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Abstract：
BACKGROUND: Few data are available on procedural complications of percutaneous coronary intervention (PCI) in the setting of acute coronary syndrome in the contemporary era.
OBJECTIVE: 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.
OBJECTIVE: 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.
摘要：
背景：在当代急性冠脉综合征的背景下，关于经皮冠状动脉介入治疗（PCI）的手术并发症的数据很少。
目的：我们试图描述非ST段抬高急性冠状动脉综合征（NSTEACS）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果的关联。
方法：在TAO（奥米沙班治疗急性冠脉综合征）中随机分组的患者，一项国际随机对照试验(ClinicalTrials.govIdentifier:NCT01076764)在接受PCI的NSTEACS患者中比较了奥米沙班与普通肝素联合依替巴肽,纳入分析.前瞻性收集手术并发症，由盲法临床事件委员会分类和裁决，血管造影检查。建立多变量模型以识别与手术并发症相关的独立临床特征。
结果：共有8656例NSTEACS患者参加了TAO试验，其中451例（5.2%）出现了至少一种并发症。最常见的并发症是无/缓慢复流（1.5％）和血流减少的夹层（1.2％）。手术并发症与死亡的7天缺血结局相关，心肌梗死或中风（24.2%vs.6.0%，比值比5.01，95％置信区间3.96-6.33；P<0.0001）和心肌梗死主要和次要出血的溶栓（6.2％vs.2.3%,优势比2.79，95%置信区间1.86-4.2；P<0.0001)。除了以前的冠状动脉旁路移植术，多变量分析未确定术前并发症的临床预测因子.
结论：在当代NSTEACS人群中，PCI手术并发症仍然很常见，很难根据临床特征预测，并与更坏的缺血和出血结局相关.
目的：我们试图描述非ST段抬高急性冠状动脉综合征（NSTEACS）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果的关联。
方法：在TAO（奥米沙班治疗急性冠脉综合征）中随机分组的患者，一项国际随机对照试验(ClinicalTrials.govIdentifier:NCT01076764)在接受PCI的NSTEACS患者中比较了奥米沙班与普通肝素联合依替巴肽,纳入分析.前瞻性收集手术并发症，由盲法临床事件委员会分类和裁决，血管造影检查。建立多变量模型以识别与手术并发症相关的独立临床特征。
结果：共有8656例NSTEACS患者参加了TAO试验，其中451例（5.2%）出现了至少一种并发症。最常见的并发症是无/缓慢复流（1.5％）和血流减少的夹层（1.2％）。手术并发症与死亡的7天缺血结局相关，心肌梗死或中风（24.2%vs.6.0%，比值比5.01，95％置信区间3.96-6.33；P<0.0001）和心肌梗死主要和次要出血的溶栓（6.2％vs.2.3%,优势比2.79，95%置信区间1.86-4.2；P<0.0001)。除了以前的冠状动脉旁路移植术，多变量分析未确定术前并发症的临床预测因子.
结论：在当代NSTEACS人群中，PCI手术并发症仍然很常见，很难根据临床特征预测，并与更坏的缺血和出血结局相关.
