Safety and efficacy of early anticoagulation drug regimens after WATCHMAN left atrial appendage closure: three-month data from the EWOLUTION prospective, multicentre, monitored international WATCHMAN LAA closure registry

Bergmann, Martin; Betts, Timothy R.; Sievert, Horst; Schmidt, Boris; Pokushalov, Evgeny; Kische, Stephan; Schmitz, Thomas; Meincke, Felix; Steín, Kenneth M.; Boersma, Lucas V.A.; İnce, Hüseyin

doi:10.4244/eij-d-17-00042

Cited by 95 publications

(77 citation statements)

References 12 publications

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“…A multicenter prospective study was conducted to evaluate the theory of combined therapy focusing mainly on the usage of the Watchman device as the LAAO modality showed that when combined with anticoagulation therapy, no significant episodes of major bleeding were seen. Of all the OACs used, the ones with the lowest bleeding rate were the NOACs [23]. In 2015, Seeger et al put forward an argument that supported this idea and further vouches for the viability of a dual combination method [24].…”

Section: Combined Therapy and Its Outcomementioning

confidence: 99%

Comparison Between Oral Anticoagulation and Left Atrial Appendage Occlusion in the Prevention of Stroke With Regard to Non-Valvular Atrial Fibrillation

Sandhu¹,

Aftab²,

Anthony³

et al. 2020

Cureus

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In the past, the most common type of atrial fibrillation leading to stroke was valvular; this was predominantly due to the prevalence of rheumatic fever, but with the advent of better-hospitalized care, the cases of valvular atrial fibrillation declined. In recent years, there has been an increase in cases of stroke due to non-valvular atrial fibrillation. Stasis of blood in the left atrial pouch leads to coagulation and thrombi formation, which may lead to stroke. Oral medication or mechanical intervention can prevent thrombi formation. Both oral anticoagulation and left atrial appendage occlusion (LAAO) have been compared to see which has better outcomes. It was observed that LAAO has greater efficacy, but with time throughout a couple of years, no considerable difference was seen when compared to warfarin. Most of the long-term randomized controlled trials have been performed with the Watchman ® device. Although the Lariat and Amplatzer LAAO devices have also shown favorable outcomes, there is still a deficiency when it comes to trials of high-quality evidence using these devices as an intervention. Dual therapy with both of these approaches showed a decline in the count of major bleeding episodes on follow-up. Overall, albeit both methods have proven useful, LAAO has a slight advantage in efficacy and leads to less hemorrhagic events.

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Section: Combined Therapy and Its Outcomementioning

confidence: 99%

Comparison Between Oral Anticoagulation and Left Atrial Appendage Occlusion in the Prevention of Stroke With Regard to Non-Valvular Atrial Fibrillation

Sandhu¹,

Aftab²,

Anthony³

et al. 2020

Cureus

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“…Tab. 3) folgern die Autoren Bergmann et al, dass die 3 am häufigsten angewendeten medikamentösen Therapien (VKA, DAPT, NOAK) sicher und effektiv nach Watchman-Implantation und die niedrigen Inzidenzen von DRT ("device related thrombus") und Blutungen bei NOAK verglichen mit VKA und DAPT (postprozedural) konsistent erscheinen, auch bei Berücksichtigung der Differenzen der Gruppen hinsichtlich CHA2DS2-VASc, HAS-BLED scores oder in Bezug auf die für die orale Antikoagulation nicht geeigneten Patienten [6].…”

Section: Bfarmunclassified

LAA-Okkluder versus orale Antikoagulation bei nonvalvulärem Vorhofflimmern in klinischen Studien: Wie ist die Evidenz?

Barth

2020

Kardiologe

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Zusammenfassung Hintergrund Die LAAO („left atrial appendage occluder“) haben bislang gemäß europäischer Leitlinie nur eine Klasse-IIb-B-Empfehlung zur Prophylaxe zerebraler Insulte bei nichtvalvulärem Vorhofflimmern z. B. bei Patienten mit Kontraindikationen für eine Langzeitgabe von oralen Antikoagulanzien, die der Goldstandard zur Thromboembolieprophylaxe bei Vorhofflimmern mit einer Präferenz von NOAC („novel oral anticoagulants“) sind. Die Studie vergleicht die Sicherheit und Effektivität der LAA-Okkluder mit oralen Antikoagulanzien in klinischen Studien. Methoden Die Komplikationsraten (z. B. Blutungen, ischämischer Insult) in klinischen Studien mit LAAO bzw. oralen Antikoagulanzien wurden anhand einer Literaturanalyse (2010–19) und der BfArM-Datenbank (SAE-Meldungen) beurteilt. Ergebnisse In der Literaturanalyse sind die besonderen Risiken der LAAO (z. B. Perikarderguss) sichtbar. In einigen Watchman-Studien bestand ein reduziertes Risiko zerebraler Insulte vergleichbar mit Warfarin. Die Auswertung der BfArM-Datenbank (Watchman-Register mit beendetem 5‑Jahres-Follow-up) zeigt z. B. einen Anteil der Patienten mit Medizinprodukt(MP)-Thrombus von 2,6 % für das Register (n = 1 dieser Patienten mit konsekutivem zerebralem Insult, mittlere Follow-up-Dauer des Registers 50,1 Monate). Der Anteil der Patienten mit ischämischem Insult bezogen auf die eingeschlossenen Patienten beträgt im Register 5,3 % (Ereignisrate 1,30 pro 100 Patientenjahre), mit hämorrhagischem Insult 0,7 % (Ereignisrate 0,17 pro 100 Patientenjahre), die kardiovaskuläre und ungeklärte Mortalität 7,1 % (Ereignisrate 1,69 pro 100 Patientenjahre), und die gesamte Mortalität 17,8 % (Ereignisrate 4,27 pro 100 Patientenjahre). Diskussion Die LAAO bieten den Vorteil, dass nach ihrer Endothelialisierung z. T. auf Gerinnungshemmer verzichtet werden und dadurch ein Einsatz bei Patienten mit erhöhten Blutungsrisiken erfolgen kann. Die Studienbetrachtung (Analyse der BfArM-Datenbank und wissenschaftlichen Literatur) bestätigt die klinische Evidenz hinsichtlich einer insgesamt sicheren Anwendung des Watchman MP in klinischen Studien.

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“…Consistent with the EWOLUTION trial, in both treatment arms, all fatal and most of the MB events occurred during the most aggressive phase of antithrombotic therapy. 6,8 In the ACT group, MBs, including three fatal events, were observed during early follow-up and occurred predominantly in patients with a high HAS-BLED score and prior bleeding events. This observation was also made in the PROTECT and PREVAIL studies, which used the ACT regimen and documented a relatively high estimated annual bleeding rate of 10.5%.…”

Section: Clinical Follow-upmentioning

confidence: 99%

“…7 In the multicenter EWOLUTION registry, patients on nonvitamin K oral anticoagulants (NOACs) had the lowest bleeding rate, without an increase in DRT or stroke rates. 8 The real-world ASAP registry, published by Reddy et al, 9 evaluated a 6-month DAPT in 150 patients undergoing LAAC with the Watchman and reported a low annual rate of ischemic stroke (IS) of 1.7%; they concluded that the Watchman occluder could be used without a warfarin transition. 9 Nevertheless, until results of upcoming randomized clinical trials will be available, the present study is supposed to compare clinical efficacy, safety, and net clinical benefit of a 3-month DAPT and 6 weeks anticoagulation plus aspirin followed by a 6 months DAPT based on the results of two real-world registries.…”

Section: Introductionmentioning

confidence: 99%

Propensity‐matched comparison of antiplatelet versus anticoagulant after left atrial appendage closure with the Watchman

Liu

Kleinecke

Busch

et al. 2020

Pacing Clinical Electrophis

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Background: Optimal antithrombotic therapy following left atrial appendage closure (LAAC) with the Watchman occluder remains uncertain. This study retrospectively compared clinical outcomes of a 3-month dual antiplatelet therapy (DAPT group) and a protocol of anticoagulation plus aspirin for 45 days followed by DAPT for 6 months (ACT group) after LAAC with the Watchman device. Methods: Of two Watchman registries (Coburg and Lichtenfels hospitals, Germany), 220 and 304 consecutive patients with successful LAAC were included. Patients in Coburg hospital received DAPT while they received ACT in Lichtenfels. After a 1:1 propensity score matching, 174 (DAPT) versus 174 (ACT) patients were compared by use of the primary efficacy endpoint of thromboembolic events and cardiovascular/unexplained death, the primary safety endpoint of nonprocedural related major bleeding events at follow-up, and the combined hazard endpoint, a composite of all above-mentioned hazards.

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Safety and efficacy of early anticoagulation drug regimens after WATCHMAN left atrial appendage closure: three-month data from the EWOLUTION prospective, multicentre, monitored international WATCHMAN LAA closure registry

Cited by 95 publications

References 12 publications

Comparison Between Oral Anticoagulation and Left Atrial Appendage Occlusion in the Prevention of Stroke With Regard to Non-Valvular Atrial Fibrillation

Comparison Between Oral Anticoagulation and Left Atrial Appendage Occlusion in the Prevention of Stroke With Regard to Non-Valvular Atrial Fibrillation

LAA-Okkluder versus orale Antikoagulation bei nonvalvulärem Vorhofflimmern in klinischen Studien: Wie ist die Evidenz?

Propensity‐matched comparison of antiplatelet versus anticoagulant after left atrial appendage closure with the Watchman

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