Coronary Artery Disease
Conditions
Keywords
Everolimus, Sirolimus, Zotarolimus, Biolimus, Drug-eluting stent
Brief summary
The objective of this study is to evaluate the long-term efficacy and safety of coronary stenting with the various types of drug-eluting stents (DES) and to determine clinical device and procedural success during commercial use of DES in the real world. The investigators will compare EES (Xience V/Promus and Xience Prime), SES (Cypher), ZES (Resolute Integrity, Endeavor Resolute, Endeavor), and BES (Biomatrix, Biomatrix Flex, and Nobori).
Detailed description
The Grand Drug-Eluting Stent (Grand-DES) Registry incorporated five different multicenter registries in South Korea. The EXCELLENT prospective cohort and the EXCELLENT-PRIME registry were dedicated for durable polymer-coated everolimus-eluting stents (DP-EES; Xience V/Promus and Xience Prime) or 1st-generation sirolimus-eluting stents (Cypher), the HOST-RESOLINTE and RESOLUTE-Korea registry for durable polymer-coated zotarolimus-eluting stents (DP-ZES; Resolute Integrity and Endeavor Resolute) or 1st-generation Endeavor-ZES, and the HOST-BIOLIMUS-3000-Korea registry for biodegradable polymer-coated biolimus-eluting stents (BP-BES; Biomatrix, Biomatrix Flex, and Nobori). During the period of 2008 through 2014, all registries enrolled all-comers without any exclusion criteria except patient's withdrawal of consent.
Interventions
DEVICEBiomatrix; Biomatrix Flex; Nobori
Biodegradable polymer-coated biolimus-eluting stents
DEVICEXience Prime
Durable polymer-coated everolimus-eluting stents
DEVICEXience V/Promus; Cypher
Durable polymer-coated everolimus-eluting stents; Sirolimus-eluting stents
DEVICEDP-ZES-RI
Durable polymer-coated zotarolimus-eluting stents
DEVICEEndeavor; Resolute
Durable polymer-coated zotarolimus-eluting stents
Sponsors
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The patient agrees to participate in this study by signing the informed consent form. * Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure | 36 months | A composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death | 36 months | All-cause death |
| Cardiac death | 36 months | Cardiac death |
| All-cause myocardial infarction | 36 months | All-cause myocardial infarction |
| Target-vessel myocardial infarction | 36 months | Target-vessel myocardial infarction |
| Patient-oriented composite outcome | 36 months | A composite of all-cause death, all-cause myocardial infarction, and any repeat revascularization |
| Clinically-driven target vessel revascularization | 36 months | Clinically-driven target vessel revascularization |
| Clinically-driven target lesion revascularization | 36 months | Clinically-driven target lesion revascularization |
| Definite or probable stent thrombosis | 36 months | Definite or probable stent thrombosis |
| Any repeat revascularization | 36 months | Any repeat revascularization |
Countries
South Korea
Outcome results
None listed