Efficacy and safety of a biodegradable polymer Cobalt-Chromium sirolimus-eluting stent (EXCEL2) in treating de novo coronary artery disease: A pooled analysis of the CREDIT II and CREDIT III trials

2017 ◽  
Vol 89 (S1) ◽  
pp. 512-519 ◽  
Author(s):  
Geng Wang ◽  
Heyang Wang ◽  
Bo Xu ◽  
Yuejin Yang ◽  
Zhiming Yang ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Biodegradable Polymer ◽  
De Novo ◽  
Pooled Analysis ◽  
Efficacy And Safety ◽  
Cobalt Chromium ◽  
Artery Disease ◽  
Sirolimus Eluting Stent

scholarly journals Preliminary Evaluation of Clinical and Angiographic Outcomes with Biodegradable Polymer Coated Sirolimus-Eluting Stent inDe NovoCoronary Artery Disease: Results of the MANIPAL-FLEX Study

Scientifica ◽  
2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Ranjan Shetty ◽  
Jayesh Prajapati ◽  
Umesh Pai ◽  
Kiran Shetty
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
De Novo ◽  
Quantitative Coronary Angiography ◽  
Target Lesion ◽  
Preliminary Evaluation ◽  
Safety And Efficacy ◽  
Artery Disease ◽  
Sirolimus Eluting Stent

Objective. The objective of the MANIPAL-FLEX study was to evaluate the feasibility, preliminary safety, and efficacy of the Supraflex sirolimus-eluting stent (SES) implantation, inde novocoronary artery disease, using clinical and quantitative coronary angiography (QCA) follow-ups.Methods. This was a prospective, nonrandomized, multicenter, single-arm study that enrolled 189 patients withde novocoronary artery disease who were treated with the Supraflex SES. Of 189 patients enrolled, the first 61 consecutive patients who consented to a 9-month follow-up evaluation by QCA, irrespective of presence of symptoms, were to be followed up with angiography at 9 months. The primary endpoint of the study was target lesion failure (TLF), including cardiac death, myocardial infarction, and target lesion revascularization during 12-month follow-up after the index procedure.Results. The mean age of the study population was58±11years, with 51.3% (97/189) of hypertensive patients. Total of 66 lesions, analyzed by offline QCA, showed good scaffolding of the target vessel with in-stent late lumen loss at 9 months of0.18±0.23 mm. The observed TLF at 30-day, 6-month, and 12-month follow-up were 2 (1.1%), 6 (3.2%), and 10 (5.3%), respectively.Conclusion. This study provides preliminary evidence for the feasibility, safety, and efficacy of the Supraflex sirolimus-eluting stent.

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