Evidence map›Paper›PMID 33728429›Full record

Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2021

Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation.

Malte Kuniss, Nikola Pavlovic, Vedran Velagic, Jean Sylvain Hermida, Stewart Healey, Giuseppe Arena, Nicolas Badenco, Christian Meyer, Jian Chen, Saverio Iacopino and 9 more

4 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 109 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
109citing papers in PubMed, 9 pooled it
26.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05296824 completednot on this map

Cryoballoon Isolation of Combined Posterior Wall and Pulmonary Veins Versus Pulmonary Veins Alone for the Treatment of Paroxysmal Atrial Fibrillation (IMPPROVE-PAF)

TypeobservationalSponsorSacramento EP ResearchRan2014 to 2021Enrolled320ConditionsParoxysmal Atrial FibrillationArmsCryoballoon ablation for the treatment of atrial fibrillation
NCT05557526 narecruitingnot on this mapstarted 2022, after this paper: background citation

Optimizing Quality of Life by Improved Patient Expectation Following Atrial Fibrillation Catheter Ablation

TypeinterventionalSponsorEvangelical Hospital DüsseldorfRan2022 to 2027Enrolled60ConditionsAtrial FibrillationArmsExpectation optimization
NCT05939076 phase3not yet recruitingnot on this mapstarted 2023, after this paper: background citation

First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation - a Randomized Study Comparing Early Trigger Isolation Using the Cryoballoon Versus Antiarrhythmic Medication

TypeinterventionalSponsorRegion Örebro CountyRan2023 to 2028Enrolled220ConditionsAtrial Fibrillation, PersistentArmsPulmonary vein isolation, dronedarone - Multaq™ OR flecainide - Tambocor™ OR propafenone - Rytmonorm™ OR sotalol - Sotacor™
NCT06296888 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Radiofrequency Balloon Catheter Ablation for Atrial Fibrillation: Durability of Pulmonary Vein Isolation and Clinical Outcome - The RABAAF Study

TypeinterventionalSponsorJim HansenRan2022 to 2024Enrolled45ConditionsAtrial FibrillationArmsRadiofrequency balloon catheter ablation
3 · Its place in the literature

Who cites it

109 citing papers in PubMed, 9 syntheses or guidelines pooled it, 220 citations in OpenAlex.

  1. Impact of catheter ablation timing according to duration of atrial fibrillation history on arrhythmia recurrences and clinical outcomes: a meta-analysis.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025
    Pooled it
  2. Atrial fibrillation burden in clinical practice, research, and technology development: a clinical consensus statement of the European Society of Cardiology Council on Stroke and the European Heart Rhythm Association.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2025
    Guideline
  3. Pooled it
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  10. Cryoballoon ablation vs. antiarrhythmic drug therapy as initial treatment for persistent atrial fibrillation: the multicentre randomized CEPAF trial.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026
    Trial
  11. Using computed tomography atrial myocardial thickness maps in cryoballoon pulmonary vein isolation: the UTMOST AF II randomized clinical trial.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2024
    Trial
  12. Article
  13. Catheter ablation of atrial fibrillation in transthyretin and light-chain cardiac amyloidosis: results from the multicentre AMYL-AF study.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026
    Observational
  14. A single centre experience of pulsed field ablation for atrial fibrillation using the Medtronic PulseSelect System: an analysis of the first 100 patients.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026
    Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. Article

49 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 14 institutions in 8 countries.

Malte KunissKerckhoff Heart Center, Benekestrasse 2-8, 61231 Bad Nauheim, Germany.ORCID 0000-0002-1593-9657
Nikola PavlovicSestre Milosrdnice University Hospital Centre, Zagreb, Croatia.ORCID 0000-0001-9187-7681
Vedran VelagicUniversity Hospital Centre Zagreb, Zagreb, Croatia.
Jean Sylvain HermidaCentre Hospitalier Universitaire d'Amiens-Picardie, Amiens, France.
Stewart HealeyMonash Health, Clayton, Australia.
Giuseppe ArenaOspedale Apuane, Massa Carrara, Italy.
Nicolas BadencoAP-HP Sorbonne Université, ICAN Institute, Hopital Pitié-Salpétrière, Paris, France.
Christian MeyerUniversity Heart Center, Hamburg, Cardiac Neuro- and Electrophysiology Research Consortium, EVK Düsseldorf, Düsseldorf, Germany.ORCID 0000-0003-0217-3960
Jian ChenHaukeland University Hospital, University of Bergen, Bergen, Norway.
Saverio IacopinoMaria Cecilia Hospital, GVM Care&Research, Cotignola, Italy.
Frédéric AnselmeCHU de Rouen, Rouen, France.ORCID 0000-0002-2130-9790
Douglas L PackerMayo Clinic Hospital-St. Mary's Campus, Rochester, MN, USA.
Heinz-Friedrich PitschnerKerckhoff Heart Center, Benekestrasse 2-8, 61231 Bad Nauheim, Germany.
Carlo de AsmundisHeart Rhythm Management Centre, Universitair Ziekenhuis Brussel, Postgraduate program in Cardiac Electrophysiology and Pacing, European Reference Networks Guard-Heart, Vrije Universiteit Brussel, Brussels, Belgium.
Stephan WillemsUniversity Heart Center, Hamburg, Asklepios Klinik St. Georg, Hamburg, Germany.
Fabio Di PiazzaMedtronic, Core Clinical Solutions, Study and Scientific Solutions, Rome, Italy.
Daniel BeckerMedtronic, Meerbusch, Germany.
Gian-Battista ChierchiaHeart Rhythm Management Centre, Universitair Ziekenhuis Brussel, Postgraduate program in Cardiac Electrophysiology and Pacing, European Reference Networks Guard-Heart, Vrije Universiteit Brussel, Brussels, Belgium.
Cryo-FIRST Investigators
Kerckhoff Klinik · DEUniversität Hamburg · DEUniversity Hospital Centre Zagreb · HRVrije Universiteit Brussel · BEAccademia di Belle Arti di Carrara · ITCentre Hospitalier Universitaire Amiens-Picardie · FRCentre Hospitalier Universitaire de Rouen · FRHaukeland University Hospital · NOHudson Institute of Medical Research · AUMaria Cecilia Hospital · ITMayo Clinic Hospital · USMedtronic (Germany) · DEMedtronic (Italy) · ITSorbonne Université · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTreatment guidelines for patients with atrial fibrillation (AF) suggest that patients should be managed with an antiarrhythmic drug (AAD) before undergoing catheter ablation (CA). This study evaluated whether pulmonary vein isolation employing cryoballoon CA is superior to AAD therapy for the prevention of atrial arrhythmia (AA) recurrence in rhythm control naive patients with paroxysmal AF (PAF). METHODS AND

resultsA total of 218 treatment naive patients with symptomatic PAF were randomized (1 : 1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD (Class I or III) and followed for 12 months. The primary endpoint was ≥1 episode of recurrent AA (AF, atrial flutter, or atrial tachycardia) >30 s after a prespecified 90-day blanking period. Secondary endpoints included the rate of serious adverse events (SAEs) and recurrence of symptomatic palpitations (evaluated via patient diaries). Freedom from AA was achieved in 82.2% of subjects in the cryoballoon arm and 67.6% of subjects in the AAD arm (HR = 0.48, P = 0.01). There were no group differences in the time-to-first (HR = 0.76, P = 0.28) or overall incidence [incidence rate ratio (IRR)=0.79, P = 0.28] of SAEs. The incidence rate of symptomatic palpitations was lower in the cryoballoon (7.61 days/year) compared with the AAD arm (18.96 days/year; IRR = 0.40, P < 0.001).

conclusionsCryoballoon CA was superior to AAD therapy, significantly reducing AA recurrence in treatment naive patients with PAF. Additionally, cryoballoon CA was associated with lower symptom recurrence and a similar rate of SAEs compared with AAD therapy.

Indexed as

Atrial FibrillationCatheter AblationCryosurgeryPulmonary VeinsAnti-Arrhythmia AgentsHumansRecurrenceTreatment OutcomeAnti-Arrhythmia AgentsAntiarrhythmic drugAtrial fibrillationCatheter ablationCryoballoonFirst-line treatmentRandomized study

Identifiers

PMID33728429
PMCPMC8286851
OpenAlexW3138837606

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.