Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Cardiovascular Research Foundation, New York, New York.
Cardiovascular Research Foundation, New York, New York; Division of Cardiology, New York-Presbyterian Hospital, Columbia University Medical Center, New York, New York.
J Am Coll Cardiol. 2017 Oct 10;70(15):1846-1857. doi: 10.1016/j.jacc.2017.08.018.
The risk of recurrent ischemic and bleeding events after primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI) may not be uniform over time, which may affect the benefit-to-risk ratio of guideline-recommended antithrombotic therapies in different intervals.
This study sought to characterize the average daily ischemic rates (ADIRs) and average daily bleeding rates (ADBRs) within the first year after primary PCI for STEMI.
Among 3,602 patients with STEMI who were enrolled in the HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial, all ischemic and bleeding events, including recurrent events, were classified according to the timing of their occurrence as acute (≤24 h after PCI), subacute (1 day to 30 days), and late (30 days to 1 year). Patients were treated with aspirin and clopidogrel for the entire year. ADIRs included cardiac death, reinfarction, and definite stent thrombosis. ADBRs included non-coronary artery bypass graft-related Thrombolysis In Myocardial Infarction major and minor bleeding. ADIRs and ADBRs were calculated as the total number of events divided by the number of patient-days of follow-up in each interval assuming a Poisson distribution. Generalized estimating equations were used to test the absolute least square mean differences (LSMD) between ADIRs and ADBRs.
The ADIR and ADBR both exponentially decreased from the acute to the late periods (p < 0.0001). Although there were no significant differences in ADIR and ADBR in the acute phase (LSMD: +0.11%; 95% confidence interval [CI]: -0.35% to 0.58%; p = 0.63), the ADBR was greater than the ADIR in the subacute phase (LSMD: -0.39%; 95% CI: -0.58% to -0.20%; p < 0.0001). In the late phase, the ADIR exceeded the ADBR (LSMD: +1.51%; 95% CI: 1.04% to 1.98%; p < 0.0001).
After primary PCI, the ADIR and ADBR both markedly decreased over time. Although the rates for bleeding exceeded those for ischemia within 30 days, the daily risk of ischemia significantly exceeded the daily risk of bleeding beyond 30 days, supporting the use of intensified platelet inhibition during the first year after STEMI.
ST 段抬高型心肌梗死（STEMI）患者行直接经皮冠状动脉介入治疗（PCI）后，复发性缺血和出血事件的风险随时间推移可能并不均一，这可能会影响不同时间段内指南推荐的抗栓治疗的获益-风险比。
本研究旨在描述 STEMI 患者行直接 PCI 后 1 年内的平均每日缺血发生率（ADIR）和平均每日出血发生率（ADBR）。
在 HORIZONS-AMI（急性心肌梗死中再灌注和支架的协调结果）试验中，纳入了 3602 例 STEMI 患者，所有缺血和出血事件（包括复发性事件）均根据发生时间分类为急性（PCI 后≤24 h）、亚急性（1 d 至 30 d）和晚期（30 d 至 1 年）。所有患者接受阿司匹林和氯吡格雷治疗 1 年。ADIR 包括心脏性死亡、再梗死和明确的支架血栓形成。ADBR 包括非冠状动脉旁路移植术相关的心肌梗死溶栓治疗大出血和小出血。假设泊松分布，ADIR 和 ADBR 分别通过每个时间段内随访的患者天数除以总事件数计算。采用广义估计方程检验 ADIR 和 ADBR 之间绝对最小二乘均数差值（LSMD）。
ADIR 和 ADBR 均从急性期呈指数下降至晚期（p < 0.0001）。虽然急性期 ADIR 和 ADBR 无显著差异（LSMD：+0.11%；95%置信区间：-0.35%至 0.58%；p = 0.63），但亚急性期 ADBR 大于 ADIR（LSMD：-0.39%；95%置信区间：-0.58%至-0.20%；p < 0.0001）。在晚期，ADIR 超过 ADBR（LSMD：+1.51%；95%置信区间：1.04%至 1.98%；p < 0.0001）。
直接 PCI 后，ADIR 和 ADBR 随时间推移均显著下降。虽然出血风险在 30 天内高于缺血风险，但在 30 天之后，缺血的每日风险明显超过出血的每日风险，这支持在 STEMI 后 1 年内强化血小板抑制治疗。
