Sussex Cardiac Centre, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.
Heart. 2012 Oct;98(19):1431-5. doi: 10.1136/heartjnl-2012-302211. Epub 2012 Jul 31.
Periprocedural myocardial infarction (PMI; ESC/ACC type 4a) is diagnosed on the basis of elevation of cardiac enzymes more than three times the 99th centile upper reference limit. Recent guidelines recommend the use of troponin instead of creatine kinase (CK) to diagnose PMI, but this assay increases diagnostic sensitivity, while the clinical significance of small increases in troponin remains undetermined. We examined the effects of using the new definition on the incidence of a composite endpoint (previously defined by CK) in a contemporary clinical randomised trial-the British Bifurcation Coronary Study (BBC ONE).
The BBC ONE trial randomly allocated 500 patients with coronary bifurcation lesions to either a simple or complex stenting strategy. The composite primary endpoint (CPEP) included death, myocardial infarction (MI) (PMI plus subsequent MI) and target vessel failure, at 9 months.
In BBC ONE the CPEP occurred in 8% versus 15.2% in the simple and complex groups, respectively (HR 2.02, 95% CI 1.17 to 3.47, p=0.009). This difference was largely driven by PMI, which occurred in nine (3.6%) versus 28 (11.2%) patients (HR 3.24, 95% CI 1.53 to 6.86, p=0.001). Using troponin, PMI would have occurred in 71 (28.4%) versus 114 (45.6%) patients, respectively (HR 1.61, 95% CI 1.27 to 2.05, p=0.001), and the CPEP in 32% versus 48% of patients (HR 1.50, 95% CI 1.2 to 1.87, p=0.001). Use of troponin increased MI detection fivefold, from 7.4% to 37.0% overall.
Use of troponin would have led to a fivefold increase in diagnosis of PMI in the BBC ONE trial. Incorporation of PMI into a composite endpoint may no longer be justified in many interventional trials.
围手术期心肌梗死(PMI;ESC/ACC 4a 型)的诊断依据是心脏酶升高超过第 99 百分位上限的 3 倍。最近的指南建议使用肌钙蛋白代替肌酸激酶(CK)来诊断 PMI,但这种检测方法提高了诊断的灵敏度,而肌钙蛋白的小幅度升高的临床意义仍未确定。我们在一项当代临床随机试验-英国分叉冠状动脉研究(BBC ONE)中,研究了使用新定义对复合终点(以前由 CK 定义)发生率的影响。
BBC ONE 试验将 500 例冠状动脉分叉病变患者随机分为简单支架或复杂支架治疗策略。复合主要终点(CPEP)包括 9 个月时的死亡、心肌梗死(PMI)(PMI 加随后的心肌梗死)和靶血管失败。
在 BBC ONE 中,简单组和复杂组的 CPEP 发生率分别为 8%和 15.2%(HR 2.02,95%CI 1.17 至 3.47,p=0.009)。这一差异主要是由 PMI 引起的,简单组有 9 例(3.6%)和复杂组有 28 例(11.2%)(HR 3.24,95%CI 1.53 至 6.86,p=0.001)。使用肌钙蛋白时,PMI 的发生率将分别为 71 例(28.4%)和 114 例(45.6%)(HR 1.61,95%CI 1.27 至 2.05,p=0.001),CPEP 的发生率将分别为 32%和 48%(HR 1.50,95%CI 1.2 至 1.87,p=0.001)。肌钙蛋白的使用使 MI 的检出率增加了五倍,从总体的 7.4%增加到 37.0%。
在 BBC ONE 试验中,使用肌钙蛋白将使 PMI 的诊断增加五倍。在许多介入性试验中,将 PMI 纳入复合终点可能不再合理。