1-month versus 12-month dual antithrombotic therapy after percutaneous coronary intervention in patients with atrial fibrillation (OPTIMA-AF): a multicentre, open-label, hybrid non-inferiority and superiority, randomised, controlled trial.

We aimed to compare the efficacy and safety of 1-month versus 12-month dual antithrombotic therapy in this population.

我们旨在比较这一人群中药物治疗1个月与12个月的疗效和安全性。

Methods

OPTIMA-AF was an active-control, randomised, hybrid non-inferiority and superiority trial in which patients with atrial fibrillation undergoing PCI with intravascular imaging guidance were randomly assigned (1:1) to receive 1-month dual antithrombotic therapy (direct oral anticoagulant [DOAC] plus P2Y12 inhibitor) followed by DOAC monotherapy or 12-month dual therapy followed by DOAC monotherapy, across 75 sites in Japan.

OPTIMA-AF 是一项活性对照、随机、混合非劣效性和优效性试验，在该试验中，接受经血管内成像指导的经皮冠状动脉介入治疗（PCI）的房颤患者被随机分配（1:1）接受为期1个月的双重抗血栓治疗（直接口服抗凝药[DOAC]加P2Y12抑制剂）后转为DOAC单药治疗，或接受为期12个月的双重治疗后转为DOAC单药治疗，试验在日本的75个地点进行。

Eligible patients were aged 20 years or older with non-valvular atrial fibrillation, a CHADS2 score of 1 or higher, undergoing PCI for native coronary lesions for chronic coronary syndrome or unstable angina, with planned post-PCI treatment with a DOAC.

符合条件的患者年龄在20岁或以上，患有非瓣膜性房颤，CHADS2评分1分或以上，因慢性冠状动脉综合征或不稳定型心绞痛接受原发性冠状动脉病变的PCI治疗，并计划在PCI后使用DOAC进行治疗。

Randomisation used web-based central allocation stratified by trial centre.

随机化使用基于网络的中心分配，按试验中心进行分层。

Investigators and patients were unmasked; clinical events were adjudicated by an independent committee masked to treatment.

研究者和患者未被蒙蔽；临床事件由一个对治疗情况不知情的独立委员会进行裁决。

The primary efficacy endpoint was a composite of all-cause death or thromboembolic events at 12 months; the primary safety endpoint was major or clinically relevant non-major bleeding at 12 months.

主要疗效终点是12个月内全因死亡或血栓栓塞事件的复合终点；主要安全性终点是12个月内的主要或临床相关的非主要出血事件。

The trial used a fixed-sequence testing strategy of non-inferiority for efficacy, superiority for safety, and superiority for efficacy.

该试验采用了一种固定序列的测试策略，即对疗效进行非劣效性检验，对安全性进行优效性检验，对疗效再次进行优效性检验。

Analyses used the full analysis set including all patients who underwent PCI, were randomly assigned to treatment, received at least one dose of study drugs, and met prespecified analysis-set criteria.

分析使用了全分析集，包括所有接受经皮冠状动脉介入治疗（PCI）、被随机分配到治疗组、至少接受一次研究药物治疗，并满足预先设定的分析集标准的患者。

This trial is registered with the Japan Registry of Clinical Trials (jRCTs051190053), and is complete.

该试验已在日本临床试验注册中心（jRCTs051190053）注册，并已完成。

Results

From Oct 7, 2019, to Sept 3, 2024, 1101 patients were assessed for eligibility; 1088 were randomly assigned to treatment and 1079 were included in the full analysis set (1-month dual therapy n=542; 12-month dual therapy n=537).

从2019年10月7日至2024年9月3日，共有1101名患者被评估以确定是否符合资格；1088名患者被随机分配接受治疗，1079名患者被纳入完整分析集（1个月双治疗组n=542；12个月双治疗组n=537）。

Median age was 76 years (IQR 70-81). 225 (21%) of 1079 patients were female and 854 (79%) were male.

中位年龄为76岁（四分位数间距70-81）。在1079名患者中，225名（21%）为女性，854名（79%）为男性。

Median CHADS2 score was 2 (IQR 2-3).

CHADS2评分的中位数为2（四分位数间距2-3）。

Median follow-up was 540 days (IQR 517-559).

随访的中位数为540天（四分位数间距517-559天）。

The primary efficacy endpoint occurred in 29 patients in the 1-month dual therapy group and 23 patients in the 12-month dual therapy group (Kaplan-Meier estimate 5·4% vs 4·3%; absolute difference 1·1 percentage points [95% CI -1·5 to 3·6]; hazard ratio[HR] 1·25 [95% CI 0·73-2·17]).

主要疗效终点在1个月双治疗组的29名患者和12个月双治疗组的23名患者中发生（Kaplan-Meier估计值分别为5.4%和4.3%；绝对差异为1.1个百分点[95%置信区间-1.5至3.6]；风险比[HR]为1.25[95%置信区间0.73-2.17]）。

The primary safety endpoint occurred in 24 patients versus 47 patients (Kaplan-Meier estimate 4·5% vs 8·8%; absolute difference -4·4 percentage points [95% CI -7·3 to -1·4]; HR 0·50 [95% CI 0·30-0·81]; p=0·0041 for superiority).

主要安全终点在24名患者和47名患者中发生（Kaplan-Meier估计值分别为4.5%和8.8%；绝对差异为-4.4个百分点[95%置信区间-7.3至-1.4]；风险比[HR]为0.50[95%置信区间0.30-0.81]；p=0.0041，显示优越性）。

interpretation

Among patients with atrial fibrillation and predominantly chronic coronary syndrome undergoing PCI with intravascular imaging guidance, 1-month dual antithrombotic therapy followed by DOAC monotherapy was non-inferior to 12-month therapy for death or thromboembolic events and reduced major or clinically relevant non-major bleeding at 12 months, suggesting an overall favourable net clinical profile.

在进行经皮冠状动脉介入治疗（PCI）并接受血管内成像引导的房颤患者和以慢性冠脉综合征为主的患者中，1个月的双重抗血小板治疗后转为直接口服抗凝药（DOAC）单药治疗，在12个月内对于死亡或血栓栓塞事件并不劣于12个月的治疗，并且减少了12个月的主要或临床相关的非主要出血事件，表明整体临床净获益是积极的。

Efficacy findings should be interpreted with appropriate caution in light of the lower-than-anticipated event rates and fixed absolute non-inferiority margin.

鉴于事件率低于预期和固定的绝对非劣效性界限，应谨慎解释疗效发现。

funding

Abbott Medical Japan.

Abbott Medical Japan.

translations

For the Japanese translation of the abstract see Supplementary Materials section.

摘要的日文翻译请参见补充材料部分。