Cardiovascular Department, Ospedali Riuniti di Bergamo, Bergamo, Italy.
Am J Cardiol. 2013 Jan 15;111(2):196-201. doi: 10.1016/j.amjcard.2012.09.019. Epub 2012 Oct 27.
Randomized controlled trials assessing new drugs and devices tend to exclude subjects who are at greatest risk. The Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial incorporated broader inclusion criteria in an attempt to include a more representative spectrum of patients presenting with ST-segment elevation myocardial infarction (STEMI). To identify the differences between this modern trial and the real world, we analyzed the characteristics and outcomes of patients with STEMI who were screened but not enrolled at a high-volume recruiting center. Of 318 consecutive patients with STEMI who were screened, 200 (62.9%) were randomized, and 118 (37.1%) were excluded. The baseline characteristics and 30-day and 1-year clinical outcomes were compared in the 2 groups. The excluded patients had numerous high-risk features compared to those randomized, including being older (67.0 ± 12.8 vs 63.0 ± 11.4 years, p = 0.004), more often had had a previous MI (34.7% vs 8.0%, p <0.001), Killip class III-IV (27.4% vs 4.0%, p <0.001), and lower hemoglobin (13.4 ± 2.3 vs 14.8 ± 1.5 g/dl, p <0.001). The excluded patients had markedly greater 30-day and 1-year rates of all-cause mortality (17.4% vs 2.0%, p <0.001, and 27.6% vs 2.5%, p <0.001, respectively), major adverse cardiovascular events (death, MI, ischemia-driven target vessel revascularization, and stroke), major bleeding, and net adverse clinical events (major adverse cardiovascular events or major bleeding). On multivariate analysis, Killip class III-IV at presentation, age, left ventricular ejection fraction, and final Thrombolysis In Myocardial Infarction flow grade 3 were independent predictors of outcome. In conclusion, despite the broadened entry criteria of the HORIZONS-AMI trial, 37.1% of all patients presenting with STEMI at a center with a high rate of enrollment were judged to be ineligible and were excluded. The excluded patients had a significantly greater risk profile and markedly increased mortality and adverse events compared to the trial-eligible group.
随机对照试验评估新药和新器械时往往排除风险最高的患者。 Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction（HORIZONS-AMI）试验纳入了更广泛的纳入标准，试图纳入更具代表性的 ST 段抬高型心肌梗死（STEMI）患者谱。为了确定该现代试验与真实世界之间的差异，我们分析了在一个高入组率的中心筛选但未入组的 STEMI 患者的特征和结局。在连续筛查的 318 例 STEMI 患者中，200 例（62.9%）被随机分组，118 例（37.1%）被排除。比较了两组患者的基线特征、30 天和 1 年临床结局。与随机分组患者相比，排除组患者具有更多的高危特征，包括年龄较大（67.0±12.8 岁 vs 63.0±11.4 岁，p=0.004）、更常发生既往心肌梗死（34.7% vs 8.0%，p<0.001）、Killip 分级 III-IV 级（27.4% vs 4.0%，p<0.001）和血红蛋白较低（13.4±2.3 克/分升 vs 14.8±1.5 克/分升，p<0.001）。排除组患者 30 天和 1 年的全因死亡率（17.4% vs 2.0%，p<0.001 和 27.6% vs 2.5%，p<0.001）、主要不良心血管事件（死亡、心肌梗死、缺血驱动的靶血管血运重建和卒中等）、大出血和净不良临床事件（主要不良心血管事件或大出血）的发生率明显更高。多变量分析显示，入院时 Killip 分级 III-IV 级、年龄、左心室射血分数和最终心肌梗死溶栓血流分级 3 是结局的独立预测因素。结论：尽管 HORIZONS-AMI 试验的纳入标准放宽，但在高入组率的中心就诊的所有 STEMI 患者中，仍有 37.1%被认为不符合入组标准而被排除。与符合试验条件的患者相比，排除组患者的风险谱明显更高，死亡率和不良事件明显增加。
