Bare Metal Stents and Drug Eluting Stents in Patients Who Underwent Blood Transfusion (TFPCI2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03788148|
Recruitment Status : Completed
First Posted : December 27, 2018
Last Update Posted : December 27, 2018
|Condition or disease||Intervention/treatment|
|Erythrocyte Transfusion Percutaneous Coronary Intervention Revascularization||Device: Stent, red blood cell transfusion|
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 Type :||Observational|
|Actual Enrollment :||28322 participants|
|Official Title:||Bare-metal Stents(BMS) Versus Drug-eluting Stents(DES) in Patients Who Underwent Periprocedural Blood Transfusion : A Nationwide Longitudinal Cohort Study|
|Actual Study Start Date :||January 3, 2018|
|Actual Primary Completion Date :||November 30, 2018|
|Actual Study Completion Date :||November 30, 2018|
- Device: Stent, red blood cell transfusion
BMS (Bare Metal Stent) and DES (drug-eluting stent) transplants with periprocedural red blood cell transfusion
- Incidence density of MACE (Major adverse clinical events) [ Time Frame: 3 years ]The first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, and stroke.
- Incidence density of MACE (Major adverse clinical events) [ Time Frame: 1 year ]The first major adverse clinical event(MACE) defined as a composite of all-cause death, revascularization, critically ill cardiovascular status, and stroke.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788148
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Gang nam-Gu, Ilwon-Dong, Korea, Republic of, 135-710|
|Principal Investigator:||Jin-Ho Choi, MD, PhD||Samsung Medical Center|