http://www.theheart.org/web_slides/1146285.do A prospective randomized trial on Embolic Protection in Patients with Atrial Fibrillation (PROTECT-AF) comparing closure of the LAA* (with the Watchman occluder) with long-term warfarin therapy

1. PROTECT-AF (Embolic Protection in
Patients with Atrial Fibrillation)

2. PROTECT-AF (Embolic Protection in Patients with
Atrial Fibrillation)
DR Holmes (Mayo Graduate School of Medicine, Rochester, MN)
American College of Cardiology 2009 Scientific Sessions/i2 Summit
• A prospective randomized trial comparing closure of the LAA* (with the
Watchman occluder) with long-term warfarin therapy
• Population and treatment:
800 patients with documented nonvalvular AF who could take long-term warfarin
but without an indication requiring warfarin; CHADS2 scores ≥1
Randomized in a device-to-control ratio of 2:1
• Outcomes:
Primary efficacy end point: all strokes, including ischemic and hemorrhagic, CV or
unexplained death, and systemic embolization
Primary safety end point: device embolization requiring retrieval, pericardial
effusion requiring intervention, and cranial, gastrointestinal, or any other
significant bleed
*left atrial appendage

3. PROTECT-AF: Results
• Safety events (mostly pericardial effusion) increased twofold in the device group
• There was a relative risk reduction of 32% of the primary end point with the device
• For all strokes, event-free probability was improved and noninferiority criteria met.
Ischemic strokes were higher in the device group, but hemorrhagic stroke was
lower in the device group, meeting superiority criteria
Safety and efficacy end pointsa
Outcomes Device events, n Device rate Control events, n Control rate Relative risk
(95% CI) (95% CI) (95% CI)
Primary safety end point 48 8.7 (6.4–11.3) 13 4.2 (2.2–6.7) 2.08 (1.18–4.13)
Primary efficacy end point 20 3.4 (2.1–5.2) 16 5.0 (2.8–7.6) 0.68 (0.37–1.41)
All stroke 15 2.6 (1.5–4.1) 11 3.5 (1.7–5.7) 0.74 (0.36–1.76)
Ischemic stroke 14 2.4 (1.3–3.9) 5 1.6 (0.5–3.1) 1.53 (0.654–5.43)
Hemorrhagic stroke 1 0.2 (0.0–0.6) 6 1.9 (0.7–3.7) 0.09 (0.00–0.45)

4. PROTECT-AF: Commentary*
"I think in clinical practice we will start using this technique in those patients who
cannot [take warfarin], and only later on when we see in practice that this really
works, then will we continue to those patients who can also take warfarin."
- Dr Horst Sievert
"I'm sure that most of you are surprised we're talking about a trial of some 600 to
800 patients . . . similar trials involved not 600 to 800 but 6000 to 8000 patients."
- Dr John Camm
*All comments from PROTECT-AF: Device closure of LAA may provide alternative to warfarin to
prevent stroke in AF (http://www.theheart.org/article/951777.do)

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