Ticagrelor vs Prasugrel in Patients With Diabetes and Multivessel Coronary Artery Disease: The TUXEDO-2 Randomized Clinical Trial.

Although both ticagrelor and prasugrel are potent inhibitors of P2Y purinergic receptor 12 (P2Y12), evidence directly comparing their efficacy and safety in this high-risk group remains limited.

尽管替格瑞洛和普拉格雷都是P2Y嘌呤受体12（P2Y12）的强效抑制剂，但直接比较这两种药物在这一高风险群体中的疗效和安全性的证据仍然有限。

Background

To compare the clinical outcomes of ticagrelor vs prasugrel, each in combination with aspirin, in patients with diabetes and multivessel coronary artery disease who underwent percutaneous coronary intervention.

比较糖尿病和多支冠状动脉疾病患者在经皮冠状动脉介入治疗后，使用替格瑞洛与阿司匹林联合治疗与普拉格雷与阿司匹林联合治疗的临床结果。

DESIGN, SETTING, AND PARTICIPANTS: The Ultrathin Strut vs Xience in a Diabetic Population With Multivessel Disease 2-India Study (TUXEDO-2) is an investigator-initiated, prospective, open-label, multicenter, 2 × 2 factorial design, 1:1 randomized clinical trial. Participants with diabetes and multivessel disease undergoing percutaneous coronary intervention were enrolled at 66 clinical sites from February 2020 to August 2024.

设计、设置和参与者：Ultrathin Strut vs Xience在糖尿病多支血管疾病患者中的研究（TUXEDO-2）是一项由研究者发起的前瞻性、开放标签、多中心、2×2因素设计、1:1随机临床试验。从2020年2月到2024年8月，共有66个临床站点的糖尿病和多支血管疾病患者在进行经皮冠状动脉介入治疗后被纳入研究。

Methods

Patients undergoing percutaneous coronary intervention were randomized to receive either ticagrelor or prasugrel, each in combination with low-dose aspirin.

接受经皮冠状动脉介入治疗的患者被随机分配接受替卡格雷或普拉格雷治疗，每种药物均与低剂量阿司匹林联合使用。

main_outcomes_and_measures

The primary outcome was a composite of death, nonfatal myocardial infarction, stroke, or major bleeding as defined by the Bleeding Academic Research Consortium at 1 year.

主要结果是1年内由出血学术研究联盟定义的死亡、非致命性心肌梗死、中风或主要出血的复合结果。

The trial was designed to test the noninferiority of ticagrelor compared with prasugrel with a noninferiority margin of 5%.

该试验旨在测试替格瑞洛与普拉格雷相比的非劣效性，非劣效性边界值设定为5%。

Results

Among the 1800 participants randomized, mean (SD) age was 60 (10) years with 1296 (72.0%) male participants, 436 (24.2%) receiving insulin therapy, and 1530 (85.0%) with triple-vessel disease.

在随机分配的1800名参与者中，平均（标准差）年龄为60（10）岁，其中1296名（72.0%）为男性参与者，436名（24.2%）接受胰岛素治疗，1530名（85.0%）患有三支血管疾病。

At 1 year, the primary end point occurred in 129 participants (16.6%) taking ticagrelor and 107 participants (14.2%) taking prasugrel (P = .12).

在1年时，主要终点事件在129名（16.6%）服用替卡格雷的参与者和107名（14.2%）服用普拉格雷的参与者中发生（P = .12）。

The risk difference of 2.33 percentage points (95% CI, -2.07 to 6.74 percentage points) failed to meet the prespecified threshold for noninferiority (P = .84).

2.33个百分点的风险差异（95% 置信区间，-2.07至6.74个百分点）未能达到预先设定的非劣效性阈值（P = .84）。

There was numerically higher (but not statistically significant) composite of death, myocardial infarction, stroke (10.43% vs 8.63%; P = .30), and major bleeding (8.41% vs 7.14%; P = .19) with ticagrelor when compared with prasugrel.

与普拉格雷相比，替卡格雷在死亡、心肌梗死、中风的复合终点（10.43% vs 8.63%；P = .30）和主要出血（8.41% vs 7.14%；P = .19）方面数值上更高（但无统计学意义）。

conclusions_and_relevance

In patients with diabetes and multivessel disease undergoing PCI, ticagrelor was not noninferior to prasugrel for the reduction of primary outcome at 1 year of follow-up.

在接受经皮冠状动脉介入治疗的糖尿病和多血管病变患者中，替卡格雷在1年随访期间对于降低主要结局事件并不优于普拉格雷。

trial_registration

CTRI/2019/11/022088.

CTRI/2019/11/022088.