Atrial Fibrillation Clinical Trial
Official title:
Management of Patients With Atrial Fibrillation Undergoing Coronary Artery Stenting: A Multicenter, Prospective Registry
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.
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.
;
Observational Model: Cohort, Time Perspective: Prospective
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