Registry to Evaluate Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting

Seoul National University Hospital3,056 enrolled

Overview

The objective of this study is to evaluate the safety and long-term effectiveness of coronary stenting with the everolimus-eluting stent (EES) and to determine clinical device and procedural success during commercial use of EES in the real world. The investigators will compare EES (Xience/Promus, prospective arm) with sirolimus-eluting stent (SES, Cypher, retrospective arm).

Study Type

OBSERVATIONAL

Enrollment

3,056

Conditions

Coronary Artery Disease

Interventions

Xience/PromusDEVICE

Active prospective registration of patients receiving everolimus-eluting stent

CypherDEVICE

Retrospective historical controls that received sirolimus-eluting stent

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (18)

Dankook University Hospital

Cheonan, South Korea

Soon Chun Hyang University Hospital Cheonan

Cheonan, South Korea

Outcomes

Primary Outcomes

Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)

Time frame: 12 months

Secondary Outcomes

In-stent & In-segment Late Loss

Time frame: 9 months

Stent Thrombosis

Time frame: 1 year

Target Vessel Failure (composite of cardiac death, MI, and TVR)

Time frame: 12 months

Any death, cardiac death, MI, TLR, TVR

Time frame: 1 year

Composite rate of cardiac death and any MI

Time frame: 1 year

Composite rate of all death and any MI

Time frame: 1 year

Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization

Time frame: 1 year

Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy

Time frame: 1 year

Clinical device and procedural success

Time frame: During the health care facility stay

Data from ClinicalTrials.gov

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