Radboud University Medical Centre, Nijmegen, the Netherlands.
JACC Cardiovasc Interv. 2011 Feb;4(2):191-7. doi: 10.1016/j.jcin.2010.10.011.
The aim of this study was to evaluate the relative frequency of access and nonaccess site bleeding, the association of these events with 1-year mortality, and the impact of randomized antithrombotic therapy.
Post-percutaneous coronary intervention (PCI) bleeding has been strongly associated with subsequent mortality. The extent to which access versus nonaccess site bleeding contributes to this poor prognosis and the role of antithrombotic therapies remains poorly understood.
The incidence and impact of Thrombolysis In Myocardial Infarction (TIMI) major/minor 30-day bleeding and randomized antithrombotic therapy were examined in a combined dataset from the REPLACE-2 (Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events), Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY), and HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trials in 17,393 PCI patients.
The TIMI major/minor bleeding occurred in 5.3% of patients, 61.4% of which (3.3%) were nonaccess site bleeds. After multivariable adjustment, TIMI bleeding was associated with an increased risk of 1-year mortality (hazard ratio [HR]: 3.17, 95% confidence interval [CI]: 2.51 to 4.00, p < 0.0001). The HR of a nonaccess site bleed was approximately 2-fold that of an access site bleed: HR: 3.94, 95% CI: 3.07 to 5.15, p < 0.0001 versus HR: 1.82, 95% CI: 1.17 to 2.83, p = 0.008, respectively. Randomization to bivalirudin versus heparin + a glycoprotein IIb/IIIa inhibitor resulted in 38% and 43% relative reductions in TIMI major/minor and TIMI major bleeding, respectively (p < 0.0001 for both), with significant reductions in both access and nonaccess site bleeding.
Nonaccess site bleeding after PCI is common, representing approximately two-thirds of all TIMI bleeding events, and is associated with a 4-fold increase in 1-year mortality. Use of bivalirudin rather than heparin + a glycoprotein IIb/IIIa inhibitor significantly decreases both nonaccess site as well as access site bleeding events by approximately 40%.
本研究旨在评估经皮冠状动脉介入治疗（PCI）后出血的发生频率和非出血部位出血的发生频率，以及这些事件与 1 年死亡率的相关性，同时评估随机抗栓治疗的影响。
PCI 后出血与后续死亡率密切相关。但目前尚不清楚出血部位（包括出血部位和非出血部位）对不良预后的影响程度，以及抗栓治疗的作用。
对 REPLACE-2（随机评估 PCI 中依替巴肽与降低临床事件）、急性血管造影和紧急介入治疗策略（ACUITY）和急性心肌梗死血栓溶解治疗-HORIZONS-AMI（急性心肌梗死中血管重建和支架治疗与结果的调和）这三项临床试验的联合数据集进行分析，共纳入 17393 例行 PCI 的患者，分析 TIMI 大出血/小出血 30 天的发生率和影响因素以及随机抗栓治疗。
5.3%的患者发生 TIMI 大出血/小出血，其中 61.4%（3.3%）为非出血部位出血。多变量调整后，TIMI 出血与 1 年死亡率升高相关（风险比[HR]：3.17，95%置信区间[CI]：2.51 至 4.00，p<0.0001）。非出血部位出血的 HR 约为出血部位出血的 2 倍：HR：3.94，95%CI：3.07 至 5.15，p<0.0001 与 HR：1.82，95%CI：1.17 至 2.83，p=0.008，分别）。与肝素+糖蛋白 IIb/IIIa 抑制剂相比，瑞替普酶与比伐卢定分别使 TIMI 大出血/小出血和 TIMI 主要出血的相对减少 38%和 43%（均 p<0.0001），且非出血部位和出血部位出血均显著减少。
PCI 后非出血部位出血较为常见，占 TIMI 出血事件的三分之二左右，与 1 年死亡率升高 4 倍相关。与肝素+糖蛋白 IIb/IIIa 抑制剂相比，瑞替普酶的使用可使非出血部位和出血部位出血事件分别减少约 40%。
