Korean Nationwide Multicenter Pooled Registry of Drug-Eluting Stents

Study Overview
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Brief Summary
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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
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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.

Official Title
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Korean Nationwide Multicenter Pooled Registry of Drug-Eluting Stents

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Biomatrix; Biomatrix Flex; Nobori
* Device: Xience Prime
* Device: Xience V/Promus; Cypher
* Device: DP-ZES-RI
* Device: Endeavor; Resolute


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria for this registry.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HOST-BIOLIMUS-Korea-3000<br>Active prospective registration of patients receiving biodegradable polymer-coated biolimus-eluting stents (BP-BES; Biomatrix, Biomatrix Flex, Nobori) | Device: Biomatrix; Biomatrix Flex; Nobori<br>* Biodegradable polymer-coated biolimus-eluting stents<br>* Other names: BP-BES;|
| EXCELLENT-PRIME<br>Active prospective registration of patients receiving durable polymer-coated everolimus-eluting stents (DP-EES; Xience Prime) | Device: Xience Prime<br>* Durable polymer-coated everolimus-eluting stents<br>* Other names: DP-EES-Prime;|
| EXCELLENT Prospective cohort<br>Active prospective registration of patients receiving durable polymer-coated everolimus-eluting stents and sirolimus-eluting stents (Xience V/Promus; Cypher) | Device: Xience V/Promus; Cypher<br>* Durable polymer-coated everolimus-eluting stents; Sirolimus-eluting stents<br>* Other names: DP-EES; SES;|
| HOST-RESOLINTE<br>Active prospective registration of patients receiving durable polymer-coated zotarolimus-eluting stents (DP-ZES-RI; Resolute Integrity) | Device: DP-ZES-RI<br>* Durable polymer-coated zotarolimus-eluting stents<br>* Other names: Resolute Integrity;|
| RESOLUTE-Korea<br>Active prospective registration of patients receiving durable polymer-coated zotarolimus-eluting stents (DP-ZES; Endeavor; Resolute) | Device: Endeavor; Resolute<br>* Durable polymer-coated zotarolimus-eluting stents<br>* Other names: DP-ZES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure | A composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target lesion revascularization | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-oriented composite outcome | A composite of all-cause death, all-cause myocardial infarction, and any repeat revascularization | 36 months | 
| All-cause death | All-cause death | 36 months | 
| Cardiac death | Cardiac death | 36 months | 
| All-cause myocardial infarction | All-cause myocardial infarction | 36 months | 
| Target-vessel myocardial infarction | Target-vessel myocardial infarction | 36 months | 
| Any repeat revascularization | Any repeat revascularization | 36 months | 
| Clinically-driven target vessel revascularization | Clinically-driven target vessel revascularization | 36 months | 
| Clinically-driven target lesion revascularization | Clinically-driven target lesion revascularization | 36 months | 
| Definite or probable stent thrombosis | Definite or probable stent thrombosis | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Everolimus, Sirolimus, Zotarolimus, Biolimus, Drug-eluting stent