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A closeup image of the WATCHMAN FLX implant on a teal background

OPTION Trial: Concomitant & Sequential Cohort Subanalysis​

Consistent with the overall primary endpoint outcomes, the WATCHMAN FLX device demonstrated equal thromboembolic protection to OAC (95% DOACs) at 36 months, while significantly reducing bleeding risks irrespective of concomitant or sequential LAAC following an ablation, providing an option for patients seeking an alternative to long-term anticoagulation regardless of the timing of LAAC relative to the ablation.​

Positive Primary Endpoints Reaffirmed

Listen to Dr. Walid Saliba (Cleveland Clinic Principal Investigator) discuss the concomitant and sequential cohort subanalysis.


 

Study design and patient disposition

The objective of the OPTION trial was to determine if LAAC with WATCHMAN FLX is a reasonable alternative to OAC following AF ablation. Consistent with this objective, this subanalysis compared outcomes among the concomitant and sequential cohorts of the WATCHMAN FLX arm to those randomized to oral anticoagulation following AF ablation. 

OPTION Clinical Trial design chart.

Primary Efficacy Endpoint

Stroke, all-cause mortality and systemic embolism

Primary Safety Endpoint

Non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding) 

 
  • Concomitant: AF ablation ± WATCHMAN FLX implantation within 10 days of randomization
  • Sequential: AF ablation 90 to 180 days prior to randomization
  • The planned ablation timing, concomitant or sequential, was not randomized but must have been specified by the investigator prior to randomizing the subject

Key Baseline Characteristics – Concomitant & Sequential Subgroups​

Irrespective of treatment (WATCHMAN FLX vs. OAC) arm​

  • The planned ablation timing, concomitant or sequential, was not randomized but must have been specified by the investigator prior to randomizing the subject. 
  • Patient characteristics between the concomitant and sequential cohorts were unbalanced, suggesting the subgroups represent disparate patient populations reflected by potential selection bias driven by baseline characteristics that may influence perceived suitability for either a concomitant or sequential procedure.​
Key baseline characteristics table.


 

Concomitant Cohort Outcomes

Concomitant Cohort Primary Endpoints

Consistent with the overall primary outcomes, concomitant LAAC with WATCHMAN FLX following AF ablation showed similar efficacy to OAC, while demonstrating a statistically significant 44% risk reduction in bleeding events at 36 months.​

OPTION Clinical Trial primary efficacy concomitant graph.
OPTION Clinical Trial primary safety concomitant graph.


 

Concomitant Cohort 3-Year Clinical Outcomes

​Concomitant LAAC with WATCHMAN FLX demonstrated similar long-term stroke protection to anticoagulation, including a 1.6% ischemic stroke rate at 3 years.​

3-year concomitant cohort outcomes graph.

Concomitant Cohort CEC-Adjudicated Procedural Events

Sensitivity analyses were performed in the on-treatment population where patients in each treatment group were tested according to LAAC or OAC treatment received and if they were compliant to protocol medication at ≥80% until a primary or secondary event or end of study. 

2.1%
Ablation + WATCHMAN FLX
Procedural Event Rate
(within 7 days)
VS
2.7%
Ablation [Only] + OAC
Procedural Event Rate
(within 7 days)


Concomitant LAAC with WATCHMAN FLX at the time of ablation resulted in similar procedure related events (2.1%) compared to the ablation-only control arm (2.7%), therefore resulting in no increase in procedural risk with the addition of the WATCHMAN FLX procedure to ablation.​


 

Sequential Cohort Outcomes

Sequential Cohort Primary Endpoints​

Consistent with the overall primary outcomes, sequential LAAC with WATCHMAN FLX following AF ablation showed similar efficacy to OAC, while demonstrating a statistically significant 62% risk reduction in bleeding events at 36 months.​

OPTION Clinical Trial primary efficacy sequential graph.
OPTION Clinical Trial primary safety sequential graph.


 

Sequential Cohort 3-Year Clinical Outcomes

​Sequential LAAC with WATCHMAN FLX demonstrated similar long-term stroke protection to anticoagulation, including a 0.9% ischemic stroke rate at 3 years.​

3-year sequential cohort clinical outcomes graph.
Saliba W, et al. Comparison of Left Atrial Appendage Closure and Oral Anticoagulation after Catheter Ablation for Atrial Fibrillation​ Concomitant and Sequential Cohorts of the OPTION Randomized Controlled Trial. Late Breaking Clinical Trial, AF Symposium 2025.​

WATCHMAN FLX is an FDA approved device being studied for an expanded indication as a first line therapy vs NOAC for NVAF patients. The use of WATCHMAN or WATCHMAN FLX as a first-line therapy for stroke risk reduction in NVAF patients is considered investigational.

Caution: Investigational Device. Limited by US law to investigational use only. Not available for sale.