Lowering PT, WATCHMAN and EP #‘s To Reflect New Reality; Flagging FXI Risk

Research evidence excerpt

Lowering PT, WATCHMAN and EP #‘s To Reflect New Reality; Flagging FXI Risk

Exec. Summary: Standalone Shift From Labor, Data, Reimbursement, FXI

CHAMPION Sub-Group Analysis: Result Suggests the Standalone Indication To Remain Unchanged but Likely to Help Class 1 Expansion for ConcomitantRisk • The CHAMPION trial showed bifurcated results amongst patients who had and hadn’t received a prior ablation (our note). LAAC performed in an excellent fashion and in-line with the very strong OPTION trial results

amongst those who had received a prior ablation with less compelling relative performance amongst those without a prior ablation.

• The primary efficacy endpoint (CV death, stroke and systemic embolism) for non-ablated patients showed a HR of 1.33 favoring NOACS (NS), with LAAC numerically inferior at 3 years. The HR for ischemic stroke and

systemic embolism was 2.16. A statistically significant reduction in major bleeding was not observed in the non-ablated cohort.

• We don’t believe that these results amongst non-ablated patients are sufficiently compelling to drive broad indication expansion/adoption amongst elderly, non-ablative candidates, whereas the very strong results seen

amongst ablated patients fully confirmed the OPTION trial and should help drive a Class I indication.

Standalone LAAC Model Assumes Low Growth; FXI(a) Not Included

• Our standalone-LAAC model treats the standalone population as distinct from that of the concomitant AF ablation plus LAAC patient group, although they may merge to some extent over time. To arrive at a pragmatic

estimate for the standalone LAAC population, we first considered annual ED encounters with a first or second diagnosis of bleeding and coding for AF in any diagnosis position. Around 64% of these encounters resulted in