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First-line Cryoablation Evidence

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FIRST-LINE Cryoablation

See the latest evidence on how first-line cryoablation improves AF patient outcomes.

Alert Indications, Safety, and Warnings

META-ANALYSIS CONFIRMS SUPERIORITY OF CRYOABLATION OVER ANTIARRHYTHMIC DRUGS AS A FIRST LINE TREATMENT

An important meta-analysis1 summarizes the findings across the 3 randomized “first-line” cryoablation trials (STOP AF First, EARLY-AF and Cryo-FIRST).​

Meta-analysis of these trials demonstrates that initial cryoablation is associated with noteworthy reductions in arrhythmia recurrence and healthcare use, and significant improvements in quality of life and symptom status when compared with initial antiarrhythmic drug therapy.​

Conclusions: Meta-analysis of three randomized first-line trials (STOP AF First, EARLY-AF and Cryo-FIRST) demonstrates cryoablation is more effective than antiarrhythmic drugs as an initial first-line therapy for patients with paroxysmal AF.​

 

Key results:

  • 39% relative reduction in the risk of atrial arrhythmia recurrence​

  • 8.32 point larger improvement in AFEQT (AF-specific quality of life) score on average​

  • 29% relative reduction in healthcare utilization​

  • 62% relative reduction in hospitalization​

  • Patients treated with first-line cryoablation were also more likely to be free of symptoms at 12 months.

Read full study

REAL-WORLD ANALYSIS OF CRYOABLATION AS A FIRST-LINE TREATMENT FOR AF PATIENTS ACROSS ITALY​

Clinical trial across cardiology centers in Italy2 examines a cohort of patients treated in a real-world setting, examining the safety and efficacy of cryoablation when applied as a first-line treatment for atrial fibrillation.  ​

Conclusions:

  • Pulmonary vein isolation by cryoablation in a first-line atrial fibrillation patient population in a real-world setting seems to be tolerated, effective and promising. ​

  • Cryoablation with a PVI strategy can be used to treat first-line patients with paroxysmal and persistent atrial fibrillation with good acute success rates, short procedure times, and acceptable safety.​

Study size:​

4,469 patients in 26 cardiology centers across Italy​

Primary endpoint:

Freedom from any atrial arrhythmia after a blanking period of 90 days following cryoablation therapy.​

Key results:

  • Acute procedural success was 99.8%​

  • The Kaplan-Meier freedom from atrial fibrillation recurrence was 86.3% at 12 months and 76% at 24 months.

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REAL-WORLD STUDY SHOWS ROBUST SAFETY, EFFICIENCY, AND EFFICACY FOR AF PATIENTS WHEN CRYOABLATION IS PERFORMED ACCORDING TO LOCAL STANDARDS OF CARE​

First Line chart

In patients with AF, compare global outcomes of cryoablation among patients with first-line treatment against patients who were refractory to AAD therapy at baseline in a real-world setting.3

Conclusion:​

Robust safety, efficiency, and efficacy across a broad range of patients with AF when cryoablation is performed according to local standards of care.​

Study size: 1394 patients​

Primary endpoint: Freedom from any atrial arrhythmia after a blanking period of 90 days following ablation therapy​

Key results:

  • 87.8 percent of patients undergoing ablation as a first treatment were free from asymptomatic or symptomatic atrial tachyarrhythmia (AF/AFL/AT) 12 months post procedure​

  • 94.1% of patients undergoing ablation as a first treatment did not have to undergo a repeat ablation procedure 12 months later​

  • 89.2% of patients undergoing ablation as a first treatment were not hospitalized for cardiovascular-related events 12 months following the procedure

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CRYO-FIRST TRIAL

Atrial Arrhythmia study result graph

Catheter Cryoablation versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation (Cryo-FIRST) is a 1:1 randomised control trial4 designed to compare the safety and efficacy of antiarrhythmic drug (AAD) therapy against cryoballoon pulmonary vein isolation (PVI) as a first-line therapy in treatment naïve patients with paroxysmal AF (PAF).

Study Size: 220 patients enrolled by 18 hospitals.

Primary Endpoint: Freedom from any atrial arrhythmia >30 seconds after blanking

Principal Investigators: Gian Battista Chierchia (BE), Malte Kuniss (DE)

Conclusions:
  • The Cryo-FIRST trial demonstrated that PVI performed with the Arctic Front Advance ™ Cryoablation catheter can reduce atrial arrhythmia recurrence safely and more effectively than AAD therapy in first-line patients with symptomatic PAF.
Key findings:
  • Cryoballoon catheter ablation was associated with a >50% reduction in the risk of atrial arrhythmia recurrence compared to AAD therapy at 12 months post-treatment
  • A similar safety profile was observed in both arms when examining serious adverse events during the study
  • AF-Specific quality of life was significantly higher in the catheter ablation group at 3, 6, 9 and 12 month follow-up
Read the full study

Watch Prof. G.B. Chierchia present :

  • The primary and secondary end point results from Cryo-FIRST

Watch Dr. M. Kuniss present:

  • The primary endpoint results from the Cryo-FIRST trial, comparing the safety and efficacy of first-line cryoablation vs. AADs

Watch Dr. A. Metzner discuss:

  • The impact of AF progression and the value of early AF ablation
  • Benefits of first-line cryoablation vs. AADs
Graph cryoballoon ablation

STOP AF FIRST TRIAL

The STOP AF First Trial5 (NCT03118518) was an FDA-regulated, prospective, multicentre randomised study designed to evaluate the safety and effectiveness of the Medtronic cryoablation system as an initial first-line treatment in patients with symptomatic paroxysmal atrial fibrillation (PAF).  Patients were randomised (1:1) to antiarrhythmic drug therapy (class I or III) or pulmonary vein isolation with the Arctic Front Advance ™ Cryoablation catheter. 

Study Size: 225 patients enrolled by 24 hospitals (U.S.)

Primary Safety Endpoint:

  • Composite of pre-specified procedure and system-related serious adverse events
  • Prespecified performance goal: failure rate <12%

Primary Efficacy Endpoint: 

Treatment success at 12 months.

Treatment failure included:

  • Acute procedural failure
  • Any subsequent AF surgery or ablation in the left atrium (including those performed during the blanking period)
  • Any of the following after the 90-day blanking period:
    • Documented AF/AT/AFL; cardioversion; class I or III AAD use (ablation arm only)

Principal Investigator: Oussama Wazni

Conclusions:

  • Freedom from primary efficacy failure at 12 months was 74.6% for the cryoballoon arm and 45% for the AAD arm (p < 0.001)
  • Two primary safety events were observed in the catheter ablation arm (estimated 12-month rate: 1.9%)

Read the full study
Graph recurrence atrial tachyarrhythmia

EARLY-AF TRIAL

Early Aggressive Invasive Intervention for Atrial Fibrillation6 (EARLY AF, NCT02825979) is a multicentre, randomized, controlled trial comparing the safety and efficacy of Arctic Front AdvanceTM Cryoablation with antiarrhythmic drug (AAD) therapy as a first line therapy. Clinical efficacy was assessed by an insertable cardiac monitor (ICM).

Study Size: 303 patients enrolled by 18 hospitals in Canada

Primary Endpoint:
Time to first recurrence of any symptomatic or asymptomatic atrial tachyarrhythmia ≥30 sec between days 91 and 365 after treatment initiation.

Principal Investigator: Jason Andrade (CA)

Key findings:
  • Freedom from asymptomatic or symptomatic atrial tachyarrhythmia (AF/AFL/AT) was 57.1% in cryoablation group vs. 32.2% in the AAD group at 12 months
  • Freedom from symptomatic arrhythmia recurrence was 89.0% in the ablation group and 73.8% in the AAD group at 12 months
  • The percentage of patients with a serious adverse event related to the trial regimen was similar between groups
Conclusions:
  • First-line ablation was associated with a significant reduction in time to first recurrence of symptomatic and asymptomatic atrial tachyarrhythmia (AF/AFL/AT)
  • Ablation was associated with larger improvements in quality of life and a higher rate of symptom resolution
Read the full study

Study Highlights

Watch Prof. J. Andrade present the key findings from EARLY-AF 

Watch Prof. J. Camm, Prof. J. Andrade, Dr. O. Wazni, and Dr. N. Pavlović discuss the Cryo-FIRST, STOP AF First, and EARLY-AF trial findings

FIRST-LINE EVIDENCE SUMMARY

Brochure capturing key data from the Cryo-FIRST, EARLY-AF, and STOP AF First trials.

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CRYO-FIRST BROCHURE

Learn more about the Cryo-FIRST trial results.

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STOP AF FIRST
FLYER

225 patients enrolled from 24 centres in the Unites States.

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References

1

Andrade J, Wazni O, Kuniss M. et al. Cryoballoon Ablation as Initial Treatment for Atrial Fibrillation. Journal of the American College of Cardiology 2021; 78:914-930 ​

2

Moltrasio M, Iacopino S, Arena G et al. First-line therapy: Insights from a real-world analysis of cryoablation in patients with atrial fibrillation. Journal of Cardiovascular Medicine: August 2021; 22: 618-623​

3

Zucchelli G, Chun J, Kaur Khelae S et al. Health Care Utilization after First-Line Cryoablation for Atrial Fibrillation: Results from the Cryo AF Global Registry, Poster presented at American Heart Assocation’s Scientific Sessions 2021

4

Hermida J, Chen J, Meyer C et al. Cryoballoon catheter ablation versus antiarrhythmic drugs as a first-line therapy for patients with paroxysmal atrial fibrillation: Rationale and design of the international Cryo-FIRST study. American Heart Journal. April 2020; 222: 64-72

5

Wazni O, Dandamudi G, Sood N et al. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. New England Journal of Medicine. January 28, 2021; 384:316-324

6

Andrade J, Wells G, Deyell M et al. Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. New England Journal of Medicine. January 28, 2021; 384:305-315