EWOLUTION 1 year follow up results

Sponsored by Boston Scientific

 
The prospective study confirms the safety and efficacy of the WATCHMAN Left atrial appendage closure device in stroke risk reduction in patients with high risk of stroke, bleeding and multiple co-morbidities.

Summary: Interview with Prof. Martin W. Bergmann on the 1 year follow-up results of the EWOLUTION study. The EWOLUTION study is the largest prospective real-life LAAC study on WATCHMAN with over 1,000 patients studied, designed to obtain clinical data on procedural success, complication rates, incidence of stroke, bleeding and long-term patient outcomes.

 
With more than 70% of patients deemed unsuitable for any oral anti-coagulation included in this study, the WATCHMAN device was confirmed to be safe and effective in a high risk population.

84%

(annual stroke rate was 1.1%)1
Reduction in ischemic stroke as compared to no therapy.2

48%

(annual major bleeding rate was 2.6%)1
Reduction in major bleeding events compared to warfarin.3

DAPT post-procedure was used in 60% of patients and WATCHMAN continued to demonstrate in this patient population low ischemic stroke and major bleeding rates, showing:

81%

(annual stroke rate was 1.4%)4
Reduction in ischemic stroke as compared to no therapy3

52%

(annual major bleeding rate was 2.5%)4
Reduction in major bleeding events compared to warfarin.3

Excluding periprocedural bleeding, reduction in major bleeding events was 60% (annual major bleeding rate excluding procedural was 2.1%).

This level of stroke risk reduction is similar to what was seen in the ARISTOTLE trial (Apixaban) in a high-risk population (CHA2DS2-VASc ≥ 3).

References:

1. Boersma LV, et al., Presented at HRS 2017 Congress
2. Friberg L, Rosenqvist M, Lip GYH. EH J 2012; 33:1500-10
3. Lip GYK, et al., J Am Coll Cardiol. 2011 Jan 11;57(2):173-80
4. Bergmann, 2017 PCR LBCT Real world net benefit of LAA closure at one year: safety and efficacy results in the EWOLUTION all-comers study

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All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations. SH-490503-AA AUG2017

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With an unrestricted educational grant from Boston Scientific

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