Background

Few data are available on procedural complications of percutaneous coronary intervention (PCI) in the setting of acute coronary syndrome in the contemporary era.

Aim

We sought to describe the prevalence of procedural complications of PCI in a non-ST-segment elevation acute coronary syndrome (NSTE ACS) cohort, and to identify their clinical characteristics and association with clinical outcomes.

Methods

Patients randomized in TAO (Treatment of Acute coronary syndrome with Otamixaban), an international randomized controlled trial (ClinicalTrials.gov Identifier: NCT01076764) that compared otamixaban with unfractionated heparin plus eptifibatide in patients with NSTE ACS who underwent PCI, were included in the analysis. Procedural complications were collected prospectively, categorized and adjudicated by a blinded Clinical Events Committee, with review of angiograms. A multivariable model was constructed to identify independent clinical characteristics associated with procedural complications.

Results

A total of 8656 patients with NSTE ACS who were enrolled in the TAO trial underwent PCI, and 451 (5.2%) experienced at least one complication. The most frequent complications were no/slow reflow (1.5%) and dissection with decreased flow (1.2%). Procedural complications were associated with the 7-day ischaemic outcome of death, myocardial infarction or stroke (24.2% vs. 6.0%, odds ratio 5.01, 95% confidence interval 3.96–6.33; P < 0.0001) and with Thrombolysis In Myocardial Infarction major and minor bleeding (6.2% vs. 2.3%, odds ratio 2.79, 95% confidence interval 1.86–4.2; P < 0.0001). Except for previous coronary artery bypass grafting, multivariable analysis did not identify preprocedural clinical predictors of complications.

Conclusions

In a contemporary NSTE ACS population, procedural complications with PCI remain frequent, are difficult to predict based on clinical characteristics, and are associated with worse ischaemic and haemorrhagic outcomes.

中文翻译：

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非ST段抬高型心肌梗死经皮冠状动脉介入治疗的冠状动脉手术并发症的患病率，临床决定因素和预后意义：当代跨国TAO试验的启示

背景

在当代，在急性冠脉综合征的背景下，鲜有关于经皮冠状动脉介入治疗（PCI）的程序并发症的数据。

目的

我们试图描述非ST段抬高急性冠状动脉综合征（NSTE ACS）队列中PCI手术并发症的发生率，并确定其临床特征以及与临床结局的关系。

方法

分析包括在一项国际随机对照试验（ClinicalTrials.gov标识符：NCT01076764）中，TAA（使用Otamixaban治疗急性冠状动脉综合征）的患者被随机化，该患者将otamixaban与未分级肝素加依替巴肽对接受PCI的NSTE ACS患者进行了比较。手术并发症由前瞻性临床事件委员会进行前瞻性收集，分类和裁决，并复查血管造影照片。构建了多变量模型，以鉴定与手术并发症相关的独立临床特征。

结果

参与TAO试验的总共8656例NSTE ACS患者接受了PCI，其中451例（5.2％）经历了至少一种并发症。最常见的并发症是无/缓慢再流（1.5％）和解剖并伴有血流减少（1.2％）。手术并发症与死亡，心肌梗塞或中风的7天缺血性结局有关（24.2％vs. 6.0％，比值比5.01，95％置信区间3.96–6.33；P  <  0.0001），并伴有严重和严重的心肌梗塞溶栓轻微出血（6.2％比2.3％，优势比2.79，95％置信区间1.86–4.2；P  <  0.0001）。除了先前的冠状动脉搭桥术外，多变量分析未发现并发症的术前临床预测因素。

结论

在当代的NSTE ACS人群中，PCI的手术并发症仍然很常见，很难根据临床特征进行预测，并且与缺血性和出血性预后较差有关。