Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie (AP-HP), Paris, France.
Quebec Heart & Lung Institute, Laval University, Quebec City, Quebec, Canada.
Eur Heart J Cardiovasc Pharmacother. 2023 Nov 2;9(7):601-607. doi: 10.1093/ehjcvp/pvad023.
Temporary dual antiplatelet therapy (DAPT) is recommended following patent foramen ovale (PFO) percutaneous closure although its benefit, compared to single antiplatelet therapy (SAPT), has not been demonstrated in this setting. We aimed at assessing outcomes following PFO closure according to the antiplatelet strategy at discharge.
The ambispective AIR-FORCE cohort included consecutive patients from seven centres in France and Canada undergoing PFO closure and discharged without anticoagulation. Patients treated in French and Canadian centres were mostly discharged with DAPT and SAPT, respectively. The primary endpoint was the composite of death, stroke, transient ischaemic attack, peripheral embolism, myocardial infarction, or BARC type ≥2 bleeding with up to 5 years of follow-up. The impact of the antiplatelet strategy on outcomes was evaluated with a marginal Cox model (cluster analyses per country) with inverse probability weighting according to propensity score. A total of 1532 patients (42.2% female, median age: 49 [40-57] years) were included from 2001 to 2022, of whom 599 (39.1%) were discharged with SAPT and 933 (60.9%) with DAPT, for ≤3 months in 894/923 (96.9%) cases. After a median follow-up of 2.4 [1.1-4.4] years, a total of 58 events were observed. In the weighted analysis, the rate of the primary endpoint up to 5 years was 7.8% in the SAPT strategy and 7.3% in the DAPT strategy (weighted hazard ratio 1.04, 95% confidence interval 0.59-1.83).
The antiplatelet strategy following PFO closure did not seem to impact clinical outcomes, thus challenging the current recommendations of temporary DAPT.
尽管尚未在该治疗环境中证实与单一抗血小板治疗(SAPT)相比,卵圆孔未闭(PFO)经皮封堵术后临时双联抗血小板治疗(DAPT)具有优势,但仍推荐采用该治疗方案。我们旨在根据出院时的抗血小板策略评估 PFO 封堵术后的结局。
前瞻性的 AIR-FORCE 队列纳入了来自法国和加拿大 7 个中心的连续 PFO 封堵患者,这些患者出院时未接受抗凝治疗。法国和加拿大中心的患者主要分别接受 DAPT 和 SAPT 治疗。主要终点是复合终点,包括死亡、卒、短暂性脑缺血发作、外周栓塞、心肌梗死或 BARC 类型≥2 出血,随访时间长达 5 年。采用边缘 Cox 模型(按国家进行聚类分析),并根据倾向评分进行逆概率加权,评估抗血小板策略对结局的影响。共纳入了 2001 年至 2022 年间的 1532 例患者(42.2%为女性,中位年龄:49[40-57]岁),其中 599 例(39.1%)出院时接受 SAPT 治疗,933 例(60.9%)接受 DAPT 治疗,894/923 例(96.9%)的治疗时间≤3 个月。中位随访 2.4[1.1-4.4]年后,共观察到 58 例事件。在加权分析中,SAPT 策略和 DAPT 策略的主要终点发生率分别为 5 年内 7.8%和 7.3%(加权风险比 1.04,95%置信区间 0.59-1.83)。
PFO 封堵术后的抗血小板策略似乎并未影响临床结局,因此对当前临时 DAPT 的推荐提出了挑战。