Rivaroxaban Monotherapy in Patients With Atrial Fibrillation and Coronary Stenting at Multiple Vessels or the Left Main Trunk: The AFIRE Trial Subanalysis.
Ontology highlight
ABSTRACT:
SUBMITTER: Ishii M
PROVIDER: S-EPMC9673635 | biostudies-literature | 2022 Nov
REPOSITORIES: biostudies-literature
Publications
Rivaroxaban Monotherapy in Patients With Atrial Fibrillation and Coronary Stenting at Multiple Vessels or the Left Main Trunk: The AFIRE Trial Subanalysis.
Ishii Mitsuru M Akao Masaharu M Yasuda Satoshi S Kaikita Koichi K Ako Junya J Matoba Tetsuya T Nakamura Masato M Miyauchi Katsumi K Hagiwara Nobuhisa N Kimura Kazuo K Hirayama Atsushi A Matsui Kunihiko K Ogawa Hisao H
Journal of the American Heart Association 20221026 21
Similar Datasets
Project description:Background Rivaroxaban monotherapy was noninferior to combination therapy (rivaroxaban plus antiplatelet therapy) in efficacy but superior in safety in the Atrial Fibrillation and Ischemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease (AFIRE) trial. Among 2,215 patients with atrial fibrillation (AF) and stable coronary artery disease (CAD), 1,378 had baseline creatinine clearance (CrCl) ≥50 mL/min and received 10 (underdose) or 15 mg/d (standard-dose) rivaroxaban. We aimed to assess the effects of rivaroxaban underdose on clinical outcomes.Methods We assessed efficacy endpoint (a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, and death from any cause) and major bleeding in the subgroup of patients with preserved renal function in the AFIRE trial.Results Age ≥75 years, female sex, lower CrCl, heart failure, and percutaneous coronary intervention history were associated with the underdose prescription. The underdose group had a similar incidence of the efficacy endpoint (3.62 vs. 3.51% per patient-year; p = 0.871) and significantly lower incidence of major bleeding (0.82 vs. 2.17% per patient-year; p = 0.022) than the standard-dose group. In patients receiving monotherapy, the incidences of efficacy endpoint and major bleeding were similar between the groups, whereas in those receiving combination therapy, the incidence of major bleeding was significantly lower in the underdose group than that in the standard-dose group.Conclusion In patients with AF, stable CAD, and preserved renal function, rivaroxaban underdose was associated with similar rates of thrombotic events but a lower incidence of hemorrhagic events than the standard dose.Clinical trial registration AFIRE UMIN Clinical Trials Registry (https://www.umin.ac.jp/ctr/), number UMIN000016612, and ClinicalTrials.gov, number NCT02642419.
| S-EPMC9420554 | biostudies-literature
Project description:No large-scale study has compared the clinical and angiographic predictors of cardiovascular events in patients with left main bifurcation (LMB) and non-LMB stenting after second-generation DES implantation. Herein, we investigated differential clinical and angiographic factors for predicting outcomes in LMB versus non-LMB stenting. A total of 2648 patients with bifurcation lesions treated with second-generation DESs from the retrospective patient cohort were divided into an LMB group (n = 935) and a non-LMB group (n = 1713). The primary outcome was the 7-year incidence of target lesion failure (TLF), defined as the composite of cardiac death, myocardial infarction, and target lesion revascularization. The incidence of TLF was 9.8%. Those in the LMB group were associated with a higher risk of TLF (14.2% versus 7.5%, p < 0.001) than those in the non-LMB group. Regarding the LMB group, independent predictors of TLF were chronic kidney disease (CKD), reduced left ventricular ejection fraction (LVEF), and two-stenting. Regarding the non-LMB group, CKD, reduced LVEF, old age, diabetes, and small diameter of the main vessel stent were independent predictors of TLF. The two-stent strategy could potentially increase TLF for the LMB lesions, and achieving the maximal diameter of the main vessel stent could result in better clinical outcomes for non-LMB lesions.
| S-EPMC8306985 | biostudies-literature
Project description:ImportanceAppropriate regimens of antithrombotic therapy for patients with atrial fibrillation (AF) and coronary artery disease (CAD) have not yet been established.ObjectiveTo compare the total number of thrombotic and/or bleeding events between rivaroxaban monotherapy and combined rivaroxaban and antiplatelet therapy in such patients.Design, setting, and participantsThis was a post hoc secondary analysis of the Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease (AFIRE) open-label, randomized clinical trial. This multicenter analysis was conducted from February 23, 2015, to July 31, 2018. Patients with AF and stable CAD who had undergone percutaneous coronary intervention or coronary artery bypass grafting 1 or more years earlier or who had angiographically confirmed CAD not requiring revascularization were enrolled. Data were analyzed from September 1, 2020, to March 26, 2021.InterventionsRivaroxaban monotherapy or combined rivaroxaban and antiplatelet therapy.Main outcomes and measuresThe total incidence of thrombotic, bleeding, and fatal events was compared between the groups. Cox regression analyses were used to estimate the risk of subsequent events in the 2 groups, with the status of thrombotic or bleeding events that had occurred by the time of death used as a time-dependent variable.ResultsA total of 2215 patients (mean [SD] age, 74 [8.2] years; 1751 men [79.1%]) were included in the modified intention-to-treat analysis. The total event rates for the rivaroxaban monotherapy group (1107 [50.0%]) and the combination-therapy group (1108 [50.0%]) were 12.2% (135 of 1107) and 19.2% (213 of 1108), respectively, during a median follow-up of 24.1 (IQR, 17.3-31.5) months. The mortality rate was 3.7% (41 of 1107) in the monotherapy group and 6.6% (73 of 1108) in the combination-therapy group. Rivaroxaban monotherapy was associated with a lower risk of total events compared with combination therapy (hazard ratio, 0.62; 95% CI, 0.48-0.80; P < .001). Monotherapy was an independent factor associated with a lower risk of subsequent events compared with combination therapy. The mortality risk after a bleeding event (monotherapy, 75% [6 of 8]; combination therapy, 62.1% [18 of 29]) was higher than that after a thrombotic event (monotherapy, 25% [2 of 8]; combination therapy, 37.9% [11 of 29]).Conclusions and relevanceRivaroxaban monotherapy was associated with lower risks of total thrombotic and/or bleeding events than combination therapy in patients with AF and stable CAD. Tapered antithrombotic therapy with a sole anticoagulant should be considered in these patients.Trial registrationClinicalTrials.gov Identifier: NCT02642419.
| S-EPMC9201742 | biostudies-literature
Project description: Not available
| S-EPMC7494704 | biostudies-literature
Project description: Not available
| S-EPMC8728729 | biostudies-literature
Project description:AimsThe present study sought to determine the rate and prognostic implications of post-procedural physiologically significant residual ischemia according to Murray law-based quantitative flow ratio (μQFR) after left main (LM) bifurcation percutaneous coronary intervention (PCI).Methods and resultsConsecutive patients undergoing LM bifurcation stenting at a large tertiary care center between January 2014 and December 2016 with available post-PCI μQFR were included. Physiologically significant residual ischemia was defined by post-PCI μQFR values ≤0.80 in the left anterior descending (LAD) or left circumflex artery (LCX). The primary outcome was 3-year cardiovascular death. The major secondary outcome was 3-year bifurcation-oriented composite endpoint (BOCE). Among 1170 included patients with analyzable post-PCI μQFR, 155 (13.2%) had residual ischemia in either LAD or LCX. Patients with vs. those without residual ischemia had a higher risk of 3-year cardiovascular mortality [5.4% vs. 1.3%; adjusted hazard ratio (HR) 3.20, 95% confidence interval (CI): 1.16-8.80]. The 3-year risk of BOCE was significantly higher in the residual ischemia group (17.8% vs. 5.8%; adjusted HR 2.79, 95% CI: 1.68-4.64), driven by higher incidence of the composite of cardiovascular death and target bifurcation-related myocardial infarction (14.0% vs. 3.3%; adjusted HR 4.06, 95% CI: 2.22-7.42). A significant, inverse association was observed between continuous post-PCI μQFR and the risk of clinical outcomes (per 0.1 μQFR decrease, HR of cardiovascular death 1.27, 95% CI: 1.00-1.62; HR of BOCE 1.29, 95% CI: 1.14-1.47).ConclusionAfter angiographically successful LM bifurcation PCI, residual ischemia assessed by μQFR was identified in 13.2% of patients and was associated with higher risk of 3-year cardiovascular death, indicating the superior prognostic value of post-PCI physiological assessment.
| S-EPMC10627280 | biostudies-literature
Project description: Not available
| S-EPMC10711560 | biostudies-literature
Project description:Left main coronary artery chronic total occlusion is an unusual finding discovered on coronary angiography. Historically, coronary artery bypass graft has been the preferred treatment. However, recent studies have revealed the role of left main percutaneous coronary intervention in selected patients. This is a case of staged left main coronary artery chronic total occlusion percutaneous coronary intervention. (Level of Difficulty: Advanced.).
| S-EPMC10107090 | biostudies-literature
Project description:BackgroundThere are few predictors of decreased fractional flow reserve (FFR) in the left circumflex coronary artery (LCx) after left main (LM) crossover stenting.ObjectivesWe aimed to determine the predictors for low FFR at LCx and possible treatment strategies for compromised LCx, together with their long-term outcomes.MethodsAltogether, 563 patients who met the inclusion criteria were admitted to our hospital from February 2015 to November 2020 with significant distal LM bifurcation lesions. They underwent single-stent crossover percutaneous coronary intervention (PCI) under intravascular ultrasound (IVUS) guidance with further LCx intervention based on the measured FFR.ResultsThe patients showed significant angiographic LCx ostial affection post-LM stenting, but only 116 (20.6%) patients had FFR < 0.8. The three-year composite major adverse cardiac events (MACE) rates were comparable between the high and low FFR groups (16.8% vs. 15.5; p = 0.744). In a multivariate analysis, low FFR at the LCx was associated with post-stenting minimal luminal area (MLA) of LCx (odds ratio [OR]: 0.032, p < .001), post-stenting LCx plaque burden (OR: 1.166, p < .001), poststenting LM MLA (OR: 0.821, p = .038), and prestenting LCx MLA (OR: 0.371, p = .044). In the low FFR group, those with compromised LCx managed with drug-eluting balloon had the lowest three-year MACE rate (8.1%), as compared to either those undergoing kissing balloon inflation (KBI) (17.5%) or stenting (20.5%) (p = 0.299).ConclusionUnnecessary LCx interventions can be avoided with FFR-guided LCx intervention. Poststenting MLA and plaque burden of the LCx, and main vessel stent length are poststenting predictors of low FFR.
| S-EPMC8495093 | biostudies-literature
Project description:BackgroundThe AFIRE (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) trial showed both noninferiority for efficacy and superiority for safety endpoints of rivaroxaban monotherapy compared with those of rivaroxaban plus antiplatelet therapy (combination therapy) in patients with atrial fibrillation and stable coronary artery disease.ObjectivesThis study sought to evaluate outcomes of rivaroxaban monotherapy in those patients across body mass index (BMI) categories.MethodsPatients were categorized into 4 groups: underweight (BMI <18.5 kg/m2), normal weight (BMI 18.5 to <25 kg/m2), overweight (BMI 25 to <30 kg/m2), and obesity (BMI ≥30 kg/m2). Efficacy (a composite of all-cause death, myocardial infarction, unstable angina requiring revascularization, stroke, or systemic embolism) and safety (major bleeding defined according to International Society on Thrombosis and Haemostasis criteria) were compared between rivaroxaban monotherapy and combination therapy across BMI categories.ResultsThis study analyzed 2,054 patients with a median age of 75.0 years and CHA2DS2-VASc score of 4. A significant interaction was not observed between BMI categories and effect of monotherapy for efficacy (P = 0.83) and safety (P = 0.07), although monotherapy was superior to combination therapy for efficacy in normal weight (HR: 0.64; 95% CI: 0.44-0.95) and safety in overweight (HR: 0.25; 95% CI: 0.10-0.62), whereas a significant difference in the endpoints was not observed in the other BMI categories.ConclusionsRivaroxaban monotherapy had a similar effect on prognosis across all BMI categories in patients with atrial fibrillation and stable coronary artery disease. (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease [AFIRE]; UMIN000016612, NCT02642419).
| S-EPMC9876995 | biostudies-literature