Therapy for Atrial Fibrillation in Patients with Drug-Eluting Stents.

Methods

In this multicenter, randomized, open-label, noninferiority trial in South Korea, we assigned patients with atrial fibrillation who had undergone the implantation of a drug-eluting stent at least 1 year earlier in a 1:1 ratio to receive NOAC monotherapy or combination therapy (NOAC plus clopidogrel).

在这项在韩国进行的多中心、随机、开放标签、非劣效试验中，我们以1:1的比例将至少1年前植入药物洗脱支架的房颤患者分配接受NOAC单药治疗或联合治疗(NOAC加用氯吡格雷)。

The primary end point was net adverse clinical events, a composite of death from any cause, myocardial infarction, stent thrombosis, stroke, systemic embolism, or major bleeding or clinically relevant nonmajor bleeding at 12 months.

主要终点是净不良临床事件，这是由任何原因导致的死亡、心肌梗死、支架血栓形成、中风、全身性栓塞或主要出血或临床相关的非主要出血在12个月内的复合指标。

The noninferiority margin was 3.0 percentage points.

非劣效性边界是3.0个百分点。

Results

A total of 960 patients underwent randomization: 482 patients to receive monotherapy and 478 to receive combination therapy.

共有960名患者进行了随机分组：482名患者接受单药治疗，478名患者接受联合治疗。

The mean age of the patients was 71.1 years, and 21.4% were women.

患者的平均年龄为71.1岁，其中21.4%为女性。

At 12 months, a primary end-point event had occurred in 46 patients (Kaplan-Meier estimate, 9.6%) in the monotherapy group and in 82 patients (Kaplan-Meier estimate, 17.2%) in the combination-therapy group, for an absolute difference of -7.6 percentage points (95.2% confidence interval[CI], -11.9 to -3.3; P<0.001 for noninferiority) and a hazard ratioof 0.54 (95.2% CI, 0.37 to 0.77; P<0.001 for superiority).

在12个月时，单药治疗组有46名患者（Kaplan-Meier估计，9.6%）和联合治疗组有82名患者（Kaplan-Meier估计，17.2%）发生了主要终点事件，绝对差异为-7.6个百分点（95.2%置信区间[CI]，-11.9至-3.3；P<0.001，证明非劣效性），以及风险比为0.54（95.2% CI，0.37至0.77；P<0.001，证明优越性）。

Major bleeding or clinically relevant nonmajor bleeding occurred in 25 patients (5.2%) in the monotherapy group and in 63 patients (13.2%) in the combination-therapy group (hazard ratio, 0.38; 95% CI, 0.24 to 0.60).

在单药治疗组中，有25名患者（5.2%）发生了主要出血或临床相关的非主要出血，在联合治疗组中，有63名患者（13.2%）发生了这些情况（风险比，0.38；95% CI，0.24至0.60）。

Conclusions

Among patients with atrial fibrillation who had undergone implantation of a drug-eluting stent at least 1 year earlier, NOAC monotherapy was noninferior to combination therapy for net adverse clinical events.

在至少1年前植入药物洗脱支架的房颤患者中，NOAC单药治疗对于净不良临床事件的非劣效性不亚于联合治疗。

(Funded by Cardiovascular Research Center and Samjin Pharmaceutical; ADAPT AF-DES ClinicalTrials.gov number, NCT04250116.).

(该研究由心血管研究中心和三进制药资助；ADAPT AF-DES临床试验注册号为NCT04250116。)