Takeaway
- Left atrial appendage (LAA) occlusion with WATCHMAN (Boston Scientific) leads to lower mortality and thromboembolism rates in patients for whom oral anticoagulation (OAC) is contraindicated.
- Editorial finds results encouraging, notes that ASAP-TOO and STROKE-CLOSE will investigate LAA closure in this population.
Why this matters
- Recent meta-analysis of PROTECT-AF and PREVAIL found WATCHMAN noninferior to vitamin K antagonists (VKA) for stroke prevention, with lower nonprocedural bleeding and mortality.
- Patients with OAC contraindication were not included in those trials.
Study design
- Prospective multinational nonrandomized 2-year real-world EWOLUTION cohort study (n=1020).
- Participants had nonvalvular Afib and were at high stroke risk; 72% ineligible for OAC.
- Outcomes: mortality, bleeding, stroke/transient ischemic attack (TIA)/systemic embolism (SE).
- Funding: Boston Scientific Corporation.
Key results
- Dual antiplatelet therapy and OAC discontinued in 85%.
- Deaths: 161 (16.4%; 95% CI, 13.8%-19.3%), mostly noncardiovascular.
- Nonprocedural major bleeding:
- 46% relative risk reduction (RRR) vs expected rates with VKA.
- Large RRR in higher-risk subgroups.
- Ischemic stroke/TIA/SE:
- 80% RRR vs predicted by CHA2DS2-VASc.
- Large RRR in higher-risk subgroups.
- Device-related thrombus: 34 of 835 (4.1%) receiving routine LAA imaging; none had subsequent stroke/TIA/SE.
Limitations
- Nonrandomized; no controls.
- OAC contraindications unclear.
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