Hizoh Istvan, Banhegyi Gyongyver, Domokos Dominika, Gulyas Zalan, Major Laszlo, Kiss Robert Gabor
Department of Cardiology, Medical Center, Hungarian Defense Forces, Budapest, Hungary.
Department of Cardiology, Medical Center, Hungarian Defense Forces, Budapest, Hungary.
Am J Cardiol. 2018 Apr 1;121(7):796-804. doi: 10.1016/j.amjcard.2017.12.033. Epub 2018 Jan 10.
Although routine aspiration thrombectomy (AT) is not recommended by the current American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions guideline, for selected cases, a class IIb indication is given because of lack of data. We studied the impact of selective AT on mortality in patients with ST-segment elevation myocardial infarction using a prospective registry. We analyzed data of 1,255 patients, of whom 535 underwent AT based on operator's decision. Separate propensity score matching procedures were performed including all patients and only those with initial TIMI (Thrombolysis In Myocardial Infarction) 0 to 1 flow, indicating the highest thrombus burden. Primary outcome measure was time to all-cause death at 1 year. Both studies were sufficiently powered to detect the hazard ratio (HR) of 0.52 seen in the TAPAS (Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study) trial. In the study with open inclusion criteria, 1-year mortality rates were 15.5% and 14.5% in the AT and conventional percutaneous coronary intervention arm, respectively (p = 0.77). The unadjusted HR was 1.05 (95% CI 0.73 to 1.51), p = 0.80, whereas the adjusted HR was 0.97 (95% CI 0.66 to 1.41), p = 0.87. In patients with initial TIMI 0 to 1 flow, mortality rate at 1 year was 15.6% in the AT and 16.7% in the standard percutaneous coronary intervention group (p = 0.76). The unadjusted and adjusted HRs were similar: 0.91 (95% CI 0.62 to 1.34), p = 0.65 and 0.93 (95% CI 0.62 to 1.37), p = 0.70, respectively. In conclusion, selective AT based on operator's discretion offers no mortality benefit of the magnitude detected in the TAPAS trial, even for patients with initial TIMI 0 to 1 flow grade.
尽管美国心脏病学会/美国心脏协会/心血管造影和介入学会现行指南不推荐常规血栓抽吸术(AT),但由于缺乏数据,对于某些特定病例给出了IIb类指征。我们使用前瞻性注册研究,探讨了选择性AT对ST段抬高型心肌梗死患者死亡率的影响。我们分析了1255例患者的数据,其中535例根据术者的决定接受了AT。进行了单独的倾向评分匹配程序,包括所有患者以及仅那些初始心肌梗死溶栓治疗(TIMI)血流分级为0至1级(表明血栓负荷最高)的患者。主要结局指标是1年时的全因死亡时间。两项研究均有足够的效力来检测急性心肌梗死经皮冠状动脉介入治疗血栓抽吸研究(TAPAS)试验中所见的0.52的风险比(HR)。在纳入标准开放的研究中,AT组和传统经皮冠状动脉介入治疗组的1年死亡率分别为15.5%和14.5%(p = 0.77)。未调整的HR为1.05(95%可信区间0.73至1.51),p = 0.80,而调整后的HR为0.97(95%可信区间0.66至1.41),p = 0.87。在初始TIMI血流分级为0至1级的患者中,AT组1年死亡率为15.6%,标准经皮冠状动脉介入治疗组为16.7%(p = 0.76)。未调整和调整后的HR相似:分别为0.91(95%可信区间0.62至1.34),p = 0.65和0.93(95%可信区间0.62至1.37),p = 0.70。总之,基于术者判断的选择性AT并未带来TAPAS试验中所检测到的那种程度的死亡率获益,即使对于初始TIMI血流分级为0至1级的患者也是如此。