JAMA cardiology最新文献

Importance: Anterior acute myocardial infarction is associated with increased risk of left ventricular (LV) thrombus. The benefit and risk of adding an oral anticoagulant to dual antiplatelet therapy (DAPT) in preventing LV thrombus remain uncertain.

Objective: To determine whether the addition of low-dose rivaroxaban to DAPT reduces the incidence of LV thrombus at 1 month in patients with anterior ST-segment elevation myocardial infarction (STEMI).

Design, setting, and participants: This multicenter, open-label, blinded-end point randomized clinical trial was performed in 29 centers in France. The trial was nested in the ongoing FRENCHIE (French Cohort of Myocardial Infarction Evaluation) registry. Between October 2021 and January 2023, patients with anterior STEMI were enrolled. The last date of participant follow-up was in March 2023. Data analysis was performed from September 2024 to July 2025.

Interventions: Patients were randomized to receive either DAPT plus rivaroxaban, 2.5 mg, twice daily for 4 weeks (n = 283) or DAPT alone (aspirin ≤100 mg per day and either clopidogrel, 75 mg per day, or ticagrelor, 90 mg twice a day [n = 277]), as soon as possible following completion of the initial percutaneous coronary intervention or angiography procedure.

Main outcomes and measures: The primary end point was presence of LV thrombus on contrast-enhanced cardiac magnetic resonance imaging at 1 month.

Results: Among 560 patients with anterior STEMI enrolled (mean [SD] age, 61.1 [11.6] years; 121 female patients [21.6%]), LV thrombus was detected in 38 patients (13.7%) receiving rivaroxaban and 47 patients (16.6%) with DAPT alone (difference, -2.9%; 95% CI, -8.9% to 3.2%; P = .34). No difference was observed between the 2 groups regarding the largest diameter of LV thrombus or the incidence of major adverse cardiovascular events. The incidence of major bleeding events (Bleeding Academic Research Consortium [BARC] ≥type 2) was also comparable (4 [1.5%] with DAPT plus rivaroxaban vs 2 [0.7%] with DAPT alone; difference, 0.7%; 95% CI, -1.3% to 3.1%), whereas minor bleeding events (BARC type 1) occurred more frequently in the DAPT plus rivaroxaban group (45 [16.4%] vs 20 [7.2%]; difference, 9.3%; 95% CI, 3.6%-14.8%).

Conclusions and relevance: In this multicenter randomized clinical trial among patients with anterior STEMI, the addition of low-dose rivaroxaban to DAPT did not demonstrate a statistically significant reduction in LV thrombus formation at 1 month but did increase minor bleeding. Given the limited power of the study, these findings should be interpreted with caution, as a modest effect cannot be excluded.

Trial registration: ClinicalTrials.gov Identifier: NCT05077683.

Importance: Transcatheter closure of patent foramen ovale (PFO) is a definitive therapy to prevent recurrent ischemic events in patients with PFO-associated embolism. However, very long-term outcome data remain scarce; these data are essential to fully understand the enduring safety and efficacy of this therapy.

Objective: To assess the 20-year clinical outcomes following PFO closure in patients with PFO-associated embolism.

Design, setting, and participants: This single-center cohort study with prospective procedure, early follow-up data collection, and retrospective long-term follow-up took place at a tertiary university hospital. The study included 130 consecutive patients who had PFO closure for cryptogenic stroke, transient ischemic attack (TIA), or peripheral embolism between 2001 and 2006. These data were analyzed from February 2025 to June 2025.

Exposure: All PFO closure procedures were technically successful and echocardiographic follow-up was performed within 1 to 6 months.

Main outcomes and measures: Long-term clinical outcomes were assessed via medical record review and telephone interviews.

Results: Mean (SD) age of the study population was 46 (14) years, with 67 women (51.5%) and 63 men (48.5%). Follow-up was complete for all but 5 patients (3.8%). At 20-year follow-up, a total of 20 patients (15.3%) had died (noncardiovascular causes in 12.2%) and recurrent ischemic events were infrequent (1 stroke [0.04 per 100 patients, per year] and 6 TIAs [0.25 per 100 patients, per year]). There was a higher prevalence of thrombophilia among patients who had recurrent ischemic events (33% vs 4.8%; P = .04). Up to 20.5% of patients discontinued antithrombotic treatment and none of them had any ischemic event at follow-up. Bleeding events occurred in 17 patients (13%) with 9 cases (6.9%) classified as major. These events were more frequent in women (19.4% vs 6.3%; P = .03) and occurred exclusively in patients receiving long-term antithrombotic therapy (17% vs 0% in patients who discontinued antithrombotic treatment; P = .04).

Conclusions and relevance: The results of this cohort study with 20-year follow-up showed the sustained very long-term safety and efficacy of transcatheter PFO closure, with less than 1% rate of recurrent stroke events. However, bleeding events occurred in about 1 in 10 patients and were more frequent in women and in patients under long-term antithrombotic therapy. These findings underscore the need for tailored long-term antithrombotic strategies after PFO closure. Further studies are warranted.