Background

Dual antiplatelet therapy (DAPT) prevents thrombotic events after coronary stent implantation but may induce bleedings, specifically in elderly patients. However, a competitive risk analysis is lacking.

Objectives

To assess the determinants of major bleeding and the balance between the competing risks of major bleeding and thrombotic events during prasugrel-based DAPT after stent implantation.

Methods

Overall, 2,291 patients randomized to drug-eluting or bare metal stents and treated with prasugrel 10mg/day for 1 year were followed over 2 years for major bleeding (BARC 3/5) and thrombotic events (cardiac death, myocardial infarction, definitive/probable stent thrombosis). Prasugrel dose was reduced to 5mg in patients >75 years and/or <60kg. Predictors of major bleeding and competing risks of major bleeding and thrombotic events were assessed.

Results

Two-year rates of major bleeding and thrombotic events were 2.9% and 9.0%, respectively. The only independent predictor of major bleeding was age (hazard ratio per year increase 1.05 [1.02,1.07], p<0.001). The relationship between major bleeding and age was non-linear, with lowest hazard ratios at 57 years and an exponential increase only above 65 years. In contrast, the relationship between thrombotic events and age was linear and continuously increasing with older age. While the competing risk of thrombotic events was higher than that of major bleeding in younger patients, the two risks were similar in older patients. After discontinuation of prasugrel, bleeding events leveled off in all patients, while thrombotic events continued to increase.

Conclusions

In prasugrel-based DAPT, age is the strongest risk factor for major bleeding, increasing exponentially >65 years. In younger patients, thrombotic events represent a higher risk than bleeding, while thrombotic and bleeding risks were similar in older patients. Important clinical implications relate to prasugrel dose in the elderly, duration of DAPT and the competing risk balance necessitating individualized treatment decisions.

中文翻译：

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支架植入后使用基于普拉格雷的双重抗血小板治疗的主要出血和血栓形成事件的竞争风险-来自BASKET-PROVE II的观察分析

背景

双重抗血小板治疗（DAPT）可以预防冠状动脉支架植入术后的血栓形成事件，但可能会引起出血，特别是在老年患者中。但是，缺乏竞争风险分析。

目标

评估支架植入后基于普拉格雷的DAPT期间主要出血的决定因素以及主要出血和血栓形成事件的竞争风险之间的平衡。

方法

总体而言，共有2291例患者随机分配至药物洗脱支架或裸金属支架并接受普拉格雷10mg /天治疗1年，为期2年，随访期间发生大出血（BARC 3/5）和血栓事件（心脏死亡，心肌梗死，确定性/可能支架血栓形成）。> 75岁和/或<60kg的患者普拉格雷剂量降至5mg。评估了大出血的预测因素以及大出血和血栓形成事件的竞争风险。

结果

两年内大出血和血栓事件的发生率分别为2.9％和9.0％。严重出血的唯一独立预测因子是年龄（每年的危险比增加1.05 [1.02,1.07]，p <0.001）。大出血与年龄之间的关系是非线性的，危险比最低，为57岁，而指数上升仅在65岁以上。相反，血栓形成事件与年龄之间的关系是线性的，并且随着年龄的增长而不断增加。尽管年轻患者的血栓事件竞争风险高于严重出血事件，但老年患者的两种风险相似。普拉格雷停用后，所有患者的出血事件均趋于平稳，而血栓事件继续增加。

结论

在基于普拉格雷的DAPT中，年龄是发生大出血的最强风险因素，呈指数增加> 65岁的趋势。在年轻患者中，血栓事件比出血的风险更高，而在老年患者中，血栓和出血的风险相似。重要的临床意义涉及老年人的普拉格雷剂量，DAPT的持续时间和竞争性风险平衡，因此需要个体化的治疗决策。