WATCHMAN Proven to reduce stroke risk

WATCHMANTM

Proven to Reduce
Stroke Risk

WATCHMAN confirms favorable efficacy outcomes from clinical studies to real-world experience

The WATCHMAN™ Device demonstrated comparable stroke risk reduction, and statistically superior reductions in haemorrhagic stroke, disabling stroke and cardiovascular death compared to warfarin over long-term follow-up in the PROTECT AF and PREVAIL studies.1

Long-term results demonstrate WATCHMAN reduces stroke, bleeding and mortality

Long-term results from a patient-level meta-analysis of the PROTECT AF (2,717 pt yrs) and PREVAIL (1,626 pt yrs) trials demonstrated that WATCHMAN offered, after 5 years of follow up1:

  • Comparable stroke risk prevention vs. warfarin
  • Statistically significant reductions in disabling and fatal stroke# (55%), non-procedure related major bleeding (52%), and mortality (41% CV death) vs. warfarin
5-Year Patient-Level Meta-Analysis of PROTECT AF and PREVAIL

Kenneth Stein, MD, FACC, FHRS

Hear Dr. Kenneth Stein, Senior Vice President & Chief Medical Officer Rhythm Management and Global Health Policy review the data and discuss the value of these data for patients.

Dr. Ian T. Meredith, AM

Hear Dr. Ian Meredith, Executive Vice President & Global Chief Medical Officer discuss the value of long-term data.

EWOLUTION two-year results confirm that
WATCHMAN is effective in a real world setting

  • EWOLUTION, the largest prospective real-life study on WATCHMAN, showed a high success of implant and sealing, with low procedural adverse event rates2
  • > 70% of the patients in the study were deemed unsuitable for any oral anti-coagulation2.
  • Two-year results confirm that WATCHMAN is safe and effective showing:
    • 83% reduction in ischemic stroke rate (1.3 per 100 pt-yrs)3 as compared to the expected rate with no therapy4.
    • 46% reduction in non-procedural major bleeding rate (2.7 per 100 pt-yrs)3 compared to the expected rate with warfarin5.

EWOLUTION 2-year data - Prof. Lucas V.A. Boersma gives his insights

Thrombo-embolic event rates
Bleeding rates

WATCHMAN LAAC proves to be an effective solution for stroke risk reduction in both high and low risk patients

  • In patients with CHA2DS2-VASc ≥ 3 an 82% reduction in ischemic stroke rate3 was observed vs. expected
  • No stroke occurred in patients with CHA2DS2-VASc < 3, resulting in 100% relative risk reduction3
Thrombo-embolic event rates according to parient's stroke risk

In EWOLUTION, WATCHMAN demonstrated low ischemic stroke and major bleeding rates reduction in patients who received dual antiplatelet therapy (DAPT) post-procedure

  • 60% of the patients in the study received DAPT post-procedure6
  • At 1 year:
    • 81% reduction in ischemic strokes (annual stroke rate was 1.4%)6 as compared to no therapy4.
    • 52% reduction in major bleeding events (annual major bleeding rate was 2.5%)6 compared to warfarin5.  Excluding periprocedural bleeding, reduction in major bleeding events was 60% (annual major bleeding rate excluding procedural was 2.1%)6
    • This level of stroke risk reduction is similar to that seen in the ARISTOTLE trial (Apixaban) in a high-risk population (CHA2DS2-VASc ≥ 3)
Thrombo-embolic event rates
Bleeding rates

WATCHMAN exhibited a favorable effect on long-term bleeding

  • The patient-level meta-analysis of the PROTECT AF and PREVAIL trials demonstrated that the longer a patient has a WATCHMAN Implant, the greater the reduction in bleeding events.7
  • At 6 months post-procedure, WATCHMAN reduced major bleeding events vs warfarin by 72% (1.0 vs 3.5; P<0.001).7
WATCHMANTM significantly reduced major bleeding* > 7 days post-procedure2

In the ASAP prospective registry, WATCHMAN demonstrated efficacy in stroke risk reduction in patients contraindicated for oral anticoagulants8

Ischemic Stroke

Proven Safety

Review safety data from clinical studies and real-life results from the EWOLUTION Registry, showing overall implant success rates for WATCHMAN.

View Safety Data

References
* Effectiveness in stroke reduction vs. estimated in the absence of therapy for comparable CHA2DS2-VASc scores based on Friberg et al. EHJ 2012
§ Effectiveness in bleeding reduction vs. estimated under VKA therapy for comparable HAS-BLED scores based on Lip et al. JACC 2011
# Two strokes in PREVAIL are excluded because the baseline MRS score was unavailable 

1 Reddy VY et al., 5-Year Outcomes After Left Atrial Appendage Closure From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975. 
2 Boersma LV et al., Efficacy and safety of left atrial appendage closure with WATCHMAN in patients with or without contraindication to oral anticoagulation: 1-Year follow-up outcome data of the EWOLUTION trial. Heart Rhythm. 2017 Sep;14(9):1302-1308. 
3 Boersma LV et al., Stroke, bleeding and mortality of WATCHMAN Left Atrial Appendage Closure in Patients with or without Contraindication to Oral Anticoagulation: 2-year final outcome data of the EWOLUTION Study. Presented at EHRA 2018 
4 Friberg L, et al., Evaluation of risk stratification schemes for ischaemic stroke and bleeding in 182 678 patients with atrial fibrillation: the Swedish Atrial Fibrillation cohort study. European Heart Journal (2012) 33, 1500–1510
5 Lip GYK, et al., Comparative Validation of a Novel Risk Score for Predicting Bleeding Risk in Anticoagulated Patients With Atrial Fibrillation. J Am Coll Cardiol. 2011 Jan 11;57(2):173-80 
6 Bergmann MW, et al., Safety and efficacy results in the EWOLUTION all-comers LAA closure study: DAPT subgroup. Presented at EuroPCR 2017 
7 Price MJ, et al., Bleeding outcomes after left atrial appendage closure compared with long-term warfarin. JACC Cardiovasc Interv. 2015;8(15):1925-1932. 
8 Reddy VY, et al., Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). JACC.2013 Jun 25;61(25):2551-6 

CAUTION: The law restricts these devices to sale by our 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. Information contained herein is for distribution outside the U.S., Japan and France.