Comparison of Outcomes After Left Atrial Appendage Closure or Oral Anticoagulation in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Comparison of Clinical Outcomes After Left Atrial Appendage Closure or Oral Anticoagulation in Patients With Atrial Fibrillation: A Retrospective Propensity Matched Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787525
• Other study ID #: 2016-00630
• Status: Completed
• Phase: N/A
• First received: May 25, 2016
• Last updated: January 2, 2017
• Start date: July 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

The aim of the study is to compare intermedium-term clinical outcomes, including thromboembolic events and bleeding complications between patients with non-valvular atrial fibrillation treated with either oral anticoagulation or who had undergone LAA-closure (left atrial closure).

A questionnaire is sent to the patients and if there is some information missing or unclear, the investigators will contact the patient or the treating physicians to get the missing/unclear information.

The study population consists of 500 patients with non-valvular atrial fibrillation (AF) who underwent LAAC between the years 2009 and 2014 in two centers (the Bern University hospital und Zurich University hospital) and a similar group of 500 patients with non-valvular AF treated with oral anticoagulation (OAC).

In order to compare the two groups and reducing the bias due to confounding variables, a propensity score matching will be performed.

Study hypothesis is that left atrial appendage closure is non-inferior in terms of efficacy and safety in comparison to lifelong oral anticoagulation in patients with non-valvular atrial fibrillation.

Description:

Non-valvular atrial fibrillation is the most common arrhythmia with an estimated prevalence of 1-2% in the general population, increasing with age. Patients with AF are at increased risk of thromboembolism, in particular ischemic stroke.

LAAC seems at the actual knowledge to be a valid alternative to OAC. The objective of this study is to compare intermedium-term clinical outcomes, including thromboembolic events and bleeding complications between patients receiving Amplatzer devices vs. propensity score matched patients treated with OAC.

A questionnaire is sent to the patients asking about thrombo-embolic events, stroke, death, any bleeding but also on their current medication, comorbidities (i.e. arterial hypertension, diabetes mellitus, renal impairment and liver disease), any hospitalizations and their quality of life. If there is some information missing or unclear, the investigators will contact the patient or the treating physicians to get the missing information.

The study is an investigator-initiated, retrospective analysis of prospectively collected data. The study population consists of 500 patients with non-valvular AF who underwent LAAC between the years 2009 and 2014 in two centers (the Bern University hospital und Zurich University hospital) and a propensity score matched patients group of 500 patients with non-valvular AF treated with OAC.

Covariates for matching will be age, gender, renal function, coronary artery disease and its status of revascularization, left-ventricular function, HAS-BLED and CHA2DS2-VASc-Score.

Study hypothesis is that left atrial appendage closure is non-inferior in terms of efficacy and safety in comparison to lifelong oral anticoagulation in patients with non-valvular atrial fibrillation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >/= 18 years

• Written informed consent to participate in the study

• Paroxysmal, persistent, or permanent non-valvular atrial fibrillation.

• Group A ("OAC"): Having been hospitalized between 2009 and 2014 in the Bern university hospital and discharged with either OAC or NOAC.

• Group B (LAA-closure): Underwent LAAC between 2009 and 2014 at the University hospitals Bern or Zurich

Exclusion Criteria:

• No full data on matching criteria (which are described below under "study design")

• Only for group A: Not matched patients having been dropped out after the propensity score matching

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Questionnaire
A clinical sweep follow up will be performed in all patients of both groups and results will be analyzed. It will be in form of a standardized questionnaire and if necessary telephone interviews asking about thrombo-embolic events, stroke, death, any bleeding but also on their current medication, comorbidities (i.e. arterial hypertension, diabetes mellitus, renal impairment and liver disease), any hospitalizations and their quality of life. For all events, the source documents will be gathered from general physicians, cardiologists, hospitals or registry offices. The questionnaire will be sent by mail to the patients. If information is missing or unclear, patients and if necessary their treating physician will be contacted by phone.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

References & Publications (4)

Nietlispach F, Gloekler S, Krause R, Shakir S, Schmid M, Khattab AA, Wenaweser P, Windecker S, Meier B. Amplatzer left atrial appendage occlusion: single center 10-year experience. Catheter Cardiovasc Interv. 2013 Aug 1;82(2):283-9. doi: 10.1002/ccd.24872. — View Citation

Reddy VY, Möbius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013 Jun 25;61(25):2551-6. doi: 10.1016/j.jacc.2013.03.035. — View Citation

Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators.. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192. Erratum in: JAMA. 2015 Mar 10;313(10):1061. — View Citation

Tzikas A, Shakir S, Gafoor S, Omran H, Berti S, Santoro G, Kefer J, Landmesser U, Nielsen-Kudsk JE, Cruz-Gonzalez I, Sievert H, Tichelbäcker T, Kanagaratnam P, Nietlispach F, Aminian A, Kasch F, Freixa X, Danna P, Rezzaghi M, Vermeersch P, Stock F, Stolcova M, Costa M, Ibrahim R, Schillinger W, Meier B, Park JW. Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug. EuroIntervention. 2016 Feb;11(10):1170-9. doi: 10.4244/EIJY15M01_06. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of intermedium-term clinical outcomes, including thromboembolic events and bleeding complications in patients receiving Amplatzer devices vs. propensity score matched patients treated with OAC.		Clinical sweep follow up, the mean follow-up will be approximately 3 years	No