Clinical trial NCT06130709: IRAF-ABLATION Study: a Multicenter International Retrospective Cohort of Patients With BTK Inhibitors-related AF Treated by Catheter Ablation
Official title: IRAF-ABLATION Study: a Multicenter International Retrospective Cohort of Patients With BTK Inhibitors-related AF Treated by Catheter Ablation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: BTKi-induced Atrial Fibrillation
Hematologic Malignancy
Atrial Fibrillation Catheter Ablation
Keywords: atrial fibrillation
Bruton tyrosine kinase inhibitors
catheter ablation,
atrial fibrillation recurrence
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult population treated with iBTK for hematologic malignancy and who developped BTKi-induced atrial fibrillation treated by cathter ablation.

Brief summary: Targeted anticancer drugs have completely changed the prognosis of malignancies during the past decades. Patients suffering from malignancies live longer and this allows adverse events of anticancer drugs to emerge, notably cardiovascular adverse events. It is particularly important because of the great morbimortality of major cardiovascular events like myocardial infarction or stroke and because of their frequency in cancer populations. Indeed, cardiovascular death is the second cause of deaths after malignancy itself in this population. Atrial fibrillation (AF) is a non rare cardiovascular adverse events associated with a shorter overall survival in some malignancies localization. The emblematic anticancer drugs promoting AF is ibrutinib belonging to the Bruton tyrosine kinase inhibitors (BTKi), which are indicated in hematological malignancies. Incidence of AF with ibrutinib is estimated to 4.92/100 person-years; 95% CI: 2.91-4.81 but is underestimated because of the absence of systematic electrocardiogram recording. The management of AF rests on anticoagulation if indicated by the CHA2DS2-VASc score, and on the choice between a rate or rhythm control strategy. Rate control is the privileged strategy because of the risk of drugs interactions of the anti-arrhythmic drugs in a context of anticancer drugs co-prescriptions. But in case of symptoms with normal heart rate, life expectancy counted in years and preserved condition, catheter ablation has to be discussed. Whereas this interventional procedure has been greatly studied in the general population, no study exists in patients with hematological malignancies. The investigators aim to describe baseline characteristics of a population of BTKi-induced AF undergone AF catheter ablation.

Detailed description: Targeted anticancer drugs have completely changed the prognosis of malignancies during the past decades. Patients suffering from malignancies live longer and this allows adverse events of anticancer drugs to emerge, notably cardiovascular adverse events. It is particularly important because of the great morbimortality of major cardiovascular events like myocardial infarction or stroke and because of their frequency in cancer populations. Indeed, cardiovascular death is the second cause of deaths after malignancy itself in this population. Atrial fibrillation (AF) is a non rare cardiovascular adverse events associated with a shorter overall survival in some malignancies localization. The emblematic anticancer drugs promoting AF is ibrutinib belonging to the Bruton tyrosine kinase inhibitors (BTKi), which are indicated in hematological malignancies. Incidence of AF with ibrutinib is estimated to 4.92/100 person-years; 95% CI: 2.91-4.81 but is underestimated because of the absence of systematic electrocardiogram recording. The management of AF rests on anticoagulation if indicated by the CHA2DS2-VASc score, and on the choice between a rate or rhythm control strategy. Rate control is the privileged strategy because of the risk of drugs interactions of the anti-arrhythmic drugs in a context of anticancer drugs co-prescriptions. But in case of symptoms with normal heart rate, life expectancy counted in years and preserved condition, catheter ablation has to be discussed. Whereas this interventional procedure has been greatly studied in the general population, no study exists in patients with hematological malignancies. The investigators aim to describe baseline characteristics of a population of BTKi-induced AF undergone AF catheter ablation.

Eligibility criteria: Inclusion Criteria:

* every adult patient treated by BTKi for a hematological malignancy
* with a new onset recurrence of AF occurring after BTKi initiation and treated by catheter ablation
* with an available 12 months follow up after catheter ablation

Exclusion Criteria:

* Patients younger than 18 years old
* Severe mitral regurgitation/stenosis or rhumatismal heart disease whatever the grade
* Permanent AF
* Patient who had AF rhythm during the first administration of BTKi

Primary outcomes:
measure: Description of the one-year AF recurrence rate after catheter ablation in a population of BTKi induced AF
timeFrame: 1 year follow-up from the catheter ablation date
Secondary outcomes:
measure: Description of the baseline characteristic of the population of BTKi induced AF with AF catheter ablation carried out
timeFrame: At inclusion (= the time of ablation date)
measure: Description of atrial electrophysiological properties during AF catheter ablation in a population of BTKi induced AF
timeFrame: At inclusion (= the time of ablation date)
measure: Description of AF catheter ablation complications at 3 months follow-up in a population of BTKi induced AF (MACE, sepsis, bleeding, hospitalization prolongation, hospitalization readmission, mortality)
timeFrame: 3 months follow-up from the ablation date
measure: Identification of baseline parameters and electrophysiologic parameters associated with AF recurrence at 12 months follow-up
timeFrame: 1 year follow-up from the catheter ablation date
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
state: Normandy
Study officials:
affiliation: Caen Normandy University Hospital, France
name: Joachim ALEXANDRE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alexandre J, Salem JE, Moslehi J, Sassier M, Ropert C, Cautela J, Thuny F, Ederhy S, Cohen A, Damaj G, Vilque JP, Plane AF, Legallois D, Champ-Rigot L, Milliez P, Funck-Brentano C, Dolladille C. Identification of anticancer drugs associated with atrial fibrillation: analysis of the WHO pharmacovigilance database. Eur Heart J Cardiovasc Pharmacother. 2021 Jul 23;7(4):312-320. doi: 10.1093/ehjcvp/pvaa037.
citation: Lyon AR, Lopez-Fernandez T, Couch LS, Asteggiano R, Aznar MC, Bergler-Klein J, Boriani G, Cardinale D, Cordoba R, Cosyns B, Cutter DJ, de Azambuja E, de Boer RA, Dent SF, Farmakis D, Gevaert SA, Gorog DA, Herrmann J, Lenihan D, Moslehi J, Moura B, Salinger SS, Stephens R, Suter TM, Szmit S, Tamargo J, Thavendiranathan P, Tocchetti CG, van der Meer P, van der Pal HJH; ESC Scientific Document Group. 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS). Eur Heart J. 2022 Nov 1;43(41):4229-4361. doi: 10.1093/eurheartj/ehac244. No abstract available.
citation: Agarwal S, Munir MB, Krishan S, Yang EH, Barac A, Asad ZUA. Outcomes and readmissions in patients with cancer undergoing catheter ablation for atrial fibrillation. Europace. 2023 Aug 2;25(9):euad263. doi: 10.1093/europace/euad263. No abstract available.