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Comparative Study
. 2024 Aug 19;20(16):1018-1028.
doi: 10.4244/EIJ-D-24-00116.

A comparison of simplified or conventional antithrombotic regimens after left atrial appendage closure in patients at high bleeding risk: the PLATEBRISK study

Pablo Antúnez-Muiños  1 , Sergio López-Tejero  1 , Pedro Cepas-Guillén  2 , Matias Mon-Noboa  3 , Juan M Ruiz-Nodar  4   5 , Luis Andrés-Lalaguna  6 , Fernando Rivero  7 , Juan Gabriel Córdoba-Soriano  8 , Ignacio J Amat-Santos  9 , Berenice Caneiro-Queija  10 , David Martí Sánchez  11 , Javier Jimeno Sánchez  12 , Fernando Torres Mezcua  4 , Fabián Blanco-Fernández  1 , Jorge Sanz Sánchez  7 , Cristina Moreno-Ambroj  13 , Rodrigo Estévez-Loureiro  10 , Luis Nombela-Franco  3 , Xavier Freixa-Rofastes  2 , Ignacio Cruz-González  1
Affiliations
Comparative Study

A comparison of simplified or conventional antithrombotic regimens after left atrial appendage closure in patients at high bleeding risk: the PLATEBRISK study

Pablo Antúnez-Muiños et al. EuroIntervention. .

Abstract

Background: Antithrombotic treatment (ATT) post-left atrial appendage occlusion (LAAO) remains controversial. Furthermore, most of the patients undergoing LAAO are at a very high bleeding risk.

Aims: This study aimed to compare a simplified versus conventional ATT after LAAO in very high bleeding risk patients.

Methods: This is a multicentre, retrospective study including very high bleeding risk patients, according to the Bleeding Academic Research Consortium (BARC) definition, who underwent LAAO. These included patients at >4% risk of BARC 3 to 5 bleeding or >1% risk of intracranial bleeding after the procedure. Two groups were established based on the discharge ATT. The simplified group included single antiplatelet treatment or no treatment, and the conventional group comprised dual antiplatelet treatment or anticoagulation (combined or not with antiplatelet therapy).

Results: A total of 1,135 patients were included. The mean CHA2DS2-VASc and HAS-BLED scores were 4.5±1.5 and 3.7±1.0, respectively. There were no differences in the composite endpoint (death, stroke, transient ischaemic attack, device-related thrombus or major bleeding) between the 2 groups (hazard ratio [HR] 0.81, 95% confidence interval [CI]: 0.59-1.11; p=0.188). Although the rate of major bleeding during the first year was numerically lower in the simplified group, it did not reach statistical significance (HR 0.67, 95% CI: 0.41-1.10; p=0.104). Nonetheless, patients with previous major bleeding presented a significantly lower rate of major bleeding when using the simplified treatment (HR 0.61, 95% CI: 0.36-0.99; p=0.049).

Conclusions: In patients with very high bleeding risk, a simplified ATT after LAAO seems to be as effective as conventional protocols. Furthermore, patients with a history of major bleeding experienced a lower risk of major bleeding with the simplified ATT.

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Conflict of interest statement

I. Cruz-González has been a proctor of Abbott, Boston Scientific, Lifetech, and Eclipse Medical. R. Estévez-Loureiro has received speaker fees from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Venus Medtech, Lifetech, and Jenscare. X. Freixa-Rofastes reports support from Abbott, Boston Scientific, and Lifetech. I.J. Amat-Santos has been a proctor of Boston Scientific. L. Nombela-Franco has been a proctor of Abbott. D. Martí Sánchez has received speaker and consulting fees from Boston Scientific and SMT. The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1. Primary indication for LAAO.
Representation of the most frequent indications for LAAO. High bleeding risk included patients with a need for anticoagulation and any comorbidity that increased the risk of bleeding. INR: international normalised ratio; LAAO: left atrial appendage occlusion; OAC: oral anticoagulation
Figure 2
Figure 2. Event rates for the primary composite endpoint of stroke, TIA, peripheral embolism, DRT or major bleeding events.
The conventional group and the simplified treatment groups are compared in the global cohort of very high bleeding risk patients according to the BARC criteria.BARC: Bleeding Academic Research Consortium; DRT: device-related thrombus; TIA: transient ischaemic attack
Figure 3
Figure 3. Event-free survival analyses.
Event-free survival analyses for the primary composite endpoint of stroke, TIA, peripheral embolism, DRT or major bleeding events (A); major bleeding events (B) and secondary endpoints, a composite of stroke, TIA, peripheral embolism, or DRT (C and D). The conventional and the simplified treatment groups are compared in this global cohort of very high bleeding risk patients according to the BARC criteria (B and C) and in the subgroup of subjects with previous major bleeding prior to LAAO (A and D). BARC: Bleeding Academic Research Consortium; CI: confidence interval; DRT: device-related thrombus; HR: hazard ratio; LAAO: left atrial appendage occlusion; TIA: transient ischaemic attack
Central illustration
Central illustration. Main findings of a simplified versus conventional treatment after LAAO in very high bleeding risk patients.
No differences were found in the composite endpoint during the first year of follow-up. Moreover, in patients with previous major bleeding, the simplified group presented a lower rate of new major bleeding during the first year post-LAAO. CI: confidence interval; DAPT: dual antiplatelet therapy; HR: hazard ratio; LAAO: left atrial appendage occlusion; OAC: oral anticoagulation; SAPT: single antiplatelet therapy
See this image and copyright information in PMC

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