The Compliance of DAPT and Statins on Clinical Outcomes in Percutaneous Coronary Intervention Patients

Study Overview
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Brief Summary
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A nationwide retrospective cohort study. To investigate the real world medication compliance and the relation with clinical outcomes. The persistence and compliance to dual anti-platelet therapy(DAPT) and dyslipidemia agents are important for the patients undergoing percutaneous coronary intervention. But, the discontinuation and compliance rate are unknown in the real world setting.

Detailed Description
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A nationwide retrospective cohort study. The persistence and compliance to dual anti-platelet therapy(DAPT) and dyslipidemia agents are important for the patients undergoing percutaneous coronary intervention. The discontinuation and uncompliance may increase a risk. But, the discontinuation and compliance rate are not well known in the real world patients undergoing bare metal stents(BMS) and drug eluting stents(DES) insertion. To investigate the real world medication compliance and the relation with clinical outcomes, administrative claim data was extracted from the Korean National Healthcare Insurance(KNHI) database. All Korean patient date undergoing PCI from January 1, 2011 to December 2011 is extracted. 5 year clinical outcomes are investigated. Primary outcomes are the MACE including all-cause death, revascularization, critically ill status, and stroke) classified by the medication compliance. Medication complinace is measured by proportion of days covered(PDC) Secondary outcomes are the patterns of medication persistence and its outcomes to understand critical points.

Official Title
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The Effect of Persistence and Compliance of Antiplatelet and Dyslipidemia Agents on Cardiovascular Outcomes in Real World Patients Undergoing Percutaneous Coronary Intervention

Conditions
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Platelet Aggregation Inhibitors, Hydroxymethylglutaryl-coa Reductase Inhibitors, Compliance, Medication, Adherence, Medication, Persistence, Medication, Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: DAPT, Statin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. All claim of percutaneous coronary intervention using stent in the National Healthcare Insurance Service of Korea between January 1st 2011 and December 31st, 2011 Exclusion Criteria: No use of stents Stent not classified into DES or BMS Use of DES and BMS together at the same initial day

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DAPT, Statin|Compliance of DATP, Compliance of Statin, Drug Eluting Stent, Bare Metal Stent|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence density of MACE | 5 year incidence densities of a major adverse clinical events(MACEs) consisting of all-cause death, revascularization, critically ill status and stroke. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance defined as a proportion of days covered (%) | PDC (Proportion of days covered) | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DAPT, Statin, Compliance, Persistence, Adherence, PCI