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It’s “not non-inferior”to anticoagulation and that’s why we use it in people who can’t use anticoagulation - chronic GI bleeders, recent Intracerebral bleeds. I don’t know anyone who got a watchman just because they didn’t want to take a DOAC. No physician would ever put in a watchman to replace a DOAC without a clear indication.
Check out the Champion AF Study.
The **CHAMPION AF trial** compared the **WATCHMAN FLX left atrial appendage closure device** with continued **DOAC therapy** in about 3,000 patients with nonvalvular atrial fibrillation.
**Main question**
Can WATCHMAN be used as a first line alternative to lifelong anticoagulation, even in patients who can tolerate a DOAC?
**Three year results**
**Outcome**
**WATCHMAN**
**DOAC**
Cardiovascular death, stroke, or systemic embolism
5.7%
4.8%
Nonprocedural major or clinically relevant bleeding
10.9%
19.0%
Major bleeding including procedural bleeding
5.9%
6.4%
Overall net clinical outcome
15.1%
21.8%
**Interpretation**
**WATCHMAN was noninferior for the main efficacy endpoint.**
It provided broadly similar protection against the combined outcome of stroke, systemic embolism, and cardiovascular death.
**WATCHMAN caused substantially less long term bleeding.**
Nonprocedural clinically important bleeding was reduced by about 45%.
**There was an important ischemic stroke signal.**
Ischemic stroke occurred in approximately 3.2% with WATCHMAN versus 2.0% with a DOAC. This was not the primary endpoint, but it prevents interpreting WATCHMAN as simply better overall.
**WATCHMAN carries procedural risks.**
Pericardial effusion requiring intervention occurred in about 0.7%, and device related thrombus was detected in about 4.8%.
**Practical takeaway**
CHAMPION AF supports WATCHMAN as a reasonable alternative to lifelong DOAC therapy for selected patients, especially those concerned about bleeding or unable to maintain anticoagulation. It does **not** prove that every stable patient doing well on apixaban should receive WATCHMAN. The tradeoff is less bleeding and freedom from chronic anticoagulation versus an invasive procedure and a possible increase in ischemic stroke.
One limitation is that the actual event rate was much lower than investigators predicted, making the noninferiority margin relatively generous. Five year follow up will be important before broadly replacing DOACs in lower bleeding risk patients. [NEJM study](https://www.nejm.org/doi/abs/10.1056/NEJMoa2517213)⁠ [ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT04394546)⁠
There’s ASAP TOO trial that compared Watchman vs antiplatelet therapy only. Watchman was superior.

It’s “not non-inferior”to anticoagulation and that’s why we use it in people who can’t use anticoagulation - chronic GI bleeders, recent Intracerebral bleeds. I don’t know anyone who got a watchman just because they didn’t want to take a DOAC. No physician would ever put in a watchman to replace a DOAC without a clear indication.
Check out the Champion AF Study.
The **CHAMPION AF trial** compared the **WATCHMAN FLX left atrial appendage closure device** with continued **DOAC therapy** in about 3,000 patients with nonvalvular atrial fibrillation.
**Main question**
Can WATCHMAN be used as a first line alternative to lifelong anticoagulation, even in patients who can tolerate a DOAC?
**Three year results**
**Outcome**
**WATCHMAN**
**DOAC**
Cardiovascular death, stroke, or systemic embolism
5.7%
4.8%
Nonprocedural major or clinically relevant bleeding
10.9%
19.0%
Major bleeding including procedural bleeding
5.9%
6.4%
Overall net clinical outcome
15.1%
21.8%
**Interpretation**
**WATCHMAN was noninferior for the main efficacy endpoint.**
It provided broadly similar protection against the combined outcome of stroke, systemic embolism, and cardiovascular death.
**WATCHMAN caused substantially less long term bleeding.**
Nonprocedural clinically important bleeding was reduced by about 45%.
**There was an important ischemic stroke signal.**
Ischemic stroke occurred in approximately 3.2% with WATCHMAN versus 2.0% with a DOAC. This was not the primary endpoint, but it prevents interpreting WATCHMAN as simply better overall.
**WATCHMAN carries procedural risks.**
Pericardial effusion requiring intervention occurred in about 0.7%, and device related thrombus was detected in about 4.8%.
**Practical takeaway**
CHAMPION AF supports WATCHMAN as a reasonable alternative to lifelong DOAC therapy for selected patients, especially those concerned about bleeding or unable to maintain anticoagulation. It does **not** prove that every stable patient doing well on apixaban should receive WATCHMAN. The tradeoff is less bleeding and freedom from chronic anticoagulation versus an invasive procedure and a possible increase in ischemic stroke.
One limitation is that the actual event rate was much lower than investigators predicted, making the noninferiority margin relatively generous. Five year follow up will be important before broadly replacing DOACs in lower bleeding risk patients. [NEJM study](https://www.nejm.org/doi/abs/10.1056/NEJMoa2517213)⁠ [ClinicalTrials.gov](https://clinicaltrials.gov/study/NCT04394546)⁠
There’s ASAP TOO trial that compared Watchman vs antiplatelet therapy only. Watchman was superior.