Bare Metal Stents and Drug Eluting Stents in Patients Who Underwent Blood Transfusion

Completed

• Conditions: Revascularization; Percutaneous Coronary Intervention; Erythrocyte Transfusion

• Registration Number: NCT03788148
• Lead Sponsor: Samsung Medical Center

Brief Summary

Retrospective cohort study of Korean National Healthcare Insurance Database. To investigate clinical outcomes of bare metal stents versus drug eluting stents in patients who underwent periprocedural red blood cell transfusion.

Detailed Description

A Korean nationwide, multi-center, retrospective observational cohort study.

The receipt of red blood cell transfusion is at high risk of cardiac events or death. But little is know regarding the comparative outcomes of BMS and DES implantation in patients who underwent periprocedural red blood cell transfusion.

Longitudinal data is collected from administrative claims in the national health insurance services of Korea. All Korean data(N=500,591) undergoing PCI from 2006 to 2015 is extracted. BMS or DES Patients(N=28,322) who received periprocedural red blood cell transfusion is investigate. Clinical outcomes until December 31, 2017 is investigate.

Primary endpoint is a time to the first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, or stroke.

Study Timeline

• Study Start: 2018-01-03
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2018-12
• Study First Submitted: 2018-12-14
• Study First Submitted QC: 2018-12-26
• Last Update Submitted: 2018-12-26
• Study First Posted: 2018-12-27
• Last Update Posted: 2018-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28322

Inclusion Criteria

• Patients with percutaneous coronary intervention from 2006 to 2015
• Patients with the implantation of BMS or DES
• Patients with the receipt of periprocedural red blood cell transfusion

Exclusion Criteria

• Patients without any of stent implantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence density of MACE (Major adverse clinical events)	1 year	The first major adverse clinical event(MACE) defined as a composite 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