Boston Scientific has commenced the trial for the comparison of left atrial appendage closure (LAAC) to direct oral anticoagulants (DOAC) for stroke risk reduction in patients with non-valvular atrial fibrillation (AF).
The Option trial will compare safety and effectiveness of the next-generation Watchman FLX LAAC platform to first-line oral anticoagulants (OAC), including DOAC and warfarin, for stroke risk reduction in patients with AF who undergo a cardiac ablation procedure.
Around 33 million patients across the globe are suffering from AF, a common heart rhythm disorder. Stroke is five times more likely to occur in patients with AF compared to someone with a normal heart rhythm, said the company.
Option trial principal investigator Dr Oussama Wazni said: “Cardiac ablation is an effective way to treat an abnormal heart rhythm for many patients, though symptomatic relief can lead these patients to stop taking their blood thinners and unknowingly put themselves at an elevated risk for a stroke.”
The randomised and controlled study will recruit 1,600 patients with non-valvular AF who are suitable for OAC therapy and have recently had or will have an ablation.
Boston Scientific will randomise patients in more than130 global sites to receive the Watchman FLX device or an OAC, including commonly prescribed DOACs or warfarin.
According to the company, the primary effectiveness endpoint is all-cause death, stroke and systemic embolism through 36 months, while the primary safety endpoint is non-procedural bleeding through 36 months.
The Watchman FLX device secured CE mark in March this year and it is an investigational device in the US. Watchman device was implanted in over 80,000 patients across the globe.
Boston Scientific global chief medical officer and executive vice-president Dr Ian Meredith said: “Beyond advancing the robust clinical literature supporting the WATCHMAN therapy, findings from the OPTION trial have the potential to expand the number of patients with atrial fibrillation who can receive an alternative to life-long anticoagulants and thus avoid their potential side effects.
“The unique study design encompasses patients who will receive a WATCHMAN FLX device either after or concurrent to an ablation procedure.” – Compelo