溶栓后常规早期侵入策略的疗效和安全性：经皮冠状动脉介入治疗中使用糖蛋白 IIb/IIIa 抑制剂的分层：TRANSFER-AMI 随机对照试验的预先指定亚组分析。
Efficacy and safety of a routine early invasive strategy after fibrinolysis stratified by glycoprotein IIb/IIIa inhibitor use during percutaneous coronary intervention: a pre-specified subgroup analysis of the TRANSFER-AMI randomised controlled trial.
机构信息
Terrence Donnelly Heart Centre, St Michael's Hospital, University of Toronto, , Toronto, Ontario, Canada.
出版信息
Heart. 2014 Jun;100(11):873-80. doi: 10.1136/heartjnl-2013-305231. Epub 2014 Jan 21.
OBJECTIVE
We evaluated the efficacy and safety of an early invasive strategy post-fibrinolysis in relation to glycoprotein (GP) IIb/IIIa inhibitor use.
METHODS
The Trial of Routine Angioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI) randomised 1059 ST elevation myocardial infarction patients to an early invasive strategy or standard therapy post-fibrinolysis. The primary end point was the composite of death, reinfarction, recurrent ischaemia, new or worsening heart failure, or cardiogenic shock at 30 days. In this pre-specified analysis, we examined efficacy and safety outcomes of an early invasive strategy after stratification by GPIIb/IIIa inhibitor use, which was permitted during percutaneous coronary intervention (PCI) at the discretion of the treating physician.
RESULTS
A total of 695 patients (65.6%) received GPIIb/IIIa inhibitors. There was significant heterogeneity (p<0.001) in the efficacy of an early invasive strategy compared to standard therapy, between the strata with GPIIb/IIIa inhibitor use (primary end point 9.6% vs 22.3% respectively, p<0.001) and without GPIIb/IIIa inhibitor use (primary end point 14.8% vs 10.4% respectively, p=0.21). Patients who received GPIIb/IIIa inhibitors had lower Global Registry of Acute Coronary Events (GRACE) risk scores compared to those without GPIIb/IIIa inhibitor use (median 121 vs 130, p<0.001). After adjusting for the interaction between GRACE risk score and treatment assignment, the heterogeneity in the efficacy of an early invasive strategy with respect to GPIIb/IIIa inhibitor use was no longer significant (p interaction=0.08).
CONCLUSIONS
The apparent difference in the efficacy of an early invasive strategy between GPIIb/IIIa inhibitor strata likely reflects an association between GPIIb/IIIa inhibitor use and baseline risk. GPIIb/IIIa inhibitor use during PCI at the discretion of the treating physician does not appear to modulate the efficacy of an early invasive strategy post-fibrinolysis.
CLINICAL TRIAL REGISTRATION
http://www.clinicaltrials.gov/ct2/show/NCT00164190, NCT00164190.
目的
我们评估溶栓后早期采用血管内介入治疗策略与糖蛋白（GP）IIb/IIIa 抑制剂使用的疗效和安全性。
方法
溶栓后常规血管成形术和支架置入以改善急性心肌梗死再灌注的试验（TRANSFER-AMI）将 1059 例 ST 段抬高型心肌梗死患者随机分为早期介入治疗策略组或溶栓后标准治疗组。主要终点为 30 天死亡、再梗死、再发缺血、新发或加重心力衰竭或心源性休克的复合终点。在此预先设定的分析中，我们通过 GPIIb/IIIa 抑制剂的使用进行分层，根据治疗医生的判断，允许在经皮冠状动脉介入治疗（PCI）期间使用 GPIIb/IIIa 抑制剂，检查了早期介入治疗策略的疗效和安全性结局。
结果
共 695 例患者（65.6%）接受了 GPIIb/IIIa 抑制剂。在 GPIIb/IIIa 抑制剂使用分层中，与标准治疗相比，早期介入治疗策略的疗效存在显著的异质性（p<0.001）（主要终点分别为 9.6%和 22.3%，p<0.001）和无 GPIIb/IIIa 抑制剂使用（主要终点分别为 14.8%和 10.4%，p=0.21）。接受 GPIIb/IIIa 抑制剂治疗的患者的全球急性冠状动脉事件注册（GRACE）风险评分低于未使用 GPIIb/IIIa 抑制剂的患者（中位数 121 比 130，p<0.001）。在调整治疗分配与 GRACE 风险评分之间的交互作用后，GPIIb/IIIa 抑制剂使用分层中早期介入治疗策略的疗效异质性不再显著（p 交互=0.08）。
结论
GPIIb/IIIa 抑制剂分层中早期介入治疗策略疗效的差异可能反映了 GPIIb/IIIa 抑制剂的使用与基线风险之间的关联。在治疗医生的判断下，在 PCI 期间使用 GPIIb/IIIa 抑制剂似乎不会调节溶栓后早期介入治疗策略的疗效。
临床试验注册
http://www.clinicaltrials.gov/ct2/show/NCT00164190，NCT00164190。
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