P5106Prevalence, clinical characteristics and outcomes of procedural complications of percutaneous coronary intervention in non ST-elevation myocardial infarction: insights from the TAO trial

Abstract

Introduction: Few data are available on procedural complications of percutaneous coronary intervention (PCI) in the contemporary era. Purpose: We sought to describe the prevalence of procedural complications of PCI in a non ST‐ segment elevation ACS cohort (NSTEACS) and to identify their clinical characteristics and their association with clinical outcomes. Methods: TAO (Treatment of Acute Coronary Syndrome with Otamixaban) was an international randomized controlled trial, comparing otamixaban to unfractionated heparin plus eptifibatide in NSTEACS patients undergoing invasive management, in 568 centers in 55 countries from April 2010 to January 2013. All patient who underwent PCI were included in the analysis. Procedural complications were prospectively collected and categorized by investigators. A multivariable model was constructed to identify independent clinical characteristics associated with procedural complications. Ischemic outcomes included death and myocardial infarction (MI) at 7 days after randomization. Bleeding outcomes included TIMI major and minor as well as GUSTO severe/moderate bleeding. Key efficacy and safety outcomes, including procedural complications, were adjudicated by a blinded clinical event committee. Results: A total of 13 225 patients were enrolled in the TAO trial, of whom 60% had a GRACE score lower than 133 pts and 8656 (65.5%) underwent PCI. Of these, 463 (5.2%) experienced procedural complications. No/slow reflow and dissection with decreased flow were the most frequent, 126 (1.5%) and 107 (1.2%), respectively. Abrupt closure occurred in 32 patients (0.4%), side branch closure in 34 (0.4%), and new intra‐coronary thrombus in PCI artery occurred in 59 patients, and in a non‐PCI artery in 7 (0.7% and 0.1% respectively); perforation occurred in 35 patients (0.4%) with 8 cases of tamponade (0.1%). By univariate analysis, patients with or without complications had similar clinical characteristics and presentation, although patients with complications more frequently had previous coronary artery grafting (6.3% versus 9.1%, p=0.016). Multivariate analysis did not identify independent predictors of complications among pre‐procedural clinical variables. At 7 days, procedural PCI complications were strongly associated with ischemic outcomes such as death (4.0% versus 1.0% OR: 4.28 [2.54 ‐ 7.2], p<0.0001) and MI (22.2% vs 5.9%, OR: 4.56 [3.58 ‐ 5.79], p<0.0001) as well as hemorrhagic outcomes such as TIMI major and minor (6.2% vs 2.3%, OR: 2.79 [1.86 ‐ 4.2], p<0.0001) and GUSTO severe/moderate bleeding (17.3% vs 7.6% OR: 2.53 [1.96 ‐ 3.28], p<0.0001). Conclusion: In a contemporary population of NSTE‐ACS patients, procedural PCI complications are frequent and associated with worse ischemic and hemorrhagic outcomes. They cannot be predicted before the procedure based on clinical characteristics. These results underline the need for improving PCI pharmacological environment and techniques.