CHAMPION Sub Group Results Should Boost Concomitant, Even as Standalone Slows

Research evidence excerpt

CHAMPION Sub Group Results Should Boost Concomitant, Even as Standalone Slows

Executive Summary

Why The CHAMPION Sub-Groups of Ablated vs Non-Ablated are Important

• The CHAMPION trial was not representative of the at-large AF population that requires OAC in that 48% of enrolled patients had a prior ablation (vs ~10% of prevalent AF pts. today). Hence, the sub-group

findings differentiating LAAC effectiveness/safety vs. NOACs among ablated versus non-ablated patients should be of great interest to professional societies, the FDA and CMS.

• The CHAMPION trial publication showed among patients who had received a prior ablation, there were better results and primary endpoint equipoise between LAAC and NOACs vs. patients who had not received

ablation prior. Prior to the subgroup presentation at HRS, based on available data, we performed an analysis of the trial where we concluded that amongst patients who hadn’t received an ablation, the ischemic

stroke/systemic embolism event rate was likely ~2% higher in the LAAC arm relative to that in the NOAC group through 3 years of follow-up

• At HRS, sub-group results among patients who had and hadn’t received prior ablation were presented. In non-ablated patients, outcomes were less compelling: ischemic stroke/systemic embolism was +240bps

higher at 3 years with LAAC (vs. our 2%), and while the composite endpoint met non-inferiority (HR 1.33), in our view, the results may not be compelling enough to garner a Class I indication for the non-ablated

group. That said, the results in patients with prior ablation were excellent and showed equipoise between LAAC and NOACs, fully supporting the results seen in OPTION, likely sufficient to drive a Class I

indication for AF ablation plus LAAC (Concomitant).