老年人出血：急性冠状动脉综合征后风险因素及对临床结局的影响，ANTARCTIC 试验的一项亚组研究。
Bleeding in the Elderly: Risk Factors and Impact on Clinical Outcomes After an Acute Coronary Syndrome, a Sub-study of the Randomized ANTARCTIC Trial.
机构信息
ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Sorbonne University, 47-83 bld de l'Hôpital, 75013, Paris, France.
ACTION Study Group, Cardiology Department, Nîmes University Hospital, Montpellier University, Nîmes, France.
出版信息
Am J Cardiovasc Drugs. 2021 Nov;21(6):681-691. doi: 10.1007/s40256-021-00468-8. Epub 2021 Jun 30.
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 .
背景
老年患者出血风险较高，但在临床试验中代表性不足。
目的
确定出血的发生率和预测因素，并评估急性冠状动脉综合征（ACS）患者经皮冠状动脉介入治疗后出血对进一步缺血性结局的影响。
方法
从 ANTARCTIC 随机试验中纳入的 877 名年龄≥75 岁的患者中，收集了 1 年内发生的 Bleeding Academic Research Consortium（BARC）出血并发症和主要不良心血管事件（MACE）的数据，MACE 定义为心血管死亡、心肌梗死和中风的复合终点。
结果
1 年内，20.6%（n=181）的患者发生了临床相关出血事件（BARC 类型 2、3 或 5），其中三分之一发生在第一个月。贫血（调整后的危险比[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（adj.HR 1.83，95%CI 1.12-2.98；p=0.015）和股动脉入路（adj.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（adj.HR 2.22，95%CI 1.14-4.30；p=0.018）与主要出血事件（BARC 类型 3 或 5）独立相关。发生临床相关出血事件的患者在 1 年内发生 MACE 的比率更高（adj.HR 2.04，95%CI 1.24-3.38；p=0.005），尤其是中风（adj.HR 5.55，95%CI 2.04-15.06；p<0.001）。
结论
在接受 ACS 支架置入术的老年患者中，有五分之一发生了临床相关出血事件，并且与进一步发生中风密切相关。与抗血小板治疗相比，合并症和年龄>85 岁预测了该老年人群的出血结局。
临床试验注册
Clinicaltrials.gov 标识符：NCT01538446。https://www.clinicaltrials.gov 。
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