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The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent is not inferior to the everolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice.
Everolimus-eluting stent is the most widely used coronary drug-eluting stent in Japan. Biolimus-eluting stent is a new coronary drug-eluting stent, which is going to be approved in 2011 by the Japanese Ministry of Health, Labor and Welfare. It has been reported that biolimus-eluting stent had lower rate of target-lesion revascularization and stent thrombosis at 9 months as compared with paclitaxel-eluting stent. However, trial results comparing biolimus-eluting stent with everolimus-eluting stent are largely unknown. The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent is not inferior to the everolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice. The design of this study is all-comer design enrolling patients scheduled for percutaneous coronary intervention using drug-eluting stents without any exclusion criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biolimus-eluting stent | Active Comparator | Biolimus-eluting stent |
|
| Everolimus-eluting stent | Active Comparator | Everolimus-eluting stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biolimus-eluting stent | Device | Biolimus-eluting stent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| target-lesion revascularization | target-lesion revascularization | 1-year |
| death or myocardial infarction at 3-year after stent implantation | death or myocardial infarction at 3-year after stent implantation | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| all-cause death | death due to any cause | 3-year |
| cardiac death | death due to cardiac origins | 3-year |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takeshi Kimura, MD, PhD | Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiovascular Medicine, Kyoto University Hospital | Kyoto | Kyoto | 606-8507 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29628128 | Derived | Ito S, Watanabe H, Morimoto T, Yoshikawa Y, Shiomi H, Shizuta S, Ono K, Yamaji K, Soga Y, Hyodo M, Shirai S, Ando K, Horiuchi H, Kimura T. Impact of Baseline Thrombocytopenia on Bleeding and Mortality After Percutaneous Coronary Intervention. Am J Cardiol. 2018 Jun 1;121(11):1304-1314. doi: 10.1016/j.amjcard.2018.02.010. Epub 2018 Mar 1. | |
| 29508236 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Everolimus-eluting stent |
| Device |
Everolimus-eluting stent |
|
| acute myocardial infarction | acute myocardial infarction | 3-year |
| stent thrombosis | stent thrombosis defined by Academic Reseach Consortium definition | 3-year |
| stroke | stroke excluding transient ischemic attacks | 3-year |
| bleeding complications | bleeding complications defined by GUSTO and TIMI definitions | 3-year |
| success rate for stent deployment | success rate for stent deployment | 3-year |
| procedure time | procedure time | 3-year |
| clinically-driven target-lesion revascularization | clinically-driven target-lesion revascularization | 3-year |
| non-target-lesion revascularization | non-target-lesion revascularization | 3-year |
| coronary artery bypass grafting | coronary artery bypass grafting | 3-year |
| target-vessel revascularization | target-vessel revascularization | 3-year |
| any repeat coronary revascularization | any repeat coronary revascularization | 3-year |
| composite of cardiac death, acute myocardial infarction in the territory of the target vessel or target-lesion revascularization | composite of cardiac death, acute myocardial infarction in the territory of the target vessel or target-lesion revascularization | 3-year |
| composite of all-cause death, acute myocardial infarction or any repeat coronary revascularization | composite of all-cause death, acute myocardial infarction or any repeat coronary revascularization | 3-year |
| Watanabe H, Morimoto T, Shiomi H, Yoshikawa Y, Kato T, Saito N, Shizuta S, Ono K, Yamaji K, Ando K, Kaji S, Furukawa Y, Akao M, Ishikawa T, Tamura T, Yamamoto Y, Muramatsu T, Suwa S, Nakagawa Y, Kadota K, Takatsu Y, Nishikawa H, Hiasa Y, Hayashi Y, Miyazaki S, Kimura T. Mortality impact of post-discharge myocardial infarction size after percutaneous coronary intervention: a patient-level pooled analysis from the 4 large-scale Japanese studies. Cardiovasc Interv Ther. 2019 Jan;34(1):47-58. doi: 10.1007/s12928-018-0517-x. Epub 2018 Mar 5. |
| 26446596 | Derived | Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, Akasaka T, Igarashi K, Tanabe K, Morino Y, Ishikawa T, Nishikawa H, Awata M, Abe M, Okada H, Takatsu Y, Ogata N, Kimura K, Urasawa K, Tarutani Y, Shiode N, Kimura T. Final 3-Year Outcome of a Randomized Trial Comparing Second-Generation Drug-Eluting Stents Using Either Biodegradable Polymer or Durable Polymer: NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-Eluting Stent Trial. Circ Cardiovasc Interv. 2015 Oct;8(10):e002817. doi: 10.1161/CIRCINTERVENTIONS.115.002817. |
| 24687156 | Derived | Natsuaki M, Kozuma K, Morimoto T, Shiomi H, Kimura T. Two-year outcome of a randomized trial comparing second-generation drug-eluting stents using biodegradable or durable polymer. JAMA. 2014 May;311(20):2125-7. doi: 10.1001/jama.2014.3584. No abstract available. |
| 23684673 | Derived | Natsuaki M, Kozuma K, Morimoto T, Kadota K, Muramatsu T, Nakagawa Y, Akasaka T, Igarashi K, Tanabe K, Morino Y, Ishikawa T, Nishikawa H, Awata M, Abe M, Okada H, Takatsu Y, Ogata N, Kimura K, Urasawa K, Tarutani Y, Shiode N, Kimura T; NEXT Investigators. Biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent: a randomized, controlled, noninferiority trial. J Am Coll Cardiol. 2013 Jul 16;62(3):181-190. doi: 10.1016/j.jacc.2013.04.045. Epub 2013 May 15. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |