Management of Patients With Atrial Fibrillation Undergoing Coronary Artery Stenting

Completed

• Conditions: Percutaneous Coronary Intervention; Atrial Fibrillation; Oral Anticoagulation
• Interventions: Procedure: PCI

• Registration Number: NCT00596570
• Lead Sponsor: University of Turku

Brief Summary

Treatment of patients suffering from atrial fibrillation pose problems when percutaneous coronary intervention with stent implantation (PCI-S) is performed. In the absence of solid evidence-based data, no definite recommendations for the management of this patient subset are currently given in the guidelines on percutaneous coronary intervention issued by the most prominent Cardiology Associations. The management of the antithrombotic treatment before invasive cardiac procedures is also incompletely defined. In this study we aim to determine in patients with atrial fibrillation undergoing PCI-S:

1. the contemporary antithrombotic management;

2. the relative safety and efficacy of the various post-PCI antithrombotic regimens;

3. the safety and efficacy of drug-eluting stents (DES), bare-metal stents (BMS), and bioactive stents (BAS);

4. the safety of various periprocedural antithrombotic strategies including glycoprotein IIb/IIIa inhibitors and bivalirudin;

5. safety and efficacy of radial vs femoral approach.

Detailed Description

AFCAS study is an observational, multi-center, prospective registry including patients with atrial fibrillation undergoing PCI-S. Follow-up time is 12 months.

Primary end points are major hemorrhagic and thrombotic/thromboembolic complications including cardiac death and secondary endpoints are Major adverse cardiac events (i.e., need for urgent re-revascularization, myocardial infarction, death), stent thrombosis and major/non major hemorrhagic complications. Clinical follow-up will be completed for all patients via telephone, or clinic visits scheduled at 1, 3, 6, and 12 months after PCI-S. The 1 and 6 months visits are optional. The patients will be asked about their clinical outcomes, hospitalizations and medications. Any additional information needed, such as specific mortality, will be obtained by contacting one of the patient's physicians or other health care professional or from death certificates. CRFs will be completed and faxed without delays after discharge, and after each follow up visit. Recruitment will take approximately 12 months. Follow-up will be 12 months for each patient.

Study Timeline

• Study Start: 2007-01
• Status Verified: 2007-12
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-08
• Study First Posted: 2008-01-17
• Study Completion: 2010-02
• Last Update Submitted: 2010-06-29
• Last Update Posted: 2010-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 996

Inclusion Criteria

• Patients with atrial fibrillation who undergo PCI.

Exclusion Criteria

• Because of the observational design, no exclusion criteria are provided.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	PCI	Patient with atrial fibrillation who underwent PCI

Primary Outcome Measures

Name	Time	Method
major hemorrhagic and thrombotic/thromboembolic complications including cardiac death	one year

Trial Locations

Locations (1)

Juhani Airaksinen; 🇫🇮 Turku, Finland