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NCT03788148 Clinical Trial

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

Percutaneous Coronary Intervention Clinical Trial

— TFPCI2  

Official title:
Bare-metal Stents(BMS) Versus Drug-eluting Stents(DES) in Patients Who Underwent Periprocedural Blood Transfusion : A Nationwide Longitudinal Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03788148
Other study ID # SMC 2017-11-132
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 3, 2018
Est. completion date November 30, 2018

Study information
Verified date December 2018
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 28322
Est. completion date November 30, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Stent, red blood cell transfusion
BMS (Bare Metal Stent) and DES (drug-eluting stent) transplants with periprocedural red blood cell transfusion

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul Gang nam-Gu, Ilwon-Dong

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence density of MACE (Major adverse clinical events) The first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, and stroke. 3 years
Primary Incidence density of MACE (Major adverse clinical events) The first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, and stroke. 1 year
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