽  
Hui Wen Sim ◽  
Poay Huan Loh ◽  
Edgar Tay ◽  
...  

2021 ◽  
Author(s):  
mingkun cao ◽  
Yuxia Yin ◽  
Chao Zhou ◽  
Wei Deng ◽  
Jianying Ma ◽  
...  

Abstract Background Drug-eluting stent (DES) with durable polymers have been proven to cause late or very late adverse events. Biodegradable polymer-coated DES was developed to address the risk by avoiding persistent inflammatory irritation from persistent polymers. However, it is unknown whether the benefits of biodegradable polymer DES will occur over longer time. Methods The trial was a prospective, multicenter and randomized non-inferiority clinical trial done in China. Patients with indications for stent implantation were assigned into Cordimax and Xience V group in a 2:1 allocation. The composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularisation (CI-TLR) was the primary endpoint target lesion failure (TLF). The pre-specified endpoint at five years was major adverse cardiac event (MACE) which was defined as a composite of all-cause death, non-fatal myocardial infarction (MI), and CI-TLR. Results 3266 patients (88.3%) completed 5-year follow-up. No difference was observed for TLF between Cordimax (7.5%) and Xience V (8.3%) group (RR: 0.90, 95% CI: 0.70 to 1.15, P = 0.39). MACE occurred in 280 patients (11.4%) in Cordimax group and 162 patients (13.1%) in Xience V group (RR: 0.85, 95% CI: 0.69 to 1.05, P = 0.13). The incidence of definite or probable stent thrombosis did not differ in both groups (Cordimax 0.7%, Xience V 0.9%; RR: 0.78, 95% CI: 0.36 to 1.66; P = 0.51). Conclusion The biodegradable polymer Cordimax stent showed a comparable result to the durable polymer Xience V stent at 5 years, showing its long-term safety and efficacy performance. Trial registration: This study is registered with ClinicalTrials.gov, number NCT03185221 (14/06/2017).


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