What is the clinical evidence from this study?

Study design: Observational. Population: Atrial fibrillation (n=298). Intervention: Short-term dual antiplatelet therapy (DAPT). Primary outcome: Major bleeding (BARC >2).

April 1, 2018EuroInterventionOpen Access

Short-term dual antiplatelet therapy after interventional left atrial appendage closure with different devices

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Key result

Short-term dual antiplatelet therapy for six weeks after left atrial appendage closure resulted in an annual major bleeding rate of 3.9% and an annual thromboembolic event rate of 1.7%.

Why the study?

Does short-term DAPT for six weeks prevent stroke and minimize bleeding in patients after LAAC?

Study Design

Type

Observational (n=298)

Multicenter

Structured PICO

Does short-term DAPT for six weeks prevent stroke and minimize bleeding in patients after LAAC?

Population

298 patients (mean age 76 years, 38.3% female) with atrial fibrillation and high bleeding risk who underwent successful left atrial appendage closure, followed for a median of 731 days.

Intervention

Short-term dual antiplatelet therapy (DAPT) with aspirin 100 mg and clopidogrel 75 mg once daily for six weeks after LAAC, followed by single antiplatelet therapy (aspirin 100 mg/d) indefinitely in the absence of significant peri-device flow or device-related thrombus.

Outcome

Primary safety endpoint: occurrence of major bleeding defined as BARC >2. Primary efficacy endpoint: incidence of any stroke or systemic embolism.safety

Short-term DAPT for six weeks after LAAC is a viable strategy with low rates of thromboembolism, though elderly patients and those with renal impairment remain at high risk for major bleeding.

Limitations

Observational design lacking a control group
Small sample size from a single center
Included different device types
Potential underestimation of device-related thrombus due to incomplete transoesophageal echocardiography follow-up
Small sample size
Single-center study
Potential underestimation of DRT rate due to incomplete TEE follow-up

Implication

May support abbreviated DAPT after LAA closure; hypothesis-generating and requires randomized confirmation before practice change.

Abstract

AIMS: We aimed to assess the feasibility, efficacy and safety of short-term dual antiplatelet therapy (DAPT) for six weeks after left atrial appendage closure (LAAC). METHODS AND RESULTS: Data of the Cardioangiologisches Centrum Bethanien-LAAC registry were analysed. DAPT (aspirin 100 mg plus clopidogrel 75 mg) was administered until transoesophageal echocardiography (TEE) evaluation six weeks after LAAC. In the absence of significant peri-device flow or device-related thrombus (DRT), the medication was decreased to single antiplatelet therapy (SAPT). Outpatient visits were timed at six-month intervals. The incidences of major bleeding (BARC ≥3) and of thromboembolic events were investigated. A total of 298 patients (76±8 years; 62% male; CHA2DS2-VASc 4.3±1.5; HAS-BLED 3.5±1.0; 61% with history of bleeding) with successful LAAC were included. TEE revealed DRT in 7/298 (2.3%) patients (five at six-week follow-up [FU] 45±10 days after implant, two during a median long-term FU of 731 days). Non-procedure-related bleeding events occurred in 25/298 (8.4%) patients and non-procedure-related thromboembolic events in 11/298 (3.7%) patients. This translated into 3.9 bleeding events/100 patient-years and 1.7 thromboembolic events/100 patient-years, respectively. Procedure-related events consisted of major bleeding in 7/298 (2.3%) patients and stroke in 2/298 (0.7%) patients. Age ≥75 years (OR 3.2; CI: 1.2-8.0; p=0.015) and renal impairment (OR 2.5; CI: 1.1-5.7; p=0.027) were identified as independent predictors for major bleeding after LAAC. CONCLUSIONS: Short-term DAPT for six weeks appears to be a viable alternative for patients after LAAC. Age ≥75 years and renal impairment increase major bleeding events threefold.

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Cite This Study

Weise et al. (2018) conducted an observational in Atrial fibrillation (n=298). Short-term dual antiplatelet therapy (DAPT) was evaluated on Major bleeding (BARC >2). Short-term dual antiplatelet therapy for six weeks after left atrial appendage closure resulted in an annual major bleeding rate of 3.9% and an annual thromboembolic event rate of 1.7%.

synapsesocial.com/papers/6a770e31a0847c3df1ec50c5 https://doi.org/10.4244/eij-d-17-00901