Stent Placement and the Risk of New-onset AF in Patients With AMI

• Conditions: Acute Myocardial Infarction; Atrial Fibrillation New Onset
• Interventions: Device: DES or BMS

• Registration Number: NCT03382990
• Lead Sponsor: Mackay Memorial Hospital

Brief Summary

The benefit of a drug-eluting stent (DES) in patients with acute myocardial infarction (AMI) is controversial. This study will aim to observe the effect of a DES on the risk of new-onset AF in patients with AMI.

Detailed Description

Acute myocardial infarction (AMI) is the leading cause of mortality in the world. Early invasive strategy with percutaneous coronary intervention (PCI) has been demonstrated to be the most effective strategy to treat AMI. Although drug-eluting stent (DES) has not shown benefits to reduce mortality rate among AMI patients compared with bare-metal stent (BMS), the use of DES in real-world is increasing because of reduced restenosis rates. AMI patients are at higher risk to develop atrial fibrillation (AF) than general population. However, whether early PCI with DES implantation is related to a reduced risk of AF still remains unclear. The purpose of this study is to investigate the association of DES implantation and the risk of AF among patients with AMI treated by early PCI.

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-19
• Last Update Submitted: 2017-12-19
• Study First Posted: 2017-12-26
• Last Update Posted: 2017-12-26
• Study Start: 2018-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40000

Inclusion Criteria

• Patients were enrolled by primary diagnostic coding as acute myocardial infarction and treatment coding as receiving PCI between 2007 and 2013 in Taiwan National Health Insurance Research Database (NHIRD)

Exclusion Criteria

1. Less than 20-years-old; Unknown sex and age
2. Not residents in Taiwan
3. Died during AMI admission
4. Previous history of AF
5. Receiving coronary artery bypass grafting (CABG), ventricular assist device (VAD), extracorporeal membrane oxygenation (ECMO), and heart transplantation during observational and/or database period
6. No stent implantation during PCI
7. Unknown stent types

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
STEMI	DES or BMS	Patients with STEMI treated with PCI and stent placement (DES or BMS)
NSTEMI	DES or BMS	Patients with NSTEMI treated with PCI and stent placement (DES or BMS)

Primary Outcome Measures

Name	Time	Method
new-onset atrial fibrillation	one year	new record or diagnostic claims of atrial fibrillation after hospital discharge from acute myocardial infarction