Established data describing the optimal duration of dual antiplatelet therapy (DAPT) after endovascular therapy (EVT) for patients with peripheral artery disease (PAD) are limited. This study is a prospective, multi-center single-arm study evaluating 1-month DAPT on clinical outcomes following EVT using drug-coated balloon (DCB) for patients with symptomatic femoropopliteal artery (FPA) disease. A total of 151 patients with de novo FPA lesions which planned DCB therapy were enrolled from seven centers. DAPT (aspirin 100 mg/day and clopidogrel 75 mg/day) was started prior to EVT and continued 1-month after EVT, and subsequent aspirin monotherapy was continued during follow-up period. The primary endpoint was 1-year primary patency, as assessed by duplex ultrasound. Secondary endpoints included re-occlusion, target lesions revascularization (TLR), major amputation, acute limb ischemia (ALI), and bleeding events at one year. Mean age was 74.6 ± 8.8 and critical limb ischemia were observed in 48 patients (31.8
Background Female sex has been associated with poor prognosis in hypertrophic cardiomyopathy (HCM), but the factors contributing to this disparity remain insufficiently defined. We aimed to clarify sex differences in clinical characteristics and factors associated with cardiovascular death in Japan. Methods This multicenter, retrospective observational study of HCM was conducted between January 1, 2006, and December 31, 2018 (REVEAL‐HCM study [Multicenter Registry to Evaluate Risk Factors for Disease Progression, Sudden Cardiac Death and Adverse Clinical Outcomes in Japanese Patients With Hypertrophic Cardiomyopathy]; UMIN000046932). Patients aged ≥16 years with HCM were enrolled. Baseline characteristics and clinical outcomes including cardiovascular death were assessed. Univariable and multivariable Cox proportional hazards models were used to identify factors associated with cardiovascular death. Results Of 3247 patients (median age, 67 years; 43% women), women were older and more symptomatic at presentation (52% New York Heart Association class II–IV versus 35% in men). Cardiovascular death was more common in women (hazard ratio [HR], 1.37 [95% CI, 1.02–1.82]; P=0.03). In multivariable analysis, older age (per 1‐year increase; HR, 1.04 [95% CI, 1.02–1.06]), advanced New York Heart Association class (HR, 1.99 [95% CI, 1.40–2.82]), history of atrial fibrillation (HR, 1.55 [95% CI, 1.10–2.18]), greater maximal wall thickness indexed to body surface area (per 1‐mm/m2 increase; HR, 1.12 [95% CI, 1.06–1.20]), and apical HCM (HR, 0.53 [95% CI, 0.32–0.88]) were independently associated with cardiovascular death, attenuating the HR for female sex. Conclusions Sex differences in clinical characteristics and outcomes were observed. The excess cardiovascular death in women with HCM was largely explained by older age, more advanced symptoms, greater indexed wall thickness, and sex‐specific differences in both the prevalence and prognostic impact of apical HCM.
Background: In patients with persistent atrial fibrillation (AF), extensive ablation for substrate modification, such as linear ablation or complex fractionated atrial electrogram ablation in addition to pulmonary vein isolation (PVI) remains controversial. Previous studies investigating extensive ablation have demonstrated its varying efficacy, suggesting the possible heterogeneity of its efficacy. Aging is a major risk factor for AF and is associated with atrial remodeling. We aimed to compare the efficacy and safety of the extensive ablation strategy compared with PVI alone strategy between young and elderly patients. Methods: This study is a post-hoc analysis of the multicenter, randomized controlled, noninferiority trial investigating the efficacy and safety of PVI-only (PVI-alone arm) compared with extensive ablation (PVI-plus arm) in patients with persistent AF (EARNEST-PVI trial). We divided the overall population into 2 groups based on age and assessed treatment effects. Results: In the young group (age <65 years, N = 206), there was no significant difference in the recurrence rate between the PVI-alone group and PVI-plus group [hazard ratio (HR): 1.00, 95 % CI: 0.57-1.73, p = 0.987], whereas the recurrence rate was significantly lower in the PVI-plus group compared to the PVI-alone group in the elderly group (age >= 65 years, N = 291) (HR: 0.47, 95 % CI: 0.29-0.76, p = 0.0021) (p for interaction = 0.0446). There were no fatal procedural complications. Conclusion: In patients with persistent AF, the extensive ablation strategy was more effective than the PVI-alone strategy in elderly patients, while the effectiveness of both approaches was comparable in young patients. Trial registration: URL: https://clinicaltrials.gov; Unique identifier: NCT03514693. URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022454 Unique ID issued by UMIN: UMIN000019449. (c) 2024 Japanese College of Cardiology. Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Background:Atrial fibrillation (AF) is a major risk factor for thromboembolic events, with left atrial thrombus (LAT) formation occurring despite oral anticoagulant (OAC) therapy in some patients. Direct oral anticoagulants (DOACs) have demonstrated efficacy in preventing thrombosis; however, their role in LAT resolution compared to warfarin remains unclear. Methods:This retrospective, multicenter study analyzed 260 AF patients with transesophageal echocardiography (TEE)-confirmed LAT among 17,436 AF patients who underwent TEE. Patients were categorized into DOAC and warfarin groups. LAT resolution, ischemic stroke/systemic embolism, major bleeding, and all-cause death were evaluated. The warfarin group was further stratified by time in therapeutic range (TTR) (<60 % and ≥ 60 %), and the DOAC group by dose (standard and low). Results:During a median follow-up of 386 [367, 413] days, LAT resolution was achieved in 62 % of patients, significantly higher in the DOAC group (74 % vs. 54 %, P = 0.001). Standard-dose DOACs had the highest resolution rates, while TTR < 60 % had the lowest (79 % vs. 49 %). DOACs were independently associated with higher LAT resolution (OR = 2.91 [1.32-6.38], P = 0.008) and fewer bleeding events (OR = 0.26 [0.08-0.80], P = 0.019). Conclusions:DOAC therapy was associated with higher LAT resolution rates and showed a fewer bleeding events compared to warfarin. DOACs may serve as first-line therapy for LAT.
