急诊冠状动脉支架术联合国产替罗非班治疗急性ST段抬高性心肌梗死的临床疗效和安全性

目的前瞻性评价急性ST段抬高性心肌梗死（STEMI）患者急诊经皮冠状动脉介入治疗（PCI）联合应用国产替罗非班治疗的临床疗效及安全性。方法入选连续160例接受急诊PCI治疗的急性STEMI患者,随机分为替罗非班组（80例）和对照组（80例）。比较两组基础临床情况、介入治疗结果、术后即刻疗效、术后30天和180天主要心脏不良事件（MACE,包括死亡、再梗死、再次靶血管重建）发生率及左室射血分数（LVEF）。结果两组基础临床情况、介入治疗结果差异均无统计学意义。与对照组相比,替罗非班组术后即刻心肌梗死溶栓试验（TIMI）3级复流血流差异无统计学意义（95．0％比87．5％,P〉0．05）,但即刻心肌组织灌注（TMP）3级（75．0％比56．3％,P〈0．05）、校正TIMI帧数（23．56±5．19）帧比（31．05±6．92）帧,P〈0．01）]、ST段抬高总和回落（6．51±3．56）mm比（4．53±2．47）mm,P〈0．01]、肌酸激酶同工酶（CK—MB）峰值（225．02±105．81）μg／L比（269．20±110．88）μg／L,P〈0．05）、肌钙蛋白Ⅰ（TnⅠ）峰值（45．25±33．00）μg／L比（56．46±29．48）μg／L,P〈0．05]及平均住院天数（11．38±4．63）天比（14．68±6．90）天,P〈0．01]均显著优于对照组。替罗非班组术后MACE发生率30天（5．0％比16．3％,P〈0．05）和180天（7．5％比18．8％,P〈0．05）明显降低,LVEF（术后30天：53％±7％比49％±9％,P〈0．01;术后180天：59％±8％比53％±9％,P〈0．01）显著提高。多因素logistic回归分析表明,年龄〉65岁比值比（OR）=3．42,P〈0．01]、替罗非班治疗（OR=0．56,P〈0．05）、住院期LVEF〈0．5（OR=2．56,P〈0．01）是术后180天MACE发生率的主要决定因素。替罗非班组术后出血并发症发生率高于对照组（16．3％和7．5％）,但差异无统计学意义（P〉0．05）。结论急诊冠状动脉支架术联合应用国产替罗非班治疗STEMI能显著提高相关梗死区域再灌注水平,明显改善术后即刻、术后30天及180天临床预后和左心室收缩功能。

Clinical outcomes and safety of primary percutaneous coronary intervention combined with tirofiban therapy in patients with acute ST-segment elevation myocardial infarction

OBJECTIVE: This prospective study was conducted to investigate the clinical outcomes and safety of primary percutaneous coronary intervention (PCI) combined with tirofiban therapy in patients with acute ST-segment elevation myocardial infarction (STEMI). METHODS: One hundred and sixty consecutive patients with acute STEMI were randomly allocated to either primary PCI combined with tirofiban therapy (Tirofiban group, n = 80) or primary PCI treatment alone (Control group, n = 80). Baseline characteristics, PCI features and clinical outcomes during hospitalization were compared between the two groups. Left ventricular ejection fraction (LVEF) and major adverse cardiac events (MACE, including death, re-infarction and target vessel revascularization) at 30 and 180 days after discharge were also compared. RESULTS: The baseline clinical characteristics were comparable between the two groups. Despite similar TIMI grade 3 flow (95% vs. 87.5%, P > 0.05) between the tirofiban and control groups immediately after the procedure, TMP grade 3 (75% vs. 56.3%, P < 0.05), corrected TIMI frame count (cTFC, 23.56 +/- 5.19 vs. 31.05 +/- 6.92, P < 0.01), resolution of sum of ST-segment elevation (6.51 +/- 3.56 mm vs. 4.53 +/- 2.47 mm, P < 0.01), peak value of CK-MB (225.02 +/- 105.81 microg/L vs. 269.20 +/- 110.88 microg/L, P < 0.05) and TnI (45.25 +/- 33.00 microg/L vs. 56.46 +/- 29.48 microg/L, P < 0.05) in tirofiban group were significantly superior to the control group related to a shorter hospital stay (11.38 +/- 4.63 days vs. 14.68 +/- 6.90 days, P < 0.01). Compared to control group, the MACE rates at 30 days (5.0% vs. 16.3%, P < 0.05) and 180 days (7.5% vs. 18.8%, P < 0.05) were also significantly reduced and LVEF was significantly improved (30 days: 53% +/- 7% vs. 49% +/- 9%, P < 0.01; 180 days: 59% +/- 8% vs. 53% +/- 9%, P < 0.01) in tirofiban group. Multivariate logistic analysis revealed that age > 65 years (OR = 3.42, P < 0.01), tirofiban therapy (OR = 0.56, P < 0.05) and LVEF < 0.5 during hospitalization (OR = 2.56, P < 0.01) were independent predictors of MACE rates at 180 days follow up. There was no significant difference in hemorrhagic complications between the two groups (16.3% vs. 7.5%, P > 0.05). CONCLUSION: Adjunctive therapy with tirofiban for patients with acute STEMI who undergo primary PCI is safe and can significantly improve re-perfusion in the infarct area and clinical outcomes at 30 as well as 180 days after procedure.