Zhang Zugui, Kolm Paul, Boden William E, Hartigan Pamela M, Maron David J, Spertus John A, O'Rourke Robert A, Shaw Leslee J, Sedlis Steven P, Mancini G B John, Berman Daniel S, Dada Marcin, Teo Koon K, Weintraub William S
Christiana Care Health System, Newark, DE 19713, USA.
Circ Cardiovasc Qual Outcomes. 2011 Mar;4(2):172-82. doi: 10.1161/CIRCOUTCOMES.110.940502. Epub 2011 Feb 8.
The COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial compared percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) to OMT alone in reducing the risk of cardiovascular events in 2287 patients with stable coronary disease. We examined the cost-effectiveness of PCI as a function of angina severity at the time of randomization.
Angina severity was assessed with the Seattle Angina Questionnaire (SAQ). Patients were grouped into tertiles based on the distribution of baseline scores such that higher tertiles represented better health status. Clinically significant improvement from baseline within individual patients was defined as score increases of >8 for physical limitation, >20 for angina frequency, and >16 for quality-of-life domains. The incremental cost-effectiveness ratio for PCI was calculated as the difference in costs divided by the difference in proportion of patients with clinically significant improvement. Improvement in angina severity was significantly greater for PCI patients in the lowest and middle tertiles. The number of patients needed to treat was much larger for the highest tertile. The added in-trial cost of PCI ranged from $7300 to $13 000. Incremental cost-effectiveness ratios ranged from $80 000 to $330 000 for the lowest and middle tertiles and from $520 000 to >$3 million for the highest tertile for 1 additional patient to achieve significant clinical improvement in health status.
The incremental cost of PCI to provide meaningful clinical benefit above that achieved by OMT alone was lower for patients with severe angina than for those with mild or no angina. However, it is uncertain that at any level of angina severity that PCI as an initial strategy would achieve a socially acceptable cost threshold. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00007657.
COURAGE（利用血运重建和积极药物评估的临床结果）试验比较了经皮冠状动脉介入治疗（PCI）联合最佳药物治疗（OMT）与单纯OMT在降低2287例稳定型冠心病患者心血管事件风险方面的效果。我们研究了随机分组时PCI作为心绞痛严重程度函数的成本效益。
用心绞痛西雅图问卷（SAQ）评估心绞痛严重程度。根据基线评分分布将患者分为三分位数组，较高的三分位数代表更好的健康状况。个体患者自基线起临床上的显著改善定义为身体限制评分增加>8分、心绞痛发作频率评分增加>20分以及生活质量领域评分增加>16分。PCI的增量成本效益比计算为成本差异除以临床上有显著改善的患者比例差异。在最低和中间三分位数组中，PCI患者的心绞痛严重程度改善显著更大。最高三分位数组的治疗所需患者数要多得多。PCI在试验中的额外成本从7300美元到13000美元不等。最低和中间三分位数组的增量成本效益比从80000美元到330000美元不等，最高三分位数组为使1例额外患者在健康状况上实现显著临床改善的增量成本效益比从520000美元到超过300万美元不等。
对于重度心绞痛患者，PCI相对于单纯OMT实现有意义临床获益的增量成本低于轻度或无心绞痛患者。然而，在任何心绞痛严重程度水平上，PCI作为初始策略是否能达到社会可接受的成本阈值尚不确定。临床试验注册——网址：http://www.clinicaltrials.gov。唯一标识符：NCT00007657。
