The Long-term Clinical Outcomes and Patterns of Transfusion in PCI Patients: Retrospective Cohort Study

Completed

• Conditions: Erythrocyte Transfusion; Percutaneous Coronary Intervention; Revascularization

• Registration Number: NCT03776266
• Lead Sponsor: Samsung Medical Center

Brief Summary

A nationwide retrospective cohort study. To investigate the long-term patterns of transfusion and clinical outcomes of patients undergoing PCI.

Detailed Description

A nationwide retrospective cohort study. Transfusion after PCI may increase a risk, but the long term effects after red blood cell transfusion is known. Longitudinal data is collected from administrative claims in the National Healthcare Insurance Service of Korea. All Korean patient date undergoing PCI inserting stent from January 1, 2011 to December 31, 2011 is extracted. Clinical outcomes until December 31, 2016 is investigated.

Primary outcome is the incidence density of red blood cell transfusion. Secondary outcomes are the association of transfusion with major adverse clinical event (MACE) consisting all-cause death, revascularization, critically ill cardiovascular status, or stroke.

Incidence density and time-dependent Cox proportional hazard regression is statistically analyzed.

Study Timeline

• Study Start: 2018-10-05
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Study First Submitted: 2018-12-13
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-14
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48786

Inclusion Criteria

• All Korean patients undergoing PCI using stent from January 1, 2011 to December 31, 2011

Exclusion Criteria

• Patients without any stent insertion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence density of transfusion	5 years	5-year incidence density of red blood cell transfusion

Secondary Outcome Measures

Name	Time	Method
Incidence density of MACE	5 years	5-year incidence densities of a major adverse clinical event (MACE) consisting of all-cause death, revascularization, critically ill cardiovascular status, and stroke

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Gang nam-Gu, Ilwon-Dong, Korea, Republic of