基于风险的精准检测策略与冠心病疑似稳定患者常规检测的生活质量结果：PRECISE随机试验的结果
Quality of Life Outcomes With a Risk-Based Precision Testing Strategy Versus Usual Testing in Stable Patients With Suspected Coronary Disease: Results From the PRECISE Randomized Trial.
作者信息
Mark Daniel B, Li Yanhong, Nanna Michael G, Kelsey Michelle D, Daniels Melanie R, Rogers Campbell, Patel Manesh R, Baloch Khaula N, Chow Benjamin J W, Anstrom Kevin J, Vemulapalli Sreekanth, Weir-McCall Jonathan R, Stone Gregg W, Chew Derek S, Douglas Pamela S
机构信息
Duke Clinical Research Institute, Duke University, Durham, NC (D.B.M., Y.L., M.D.K., M.R.D., M.R.P., K.N.B., S.V., P.S.D.).
Division of Cardiology, Duke University Medical Center, Durham, NC (D.B.M., M.D.K., M.R.P., S.V., P.S.D.).
出版信息
Circ Cardiovasc Qual Outcomes. 2025 Feb;18(2):e011414. doi: 10.1161/CIRCOUTCOMES.124.011414. Epub 2025 Feb 3.
BACKGROUND
The PRECISE (Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization) trial compared an investigational precision diagnostic testing strategy (n=1057) with usual testing (n=1046) in patients with stable chest pain and suspected coronary artery disease. Quality of life (QOL) outcomes were a prespecified secondary end point.
METHODS
We assessed QOL by structured interviews in all trial participants at baseline and 45 days, 6 months, and 12 months postrandomization. QOL assessments included angina-related QOL (19-item Seattle Angina Questionnaire [SAQ-19]), generic health status (EQ-5D), and a 4-item care satisfaction survey (at 45 days only). The prespecified primary comparison was the 6-month SAQ Summary score outcomes (scale, 0 to 100; higher scores indicate greater health status). QOL data collection rates were high, with 99% complete baseline SAQ scores and 86.5% complete at the 6-month primary comparison follow-up. All comparisons were made as randomized.
RESULTS
At baseline, mean SAQ Summary scores were 70.9 in the Precision Strategy group (n=1050) and 70.4 in the Usual Testing group (n=1042). By 6 months, mean SAQ Summary scores had improved to 89.9 in the Precision Strategy group and 89.2 in the Usual Testing group, with a mean adjusted difference of 0.8 (95% CI, -0.3 to 2.0). The SAQ component scores showed similar improvement from baseline in both groups and no statistically significant or clinically meaningful differences between the 2 groups at any follow-up time point. By 6 months, 66% of patients in both groups were chest pain-free. EQ-5D visual analog scores also improved from baseline and showed no difference between groups during follow-up. Care satisfaction scores were high and similar at 45 days.
CONCLUSIONS
In stable patients with symptoms suggesting coronary artery disease, angina-related and overall QOL improved substantially over the initial 6 months independent of the testing strategy assigned.
REGISTRATION
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03702244.
背景
PRECISE（心脏症状优化评估与血运重建前瞻性随机试验）试验比较了在稳定型胸痛且疑似冠心病患者中，一种研究性精准诊断测试策略（n = 1057）与常规测试（n = 1046）的效果。生活质量（QOL）结果是预先设定的次要终点。
方法
我们通过结构化访谈对所有试验参与者在基线、随机分组后45天、6个月和12个月时进行生活质量评估。生活质量评估包括与心绞痛相关的生活质量（19项西雅图心绞痛问卷[SAQ - 19]）、一般健康状况（EQ - 5D）以及一项4项护理满意度调查（仅在45天时进行）。预先设定的主要比较指标是6个月时的SAQ总结评分结果（范围为0至100；分数越高表明健康状况越好）。生活质量数据收集率很高，基线时SAQ评分的完成率为99%，在6个月主要比较随访时的完成率为86.5%。所有比较均按照随机分组进行。
结果
在基线时，精准策略组（n = 1050）的平均SAQ总结评分为70.9，常规测试组（n = 1042）为70.4。到6个月时，精准策略组的平均SAQ总结评分提高到89.9，常规测试组为89.2，平均调整差异为0.8（95%CI，-0.3至2.0）。SAQ各分量评分在两组中从基线开始均有类似改善，在任何随访时间点两组之间均无统计学显著差异或临床意义上的差异。到6个月时，两组中66%的患者无胸痛症状。EQ - 5D视觉模拟评分也从基线开始有所改善，随访期间两组之间无差异。45天时护理满意度评分很高且相似。
结论
在有症状提示冠心病的稳定患者中，与心绞痛相关的生活质量和总体生活质量在最初6个月内显著改善，与所分配的测试策略无关。
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