Temporal modulation of antiplatelet therapy in high-risk patients undergoing complex percutaneous coronary intervention: the TAILORED-CHIP randomized clinical trial.

This study aimed to investigate the efficacy and safety of tailored antiplatelet treatment with temporal modulation of the intensity of platelet inhibition in patients undergoing complex high-risk PCI.

本研究旨在研究在进行复杂高危PCI的患者中，根据时间调节血小板抑制强度的个性化抗血小板治疗的疗效和安全性。

Methods

We randomly assigned 2018 patients with high-risk anatomical or clinical characteristics undergoing complex PCI to a tailored antiplatelet strategy with early escalation (low-dose ticagrelor at 60 mg twice daily plus aspirin <6 months) and late de-escalation (clopidogrel monotherapy >6 months) or dual antiplatelet therapy (clopidogrel plus aspirin for 12 months).

我们随机分配了2018名具有高风险解剖或临床特征的患者，这些患者正在接受复杂的经皮冠状动脉介入治疗（PCI），采用早期升级（低剂量替格瑞洛60 mg每日两次加阿司匹林<6个月）和晚期降级（氯吡格雷单药治疗>6个月）的个体化抗血小板策略，或双联抗血小板治疗（氯吡格雷加阿司匹林12个月）。

The primary outcome was a composite of death from any cause, myocardial infarction, stroke, stent thrombosis, unplanned urgent revascularization, and clinically relevant bleeding (Bleeding Academic Research Consortium Type 2, 3, or 5) at 12 months.

主要结果是12个月时由任何原因导致的死亡、心肌梗死、中风、支架血栓形成、计划外紧急血管重建和临床相关出血（Bleeding Academic Research Consortium 2型、3型或5型）的复合终点。

Results

The mean age was 64.0 years, 22.6% had left main PCI, 19.5% had complex bifurcation PCI, 84.1% had diffuse long lesions, 93.7% had multivessel PCI, and 36.7% had medically treated diabetes.

平均年龄为64.0岁，22.6%的患者接受了左主干PCI，19.5%的患者接受了复杂分叉病变PCI，84.1%的患者有弥漫性长病变，93.7%的患者接受了多血管PCI，36.7%的患者有糖尿病并接受药物治疗。

At 12 months, a primary outcome event occurred in 105 patients (10.5%) assigned to tailored antiplatelet therapy and in 89 patients (8.8%) assigned to dual antiplatelet therapy [hazard ratio, 1.19; 95% confidence interval(CI), 0.90-1.58; P = .21].

在12个月时，被分配到定制抗血小板治疗的105名患者（10.5%）和被分配到双重抗血小板治疗的89名患者（8.8%）发生了主要结果事件[风险比，1.19；95%置信区间（CI），0.90-1.58；P = .21]。

The incidenceof major ischaemic events appeared to be similar in both groups.

两组主要缺血事件的发生率似乎相似。

The incidenceof clinically relevant bleeding at 12 months was 7.2% in the tailored-therapy group and 4.8% in the dual-therapy group (difference, 2.45% points; 95% CI, 0.37-4.53).

在12个月时，定制治疗组的临床相关出血发生率为7.2%，双治疗组为4.8%（差异，2.45个百分点；95%置信区间，0.37-4.53）。

Conclusions

Among high-risk patients undergoing complex PCI, tailored antiplatelet strategy with early escalation and late de-escalation, as compared with dual antiplatelet therapy, did not decrease the incidenceof primary net adverse events at 12 months.

在进行复杂经皮冠状动脉介入治疗的高风险患者中，与双抗血小板治疗相比，早期升级和晚期降级的个性化抗血小板策略并没有降低12个月主要不良事件的发生率。

clinical_trial_registration

ClinicalTrials.gov number, NCT03465644.

ClinicalTrials.gov编号，NCT03465644。