行择期经皮冠状动脉介入治疗的患者中血肿至少 5cm 与结局：来自依诺肝素在 PCI 患者中安全性和疗效的国际随机评估（STEEEPLE）试验的观察。

Hematomas of at least 5 cm and outcomes in patients undergoing elective percutaneous coronary intervention: insights from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial.

机构信息

Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand.

出版信息

Am Heart J. 2010 Jan;159(1):110-6. doi: 10.1016/j.ahj.2009.10.034.

DOI:10.1016/j.ahj.2009.10.034

PMID:20102875

Abstract

BACKGROUND

Major bleeding significantly impacts outcomes in patients undergoing percutaneous coronary intervention (PCI). No uniform definitions exist for major and minor bleeding. Hematomas > or =5 cm at the femoral puncture site are considered major bleeding events in some trials and minor in others. Limited information is available on the incidence and clinical relevance of hematomas > or =5 cm in PCI patients.

METHODS

Data from the STEEPLE trial in patients undergoing elective PCI were used to assess the impact of hematomas > or =5 cm on ischemic outcomes (mortality, nonfatal myocardial infarction, or urgent target vessel revascularization) up to day 30 and all-cause 1-year mortality. Hematoma data were available for 3,342 of 3,528 patients in STEEPLE. Patients with (n = 103) and without (n = 3,239) hematomas > or =5 cm were evenly distributed across treatment groups.

RESULTS

No differences were observed in 30-day ischemic outcomes between patients with and without hematomas (5.8% vs 5.9%, respectively; P = .96). No transfusions were observed in patients with hematomas as compared with patients without hematomas (0% and 0.4%, respectively; P = .52). A greater reduction in hemoglobin was observed (pre- vs post-PCI) in patients with hematomas as compared with patients without hematomas (-0.84 vs -0.35 g/L, P < or = .001). No significant difference in all-cause 1-year mortality was observed between patients with and without hematomas (0.0% vs 1.7%, P = .98).

CONCLUSIONS

After PCI, hematomas > or =5 cm had no effect on 30-day ischemic events or 1-year mortality. Although there is no agreed classification for large hematomas, the lack of a relationship between hematomas > or =5 cm and clinical outcome after PCI justifies the classification of these hematomas as minor bleeds in STEEPLE.

摘要

背景

在接受经皮冠状动脉介入治疗（PCI）的患者中，大出血显著影响其结局。对于大出血和小出血尚无统一的定义。一些试验中，股动脉穿刺部位血肿＞5cm 被认为是大出血事件，而另一些试验中则被认为是小出血。关于 PCI 患者中血肿＞5cm 的发生率及其临床相关性，目前仅有有限的信息。

方法

使用在接受择期 PCI 的患者中进行的 STEEPLE 试验的数据，评估血肿＞5cm 对缺血性结局（死亡、非致死性心肌梗死或紧急靶血管血运重建）的影响，直至第 30 天以及全因 1 年死亡率。STEEPLE 中血肿数据可用于 3528 例患者中的 3342 例。有（n=103）和无（n=3239）血肿＞5cm 的患者在治疗组之间均匀分布。

结果

在有和无血肿的患者中，30 天缺血性结局无差异（分别为 5.8%和 5.9%，P=.96）。与无血肿患者相比，有血肿患者未观察到输血（分别为 0%和 0.4%，P=.52）。与无血肿患者相比，有血肿患者血红蛋白下降更多（PCI 前 vs PCI 后）（-0.84 vs -0.35g/L，P＜或=.001）。有和无血肿患者的全因 1 年死亡率无显著差异（分别为 0.0%和 1.7%，P=.98）。