Lower rate of major bleeding in very high risk patients undergoing left atrial appendage occlusion: A propensity score-matched comparison with direct oral anticoagulant.
Long-term oral anticoagulation is the mainstay therapy for thromboembolic (TE) prevention in patients with atrial fibrillation. However, left atrial appendage occlusion (LAAO) could be a safe alternative to direct oral anticoagulants (DOACs) in patients with a very high TE risk profile.
The purpose of this study was to compare the safety and efficacy of LAAO vs DOACs in patients with atrial fibrillation at very high stroke risk (CHA2DS2-VASc [congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category] score ≥ 5).
Data from patients with CHA2DS2-VASc score ≥ 5 were extracted from a prospective multicenter database. To attenuate the imbalance in covariates between groups, propensity score matching was used (covariates: CHA2DS2-VASc and HAS-BLED [hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol] scores), which resulted in a matched population of 277 patients per group. The primary end point was a composite of cardiovascular death, TE events, and clinically relevant bleeding during follow-up.
Of 2381 patients, 554 very high risk patients were included in the study (mean age 79 ± 7 years; CHA2DS2-VASc score 5.8 ± 0.9; HAS-BLED score 3.0 ± 0.9). The mean follow-up duration was 25 ± 11 months. A higher incidence of the composite end point was documented with DOACs compared with LAAO (14.9 events per 100 patient-years in the DOAC group vs 9.4 events per 100 patient-years in the LAAO group; P = .03). The annualized clinically relevant bleeding risk was higher with DOACs (6.3% vs 3.2%; P = .04), while the risk of TE events was not different between groups (4.1% vs 3.2%; P = .63).
In high-risk patients, LAAO had a similar stroke prevention efficacy but a significantly lower risk of clinically relevant bleeding when compared with DOACs. The clinical benefit of LAAO became significant after 18 months of follow-up.
Magnocavallo M
，Della Rocca DG
，Vetta G
，Mohanty S
，Gianni C
，Polselli M
，Rossi P
，Parlavecchio A
，Fazia MV
，Guarracini F
，De Vuono F
，Bisignani A
，Pannone L
，Raposeiras-Roubín S
，Lochy S
，Cauti FM
，Burkhardt JD
，Boveda S
，Sarkozy A
，Sorgente A
，Bianchi S
，Chierchia GB
，de Asmundis C
，Al-Ahmad A
，Di Biase L
，Horton RP
，Natale A
... -
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Long-term risks and benefits of oral anticoagulation in atrial fibrillation patients with cancer: A report from the GLORIA-AF registry.
Anticoagulation therapy in patients with atrial fibrillation (AF) and concomitant cancer can be challenging due to the significantly increased risk of both embolism and bleeding. Moreover, the benefits and risks of vitamin K antagonists (VKA, eg. warfarin) versus non-vitamin K antagonist oral anticoagulants (NOACs) in such patients are less well understood.
From the prospective, global, multi-centered Global Registry on Long-Term Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF), we characterized these patients according to their history of prior cancer when enrolled. All patients received anticoagulant therapy. The primary outcome was the composite of all-cause mortality, stroke, transient ischemic attack, systemic embolism. The secondary endpoints were all-cause mortality, cardiovascular death, stroke, major bleeding and thromboembolism during the 3 years follow-up period. Cox regression analyses were used to calculate the hazard ratio (HR) and confidence interval (CI) following propensity score matching (PSM).
Overall, among 16,700 patients enrolled in Phase III in GLORIA-AF, 1725 (10%) patients had concomitant cancer(s) at enrolment. After PSM, the primary outcome occurred in 250 (14.8%) of patients with cancer(s) and 160 (9.3%) without cancer(s) (HR, 1.62 [95% CI, 1.33-1.97], p < .001) during the 3 years follow-up period. The risk of all-cause mortality was significantly higher in patients with cancer(s) versus non- cancer(s) (HR, 1.71 [95% CI, 1.37-2.12], p < .001). In patients with cancer(s), after PSM, the use of NOACs was associated with reduced risk of the primary outcome compared with that of VKA (HR, .69 [95% CI, .49-.99], p = .043), as well as a lower risk of thromboembolism (HR, .49 [95% CI, .24-1.00], p = .051), but the risk of major bleeding was not significantly different (HR, .87 [95% CI, .48-1.56], p = .635). Subgroup analysis in patients with cancers showed a reduced risk of major bleeding with NOACs compared with VKA (HR, .18 [95% CI, .04-.8], p = .024) in patients with coronary artery disease (CAD). For the main cancer subtypes (genitourinary, breast, gastrointestinal, haematological and skin), the trends for the risk of primary outcome were consistently favouring NOACs compared with VKA without any significant interaction among these five cancers.
Cancer is a common comorbidity in patients with AF and is associated with increased risk of composite of all-cause mortality and thromboembolism. Compared with VKA, NOACs was associated with a lower risk of composite events and showed an advantage in lower risk of thromboembolism, as well as a reduced risk of major bleeding when CAD was also present.
Li M
，Huang B
，Lam SHM
，Ishiguchi H
，Liu Y
，Olshansky B
，Huisman MV
，Chao TF
，Lip GYH
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Left atrial appendage occlusion devices vs direct oral anticoagulants for atrial fibrillation: An updated systematic review and meta-analysis.
Direct Oral Anticoagulants (DOACs) are the first line anticoagulation for patients with non-valvular atrial fibrillation (NVAF). Percutaneous Left Atrial Appendage Occlusion (LAAO) has emerged as a new therapy and its safety and effectiveness compared with DOACs are still controversial.
A systematic review of randomized controlled trials and observational studies was conducted, focusing on patients with NVAF. Outcomes analyzed included: (1) all-cause mortality; (2) cardiovascular (CV) mortality; (3) thromboembolic events; (4) stroke or transient ischemic attack (TIA); (5) bleeding events; and a (6) composite of death, hemorrhagic, and thromboembolic events. We performed a subgroup analysis of major bleeding according to different definitions: (1) Bleeding Academic Research Consortium (BARC); (2) International Society on Thrombosis and Haemostasis (ISTH); and (3) other definitions.
Ten studies involving 18,507 patients were included, with 42.35 % undergoing LAAO. In pooled analysis, LAAO was associated with lower rates of all-cause mortality (HR 0.63; 95 % CI 0.50-0.80), cardiovascular mortality (HR 0.56; 95 % CI 0.45-0.70), and of the composite outcome (HR 0.73; 95 % CI 0.58-0.92). A trend towards lower stroke/TIA events was observed but not statistically significant. Overall bleeding events did not significantly differ between groups; using the ISTH definition, LAAO showed significantly lower incidence of bleeding events (HR 0.63; 95 % CI 0.43-0.91). No difference was found in thromboembolic events.
LAAO was associated with a significantly lower all-cause mortality and cardiovascular mortality, as well as the composite of death, hemorrhagic or thromboembolic events, as compared with DOACs.
Fernandes JM
，Pinheiro RPS
，Serpa F
，de Andrade NM
，Pereira V
，Sbardelotto ÂEE
，Gomes WF
... -
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Left atrial appendage closure in patients with failure of anticoagulation therapy: A multicenter comparative study on the hybrid strategy using DOACs and VKAs.
Patients with non-valvular atrial fibrillation (nvAF) who experienced a cardioembolic (CE) event despite adequate oral anticoagulation (OAC) are at high risk of recurrence and the combination between percutaneous left atrial appendage closure (LAAC) and long-term OAC may be a valuable option. The aim of this study was to compare the safety and the efficacy of post-LAAC long-term assumption of direct oral anticoagulants (DOACs) vs. vitamin K antagonists (VKAs) in this population.
Consecutive nvAF patients who experienced OAC failure despite adequate OAC therapy and underwent LAAC were retrospectively enrolled from three Italian centers. Patients were divided according to the anticoagulation strategy following LAAC: DOAC group and VKA group. The primary endpoint was a composite of all-cause death, CE event, and major bleeding, while secondary endpoint was a composite of CE event and major bleeding.
Overall, 132 patients (39 % females; mean age 69 ± 11 years), including 73 patients on DOAC and 59 patients on VKA, were enrolled. At a median follow up of 61 ± 23 months, the DOAC group reported lower rate of primary endpoint (HR 0.42, 95 %CI 0.18-0.99, p = 0.038) and lower rate of secondary endpoint (HR 0.28, 95 %CI 0.09-0.89, p = 0.02). No significant differences were detected regarding the type of DOAC assumed. Previous cerebrovascular events, CHA2DS2-VASc, CHADS2, HAS-BLED, and renal dysfunction were predictors of the primary endpoint.
Long-term DOAC assumption was associated with higher free from primary and secondary endpoint with respect to VKA in nvAF patients undergoing LAAC for OAC failure.
Preda A
，Falasconi G
，Melillo F
，Margonato D
，Posteraro GA
，Vella C
，Marzi A
，Guarracini F
，Bella PD
，Agricola E
，Gaspardone A
，Montorfano M
，Mazzone P
... -
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