E W OLUTION - Efficacy and safety of LAAO in patients with prior - - PowerPoint PPT Presentation

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E W OLUTION - Efficacy and safety of LAAO in patients with prior - - PowerPoint PPT Presentation

Sep 08, 2023 251 likes •438 views

E W OLUTION - Efficacy and safety of LAAO in patients with prior ischemic and hemorrhagic stroke Prof. Dr. Lucas Boersma, MD/PhD/FESC St. Antonius Hospital, Nieuwegein, The Netherlands AMC/University of Amsterdam, The Netherlands H. Ince

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  • Prof. Dr. Lucas Boersma, MD/PhD/FESC
  • St. Antonius Hospital, Nieuwegein, The Netherlands

AMC/University of Amsterdam, The Netherlands

  • H. Ince

Vivantes Klinikum Urban, Berlin, Germany

  • S. Kische

Vivantes Klinikum im Friedrichshain, Berlin, Germany

  • E. Pokushalov

State Res Inst of Circ Path. Novosibirsk, Russian Federation

  • B. Schmidt

Cardiology Centre Bethanien, Frankfurt Am Main, Germany

  • T. Betts

John Radcliffe Hospital, Oxford, United Kingdom

  • H. Sievert

CardioVascular Center Frankfurt, Frankfurt, Germany

  • M. W. Bergmann

Cardiologicum Hamburg, Hamburg, Germany

  • n behalf of all the EWOLUTION investigators

EWOLUTION - Efficacy and safety of LAAO in patients with prior ischemic and hemorrhagic stroke

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Study Objective: Collect real-world WATCHMAN LAAO experience outside of selected populations in prior RCT Study Design: Prospective, single-arm, multi-center registry of the Watchman LAA Closure Technology Primary Endpoint: Primary analysis includes procedural success and safety, incidence of stroke, bleeding, and death after 2 yr of FU Investigator and Medical Safety Group for adjudication Patient Population: >1000 patients Number of Sites: 47 throughout Europe, Russia and Middle East Enrollment: Started October 2013 - Completed May 2015 Follow-up: Standard practice at participating centers

  • Normally 1-3 months post-procedure
  • Annually thereafter for a total of 2 years

Registry on WATCHMAN Outcomes in Real-Life Utilization: EWOLUTION

Boersma et al. Cath Card Int 2015

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EWOLUTION – complete 2 year patient flow

Study population Implant of WATCHMAN: N = 1020 Informed consent obtained: N = 1025 Patients with successful Watchman implant: N = 1005 Anatomy considered not suitable at prescreening: N = 5

Pts with completed 2 yrs FU: N = 784/1005 (78%) Pts with CT/TEE: N = 835/1005 (83%) Total #CT/TEEs: N = 1145 (avg 1.4/pt)

Deceased: N = 161 Withdrawn: N = 18 Lost to FU: N = 42 End of study < 1 year (N = 221)

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EWOLUTION – Stroke risk profile in AF patients

0.2 0.6 2.2 3.2 4.8 7.2 9.7 11.2 10.8 12.2 0.2 0.6 2.5 3.7 5.5 8.4 11.4 13.1 12.6 14.4

2 4 6 8 10 12 14 16 1 2 3 4 5 6 7 8 9

Expected ischemic strokes per 100 PY based on CHA2DS2-VASc (Friberg)

Treated with ASA Untreated 50 100 150 200 250 1 2 3 4 5 6 7 8 9

CHA2DS2-VASc distribution in EWOLUTION

Nr pts

CHA2DS2-VASc score ≥ 5 49% HAS-BLED ≥ 3 40% Major Bleeding/predisposition bleeding 39% Contra-indication (N)OAC 73%

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EWOLUTION – OAT at Follow-Up

Pts with first medication change info: N = 946 Pts with known medication: N = 998 Pts without FU information: N = 52

IMPLANT FIRST CHANGE 2-YR FU None SAPT DAPT (N)OAC 6% 7% 60% 27% 8% 58% 26% 8% 14% 71% 7% 8% IMPLANT FIRST CHANGE 2-YR FU

After 2 years 85% of pts were on SAPT or nothing

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Time to final single APT or nothing

Time Kaplan-Meier Event Rate 45 Days 8.3% 3 months 23.6% 6 months 45.5% 1 year 75.0% 2 years 95.1%

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EWOLUTION – High risk subgroup characteristics

* More pts on SAPT/none p<0.001)

Post implant medications N CHA2DS2-VASc HAS-BLED (N)OAC single/ none DAPT EWOLUTION all pts 1020 4.5 2.3 27% 14% 60% Hx ischemic stroke/TIA 311 5.5 2.6 29% 15% 56% Hx hemorrhagic stroke 153 5.4 2.8 11%* 27% 62% Hx Major Bleed 318 4.8 3.2 15% 17% 67%

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Device thrombus and medication – no relation

0.8% 4.8% 4.9% 4.5% 2.0% 0.0% 1.0% 2.0% 3.0% 4.0% 5.0% 6.0% VKA NOAC DAPT single APT None

P = 0.208

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EWOLUTION – Thrombo-embolic event rates

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EWOLUTION – No Stroke/TIA/SE in low risk patients

N = 118 N = 902

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EWOLUTION – Stroke in high risk subgroups

7.2 9.5 9.3 7.8 1.3 2.3 1.8 1.2 2 4 6 8 10 12

EWOLUTION all (N=1020) Hx stroke/TIA (N=311) Hx hemorrhagic stroke (N=153) Hx Major Bleed (N=318)

Thromboembolic events /100 pt- yrs

CHA2DS2- VASc 4.5 CHA2DS2- VASc 4.8 CHA2DS2- VASc 5.4 CHA2DS2- VASc 5.5

83% RRR 76% RRR 81% RRR 85% RRR

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EWOLUTION – Stroke/TIA/TE in high risk subgroups

CHA2DS2

  • VASc

4.5 CHA2DS2- VASc 5.5 CHA2DS2- VASc 4.8 CHA2DS2- VASc 5.4

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EWOLUTION – Bleeding rates for all pts

N = 1020

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EWOLUTION – Bleeding in high risk subgroups

5.0 5.4 5.6 6.5 2.7 3.2 1.8 4.5 1 2 3 4 5 6 7

EWOLUTION all (N=1020) Hx stroke/TIA (N=311) Hx hemorrhagic stroke (N=153) Hx Major Bleed (N=318)

Major Bleedings /100 pt-yrs HAS-BLED 2.3 HAS-BLED 2.6 HAS-BLED 2.8 HAS-BLED 3.2

46% RRR 41% RRR 67% RRR 30% RRR

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Consistent low stroke rate with WATCHMAN

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  • WATCHMAN LAAC was studied in an all-comers prospective registry with >70%
  • f pts contra-indicated to oral anticoagulation
  • Implant and LAA sealing success exceeding that of prior RCT and registries, with

lower procedural adverse event rates1 During the complete 2-year follow-up:

  • Most pts were on (D)APT (77%) or no anticoagulation (14%)
  • Device-thrombus was low (4.1%) and unrelated to stroke or anticoagulation type
  • Ischemic stroke rate was 1.3 per 100 pt-yrs (83% RR reduction)
  • Post-procedural major bleeding was 2.7 per 100 pt-yrs (46% RR reduction)
  • High risk pts with prior ischemic/hemorrhagic stroke had the same benefit of

stroke/TIA/SE prevention and the same low bleeding rates

EWOLUTION - Conclusions

  • 1. Boersma et al. EHJ 2016
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THANK YOU