Table-4.
Clinical Outcomes | Leak= 0 mm (N=37,696) | Leak= 0–5 mm (N=13,258) | Leak >5 mm (N= 379) |
---|---|---|---|
Ischemic Stroke | 1.39% (1.27%–1.52%) | 1.61% (1.39%–1.84%) | 1.42% (0.18%–2.66%) |
Stroke, TIA, or SE | 2.98% (2.80%–3.17%) | 3.49% (3.16%–3.81%) | 3.13% (1.31%–4.94%) |
Major Bleeding | 7.58% (7.3%–7.86%) | 8.57% (8.07%–9.07%) | 6.82% (4.19%–9.45%) |
Death | 5.97% (5.72%–6.23%) | 6.41% (5.97%–6.85%) | 7.96% (5.13%–10.78%) |
Any MAE | 17.43% (17.02%–17.83%) | 19.44% (18.73%–20.15%) | 19.61% (15.46%–23.76%) |
TIA; transient ischemic attack, SE; systemic embolization, MASE: major adverse serious event which included death, cardiac arrest, ischemic, hemorrhagic, or undetermined stroke, TIA, SE, major bleeding, major vascular complication (fistula or pseudoaneurysm requiring fibrin injection, angioplasty, or surgical repair), myocardial infarction, pericardial effusion requiring intervention, or device embolization.