Background

Elderly patients are at high-risk of bleeding, but are under-represented in clinical trials.

Objectives

The aims were to determine the incidence and the predictive factors of bleeding and to assess the impact of bleeding on further ischemic outcomes in elderly patients after acute coronary syndrome (ACS) treated with percutaneous coronary intervention.

Methods

From the 877 patients aged ≥ 75 years included in the ANTARCTIC randomized trial, data on Bleeding Academic Research Consortium (BARC) bleeding complications and major adverse cardiovascular events (MACE), defined as the composite of cardiovascular death, myocardial infarction, and stroke, were collected over 1 year.

Results

Clinically relevant bleeding events (BARC types 2, 3, or 5) were observed in 20.6% of patients (n = 181) at 1 year, of which, one third occurred in the first month. Anemia (adjusted hazard ratio [adj.HR] 3.98, 95% confidence interval [CI] 1.41–11.22; p = 0.009), severe chronic renal failure (adj.HR 1.83, 95% CI 1.12–2.98; p = 0.015), and femoral access (adj.HR 2.54, 95% CI 1.71–3.77; p < 0.001) were independently associated with clinically relevant bleeding events, while age > 85 years (adj.HR 2.22, 95% CI 1.14–4.30; p = 0.018) was independently associated with major bleeding events (BARC types 3 or 5). Patients with a clinically relevant bleeding event had a higher rate of MACE at 1 year (adj.HR 2.04, 95% CI 1.24–3.38; p = 0.005), with a particularly strong effect on stroke (adj.HR 5.55, 95% CI 2.04–15.06; p < 0.001).

Conclusions

Clinically relevant bleeding events were observed in one out of five elderly patients undergoing stenting for an ACS and were strongly associated with further stroke occurrence. Rather than the antiplatelet therapy, comorbidities and an age > 85 years predicted bleeding outcomes in this elderly population.

Clinical Trial Registration

Clinicaltrials.gov identifier: NCT01538446. https://www.clinicaltrials.gov.

中文翻译：

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老年人出血：急性冠状动脉综合征后的危险因素和对临床结果的影响，一项随机南极试验的子研究

背景

老年患者出血风险高，但在临床试验中的代表性不足。

目标

目的是确定出血的发生率和预测因素，并评估出血对急性冠状动脉综合征 (ACS) 经皮冠状动脉介入治疗后老年患者进一步缺血结局的影响。

方法

从 ANTARCTIC 随机试验中纳入的 877 名年龄≥75 岁的患者中，出血学术研究联盟 (BARC) 出血并发症和主要不良心血管事件 (MACE) 的数据被定义为心血管死亡、心肌梗塞和中风的复合材料。收集超过 1 年。

结果

 1 年时，20.6% 的患者 ( n = 181)观察到临床相关出血事件（BARC 2、3 或 5 型），其中三分之一发生在第一个月。贫血（调整后的风险比 [adj.HR] 3.98，95% 置信区间 [CI] 1.41–11.22；p  = 0.009），严重慢性肾功能衰竭（调整后的 HR 1.83，95% CI 1.12–2.98；p  = 0.015），和股骨通路（调整 HR 2.54，95% CI 1.71–3.77；p  < 0.001）与临床相关出血事件独立相关，而年龄 > 85 岁（调整 HR 2.22，95% CI 1.14–4.30；p = 0.018) 与大出血事件（BARC 3 型或 5 型）独立相关。发生临床相关出血事件的患者在 1 年时的 MACE 发生率较高（调整 HR 2.04，95% CI 1.24-3.38；p  = 0.005），对卒中影响特别大（调整 HR 5.55，95% CI 2.04–15.06；p  < 0.001)。

结论

在因 ACS 接受支架置入术的五分之一老年患者中观察到临床相关的出血事件，并且与进一步中风的发生密切相关。与抗血小板治疗不同，合并症和年龄 > 85 岁可预测该老年人群的出血结果。

临床试验注册

Clinicaltrials.gov 标识符：NCT01538446。https://www.clinicaltrials.gov。