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IMPACT

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Study Design

Disclaimer

The IMPACT study was closed prematurely on June 12, 2013 by the Steering Committee and BIOTRONIK due to futility to affect the primary endpoint.

Key Result 1

The primary event rate did not differ between the intervention and control groups (2.4 vs. 2.3/100 patient-years, respectively; HR 1.06).

Key Result 2

Major bleeding rates were 1.6 and 1.2/100 patient-years (HR 1.39; 95% CI 0.89–2.17; P = 0.145). In patients with AT, thromboembolism rates were 1.0 vs. 1.6 per 100 patient-years (relative risk −35.3%; 95% CI −70.8 to 35.3%; P = 0.251).

Key Result 3

Although AT burden was associated with thromboembolism, there was no temporal relationship between AT and stroke.

Clinical Relevance

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