Dataset Information

Comparison of clinical outcomes between multiple antithrombotic therapy versus left atrial appendage occlusion with dual antiplatelet therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation.

ABSTRACT:

Background

Complex antithrombotic regimens are recommended for patients with atrial fibrillation (AF) undergoing drug-eluting stent (DES) implantation but carry high bleeding risk.

Hypothesis

We aimed to evaluate whether left atrial appendage occlusion (LAAO) with dual antiplatelet therapy (DAPT) improve clinical outcomes when compared with multiple antithrombotic therapy (MAT) in patients with AF undergoing DES implantation.

Methods

Among 475 AF patients who underwent DES, 41 patients treated by LAAO with DAPT and 434 patients on MAT were compared. MAT was defined as any combination of warfarin-based antithrombotic therapy. Among the MAT group, 34.8% were on triple antithrombotic therapy. The primary endpoint was a net adverse clinical event (NACE), a composite of cerebrovascular accident (CVA) and major bleeding. Secondary endpoints were CVA, major bleeding, major adverse cardiac and cerebral event (MACCE), MI, cardiovascular death, and all-cause death. Additional analysis between the new oral anticoagulant (NOAC)-based antithrombotic therapy group (n = 45) and the LAAO group was performed for the same endpoints. To adjust the confounding factors, inverse probability of treatment weighting (IPTW) was applied during the endpoint analysis.

Results

The LAAO group showed higher incidences of diabetes mellitus, prior CVA, higher CHA2DS2-VASc score (4.56±1.55 vs. 2.96±1.60; P<0.0001), and higher HAS-BLED score (3.24±1.20 vs. 2.13±0.75; P<0.0001). NACE occurred less frequently in the LAAO group than the MAT group at 24 months (9.4% vs. 15.3%; hazard ratio 0.274; 95% confidence interval 0.136 - 0.553; P = 0.0003), mainly driven by the reduction in major bleeding (2.4% vs. 9.3%; hazard ratio 0.119; 95% confidence interval 0.032 - 0.438; P = 0.001). The LAAO group with greater thrombotic and hemorrhagic risks showed comparable primary/secondary outcomes with the NOAC-based anti-thrombotic therapy group.

Conclusions

Among patients with AF who underwent DES implantation, the LAAO group had better net clinical outcomes for preventing CVA and major bleeding than the MAT group. Further large-scale trials including comparisons with NOACs are warranted.

SUBMITTER: Kook H

PROVIDER: S-EPMC7790384 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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Publications

Comparison of clinical outcomes between multiple antithrombotic therapy versus left atrial appendage occlusion with dual antiplatelet therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation.

Kook Hyungdon H Kim Hee-Dong HD Shim Jaemin J Kim Young-Hoon YH Kim Jung-Sun JS Pak Hui-Nam HN Lee Hyun-Jong HJ Choi Rak-Kyeong RK Kang Woong-Chol WC Shin Eun-Seok ES Park Jai-Wun JW Yu Cheol Woong CW Lim Do-Sun DS

PloS one 20210107 1

<h4>Background</h4>Complex antithrombotic regimens are recommended for patients with atrial fibrillation (AF) undergoing drug-eluting stent (DES) implantation but carry high bleeding risk.<h4>Hypothesis</h4>We aimed to evaluate whether left atrial appendage occlusion (LAAO) with dual antiplatelet therapy (DAPT) improve clinical outcomes when compared with multiple antithrombotic therapy (MAT) in patients with AF undergoing DES implantation.<h4>Methods</h4>Among 475 AF patients who underwent DES, ...[more]

PMID: 33411816

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Project description:BackgroundEnd-stage renal disease yields susceptibility to both ischemia and bleeding. The optimal duration of dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation is not established in dialysis patients, who are usually excluded from randomized studies. Since recent studies implied the benefits of prolonged DAPT >12 months in chronic kidney disease, we investigated the effectiveness and safety of prolonged DAPT in dialysis patients with higher cardiovascular risks.MethodsIn this nationwide population-based study, we analyzed dialysis patients who underwent DES implantation from 2008 to 2015. Continued DAPT was compared with discontinued DAPT using landmark analyses, including free-of-event participants at 12 (n = 2246), 15 (n = 1925) and 18 months (n = 1692) after DES implantation. The primary outcome was major adverse cardiovascular events (MACEs): a composite of mortality, nonfatal myocardial infarction, coronary revascularization and stroke. Major bleeding was a safety outcome. Inverse probability of treatment weighting Cox regression was performed.ResultsMean follow-up periods were 278.3-292.4 days, depending on landmarks. Overall, incidences of major bleeding were far lower than those of MACE. Continued DAPT groups showed lower incidences of MACE and higher incidences of major bleeding, compared with discontinued DAPT groups. In Cox analyses, continued DAPT reduced the hazards of MACE at the 12- [hazard ratio (HR) = 0.74, 95% confidence interval (CI) 0.61-0.90; P = 0.003], 15- (HR = 0.78, 95% CI 0.64-0.96; P = 0.019) and 18-month landmarks (HR = 0.79, 95% CI 0.63-0.99; P = 0.041), but without a significant increase in major bleeding at 12 (HR = 1.39, 95% CI 0.90-2.16; P = 0.14), 15 (HR = 1.13, 95% CI 0.75-1.70; P = 0.55) or 18 months (HR = 1.27, 95% CI 0.83-1.95; P = 0.27).ConclusionsProlonged DAPT reduced MACE without significantly increasing major bleeding in patients who were event-free at 12 months after DES implantation. In deciding on DAPT duration, prolonged DAPT should be considered in dialysis patients.

Project description:BackgroundThe use of anticoagulants and antiplatelet therapies is associated with a higher risk of bleeding in atrial fibrillation (AF) patients after percutaneous coronary intervention, especially after stent implantation. However, no accurate bleeding risk prediction tool has been developed for these patients. The aim of this study was thus to establish a bleeding risk prediction model (predictive nomogram) for patients with AF after stent implantation.MethodsConstruction of the predictive nomogram was based on a retrospective study, which enrolled 943 AF patients who underwent drug-eluting stent implantation between May 2012 and September 2016. A range of factors, including demographics, comorbidities, medication strategies, arterial access, and laboratory tests, were collected as baseline data. The least absolute shrinkage and selection operator (LASSO) and multivariate logistic regression analysis were used to identify the key clinical features for construction of the predictive nomogram. The concordance index (C-index) and internal validation were used to evaluate the efficacy of the nomogram.ResultsOf the 943 AF patients that underwent stent implantation, the occurrence of bleeding events was 8.2% (77 out of 943). Key predictors included the number of antiplatelet drugs, peptic ulcer, cerebral infarction, type 2 diabetes, thrombocytopenia, anemia, prior myocardial infarction, sex (male), use of anticoagulant drugs, liver dysfunction, hypertension, and acute myocardial infarction. These predictors were used to construct the nomogram. The C-index for the prediction of bleeding risk by the nomogram was 0.841 (95% CI: 0.79-0.89), which indicated good discrimination and calibration. The C-index of internal validation was 0.795, which demonstrated good efficacy of the model.ConclusionsThis study suggests that our novel nomogram can accurately predict bleeding risk in AF patients after stent implantation during hospitalization, thereby helping to avoid complications. The nomogram may also be helpful for the creation of individualized post-discharge medication strategies.

Project description:ObjectivesThe aim of this study was to compare bleeding, thromboembolic, device-related thrombus (DRT), and all-cause mortality events between patients treated with short-term oral anticoagulation (OAC) and those treated with short-term antiplatelet therapy (APT) following left atrial appendage occlusion (LAAO).BackgroundShort-term OAC is recommended for patients following LAAO. However, in practice many patients receive APT rather than OAC because of excessive bleeding risk. However, the safety and efficacy of APT compared with OAC have been debated.MethodsA search was conducted of databases for studies comparing OAC with APT following LAAO. The outcomes of interest were all-cause stroke, major bleeding, DRT, and all-cause mortality. Noncomparative studies were pooled into a single study to generate comparisons of the studies' outcomes. Effects measure were pooled using the random-effect model.ResultsA total of 83 studies with 12,326 patients (APT, n = 7,900; OAC, n = 4,151) were included. Mean CHA2DS2-VASc and HAS-BLED scores were 4.1 ± 1.6 and 3.0 ± 1.3, respectively. There were no significance differences between the APT and OAC groups with regard to stroke (risk ratio [RR]: 1.04; 95% confidence interval [CI]: 0.54 to 1.98; p = 0.91; I2 = 31%), major bleeding (RR: 1.12; 95% CI: 0.68 to 1.84; p = 0.65; I2 = 53%), DRT (RR: 1.33; 95% CI: 0.74 to 2.39; p = 0.33; I2 = 36%), and all-cause mortality (RR: 1.29; 95% CI: 0.40 to 4.09; p = 0.18; I2 = 36%). These findings persisted in multiple secondary analyses: 1) excluding studies that reported no events; 2) including comparative studies only; 3) excluding patients who were treated with single APT; and 4) removing one study at a time to assess the effect of each study on the overall effect size. There was also no difference in the studies' endpoints among patients who received different LAAO devices.ConclusionsIn a meta-analysis of observational data, there were no differences in the occurrence of stroke, major bleeding DRT, and all-cause mortality in patients treated with short-term OAC or APT following LAAO.

Dataset Information

Comparison of clinical outcomes between multiple antithrombotic therapy versus left atrial appendage occlusion with dual antiplatelet therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation.

Background

Hypothesis

Methods

Results

Conclusions

Publications

Comparison of clinical outcomes between multiple antithrombotic therapy versus left atrial appendage occlusion with dual antiplatelet therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation.

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