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.​


Study Design & 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 and Procedural Characteristics (ITT)

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​

Stats of WATCHMAN FLX + ablation at 2.1% vs. ablation + OAC at 2.7%.
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.
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