MultiCenter expeRience in AFib Patients Treated With OAC (CRAFT)

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation, Non-vitamin K Oral Anticoagulants, Vitamin K Antagonists, ROCKET-AF, RE-LY, ARISTOTLE

Brief summary

According to current guidelines for non-valvular atrial fibrillation treatment, the first line drugs are non-vitamin K oral anticoagulants (NOACs), which are preferred over vitamin K antagonists (VKAs). However, it is not clearly confirmed, how the success of NOACs approval trials (ROCKET-AF (rivaroxaban), RE-LY (dabigatran) and ARISTOTLE (apixaban) reflects on real-life clinical practice. The aim of this study is to assess treatment of AF patients with oral anticoagulants (OACs) in an academic and district hospital, with regard to inclusion/exclusion criteria used in the clinical trials.

Detailed description

Atrial fibrillation (AF) is a common arrhythmia associated with increased cardiovascular morbidity and mortality. An integral element of management of patients with AF is anticoagulation to prevent thromboembolic events. Non-vitamin K oral anticoagulants and vitamin K antagonists are two main drugs groups used in treatment. Primary objective of the study is to assess the treatment of AF patients with OACs (the frequency of prescription of VKAs vs NOACs), compare the clinical characteristics of the real-life AF patients with populations included in the randomized clinical trials (ROCKET-AF, RE-LY and ARISTOTLE) and population gathered from the university department and the district hospital. Secondary objective of the study is to assess the long-term outcomes of patients with AF treated with OACs. The CRAFT (MultiCenter expeRience in AFib patients Treated with OAC) is a multicenter retrospective analysis of hospital records of patients with AF managed in the First Department of Cardiology of Medical University of Warsaw and in John Paul II Western Hospital in Grodzisk Mazowiecki. Gathered data will include demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline characteristics (i.e. blood pressure), laboratory investigations (blood tests, including renal and hepatic function), echocardiographic parameters and concomitant medications. Data will be collected from the moment of patient's discharge. Each patient will be evaluated regarding to common and new scales assessing risk of thromboembolic (CHA2DS2-VASc ) and bleeding (HAS-BLED, HEMORR2HAGES, modifiable and non-modifiable risk factors for bleeding in anticoagulated patients basing on the current guidelines for AF treatment) events, as well as SAMeTT2R2 score to predict the quality of treatment on OACs.

Rutkowski K, Krzowski B, Balsam P, Grabowski M, Kraj L, Maciejewski C, Lodziński P, Peller M.

2026-01-04

10.12659/msm.951355

Hemorrhagic Complications in Patients with Atrial Fibrillation Treated with Novel Oral Anticoagulants: Results from the CRAFT Study.

Styczkiewicz M, Wawrzeńczyk M, Sukiennik A, Krzowski B, Maciejewski C, Lodziński P, Kraj L, Opolski G, Grabowski M, Balsam P, Peller M.

2025-12-27

10.3390/jcm15010229

Practical use case of natural language processing for observational clinical research data retrieval from electronic health records: AssistMED project.

Maciejewski C, Ozierański K, Basza M, Barwiołek A, Ciurla M, Bożym A, Krajsman MJ, Lodziński P, Opolski G, Grabowski M, Cacko A, Balsam P.

2024-03-191 citations

10.20452/pamw.16704

Clinical outcomes and predictors of long-term mortality, hemorrhagic and thromboembolic events in atrial fibrillation patients at different stages of chronic kidney disease: The CRAFT trial.

Styczkiewicz M, Wawrzeńczyk M, Peller M, Krzowski B, Maciejewski C, Lodziński P, Kraj L, Opolski G, Grabowski M, Balsam P.

2023-11-211 citations

10.1016/j.ijcha.2023.101306

Administrative Data in Cardiovascular Research—A Comparison of Polish National Health Fund and CRAFT Registry Data

Cezary Maciejewski, Krzysztof Ozierański, Mikołaj Basza, Piotr Lodziński, Andrzej Śliwczyński et al. (13 authors)

International Journal of Environmental Research and Public Health2022-09-223 citations

10.3390/ijerph191911964

District versus academic hospital – clinical outcomes of patients with atrial fibrillation. MultiCenter expeRience in Atrial Fibrillation Patients Treated With Oral Anticoagulants (CRAFT) study

Piotr Lodziński, Monika Gawałko, Leszek Kraj, Andrzej Śliwczyński, Cezary Maciejewski et al. (12 authors)

Polskie Archiwum Medycyny Wewnętrznej2021-07-024 citations

10.20452/pamw.16053

Antithrombotic Management and Long-Term Outcomes of Patients with Atrial Fibrillation. Insights from CRAFT Trial

Paweł Balsam, Piotr Lodziński, Monika Gawałko, Leszek Kraj, Andrzej Śliwczyński et al. (12 authors)

Journal of Clinical Medicine2021-04-193 citations

10.3390/jcm10081780

Randomized controlled clinical trials versus real-life atrial fibrillation patients treated with oral anticoagulants. Do we treat the same patients?

Balsam P, Tymińska A, Ozierański K, Zaleska M, Żukowska K, Szepietowska K, Maciejewski K, Peller M, Grabowski M, Lodziński P, Kołtowski Ł, Praska-Ogińska A, Zaboyska I, Bednarski J, Filipiak KJ, Opolski G.

2018-11-084 citations

10.5603/cj.a2018.0135

Clinical characteristics and thromboembolic risk of atrial fibrillation patients with and without congestive heart failure. Results from the CRATF study

Paweł Balsam, Monika Gawałko, Michał Peller, Agata Tymińska, Krzysztof Ozierański et al. (16 authors)

Medicine2018-11-0113 citations

10.1097/md.0000000000013074

Comparison of clinical characteristics of real-life atrial fibrillation patients treated with vitamin K antagonists, dabigatran, and rivaroxaban: results from the CRAFT study.

Balsam P, Ozierański K, Tymińska A, Żukowska K, Zaleska M, Szepietowska K, Maciejewski K, Peller M, Grabowski M, Lodziński P, Praska-Ogińska A, Zaboyska I, Kołtowski Ł, Kowalczuk A, Bednarski J, Filipiak KJ, Opolski G.

2018-01-1912 citations

10.5603/kp.a2018.0027

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* paroxysmal, persistent, long-standing persistent or permanent AF * valvular or non-valvular AF * treatment with OACs (apixaban, dabigatran, rivaroxaban, acenocoumarol, warfarin)

Exclusion criteria

* lack of OAC at hospital discharge

Design outcomes

Primary

Measure	Time frame	Description
Comparison of clinical characteristics of the real-life AF patients with populations included in the randomized clinical trials (ROCKET-AF, RE-LY and ARISTOTLE)	Through the study completion, an average of 3 months.	Compared data will include: demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline characteristics, laboratory investigations, echocardiographic parameters and concomitant medications. Each patient will be evaluated regarding to the modifiable and non-modifiable risk factors for bleeding basing on the current guidelines for AF treatment, CHA2DS2-VASc, HAS-BLED, HEMORR2HAGES scales and SAMeTT2R2 score.
Comparison of clinical characteristics of the AF patients treated in university department with population gathered from the district hospital	Through the study completion, an average of 3 months.	Compared data will include: demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline characteristics, laboratory investigations, echocardiographic parameters and concomitant medications. Each patient will be evaluated regarding to the modifiable and non-modifiable risk factors for bleeding basing on the current guidelines for AF treatment, CHA2DS2-VASc, HAS-BLED, HEMORR2HAGES scales and SAMeTT2R2 score.

Secondary

Measure	Time frame
Assessment of the frequency of VKAs vs NOACs prescription in AF patients treatment of with OACs	Through the study completion, an average of 3 months.
Assessment of long-term outcomes (death, hospitalizations, minor/major/life-threatening bleeding, thromboembolic events)	Through the study completion, an average of 3 months.

Countries

Poland

Contacts

Primary ContactPaweł Balsam, PhD

pawel.balsam@me.com605 152 120

Backup ContactKrzysztof Ozierański, MD

krzysztof.ozieranski@gmail.com509 996 947

Outcome results